# K042335: Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model 6C06-05

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Sep 17, 2004 after 18 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 2 generations back to K950469 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990393: Architect Progesterone Mastercheck Model #6C26-05, Bio-Rad (1999) Summary page 4.

## Indications for use
Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECT | System. Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECT { System.

Source page: https://510kreport.com/device/K042335
Methodology: https://510kreport.com/methodology