# K002609: Tina-Quant Rheumatoid Factors II Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 5, 2000 after 14 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032535: Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test System (2003), 7 descendants of its own
- K062035: Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control (2006), 6 descendants of its own
- K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an (2007), 5 descendants of its own
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H (2007), 4 descendants of its own
- K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC (2009), 1 descendant of its own

## Recalls of this device
- Sep 30, 2002 · Not classified · Z-1030-03: Test results may exhibit a positive bias when plasma samples are used for the assay.

Source page: https://510kreport.com/device/K002609
Methodology: https://510kreport.com/methodology