# K133816: Immulite 2000 Free Psa Calibration Verification Material

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jun 24, 2014 after 190 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: 3 generations back to K993210 (2000). 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)
- K131536: Immulite 2000 Psa Calibration Verification Material, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 1.

## Indications for use
The IMMULITE® Free PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.

Source page: https://510kreport.com/device/K133816
Methodology: https://510kreport.com/methodology