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.
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Microbiology
The Nucleic Acid-Based System for Mycobacterium Tuberculosis Complex with Resistance Markers, Direct Specimen is a microbiology in vitro diagnostic device intended for use with specimens from patients with clinical suspicion of tuberculosis (TB), providing simultaneous detection of Mycobacterium tuberculosis complex and key antimicrobial resistance markers directly from clinical specimens without culture. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3373, requiring 510(k) premarket notification. Rapid resistance detection is essential for guiding appropriate anti-TB therapy. It is not an implant and is not life-sustaining.
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.