510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Clinical Chemistry
The immunoassay for detection of amniotic fluid proteins is a clinical chemistry device intended for use by healthcare professionals to aid in the detection of fetal membrane rupture (premature rupture of membranes) in pregnant women presenting with signs or symptoms suggestive of such rupture. It is classified as FDA Class 1 under regulation 862.1550 in the Clinical Chemistry specialty, and while Class 1 and 510(k) exempt (submission type 4), GMP requirements still apply. Product code NQM is not eligible for third-party review.
510(k) Clearances
2 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.