510(k) Report

510(k) · Cleared

Cleared

Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131

K020724510(k) TraditionalCleared May 9, 200264-day reviewClass I21 CFR 862.1475

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

Dade Behring, Inc. · MRR System, Test, Low Density, Lipoprotein

Cleared on May 9, 2002 as substantially equivalent to K971573 (Genzyme Corp., 1997) after a 64-day review. Its family tree reaches back 1 generation to 1997. 8 later devices descend from it.

Decided
May 9, 2002
Review
64 days
Class
Class I
Product code
MRR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K971573 (1997). 8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared2008: 1 descendant cleared2006: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant clearedK971573 · N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set · Genzyme Corp. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K971573 · N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set · Genzyme Corp. · 19970
  1. Root · 1 generation backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
  2. This deviceK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
  3. Descendant · cites it directly · 4 of its ownK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
  4. Descendant · 2 generations on · 2 of its ownK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
  5. Descendant · 3 generations on · 1 of its ownK113830 Vantera Clinical AnalyzerLiposcience · 2012
  6. Descendant · cites it directly · 1 of its ownK061655 Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · Recalled
  7. Descendant · cites it directly · 0 of its ownK241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol…Siemens Healthcare Diagnostics, Inc. · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12011: 12012: 12014: 12015: 12023: 12024: 1
2006high 1 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008 · cites it directly4descendants
  • K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011 · 2 generations on2descendants
  • K113830Vantera Clinical AnalyzerLiposcience · 2012 · 3 generations on1descendant
  • K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc. · 2006 · cites it directly1descendant
  • K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971573N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator…Genzyme Corp.1997—
0 (this device)K020724Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Dade Behring, Inc.2002—
+1K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience2008—
+2K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc.2011—
+3K113830Vantera Clinical AnalyzerLiposcience2012—
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20067
+1K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201110
201210
201410
201510
202310
202410
FIG. 1 — Lineage of K020724, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MRR? 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 MRR device

  1. #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K971573N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL…
Summary page 1
…tomated LDL Cholesterol Flex® reagent cartridge method FDA Classification Name: Lipoprotein test system Predicate Device: The Genzyme N-geneous™ LDL-Cholesterol assay (K971573) and the Beta-Quantification reference method utilized by the Cholesterol Reference Method Laboratory Network (CRMLN). Device De…
Genzyme Corp.1997—
*—Beta-Quantification reference method utilized by the Cholesterol Reference Method…
Named without a submission number
—

Also cleared against K971573: 6 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience20084
K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.20061
K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.20240

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, K063841 (Liposcience, 2008) has gone furthest, with 4 descendants of its own.
  • 6 other devices also cite its predicate K971573.

How does its category compare?

All MRR devices

MRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRR

1in 2024

2008: 12009: 22017: 12023: 12024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRR

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

Recalls per year · MRR

1in 2025

2008: 22018: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MRR

1in 2024

2011: 32017: 32018: 22020: 12021: 12022: 12023: 12024: 1
2007high 3 (2011) · low 0 (2007)2025

MAUDE reports naming product code MRR, 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
20081—20
20092—00
20100—00
20110—03
20120—00
20130—00
20140—00
20150—00
20160—00
20171—03
20180—12
20190—00
20200—01
20210—01
20220—01
20231—01
20241—01
20250—10
20260—0—

What is it indicated for?

The Dade Behring Dimension® Automated LDL Cholesterol Flex® reagent cartridge method is an in vitro diagnostic test intended for the quantitative determination of low-density lipoprotein cholesterol in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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 K971573

6 other devices cite the same predicate.

  • K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G Calibrator, Elitrol II &…Elitechgroup Seppim S.A.S. · 2011
  • K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics · 2008
  • K060854Abx Pentra 400: LipoproteinsHoriba Abx · 20062 recalls
  • K043264LDL-EX Seiken Assay KitDenka Seiken Co., Ltd. · 2005
  • K014103Synchron Systems Direct LDL Chloesterol Reagent and CalibratorBeckman Coulter, Inc. · 20021 recall
  • K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, 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 MRR

The MRR category page

  • K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc. · 2024
  • K210801AXINON® LDL-p Test SystemNumares AG · 2023
  • K161691Direct LDL Cholesterol (LDL)Randox Laboratories Limited · 2017
  • K091333S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc. · 2009
  • K090734Easyra DLDL Reagent, Calibrator; Easyqc Chemistry NO Electrolytes, with ElectrolytesMedica Corp. · 2009

https://510kreport.com/device/K020724 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020724: Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020724

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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