Cleared Traditional

K900202 - SNAP MYCOBACTERIA AVIUM COMPLEX

K900202 is the FDA 510(k) clearance for SNAP MYCOBACTERIA AVIUM COMPLEX by Syngene, Inc.. It is a Class 1 Microbiology device (product code LQF) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900202 · Syngene, Inc. · Microbiology device
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Apr 1990
Decision
77d
Days
Class 1
Risk

K900202 is an FDA 510(k) clearance for the SNAP MYCOBACTERIA AVIUM COMPLEX. Classified as Dna-reagents, Mycobacterium Spp. (product code LQF), Class I - General Controls.

Submitted by Syngene, Inc. (San Diego, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3370 - 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 Syngene, Inc. devices

Submission Details

510(k) Number K900202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date April 03, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQF Dna-reagents, Mycobacterium Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3370
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.

Regulatory Peers - LQF Dna-reagents, Mycobacterium Spp.

All 13
Devices cleared under the same product code (LQF) and FDA review panel - the closest regulatory comparables to K900202.
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K897078 · Gen-Probe, Inc. · May 1990
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
K896492 · Gen-Probe, Inc. · Apr 1990
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
K896493 · Gen-Probe, Inc. · Apr 1990
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE
K890089 · Gen-Probe, Inc. · Mar 1989
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.
K871795 · Gen-Probe, Inc. · Jul 1987
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
K864597 · Gen-Probe, Inc. · Apr 1987