# K983507: Vitros Immunodiagnostic Products Testosterone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 4, 1998 after 28 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 1 generation back to K813401 (1981). 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)
- K813401: Coat-a-Count Testosterone Ria Kit, Diagnostic Products Corp. (1981) Summary page 1.

## Indications for use
For the in vitro quantitative measurement of testosterone in human serum and plasma (EDTA or heparin). For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of testosterone in human serum and plasma (EDTA or heparin). For in vitro use in monitoring the performance of the Vitros Immunodiagnostic System when used for the measurement of testosterone.

Source page: https://510kreport.com/device/K983507
Methodology: https://510kreport.com/methodology