Cleared Traditional

K974342 - ROCHE COBAS AMPLICOR CT/NG TEST FOR NEI...

K974342 is the FDA 510(k) clearance for ROCHE COBAS AMPLICOR CT/NG TEST FOR NEI... by Roche Molecular Systems, Inc.. It is a Class 2 Microbiology device (product code LSL) cleared through the Traditional 510(k) pathway after a 556-day FDA review.

K974342 · Roche Molecular Systems, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
May 1999
Decision
556d
Days
Class 2
Risk

K974342 is an FDA 510(k) clearance for the ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 28, 1999 after a review of 556 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K974342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date May 28, 1999
Days to Decision 556 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
454d slower than avg
Panel avg: 102d · This submission: 556d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LSL Dna-reagents, Neisseria

All 35
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K974342.
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351 · Becton, Dickinson & CO · Sep 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · Gen-Probe, Inc. · May 2001
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · Roche Molecular Systems, Inc. · Dec 1999
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories · May 1996
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979 · Gen-Probe, Inc. · Oct 1994
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301 · Gen-Probe, Inc. · Apr 1994