510(k) Report

510(k) · Cleared

Cleared

N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set

K971573510(k) TraditionalCleared Jun 18, 199749-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

Genzyme Corp. · LBR Ldl & Vldl Precipitation, Hdl

Cleared on Jun 18, 1997 after a 49-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.

Decided
Jun 18, 1997
Review
49 days
Class
Class I
Product code
LBR
Recalls
None
Predicates
0

21 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared1999: 1 descendant cleared2006: 2 descendants cleared2011: 3 descendants cleared2008: 2 descendants cleared2005: 1 descendant cleared2024: 1 descendant cleared2007: 1 descendant cleared2012: 4 descendants cleared2009: 1 descendant cleared2015: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
  2. Descendant · cites it directly · 8 of its ownK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
  3. Descendant · 2 generations on · 4 of its ownK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
  4. Descendant · cites it directly · 4 of its ownK991733 Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 1999
  5. Descendant · cites it directly · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1999: 12002: 22005: 12006: 22007: 12008: 22009: 12011: 32012: 42014: 12015: 12023: 12024: 1
1999high 4 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all
  • K020724Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Dade Behring, Inc. · 2002 · cites it directly8descendants
  • K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008 · 2 generations on4descendants
  • K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 1999 · cites it directly4descendants
  • K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · cites it directly3descendants
  • K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971573N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator…Genzyme Corp.1997—
+1K020724Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Dade Behring, Inc.2002—
+2K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience2008—
+1K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc.1999—
+1K060854Abx Pentra 400: LipoproteinsHoriba Abx20062
+3K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200220
200510
200620
200710
200820
200910
201130
201240
201410
201510
202310
202410
FIG. 1 — Lineage of K971573, 1997–2024Source: 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 LBR? 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? (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
*—Direct LDL Cholesterol Immunoseparation Reagent
Named without a submission number
—
*—B-Quantification methods
Named without a submission number
—

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K020724Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Dade Behring, Inc.20028
K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc.19994
K060854Abx Pentra 400: LipoproteinsHoriba Abx20063
K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110
K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics20080
K043264LDL-EX Seiken Assay KitDenka Seiken Co., Ltd.20050
K014103Synchron Systems Direct LDL Chloesterol Reagent and CalibratorBeckman Coulter, Inc.20020

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, K020724 (Dade Behring, Inc., 2002) has gone furthest, with 8 descendants of its own.

How does its category compare?

All LBR devices

LBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBR

1in 2015

2008: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBR

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

Recalls per year · LBR

1in 2018

2009: 42016: 12018: 1
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LBR

8in 2025

2007: 12008: 12011: 12012: 12016: 12019: 22021: 12022: 22023: 22024: 12025: 8
2007high 8 (2025) · low 0 (2009)2025

MAUDE reports naming product code LBR, 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—01
20081—01
20090—40
20100—00
20110—01
20120—01
20130—00
20140—00
20151—00
20160—11
20170—00
20180—10
20190—02
20200—00
20210—01
20220—02
20230—02
20240—01
20250—08
20260—0—

What is it indicated for?

Reagents:

For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C)

in human serum or plasma.

Calibrators:

For the calibration of the N-geneous™ LDL Cholesterol assay in serum or plasma.

Controls:

To monitor the performance of Genzyme LDL Cholesterol Reagents.

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

More from Genzyme Corp.

38 FDA decisions under this applicant name. See the company

Recent decisions in LBR

The LBR category page

  • K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo) · 2015
  • K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics · 2008
  • K050823Direct HDL Cholesterol and Direct HDL/LDL CalibratorTeco Diagnostics · 2005
  • K023784Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerHemagen Diagnostics, Inc. · 2002
  • K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 20011 recall

https://510kreport.com/device/K971573 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971573

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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