# K984321: Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jan 22, 1999 after 50 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935286 (1994). 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)
- K935286: Quantaphase II B12/Folate, Bio-Rad (1994) Summary page 2.

## Recalls of this device
- Aug 28, 2018 · Class II · Z-0392-2019: The reagent pack exhibits the potential for an increased frequency of calibration failures.

## Indications for use
1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of anemia. 3. The VITROS Immunodiagnostic Products Vitamin B12 Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).

Source page: https://510kreport.com/device/K984321
Methodology: https://510kreport.com/methodology