# K132739: Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 14, 2014 after 133 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001015 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102086: Elecsys CA 125 II Calcheck 5, Roche Diagnostics (2010) Summary page 1.
- K122242: Elecsys CA 15-3 II Calcheck 5, Roche Diagnostics (2012) Summary page 5.
- K122534: Immulite 1000 Third Generation Psa Calibration Verification Material, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 9.

## Indications for use
The IMMULITE® 2000 AFP Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of AFP antigen. The IMMULITE® BR-MA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE BR-MA assay on the IMMULITE 2000 systems The IMMULITE® OM-MA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE OM-MA assay on the IMMULITE 2000 systems

Source page: https://510kreport.com/device/K132739
Methodology: https://510kreport.com/methodology