Cleared Traditional

K973718 - ROCHE COBAS AMPLICOR CT/NG TEST FOR CHL...

K973718 is the FDA 510(k) clearance for ROCHE COBAS AMPLICOR CT/NG TEST FOR CHL... by Roche Molecular Systems, Inc.. It is a Class 1 Microbiology device (product code MKZ) cleared through the Traditional 510(k) pathway after a 442-day FDA review.

K973718 · Roche Molecular Systems, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
442d
Days
Class 1
Risk

K973718 is an FDA 510(k) clearance for the ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS. Classified as Dna Probe, Nucleic Acid Amplification, Chlamydia (product code MKZ), Class I - General Controls.

Submitted by Roche Molecular Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 15, 1998 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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 K973718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1997
Decision Date December 15, 1998
Days to Decision 442 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
340d slower than avg
Panel avg: 102d · This submission: 442d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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 - MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia

All 16
Devices cleared under the same product code (MKZ) and FDA review panel - the closest regulatory comparables to K973718.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
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GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
K043072 · Gen-Probe, Inc. · Jan 2005
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · Roche Molecular Systems, Inc. · Aug 1999
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507 · Roche Molecular Systems, Inc. · Jun 1997
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
K962217 · Gen-Probe, Inc. · Nov 1996
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · Abbott Laboratories · Dec 1995