Cleared Traditional

ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973707) - FDA 510(k) Clearance

Class I Microbiology device.

K973707 · Roche Molecular Systems, Inc. · Microbiology device
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Aug 1999
Decision
674d
Days
Class 1
Risk

K973707 is an FDA 510(k) clearance for the ROCHE 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 August 4, 1999 after a review of 674 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 K973707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1997
Decision Date August 04, 1999
Days to Decision 674 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
572d slower than avg
Panel avg: 102d · This submission: 674d
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.