# K984166: Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin B12/Folate Reagent P3

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Feb 5, 1999 after 77 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- 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 1.

## Recalls of this device
- Jul 3, 2024 · Class II · Z-2580-2024: It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5

## Indications for use
The VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of folate in human serum and plasma (heparin) and whole blood (red cell folate), to aid in the differential diagnosis of anemia. The VITROS Immunodiagnostic Products Folate Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of folate in human serum and plasma (heparin). The VITROS Immunodiagnostic Products Red Cell Folate Pack - for whole blood sample preparation, to allow the in vitro quantitative measurement of red cell folate using the VITROS Immunodiagnostic System.

Source page: https://510kreport.com/device/K984166
Methodology: https://510kreport.com/methodology