# K013900: Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Dec 21, 2001 after 28 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: 2 generations back to K973517 (1997). 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)
- K990026: Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers, Ortho-Clinical Diagnostics, Inc. (1999) 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 Vitamin B12.

Source page: https://510kreport.com/device/K013900
Methodology: https://510kreport.com/methodology