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.
Hepatitis A Test (Antibody And Igm Antibody)
Microbiology
Hepatitis A Test (Antibody and IgM Antibody) is a serological diagnostic test used to detect total anti-hepatitis A virus (HAV) antibodies and/or IgM-specific antibodies in patient serum, where the presence of anti-HAV IgM indicates acute or recent infection and total anti-HAV indicates prior infection or vaccination-conferred immunity. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOL, regulated under 21 CFR 866.3310, within the Microbiology medical specialty. No special flags apply to this device.
510(k) Clearances
23 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.