Cleared Traditional

K070174 - AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACH...

Also marketed or referenced as:
ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY

K070174 is the FDA 510(k) clearance for AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACH... by Roche Diagnostics Corporation. It is a Class 1 Microbiology device (product code MKZ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K070174 · Roche Diagnostics Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
88d
Days
Class 1
Risk

K070174 is an FDA 510(k) clearance for the 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 Corporation (Indianapolis, US). The FDA issued a Cleared decision on April 16, 2007 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corporation devices

Submission Details

510(k) Number K070174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2007
Decision Date April 16, 2007
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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 17
Devices cleared under the same product code (MKZ) and FDA review panel - the closest regulatory comparables to K070174.
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K091724 · Becton, Dickinson & CO · Nov 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · Becton, Dickinson & CO · Jun 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824 · Becton, Dickinson & CO · Dec 2008
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