# K990026: Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jan 29, 1999 after 24 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: 1 generation back to K973517 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973517: Vitros Immunodiagnostic Products Range Verifiers, Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 1.

## Most influential descendants
- K013900: Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers (2001), 0 descendants of its own

## Indications for use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of folate in human serum, plasma (heparin) and whole blood. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of vitamin B12 in human serum and plasma [EDTA or heparin].

Source page: https://510kreport.com/device/K990026
Methodology: https://510kreport.com/methodology