# K984074: Architect Total T4 Mastercheck, List NO. 6C49-05

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 20, 1998 after 4 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
- Feb 27, 2008 · Not classified · Z-1570-2008: Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 

## Indications for use
Architect Total T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect / System

Source page: https://510kreport.com/device/K984074
Methodology: https://510kreport.com/methodology