510(k) · Cleared
ClearedTinaquant Rheumatoid Factor Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DHR System, Test, Rheumatoid Factor
Cleared on Jun 17, 1997 as substantially equivalent to K850296 (Behring Diagnostics, Inc., 1985) after a 64-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jun 17, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- DHR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K850296 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK850296 Laser RF Test -Rheumatoid Factor (S) ReagentsBehring Diagnostics, Inc. · 1985
- This deviceK971379 Tinaquant Rheumatoid Factor AssayBoehringer Mannheim Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850296 | Laser RF Test -Rheumatoid Factor (S) Reagents | Behring Diagnostics, Inc. | 1985 | — |
| 0 (this device) | K971379 | Tinaquant Rheumatoid Factor Assay | Boehringer Mannheim Corp. | 1997 | — |
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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K850296 | Laser RF Test -Rheumatoid Factor (S) ReagentsSummary page 1…cial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring Laser Rf Test - Rheumatoid Factor (S) Reagents (K850296). Continued on next page page 26 BOEHRINGERLU(K) Summary, Continued MANNHEIM CORPORATION 4. Device Descriptio… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
The Tinaquant Rheumatoid Factor assay is an immunoturbidometric assay for the quantitative determination of rheumatoid factor (antibodies to immunoglobulins) in human serum or plasma using automated clinical chemistry analyzers. Measurement of rheumatoid factor may be used as an aid in the diagnosis of rheumatoid arthritis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971379: Tinaquant Rheumatoid Factor Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971379
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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