# K984324: Architect Prolactin Mastercheck, Model Number 6C27-05

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 15, 1998 after 12 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 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.

## Recalls of this device
- Jul 6, 2007 · Not classified · Z-1222-2007: The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested to

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

Source page: https://510kreport.com/device/K984324
Methodology: https://510kreport.com/methodology