Cleared Traditional

K053446 - GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TR...

K053446 is an FDA 510(k) clearance for GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TR..., manufactured by Gen-Probe, Inc.. The device is a Class 1 Microbiology device with product code MKZ cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K053446 · Gen-Probe, Inc. · Microbiology device
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Jul 2006
Decision
225d
Days
Class 1
Risk

K053446 is an FDA 510(k) clearance for the GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088. 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 July 25, 2006 after a review of 225 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

FDA 510(k) Submission Details - K053446

510(k) Number K053446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2005
Decision Date July 25, 2006
Days to Decision 225 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
123d slower than avg
Panel avg: 102d · This submission: 225d
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 16
Devices cleared under the same product code (MKZ) and FDA review panel - the closest regulatory comparables to K053446.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
K063451 · Gen-Probe, Inc. · Jan 2007
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
K061413 · Gen-Probe, Inc. · Oct 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287 · Roche Diagnostics Corp. · Aug 2006
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 CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · Roche Molecular Systems, Inc. · Dec 1998