# K013899: Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Jan 24, 2002 after 62 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933142 (1993). 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)
- K933142: Access Vitamin B12 Assay, Bio-Rad Laboratories, Inc. (1993) Summary page 1.

## 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.
- Dec 18, 2002 · Not classified · Z-0557-03: Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.

## Indications for use
The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/ 2 and the VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3 quantitatively measures vitamin B12 concentration in human serum and plasma (EDTA or heparin), to aid in the diagnosis of anemia using the VITROS ECi Immunodiagnostic System with Intellicheck. The VITROS Immunodiagnostic Products Vitamin B12 Calibrators- for 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/K013899
Methodology: https://510kreport.com/methodology