To check a medical test’s FDA status, search FDA’s In Vitro Diagnostic (IVD) Tests resource and Devices@FDA using the exact test and manufacturer names, then verify that a matching record covers the product and intended use being advertised. If the seller names a regulatory pathway or decision number, confirm it in that pathway’s FDA database. A registration or listing entry alone is not proof that a test is cleared, approved, or authorized.
Start with the exact test and the claim being made
FDA status is specific to a product and its intended use. A result for a similarly named test—or a test from the same company—does not establish the status of the product you are checking. Before searching, copy the identifying details from the package, the seller’s page, or the test’s instructions for use.
- Exact test or device name, including the brand name and any model or version identifier shown.
- Manufacturer or applicant name. The company selling a test may not be the name used in its FDA record.
- Specimen type, such as blood or saliva, if stated.
- What the test claims to detect and the intended use described in its labeling.
- The exact regulatory wording: “cleared,” “approved,” “classified,” or “authorized under EUA,” plus any decision number the seller provides.
Keep the claim and the FDA record side by side as you search. A broad match for a disease or test category is not enough; compare the specific device identity and stated use. A test may share a name or target with another product yet have different labeling or a different authorized purpose. Note whether the claim is about screening, diagnosis, or another use only if the product’s own labeling says so; do not assume a match on the condition alone establishes a match on intended use.
If the product page does not identify the manufacturer, specimen, or intended use clearly, look at the package and current instructions for use. Save or note the exact wording and any cited number. That gives you a precise claim to compare with an FDA record and makes it easier to ask the company a specific follow-up question.
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Use FDA’s test and device search resources
Search the IVD Tests resource first
For a home or laboratory diagnostic test, begin with FDA’s In Vitro Diagnostic (IVD) Tests resource. Search by the test name, test type, company, or another meaningful keyword. Try the exact name first, then useful variants such as a shortened name, spelling variation, or manufacturer name. Open plausible matches and inspect the product information and any linked decision summary rather than treating the search-result title as confirmation.
Use a disease or test category as a starting point only; it may return a group of products rather than the particular one you need. Search the company name separately, especially if the product name is a brand name not used in an FDA entry. If a likely entry appears, read the record’s details and compare them with your notes on the test’s identity and use.
Search Devices@FDA as a second check
FDA describes Devices@FDA as a catalog of cleared and approved medical-device information. Search using the device’s exact name and the company name. This broader search is useful when the first search does not produce a clear match or when you want to check whether a decision appears under a different name.
The databases serve related but not identical lookup purposes. A result in one general resource is a lead to inspect, not a reason to skip checking a pathway-specific record when the company names a pathway or decision number. If a match is unclear, try alternate product and applicant names before deciding that no matching record exists.
Verify the claimed pathway or decision number
If the company cites a 510(k), PMA, or De Novo decision, use the corresponding FDA resource instead of relying only on a general search result. The 510(k) database provides fields for device name, 510(k) number, product code, and panel. Its records include details such as the device name, applicant, product code, decision date, decision, and summary or statement information. The PMA database can be searched by PMA number, device, or applicant; the De Novo database by device or requester.
Read the record rather than checking only that a number produces a result. Confirm that the name and applicant make sense for the product, inspect the decision and date, and review summary or statement information when available. A number attached to a different device, company, or use does not by itself substantiate the marketing claim you are evaluating.
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The FDA lookup tools are free to use; you do not need to buy a test or a separate product to check a public FDA record. When the claim cites a pathway, the matching pathway resource is the most direct place to verify the number.
If the claim specifically says the product is “authorized under EUA,” consult FDA’s medical-device Emergency Use Authorization resources. Check that the product and the use described in the authorization match what is being promoted.
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- Capture the claim and labeling. Record the exact name, manufacturer, specimen, intended use, and any FDA decision number shown on the package, website, or instructions for use. Preserve the specific words the seller uses about FDA status.
- Search the IVD Tests resource. Try the exact test name, then the company and meaningful name variants. Open each plausible record. Search by test type or another keyword as a supplement, not as the only identifier.
- Compare the record with the marketed test. Check that the identity and intended use in the FDA record align with the specific product and claim in front of you. A similar name is only a lead for further checking. Compare the manufacturer or applicant and specimen details as well as the product name.
