Cleared Traditional

K012966 - ROCHE COBAS TAQMAN ANALYZER

K012966 is an FDA 510(k) clearance for ROCHE COBAS TAQMAN ANALYZER, manufactured by Roche Molecular Systems, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K012966

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.

JJF Device Classification - Class 1, General Controls

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 44
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