# K122323: Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (Alpi

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 28, 2012 after 27 days
- Product code: CJO (Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860021 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System, Bayer Corp. (1999) Summary page 1.
- K061818: Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330), Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Aug 25, 2020 · Class II · Z-0134-2021: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 uk

## Indications for use
The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista® System.

Source page: https://510kreport.com/device/K122323
Methodology: https://510kreport.com/methodology