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.
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Immunology
The Anti-DNA Antibody Enzyme-Labeled Antigen and Control is an in vitro diagnostic device used to detect antibodies against double-stranded DNA in patient serum, primarily as an aid in the diagnosis and monitoring of systemic lupus erythematosus (SLE) and other autoimmune conditions. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LRM, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k) Clearances
29 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.