Cleared Traditional

K022874 - GEN-PROBE APTIMA COMBO 2 ASSAY (FDA 510(k) Clearance)

Class I Microbiology device.

K022874 · Gen-Probe, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
53d
Days
Class 1
Risk

K022874 is an FDA 510(k) clearance for the GEN-PROBE APTIMA COMBO 2 ASSAY. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on September 17, 2002 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gen-Probe, Inc. devices

Submission Details

510(k) Number K022874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2002
Decision Date September 17, 2002
Days to Decision 53 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 102d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.