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.
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Immunology
This is an immunological reagent kit for detecting multiple autoantibodies simultaneously using indirect immunofluorescence, providing a substrate antigen and control components for broad-spectrum autoimmune antibody screening in clinical laboratory settings. Simultaneous detection of multiple autoantibodies is useful for evaluating systemic autoimmune diseases such as lupus and mixed connective tissue disease. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DBL, regulated under 21 CFR 866.5660, within the Immunology specialty.
510(k) Clearances
24 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.