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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Chronic Lymphocytic Leukemia Fish Probe Kit
Immunology
The Chronic Lymphocytic Leukemia FISH Probe Kit (product code OVQ) is an in vitro diagnostic test intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL) using fluorescence in situ hybridization (FISH). The assay may be used to dichotomize CLL into prognostic groups and is used as an aid in determining disease prognosis in combination with additional biomarkers and clinical information. As an FDA Class 2 device under regulation 866.6040, it requires 510(k) premarket clearance and falls within the Immunology specialty, reviewed by the Pathology panel. The device is eligible for third-party review and is not an implant or 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.