510(k) · Cleared
Recalled · 2004Roche Cobas Taqman Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use
Cleared on Feb 1, 2002 as substantially equivalent to K964506 (Roche Molecular Systems, Inc., 1997) after a 150-day review. Its family tree reaches back 2 generations to 1993. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 1, 2002
- Review
- 150 days
- Class
- Class I
- Product code
- JJF
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922906 (1993). 4 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 1 generation backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- This deviceK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
- Descendant · 2 generations on · 3 of its ownK070597 Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and…Nanosphere, Inc. · 2007
- Descendant · 3 generations on · 3 of its ownK071188 Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK092705 Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series)…Abbott Molecular, Inc. · 2010 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K033734Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · cites it directly10descendants
- K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005 · 2 generations on4descendants
- K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 2007 · 2 generations on3descendants
- K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007 · 3 generations on3descendants
- K092705Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501Abbott Molecular, Inc. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −1 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| 0 (this device) | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | — |
| +1 | K033734 | Lightcycler Instrument Version 1.2 | Roche Diagnostics Corp. | 2003 | 1 |
| +2 | K051713 | Jbaids Anthrac Detection System | Idaho Technology, Inc. | 2005 | — |
| +2 | K070597 | Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic… | Nanosphere, Inc. | 2007 | — |
| +3 | K071188 | Modification to Jbaids Anthrax Detection System | Idaho Technology, Inc. | 2007 | — |
| +1 | K092705 | Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02… | Abbott Molecular, Inc. | 2010 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964506 | Roche Cobas Amplicor AnalyzerSummary page 2…AS TagMan Analyzer Predicate Regulatory Classification Predicate Predicate Device Class Number Product Name 510(k) Number COBAS AMPLICOR Class 1 862.2170 COBAS AMPLICOR K964506 Analyzer Analyzer 510(k) Premarket Notification August 31, 2001 CONFIDENTIAL AND PROPRIETARY 807.87(h), Attachment 1 Page 2… | 1997 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2004 | Not classified | Z-1119-04 | Other | 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 | Other | 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 | Other | A false positive result may be reported. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K033734 (Roche Diagnostics Corp., 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All JJF devicesJJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJF
FDA has decided no JJF device since 2007.
Median 510(k) review, days · JJF
Too few JJF 510(k)s in any year since 2007 to give a median.
Recalls per year · JJF
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJF
2in 2025
MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 10 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 3 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012966 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012966: Roche Cobas Taqman Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012966
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026