# K003261: Creatinine Plus

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 16, 2000 after 29 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 6 cite it directly.
0 of 16 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
- K024098: Cobas Integra Creatinine Plus Ver.2 Assay (2002), 7 descendants of its own
- K070383: Enzymatic Creatinine Assay (265 Series) (2007), 2 descendants of its own
- K183555: GEM Premier ChemSTAT (2019), 1 descendant of its own
- K113726: Epoc Chloride Test and Epoc Creatinine Test (2012), 1 descendant of its own
- K110137: Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, and Abx Pentra Urin (2011), 1 descendant of its own

## Recalls of this device
- May 7, 2015 · Class II · Z-1923-2015: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine p

Source page: https://510kreport.com/device/K003261
Methodology: https://510kreport.com/methodology