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.
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
Microbiology
The Human Immunodeficiency Virus (HIV) Viral Load Monitoring Test is a prescription in vitro diagnostic device for the quantitative measurement of HIV ribonucleic acid (RNA) in human body fluids, used to monitor HIV viral load in infected patients to assess disease progression and the effectiveness of antiretroviral therapy. Accurate viral load quantification is essential for guiding treatment decisions and detecting treatment failure. Classified as FDA Class 2 under regulation 866.3958, it requires 510(k) clearance in the Microbiology specialty. The device is not an implant and not life-sustaining.
No 510(k) clearances found for "QUM". Try a different K-number, product code, or device name.
What 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.