Cleared Traditional

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT (K962217) - FDA 510(k) Clearance

Class I Microbiology device.

K962217 · Gen-Probe, Inc. · Microbiology device
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Nov 1996
Decision
170d
Days
Class 1
Risk

K962217 is an FDA 510(k) clearance for the GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT. Classified as Dna Probe, Nucleic Acid Amplification, Chlamydia (product code MKZ), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 170 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 Gen-Probe, Inc. devices

Submission Details

510(k) Number K962217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date November 27, 1996
Days to Decision 170 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
68d slower than avg
Panel avg: 102d · This submission: 170d
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 7
Devices cleared under the same product code (MKZ) and FDA review panel - the closest regulatory comparables to K962217.
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K081824 · Becton, Dickinson & CO · Dec 2008
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287 · Roche Diagnostics Corp. · Aug 2006
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · Abbott Laboratories · Dec 1995