# K990783: Vitros Immunodiagnostic Products CA15-3 Range Verifiers, CA125 II Range Verifiers, Psa Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Mar 25, 1999 after 16 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: 1 generation back to K973517 (1997). 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)
- K973517: Vitros Immunodiagnostic Products Range Verifiers, Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 1.

## Indications for use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of DF3 defined antigen. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of OC 125 defined antigen. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of PSA.

Source page: https://510kreport.com/device/K990783
Methodology: https://510kreport.com/methodology