510(k) Report

510(k) · Cleared

Cleared

Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol Calibrator

K032932510(k) TraditionalCleared Mar 10, 2004170-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

Stanbio Laboratory · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Cleared on Mar 10, 2004 as substantially equivalent to K000568 (Roche Diagnostics Corp., 2000) after a 170-day review. Its family tree reaches back 1 generation to 2000.

Decided
Mar 10, 2004
Review
170 days
Class
Class I
Product code
LBS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000568 (2000). No later device cites it as a predicate yet.

K000568 · HDL Cholesterol Plus · Roche Diagnostics Corp. · 20002000200220042006
K000568 · HDL Cholesterol Plus · Roche Diagnostics Corp. · 20000
  1. Root · 1 generation backK000568 HDL Cholesterol PlusRoche Diagnostics Corp. · 2000
  2. This deviceK032932 Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol…Stanbio Laboratory · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000568HDL Cholesterol PlusRoche Diagnostics Corp.2000—
0 (this device)K032932Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol CalibratorStanbio Laboratory2004—
FIG. 1 — Lineage of K032932, 2000–2004Source: 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 LBS? 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
*K000568HDL Cholesterol Plus
Summary page 1
…alence of Device The Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system (Stanbio) is substantially equivalent to HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche). Description of )evice The device is a system using the reagent and…
Roche Diagnostics Corp.2000—
*—HDL/LDL Cholesterol Plus Calibrator (Roche)
Named without a submission number
—

Also cleared against K000568: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 2 other devices also cite its predicate K000568.

How does its category compare?

All LBS devices

LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBS

2in 2016

2007: 22008: 32010: 22011: 32012: 12014: 12016: 2
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBS

118in 2011

2008: 129 days median2011: 118 days median
2007high 129 (2008) · low 118 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LBS

1in 2013

2008: 12012: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LBS

6in 2025

2010: 22011: 32016: 12017: 42019: 22020: 12021: 12022: 22023: 52024: 22025: 6
2007high 6 (2025) · low 0 (2007)2025

MAUDE reports naming product code LBS, 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
20072—00
2008312910
20090—00
20102—02
2011311803
20121—10
20130—10
20141—00
20150—00
20162—01
20170—04
20180—00
20190—02
20200—01
20210—01
20220—02
20230—05
20240—02
20250—06
20260—0—

What is it indicated for?

Direct HDL Cholesterol LiquiColor ® and Direct HDL'LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma.

HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

Indications for use as stated in the FDA summary.

Also cleared against K000568

2 other devices cite the same predicate.

  • K033610HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2003
  • K014018Cholesterol 1, 2, 3Imi · 2002

More from Stanbio Laboratory

47 FDA decisions under this applicant name. See the company

  • K090093Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemStanbio Laboratory · 2009
  • K081719Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemStanbio Laboratory · 20081 recall
  • K050283Creatinine LiquicolorStanbio Laboratory · 2005
  • K050266Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory · 2005
  • K042169Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerStanbio Laboratory · 2005

Recent decisions in LBS

The LBS category page

  • K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo) · 2016
  • K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd. · 2016
  • K132711Carolina Liquid Chemistries HDL Cholesterol ReagentCarolina Liquid Chemistries Corp. · 2014
  • K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 20121 recall
  • K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011

https://510kreport.com/device/K032932 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032932: Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032932

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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