# K984625: Architect Folate Masterchek, Model # 6C12-05

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Feb 2, 1999 after 36 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 K950469 (1995). 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)
- K950469: Document Serum Multianalyte Calibration Verification Test Set, Casco Standards (1995) Summary page 1.

## Indications for use
Architect Folate MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Folate assay on the Abbott Architect System.

Source page: https://510kreport.com/device/K984625
Methodology: https://510kreport.com/methodology