510(k) Report

510(k) · Cleared

Cleared

Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test System

K032535510(k) SpecialCleared Sep 10, 200323-day reviewClass II21 CFR 866.5775

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 10, 2003 as substantially equivalent to K002609 (Roche Diagnostics Corp., 2000) after a 23-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided
Sep 10, 2003
Review
23 days
Class
Class II
Product code
DHR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002609 (2000). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 2 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant clearedK002609 · Tina-Quant Rheumatoid Factors II Test System · Roche Diagnostics Corp. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 2 descendants K002609 · Tina-Quant Rheumatoid Factors II Test System · Roche Diagnostics Corp. · 2000 · recalled0+5
  1. Root · 1 generation backK002609 Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp. · 2000 · Recalled
  2. This deviceK032535 Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II…Roche Diagnostics Corp. · 2003
  3. Descendant · cites it directly · 6 of its ownK062035 Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and…Dade Behring, Inc. · 2006
  4. Descendant · 2 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  5. Descendant · 3 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  6. Descendant · 4 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
  7. Descendant · 4 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 12023: 1
2006high 2 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K062035Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlDade Behring, Inc. · 2006 · cites it directly6descendants
  • K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · 2 generations on5descendants
  • K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 3 generations on4descendants
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 4 generations on1descendant
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002609Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp.20001
0 (this device)K032535Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp.2003—
+1K062035Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlDade Behring, Inc.2006—
+2K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
+3K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…Dade Behring, Inc.2007—
+4K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092
+4K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200910
202310
FIG. 1 — Lineage of K032535, 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), 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K002609Tina-Quant Rheumatoid Factors II Test System
Summary page 1
…rheumatoid arthritis. Predicate We claim substantial equivalence to the currently marketed Tina-quant@ Device Rheumatoid Factors I1 Test System. (K002609). 24…
Roche Diagnostics Corp.20001

Also cleared against K002609: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062035Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlDade Behring, Inc.20066

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 a recall.
  • Of its descendants, K062035 (Dade Behring, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K002609.

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—

What is it indicated for?

Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis.

Indications for use as stated in the FDA summary.

Also cleared against K002609

1 other device cites the same predicate.

  • K024067Rheumatoid Factor (RF)Abbott Laboratories · 2003

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • 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

  • K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical Company · 2020
  • 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/K032535 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032535: Modification to:Roche Diagnostics 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/K032535

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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