# K070383: Enzymatic Creatinine Assay (265 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jun 22, 2007 after 133 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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
- 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
- K193649: Yumizen C1200 Creatinine PAP (2021), 0 descendants of its own

## Recalls of this device
- Feb 12, 2009 · Not classified · Z-2326-2009: Labeled with extended expiration date (24 months instead of 18 months)
- Feb 12, 2009 · Not classified · Z-2327-2009: Labeled with extended expiration date (24 months instead of 18 months)

## Indications for use
The Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This device is intended for professional use and INVITRO diagnostic use only.

Source page: https://510kreport.com/device/K070383
Methodology: https://510kreport.com/methodology