510(k) · Cleared
Recalled · 2011Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DHR System, Test, Rheumatoid Factor
Cleared on Sep 20, 2004 as substantially equivalent to K000534 (Roche Diagnostics Corp., 2000) after a 73-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 20, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- DHR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000534 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000534 Cobas Integra Reagent Cassette for Rheumatoid Factor IIRoche Diagnostics Corp. · 2000
- This deviceK041863 Vitros Chemistry Products RF Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK052645 Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros…Ortho-Clinical Diagnostics · 2005
- Descendant · 2 generations on · 0 of its ownK060650 Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros…Ortho-Clinical Diagnostics, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See all- K052645Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS…Ortho-Clinical Diagnostics · 2005 · cites it directly1descendant
- K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000534 | Cobas Integra Reagent Cassette for Rheumatoid Factor II | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K041863 | Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | K052645 | Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry… | Ortho-Clinical Diagnostics | 2005 | — |
| +2 | K060650 | Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000534 | Cobas Integra Reagent Cassette for Rheumatoid Factor IISummary page 3…valent to the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay (predicate device) which was cleared by the FDA (K000534) for IVD use. The relationship between the VITROS RF and the predicate device, determined… | 2000 |
| Kept off the family tree | K904768 | FDA’s K904768 is Kodatrol I and II Control and Diluent Set 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…substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use. Table 2 lists the similarities and differences of the device chara… | 1990 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052645 | Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS… | 2005 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2011 | Not classified | Z-0714-2012 | Nonconforming Material/Component | Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K052645 (Ortho-Clinical Diagnostics, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHR
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · DHR
Too few DHR 510(k)s in any year since 2007 to give a median.
Recalls per year · DHR
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHR
2in 2025
MAUDE reports naming product code DHR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 19 |
| 2011 | 1 | — | 3 | 400 |
| 2012 | 0 | — | 2 | 91 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 2 | 1 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041863: Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041863
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026