# K990016: Vitros Immunodiagnostic Products Anemia Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 19, 1999 after 135 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: 2 generations back to K891475 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981532: Lyphochek Immunoassay Plus Control, Bio-Rad (1998) Summary page 1.

## Indications for use
Assayed controls for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of the analytes listed in this package insert (ferritin, folate, and vitamin B12).

Source page: https://510kreport.com/device/K990016
Methodology: https://510kreport.com/methodology