510(k) Report

510(k) · Cleared

Cleared

Igg Flex Reagent Cartridge

K990551510(k) TraditionalCleared Mar 25, 199931-day reviewClass II21 CFR 866.5510

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

Dade Behring, Inc. · CFQ Radioimmunoassay, Immunoglobulins (G, A, M)

Cleared on Mar 25, 1999 as substantially equivalent to K922273 (Beckman Instruments, Inc., 1992) after a 31-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.

Decided
Mar 25, 1999
Review
31 days
Class
Class II
Product code
CFQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K922273 (1992). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2015: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant clearedK922273 · Array (R) 360 · Beckman Instruments, Inc. · 19921990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K922273 · Array (R) 360 · Beckman Instruments, Inc. · 19920
  1. Root · 1 generation backK922273 Array (R) 360Beckman Instruments, Inc. · 1992
  2. This deviceK990551 Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
  3. Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  5. Descendant · 2 generations on · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · Recalled
  7. Descendant · 3 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22015: 2
2005high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 2 generations on1descendant
  • K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · 2 generations on1descendant
  • K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922273Array (R) 360Beckman Instruments, Inc.1992—
0 (this device)K990551Igg Flex Reagent CartridgeDade Behring, Inc.1999—
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.200532
+2K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+2K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.20063
+2K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics20155
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…Siemens Healthcare Diagnostics20152

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
201520
FIG. 1 — Lineage of K990551, 1992–2015Source: 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.

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  • 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
*K922273Array (R) 360
Summary page 1
…16, 1999 Name of Product: IGG Flex™ Reagent Cartridge FDA Classification Name: Immunoglobulin G Test System Predicate Device: Beckman Array® Immunoglobulin G Method (K922273) Device Description: The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetri…
Beckman Instruments, Inc.1992—

Also cleared against K922273: 7 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055

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.
  • Of its descendants, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 descendants of its own.
  • 7 other devices also cite its predicate K922273.

How does its category compare?

All CFQ devices

CFQ Radioimmunoassay, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFQ

FDA has decided no CFQ device since 2007.

Median 510(k) review, days · CFQ

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

Recalls per year · CFQ

No recall names CFQ since 2007.

Adverse event reports per year · CFQ

1in 2018

2008: 12009: 12012: 32016: 12018: 1
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code CFQ, 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—01
20090—01
20100—00
20110—00
20120—03
20130—00
20140—00
20150—00
20160—01
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.

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

Also cleared against K922273

7 other devices cite the same predicate.

  • K994296Dimension C3 Flex Reagent CartridgeDade Behring, Inc. · 2000
  • K994293Dimension C4 Flex Reagent CartridgeDade Behring, Inc. · 2000
  • K994294Dimension TRNF Flex Reagent CartridgeDade Behring, Inc. · 2000
  • K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000
  • K990552Immunoglobulin a Test SystemDade Behring, Inc. · 1999
  • K990553Igm Flex Reagent CartridgeDade Behring, Inc. · 1999

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in CFQ

The CFQ category page

  • K981786Iga Minineph AntiserumThe Binding Site, Ltd. · 1999
  • K990552Immunoglobulin a Test SystemDade Behring, Inc. · 1999
  • K990553Igm Flex Reagent CartridgeDade Behring, Inc. · 1999
  • K951013Olympus Igg Immunoturbidimetric ReagentOlympus America, Inc. · 1995
  • K951055Olympus Iga Immunoturbidimetric ReagentOlympus America, Inc. · 1995

https://510kreport.com/device/K990551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990551: Igg Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990551

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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