Cleared Traditional

K053287 - COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA...

K053287 is the FDA 510(k) clearance for COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA... by Roche Diagnostics Corp.. It is a Class 1 Microbiology device (product code MKZ) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K053287 · Roche Diagnostics Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
258d
Days
Class 1
Risk

K053287 is an FDA 510(k) clearance for the COBAS 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 Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 10, 2006 after a review of 258 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 Diagnostics Corp. devices

Submission Details

510(k) Number K053287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date August 10, 2006
Days to Decision 258 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
156d slower than avg
Panel avg: 102d · This submission: 258d
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

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