510(k) Report

510(k) · Cleared

Recalled · 2002

Tina-Quant Rheumatoid Factors II Test System

K002609510(k) TraditionalCleared Sep 5, 200014-day reviewClass II21 CFR 866.5775Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics Corp. · DHR System, Test, Rheumatoid Factor

Cleared on Sep 5, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.

Decided
Sep 5, 2000
Review
14 days
Class
Class II
Product code
DHR
Recalls
1
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK002609 Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp. · 2000
  2. Descendant · cites it directly · 7 of its ownK032535 Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II…Roche Diagnostics Corp. · 2003
  3. Descendant · 2 generations on · 6 of its ownK062035 Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and…Dade Behring, Inc. · 2006
  4. Descendant · 3 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  5. Descendant · 4 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  6. Descendant · 5 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 22006: 12007: 22008: 22009: 12023: 1
2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 9 · See all
  • K032535Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp. · 2003 · cites it directly7descendants
  • K062035Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlDade Behring, Inc. · 2006 · 2 generations on6descendants
  • K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · 3 generations on5descendants
  • K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 4 generations on4descendants
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002609Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp.2000—
+1K032535Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp.2003—
+2K062035Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlDade Behring, Inc.2006—
+3K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
+4K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…Dade Behring, Inc.2007—
+5K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200610
200720
200820
200910
202310
FIG. 1 — Lineage of K002609, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032535Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp.20037
K024067Rheumatoid Factor (RF)Abbott Laboratories20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 30, 2002Not classifiedZ-1030-03OtherTest results may exhibit a positive bias when plasma samples are used for the assay.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K032535 (Roche Diagnostics Corp., 2003) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DHR devices

DHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DHR

1in 2020

2007: 12009: 12010: 12011: 12015: 12016: 12017: 12018: 12019: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

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

2010: 12011: 32012: 22018: 22019: 1
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DHR

2in 2025

2010: 192011: 4002012: 912018: 12024: 32025: 2
2007high 400 (2011) · low 0 (2007)2025

MAUDE reports naming product code DHR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20101—119
20111—3400
20120—291
20130—00
20140—00
20151—00
20161—00
20171—00
20181—21
20191—10
20201—00
20210—00
20220—00
20230—00
20240—03
20250—02
20260—0—

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

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  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

Recent decisions in DHR

The DHR category page

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  • K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc. · 2019
  • K182747EliA RF IgM ImmunoassayPhadia AB · 20181 recall
  • K162263Optilite Rheumatoid Factor KitThe Binding Site Group, Ltd. · 20171 recall
  • K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group, Ltd. · 20162 recalls

https://510kreport.com/device/K002609 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002609: Tina-Quant Rheumatoid Factors II Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002609

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026