Cleared Traditional

ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974342) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974342 · Roche Molecular Systems, Inc. · Microbiology device
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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
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 44
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K974342.
Aptima Neisseria gonorrhoeae Assay
K231329 · Hologic, Inc. · Jan 2024
Aptima Combo 2 Assay (Panther System)
K180681 · Hologic, Inc. · Jun 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · Roche Molecular Systems, Inc. · Mar 2018
Xpert CT/NG
K173840 · Cepheid · Mar 2018
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · Roche Diagnostics Corp. · Aug 2006
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories · May 1996