# K964506: Roche Cobas Amplicor Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: May 21, 1997 after 194 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922906 (1993). 3 ancestors in all.
15 later devices descend from it; 1 cites 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)
- K940390: Impact, Matrix Technologies Corp. (1994) Summary page 2.
- K950104: ELX800 and EL800 Automated Microplate Readers, Bio-Tek Instruments, Inc. (1995) Summary page 2.
- K922906: Amplicor Chlamydia Trachomatis Test, Roche Molecular Systems, Inc. (1993) Summary page 2.
- (no number) Perkin-Elmer 5600 Thermal cycler: named in the summary without a submission number
- (no number) Fisher Dry Heat Incubator Model 630D: named in the summary without a submission number
- (no number) Bio-Tek Instruments Automated Microplate Washer Model ELP40: named in the summary without a submission number

## Most influential descendants
- K012966: Roche Cobas Taqman Analyzer (2002), 14 descendants of its own
- 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

## Recalls of this device
- May 21, 2007 · Not classified · Z-1106-2007: 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 r

## Indications for use
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.

Source page: https://510kreport.com/device/K964506
Methodology: https://510kreport.com/methodology