# K041863: Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FS

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 20, 2004 after 73 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
Longest line of descent: 1 generation back to K000534 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K000534: Cobas Integra Reagent Cassette for Rheumatoid Factor II, Roche Diagnostics Corp. (2000) Summary page 3.

## Cited in the summary but kept off the family tree
- K904768: Kodatrol I and II Control and Diluent Set, Eastman Kodak Company (1990). Our reading of the summary gave K904768, FDA’s number for Kodatrol I and II Control and Diluent Set (Eastman Kodak Company). Its FDA name has none of the distinctive words the summary uses for the device it names, “VITROS Chemistry Products Performance Verifiers I and II”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K052645: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873; (2005), 1 descendant of its own
- K060650: Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702 (2006), 0 descendants of its own

## Recalls of this device
- Nov 10, 2011 · Not classified · Z-0714-2012: Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator I to calibrate VITROS 5,F FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF). For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K041863
Methodology: https://510kreport.com/methodology