# K963048: Immage System Rheumatoid Factor (RF) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Nov 4, 1996 after 90 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: 1 generation back to K942328 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942328: N Latex RF, Behring Diagnostics, Inc. (1994) Summary page 1.

## Most influential descendants
- K971602: Array Systems Rheumatoid Factor (Rfmpe) Reagent (1997), 0 descendants of its own
- K971788: Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF Calibrator (1997), 0 descendants of its own

## Recalls of this device
- Jan 27, 2012 · Class II · Z-0003-2013: The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lot
- May 31, 2011 · Not classified · Z-2887-2011: The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.

## Indications for use
The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

Source page: https://510kreport.com/device/K963048
Methodology: https://510kreport.com/methodology