- Search Devices@FDA. Use the device and company names to look for a matching cleared or approved device record. A different naming convention may make this second check useful.
- Check the pathway-specific database. Enter any claimed 510(k), PMA, or De Novo number in the appropriate resource and inspect the record details. For an EUA claim, check FDA’s EUA information for the product and authorized use.
- Resolve an uncertain match before drawing a conclusion. Ask the manufacturer for the FDA decision number and current instructions for use, then verify the number in the relevant FDA database. If the question remains consequential or disputed, seek clarification from FDA.
For a manufacturer inquiry, ask for the specific decision number, the name under which the decision appears, and current instructions for use. If the seller says the product is covered by a different company’s filing or a related device record, ask how that record applies to this exact test and use. Then verify the answer against the FDA entry instead of relying on an unsupported assurance.
This process verifies whether an FDA record appears to cover the test and use being claimed. A database match by itself does not establish that the test is clinically suitable for a particular person or situation. The official tools are intended to help identify regulatory records; they do not replace a clinician’s judgment about an individual patient’s needs.
Understand what each FDA status means
“FDA-cleared” and “FDA-approved” are not interchangeable shorthand. FDA uses different regulatory routes, with different decision bases. The wording in a seller’s claim should match the type of decision shown in the relevant record. The central question is not simply whether a product appears somewhere in an FDA database, but what decision the record reflects and whether it covers the product and use being promoted.
| Record or claim | What it means | What to verify |
|---|---|---|
| 510(k) cleared | FDA determined that the device is substantially equivalent to a legally marketed predicate device that is not subject to PMA. FDA describes a 510(k) as a premarketing submission to demonstrate substantial equivalence. | Find the 510(k) number or device record, then compare the device identity and intended use with the marketed test. |
| PMA approved | Premarket approval is FDA’s route for Class III devices. FDA says approval rests on sufficient valid scientific evidence providing reasonable assurance of safety and effectiveness for the intended use or uses. | Search by PMA number, device, or applicant and confirm that the record corresponds to the product and use in the claim. |
| De Novo classified | De Novo is a risk-based classification pathway for certain novel, low- to moderate-risk devices. It is distinct from both 510(k) clearance and PMA approval. A De Novo order can permit marketing and establish a classification that may serve as a predicate for later 510(k) submissions. | Search the De Novo database by device or requester. Use the status wording shown by FDA rather than relabeling it as a 510(k) clearance or PMA approval. |
| Authorized under EUA | An Emergency Use Authorization applies in the context of a qualifying declared public health emergency. It may cover an unapproved product or an unapproved use of an approved product. | Check the FDA EUA resource for the specific product and use. Describe the status as EUA authorization, not ordinary approval or clearance. |
| Registered or listed | Establishment registration and device listing are administrative records, not a device decision that establishes clearance, approval, or authorization. | Do not treat a registration or listing entry as a substitute for the relevant decision record. |
510(k) clearance is not PMA approval
FDA’s description of a 510(k) is specific: “A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).” In practical terms, when a seller says “FDA-cleared,” look for a 510(k) record and confirm the decision there. Do not translate a clearance into “FDA-approved” simply because that wording sounds more familiar.
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PMA approval has a different basis. FDA describes PMA as its premarket approval route for Class III devices and states that approval rests on sufficient valid scientific evidence to provide reasonable assurance of safety and effectiveness for the intended use or uses. If a seller claims PMA approval, look for a PMA record and check its device, applicant, and use rather than looking for a 510(k) number.
De Novo and EUA are distinct statuses
De Novo is a separate, risk-based classification route for certain novel low- to moderate-risk devices. A De Novo order can permit marketing and establish a classification that may later serve as a predicate for 510(k) submissions. That relationship does not make the original De Novo order itself a 510(k) clearance or PMA approval.
An EUA is also distinct. It is an emergency authorization in a qualifying public health emergency, not ordinary FDA approval or clearance. It may apply to an unapproved product or to an unapproved use of a product that is otherwise approved. Match both the product and the authorized use in FDA’s EUA information, and describe the status accurately as authorization under EUA.
Do not mistake registration or listing for a device decision
A company may advertise that it is “FDA registered” or that its device is “FDA listed.” Those statements do not establish that FDA has cleared, approved, or authorized the particular test. FDA explicitly cautions that an establishment’s registration and device listings do not denote approval, clearance, or authorization of the facility or its devices.
