# K984323: Architect LH Mastercheck, Model Number 6C25-05

- 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). Our OCR of the scanned summary read K850469, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Casco Standards Document Serum Multi-Analyte Verification Test Set”.

## Recalls of this device
- Sep 5, 2008 · Not classified · Z-0216-2009: The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results 

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

Source page: https://510kreport.com/device/K984323
Methodology: https://510kreport.com/methodology