510(k) Report

510(k) · Cleared

Cleared

N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator

K962186510(k) TraditionalCleared Aug 19, 199674-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 Aug 19, 1996 after a 74-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.

Decided
Aug 19, 1996
Review
74 days
Class
Class I
Product code
LBR
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2012: 3 descendants cleared1995200020052010201520202025
  1. This deviceK962186 N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp. · 1996
  2. Descendant · cites it directly · 3 of its ownK971526 Ace HDL-C ReagentSchiapparelli Biosystems, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK113262 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  4. Descendant · 3 generations on · 0 of its ownK122757 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  5. Descendant · 2 generations on · 0 of its ownK112538 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  6. Descendant · cites it directly · 0 of its ownK971190 N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp. · 1997

Most influential descendants

Showing 5 of 5 · See all
  • K971526Ace HDL-C ReagentSchiapparelli Biosystems, Inc. · 1997 · cites it directly3descendants
  • K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012 · 2 generations on1descendant
  • K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012 · 3 generations on0descendants
  • K112538Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012 · 2 generations on0descendants
  • K971190N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962186N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp.1996—
+1K971526Ace HDL-C ReagentSchiapparelli Biosystems, Inc.1997—
+2K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+3K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+2K112538Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+1K971190N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
201230
FIG. 1 — Lineage of K962186, 1996–2012Source: 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 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
Get a 510(k) Report

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
*—Phosphotungstic Acid MgCl₂ (PTA) precipitation method
Named without a submission number
—

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K971526Ace HDL-C ReagentSchiapparelli Biosystems, Inc.19973
K971190N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme 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, K971526 (Schiapparelli Biosystems, Inc., 1997) has gone furthest, with 3 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?

The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human 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.

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/K962186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962186: N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962186

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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