Classified. Not waived.

A product-code lookup for an in vitro diagnostic returns the same shape of record FDA Radar derives a profile from for any device: device class, regulation number, review panel, a submission pathway, and a handful of yes/no flags. For an IVD, that record answers whether the test can be sold. It says nothing about where it can be run — and the field that would answer that lives somewhere else entirely.

One record, seven fields, no complexity flag

FDA Radar’s own product-code lookup pulls device_class, regulation_number, submission_type_id, implant_flag, life_sustain_support_flag, and gmp_exempt_flag from openFDA’s device classification endpoint — the same interface FDA documents at open.fda.gov. Every one of those fields describes a determination FDA makes under the Food, Drug, and Cosmetic Act, in 21 CFR. None of them, and no other field the endpoint returns, says whether a cleared or approved IVD is categorized as waived, moderate, or high complexity.

A different statute, a different scorecard

Test complexity isn’t an FDA device classification at all. It is a determination under the Clinical Laboratory Improvement Amendments, codified at 42 CFR 493.17 — a wholly separate title of the Code of Federal Regulations, resting on CLIA’s own statute rather than the FD&C Act, even though CDRH’s Office of In Vitro Diagnostics performs the technical review for FDA. The categorization isn’t a general finding: FDA scores a manufacturer’s package insert against seven named criteria, each worth one to three points, and a total above twelve makes the test high complexity by default. A newly cleared test starts there, in the most restrictive category, unless the manufacturer specifically requested and received a lower one.

The database that isn’t in openFDA

FDA keeps the list of tests it has categorized as waived or moderate complexity on its own CLIA Categorizations search page — a legacy lookup tool, not an openFDA endpoint, and not a source FDA Radar’s classification derivation or any of its five monitored feeds reaches. A manufacturer that wants waiver status decided alongside clearance, rather than after it, can file both at once through FDA’s Dual 510(k) and CLIA Waiver by Application pathway — one submission, one MDUFA user fee, the ordinary 510(k) Refuse to Accept policy applied to both halves, with a stated FDA goal of 180 days, or 320 if an advisory panel is required. File the CLIA waiver request on its own, after clearance, and it runs entirely outside that clock.

A 510(k) says a test may be sold. CLIA says who is allowed to run it.

The practice

A competitor’s clearance under a product code in your own portfolio says they can compete for the same customers. It says nothing about whether their test ever reached a physician’s office or a pharmacy instead of a certified laboratory, because that fact lives on a database none of FDA Radar’s sources monitors and no classification field carries; see what we monitor and how often. Checking a specific test’s current complexity category, or deciding whether a specific assay is worth pursuing waiver for, is a call for the regulatory and laboratory-operations professionals who own that submission — this is regulatory intelligence and method, about where one fact lives relative to another, never advice on a specific product’s own path to a waiver.