# K023091: ST Aia-Pack Testosterone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Dec 17, 2002 after 91 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831342 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831342: Coat-a-Count NO-Extraction Testosterone, Diagnostic Products Corp. (1983) Summary page 1.

## Recalls of this device
- Jun 12, 2026 · Class II · Z-2746-2026: The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low tota
- Nov 30, 2018 · Class II · Z-0674-2019: 
- Mar 5, 2018 · Class II · Z-2093-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

## Indications for use
ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only. ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only.

Source page: https://510kreport.com/device/K023091
Methodology: https://510kreport.com/methodology