# K024098: Cobas Integra Creatinine Plus Ver.2 Assay

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 19, 2002 after 7 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003261 (2000). 1 ancestor in all.
7 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003261: Creatinine Plus, Roche Diagnostics Corp. (2000) Summary page 1.

## Most influential descendants
- K183555: GEM Premier ChemSTAT (2019), 1 descendant of its own
- K113726: Epoc Chloride Test and Epoc Creatinine Test (2012), 1 descendant of its own
- K223090: GEM Premier ChemSTAT (2023), 0 descendants of its own
- K200107: epoc Blood Analysis System (2020), 0 descendants of its own
- K132399: Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine Control BI-Level (2014), 0 descendants of its own

## Recalls of this device
- Dec 14, 2018 · Class II · Z-1125-2019: COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
- Jun 11, 2008 · Not classified · Z-0008-2009: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

## Indications for use
The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Source page: https://510kreport.com/device/K024098
Methodology: https://510kreport.com/methodology