FDA states: “When a facility registers its establishment and lists its devices, the resulting entry in the FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.” This distinction matters because a registration or listing may be presented in marketing language in a way that sounds like a product decision. It is not a substitute for a 510(k), PMA, De Novo, or EUA record matching the claim.
Look for the actual kind of decision the seller claims—such as a 510(k) clearance, PMA approval, De Novo order, or EUA—and confirm it in the matching FDA resource. A registration or listing record may identify an establishment or device, but it does not answer whether a specific test has the decision the seller implies. If the only evidence offered is an establishment registration or listing, ask for the relevant decision number and verify it independently.
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What a missing search result does—and does not—show
A failed search is not enough to conclude that a product is definitely unregulated. The test could be recorded under a different name or company, or the first resource may not be the relevant pathway database. Search alternate names and the manufacturer, check the appropriate pathway resource, and request the decision number and current labeling from the company.
There is no single negative-search result that resolves every possible product and pathway. A keyword search may miss a record because the name differs from the branding on the package; the company could cite a particular number that needs to be checked in its own database; or you may have started in a resource that is not the right one for the claim. Treat the absence of an obvious match as a reason to continue checking, not as definitive proof of either status.
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Random freezes, missing sound and display glitches usually trace back to one bad driver. Find and replace yours safely.Free scan · under a minuteIf you still cannot reconcile the record with the marketed product, do not substitute a broad category match or registration entry for proof. Ask FDA for clarification when the distinction matters or a claim is disputed. A negative keyword search alone does not resolve every product’s regulatory status. Likewise, finding a record with a similar name should not be treated as confirmation until the device identity and intended use line up.
Separate regulatory status from whether a test is right for you
FDA database records help establish what decision or authorization is recorded for a device and the use covered by that record. They do not, by themselves, tell you whether a particular test is appropriate for your symptoms, medical history, or care plan. If you are deciding whether to use a test or how to act on its result, consult a qualified healthcare professional and follow the product’s current instructions.
Keep two questions separate: what FDA status is recorded for this exact product and use, and whether that test is appropriate for your circumstances. The first is a database verification task. The second depends on your individual situation and should not be answered from a search result alone.
Frequently Asked Questions
Where should I start when checking a home or laboratory test?
Start with FDA’s In Vitro Diagnostic (IVD) Tests resource. Search the exact test name, test type, company, and useful name variants, then open plausible records and compare the product identity and intended use. Use Devices@FDA as a second check.
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Is an FDA-registered or FDA-listed test FDA-approved?
Not necessarily. FDA says establishment registration and device listing do not denote approval, clearance, or authorization of the facility or its devices. Look for the actual decision record, such as a 510(k), PMA, De Novo, or EUA record, that matches the product and claim.
What is the difference between FDA-cleared and FDA-approved?
“FDA-cleared” commonly refers to a 510(k) substantial-equivalence decision. “FDA-approved” commonly refers to PMA approval for a Class III device. They are different regulatory routes, so check the wording and decision type in the FDA record.
What does De Novo mean for a medical test?
De Novo is a risk-based classification pathway for certain novel, low- to moderate-risk devices. A De Novo order is distinct from 510(k) clearance and PMA approval, though its classification may serve as a predicate for later 510(k) submissions.
Does an EUA mean a test is FDA-approved?
No. EUA is an emergency-use authorization, not ordinary approval or clearance. Check FDA’s EUA resource to confirm the exact product and authorized use, and describe the status as EUA authorization.
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What if I cannot find the test in an FDA database?
Search alternate product names and the manufacturer, then check the pathway-specific resource if the seller gives a number or pathway. Ask the manufacturer for the decision number and current instructions for use. If the match remains consequential or disputed, seek clarification from FDA; a failed keyword search alone does not prove the product is unregulated.
The Bottom Line
Search FDA’s IVD Tests resource and Devices@FDA using the exact test and manufacturer names, then verify any claimed decision number in the matching pathway database. Compare the record’s device identity and intended use with the product being promoted. Registration or listing alone is not proof of clearance, approval, or authorization, and an unsuccessful search alone is not a definitive conclusion.
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