# K012966: Roche Cobas Taqman Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Feb 1, 2002 after 150 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922906 (1993). 4 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964506: Roche Cobas Amplicor Analyzer, Roche Molecular Systems, Inc. (1997) Summary page 2.

## Most influential descendants
- K033734: Lightcycler Instrument Version 1.2 (2003), 10 descendants of its own
- K051713: Jbaids Anthrac Detection System (2005), 4 descendants of its own
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test (2007), 3 descendants of its own
- K071188: Modification to Jbaids Anthrax Detection System (2007), 3 descendants of its own
- K092705: Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501 (2010), 2 descendants of its own

## Recalls of this device
- May 24, 2004 · Not classified · Z-1119-04: Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
- May 24, 2004 · Not classified · Z-1120-04: Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
- Mar 6, 2003 · Not classified · Z-0917-03: A false positive result may be reported.

## Indications for use
The COBAS TagMan Analyzer is a fully automated amplification and detection system for nucleic acids using 5° nuclease technology. The COBAS TagMan Analyzer is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the Analyzer.

Source page: https://510kreport.com/device/K012966
Methodology: https://510kreport.com/methodology