# K052649: DRG SLV Testosterone Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Drg Intl., Inc.
- Decided: Jan 27, 2006 after 123 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LIA saliva test: named in the summary without a submission number

## Recalls of this device
- Jul 5, 2024 · Class III · Z-2622-2024: Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
- May 21, 2019 · Class II · Z-2159-2019: Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed signific

## Indications for use
An enzyme immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Source page: https://510kreport.com/device/K052649
Methodology: https://510kreport.com/methodology