Cleared Traditional

K964507 - ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST

K964507 is an FDA 510(k) clearance for ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMA..., manufactured by Roche Molecular Systems, Inc.. The device is a Class 1 Microbiology device with product code MKZ cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K964507 · Roche Molecular Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
217d
Days
Class 1
Risk

K964507 is an FDA 510(k) clearance for the ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST. 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 June 13, 1997 after a review of 217 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Molecular Systems, Inc. devices

FDA 510(k) Submission Details - K964507

510(k) Number K964507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1996
Decision Date June 13, 1997
Days to Decision 217 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
115d slower than avg
Panel avg: 102d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

MKZ Device Classification - Class 1, General Controls

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 17
Devices cleared under the same product code (MKZ) and FDA review panel - the closest regulatory comparables to K964507.
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ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · Roche Molecular Systems, Inc. · Dec 1998
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
K962217 · Gen-Probe, Inc. · Nov 1996
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · Abbott Laboratories · Dec 1995
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906 · Roche Molecular Systems, Inc. · Jun 1993