# K070727: Advia Chemistry Enzymatic Creatinine_2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Aug 3, 2007 after 141 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973993 (1998). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973993: Randox Creatinine, Randox Laboratories, Ltd. (1998) Summary page 1.
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System, Bayer Corp. (1999) Summary page 1.

## Most influential descendants
- K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (2016), 2 descendants of its own
- K242685: Atellica® CH Creatinine_3 (Crea3) (2024), 1 descendant of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own
- K212223: Atellica CH Enzymatic Creatinine_3 (ECre3) (2021), 0 descendants of its own

## Recalls of this device
- May 4, 2020 · Class II · Z-2283-2020: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- May 4, 2020 · Class II · Z-2282-2020: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- Dec 18, 2019 · Class II · Z-1230-2020: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe met
- Dec 18, 2019 · Class II · Z-1231-2020: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe met
- Mar 17, 2016 · Class II · Z-1654-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

## Indications for use
For in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma, and urine on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

Source page: https://510kreport.com/device/K070727
Methodology: https://510kreport.com/methodology