# K983513: Vitros Immunodiagnostic Products Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 3, 1998 after 27 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 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 immunoassays which include Testosterone and NTx.

Source page: https://510kreport.com/device/K983513
Methodology: https://510kreport.com/methodology