# K991598: Cobas Integra Acetaminophen

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 22, 1999 after 73 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- 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 K954992 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954992: Roche Cobas Integra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K110726: Roche Acetaminophen Assay (2011), 0 descendants of its own

## Recalls of this device
- Dec 7, 2010 · Not classified · Z-1680-2011: The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of 

## Indications for use
The cassette COBAS INTEGRA Acetaminophen contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.

Source page: https://510kreport.com/device/K991598
Methodology: https://510kreport.com/methodology