# K971788: Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jun 3, 1997 after 20 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942328 (1994). 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)
- K963048: Immage System Rheumatoid Factor (RF) Reagent, Beckman Instruments, Inc. (1996). Our OCR of the scanned summary read K963043, FDA’s number for Endospot (Corin USA). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “IMMAGE Immunochemistry System Rheumatoid Factor (RF) Reagent Test…”.

## Recalls of this device
- Jun 20, 2011 · Not classified · Z-1194-2012: The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures.
- Jun 21, 2010 · Not classified · Z-1743-2011: The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot M907325 will not remain stable to the labeled expiration date.

## Indications for use
The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent , in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.

Source page: https://510kreport.com/device/K971788
Methodology: https://510kreport.com/methodology