510(k) · Cleared

Recalled · 2007

Roche Cobas Amplicor Analyzer

K964506510(k) TraditionalCleared May 21, 1997194-day reviewClass I21 CFR 862.2170Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Molecular Systems, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on May 21, 1997 as substantially equivalent to K940390 (Matrix Technologies Corp., 1994) and 2 other predicates after a 194-day review. Its family tree reaches back 1 generation to 1993. 15 later devices descend from it. It has been recalled once.

Decided: May 21, 1997
Review: 194 days
Class: Class I
Product code: JJF
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K922906 (1993). 3 ancestors in all. 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
This deviceK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997
Descendant · cites it directly · 14 of its ownK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
Descendant · 2 generations on · 10 of its ownK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
Descendant · 3 generations on · 4 of its ownK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
Descendant · 3 generations on · 3 of its ownK070597 Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and…Nanosphere, Inc. · 2007
Descendant · 4 generations on · 3 of its ownK071188 Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2002high 2 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 15 · See all

K012966Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · cites it directly14descendants
K033734Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · 2 generations on10descendants
K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005 · 3 generations on4descendants
K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 2007 · 3 generations on3descendants
K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922906	Amplicor Chlamydia Trachomatis Test	Roche Molecular Systems, Inc.	1993	—
0 (this device)	K964506	Roche Cobas Amplicor Analyzer	Roche Molecular Systems, Inc.	1997	—
+1	K012966	Roche Cobas Taqman Analyzer	Roche Molecular Systems, Inc.	2002	3
+2	K033734	Lightcycler Instrument Version 1.2	Roche Diagnostics Corp.	2003	1
+3	K051713	Jbaids Anthrac Detection System	Idaho Technology, Inc.	2005	—
+3	K070597	Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic…	Nanosphere, Inc.	2007	—
+4	K071188	Modification to Jbaids Anthrax Detection System	Idaho Technology, Inc.	2007	—

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
2002	1	0
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

FIG. 1 — Lineage of K964506, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K940390	Impact Summary page 2 …OBAS AMPLICOR Analyzer Predicate Device Regulatory Class a ate Product \| Predicaie \| Number . Name S10(k) Number Automated Pipettor Class 1 862.2750 Matrix Technologies K940390 Impact Pipettor Thermal cycler (incubator) Class 1 exempt 862.2750 Perkin-Elmer 5600 NA Thermal cycler Incubator Class 1 exempt 8…	Matrix Technologies Corp.	1994	—
*	K950104	ELX800 and EL800 Automated Microplate Readers Summary page 2 …tantially equivalent to the Roche AMPLICOR Chlamydia trachomatis Test (K922906/C, June 15,1993) performed on the Perkin-Elmer 9600 thermal cycler and the Bio-Tek EL800 (K950104) microtiter plate reader. IV. Description of the Device: The COBAS AMPLICOR is a flexible, automated bench top batch analyzer t…	Bio-Tek Instruments, Inc.	1995	1
*	K922906	Amplicor Chlamydia Trachomatis Test Summary page 2 …he COBAS AMPLICOR Chlamydia trachomatis Test performed on the Roche COBAS AMPLICOR analyzer is substantially equivalent to the Roche AMPLICOR Chlamydia trachomatis Test (K922906/C, June 15,1993) performed on the Perkin-Elmer 9600 thermal cycler and the Bio-Tek EL800 (K950104) microtiter plate reader. IV.…	Roche Molecular Systems, Inc.	1993	—
*	—	Perkin-Elmer 5600 Thermal cycler Named without a submission number			—
*	—	Fisher Dry Heat Incubator Model 630D Named without a submission number			—
*	—	Bio-Tek Instruments Automated Microplate Washer Model ELP40 Named without a submission number			—

Also cleared against K940390: 1 other device →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012966	Roche Cobas Taqman Analyzer	Roche Molecular Systems, Inc.	2002	14

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 21, 2007	Not classified	Z-1106-2007	Other	For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K012966 (Roche Molecular Systems, Inc., 2002) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate K940390.

How does its category compare?

All JJF devices

JJF 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

2007high 3 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)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	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

The COBAS AMPLICOR Analyzer is an in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures.

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/K964506 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964506: Roche Cobas Amplicor Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964506

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026