Cleared Traditional

K012966 - ROCHE COBAS TAQMAN ANALYZER

K012966 is the FDA 510(k) clearance for ROCHE COBAS TAQMAN ANALYZER by Roche Molecular Systems, Inc.. It is a Class 1 Chemistry device (product code JJF) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K012966 · Roche Molecular Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
150d
Days
Class 1
Risk

K012966 is an FDA 510(k) clearance for the ROCHE COBAS TAQMAN ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K012966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2001
Decision Date February 01, 2002
Days to Decision 150 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 32
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