# K951595: Roche Cobas Integra Analyzer, Reagent Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Sep 8, 1995 after 155 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
88 later devices descend from it; 32 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae (1998), 20 descendants of its own
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents (1997), 17 descendants of its own
- K003400: CRP HS Test System (2001), 12 descendants of its own
- K063543: Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226 (2006), 10 descendants of its own
- K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) (1998), 9 descendants of its own

## Recalls of this device
- Apr 26, 2021 · Class II · Z-1675-2021: Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integ
- Jul 15, 2016 · Class II · Z-0100-2017: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarif
- Sep 16, 2013 · Class II · Z-0168-2014: Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the co
- Nov 19, 2012 · Class III · Z-0696-2013: A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be consider
- Jun 11, 2008 · Not classified · Z-0007-2009: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
- Jun 11, 2008 · Not classified · Z-0012-2009: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
- Feb 13, 2003 · Not classified · Z-0667-03: After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.

Source page: https://510kreport.com/device/K951595
Methodology: https://510kreport.com/methodology