Cleared Traditional

AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K922906) - FDA 510(k) Clearance

Class I Microbiology device.

K922906 · Roche Molecular Systems, Inc. · Microbiology device
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Jun 1993
Decision
363d
Days
Class 1
Risk

K922906 is an FDA 510(k) clearance for the 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 15, 1993 after a review of 363 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K922906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1992
Decision Date June 15, 1993
Days to Decision 363 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
261d slower than avg
Panel avg: 102d · This submission: 363d
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.