# K032881: Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 10, 2003 after 25 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905215 (1991). 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)
- K022603: Immulite 1000 Automated Immunoassay Analyzer, Diagnostic Products Corp. (2002) Summary page 2.
- K955870: Immulite Total Testosterone, Diagnostic Products Corp. (1996) Summary page 2.

## Recalls of this device
- Oct 25, 2022 · Class II · Z-0355-2023: Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to t
- Jan 3, 2006 · Not classified · Z-0528-06: The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observe

## Indications for use
The IMMULITE/IMMULITE 1000 Total Testosterone is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The IMMULITE 2000 Total Testosterone is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

Source page: https://510kreport.com/device/K032881
Methodology: https://510kreport.com/methodology