# K153365: ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 18, 2015 after 28 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K860021 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061923: Dimension Vista Enzyme 1 Calibrator (Enz 1 Cal - KC310), Dade Behring, Inc. (2006) Summary page 5.
- K103612: Dimension Visa Enz 2 Cal, Siemens Healthcare Diagnostics, Inc. (2011) Summary page 5.

## Indications for use
ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehydrogenase L-P (LDLP), Cholinesterase (CHE), an& Lipase (LIP) assays on the ADVIA Chemistry systems. ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents (ALT_c); Alanine Aminotransferase (P5P) (ALTPSP); Alanine Aminotransferase (P5P), Concentrated Reagents (ALTP_c); Aspartate Aminotransferase (AST); Aspartate Aminotransferase, Concentrated Reagents (AST_c); Aspartate Aminotransferase (P5SP) (ASTP5P); and Aspartate Aminotransferase (P5P), Concentrated Reagents (ASTP_c) assays on the ADVIA Chemistry systems.

Source page: https://510kreport.com/device/K153365
Methodology: https://510kreport.com/methodology