510(k) Report

510(k) · Cleared

Cleared

N/T Rheumatology Control SL/1 and SL/2

K962373510(k) TraditionalCleared Jul 11, 199621-day reviewClass II21 CFR 866.5270

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

Behring Diagnostics, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Jul 11, 1996 after a 21-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided
Jul 11, 1996
Review
21 days
Class
Class II
Product code
DCK
Recalls
None
Predicates
0

13 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared1998: 1 descendant cleared1997: 1 descendant cleared2002: 2 descendants cleared2007: 2 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962373 N/T Rheumatology Control SL/1 and SL/2Behring Diagnostics, Inc. · 1996
  2. Descendant · cites it directly · 6 of its ownK062035 Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and…Dade Behring, Inc. · 2006
  3. Descendant · 2 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  4. Descendant · 3 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  5. 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
  6. Descendant · 4 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12002: 22006: 32007: 22008: 22009: 12023: 1
1997high 3 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 13 · 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
0 (this device)K962373N/T Rheumatology Control SL/1 and SL/2Behring Diagnostics, Inc.1996—
+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
199710
199810
200220
200630
200720
200820
200910
202310
FIG. 1 — Lineage of K962373, 1996–2023Source: 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 DCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DCK device

  1. #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*—N/T CRP Control Serum
Named without a submission number
—
*—N/T RF Control Serum
Named without a submission number
—
*—N/T ASL Control Serum
Named without a submission number
—

What descends from it? (13)

See all 13

6 later devices cite 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
K982087Roche CRP T Control NRoche Diagnostic Systems, Inc.19981
K061802Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp…Dade Behring, Inc.20060
K061825Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and…Dade Behring, Inc.20060
K021381Modification to N/T Rheumatology Controls SL 1 & 2Dade Behring, Inc.20020
K973629Precinorm RF, Precipath RFBoehringer Mannheim Corp.19970

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?

  • Of its descendants, K062035 (Dade Behring, Inc., 2006) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DCK devices

DCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCK

1in 2025

2011: 12012: 12015: 22016: 12017: 12019: 22020: 12022: 12025: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCK

Too few DCK 510(k)s in any year since 2007 to give a median.

Recalls per year · DCK

1in 2024

2008: 12009: 12013: 12016: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DCK

1in 2021

2008: 12011: 12012: 12014: 12021: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code DCK, 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
20070—00
20080—11
20090—10
20100—00
20111—01
20121—01
20130—10
20140—01
20152—00
20161—10
20171—00
20180—00
20192—00
20201—00
20210—01
20221—00
20230—00
20240—10
20251—00
20260—0—

What is it indicated for?

Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively.

In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Behring Diagnostics, Inc.

146 FDA decisions under this applicant name. See the company

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997

Recent decisions in DCK

The DCK category page

  • K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC · 2025
  • K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics · 2022
  • K192028Yumizen C1200 CRPHoriba Abx Sas · 2020
  • K192118CRP VarioSENTINEL CH. SpA · 2019
  • K191993Yumizen C1200 CRPHoriba Abx Sas · 2019

https://510kreport.com/device/K962373 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962373: N/T Rheumatology Control SL/1 and SL/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962373

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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