510(k) Report

510(k) · Cleared

Cleared

Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2

K003597510(k) TraditionalCleared Feb 5, 200176-day reviewClass II21 CFR 862.1377

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

Diagnostic Products Corp. · LPS Urinary Homocystine (Nonquantitative) Test System

Cleared on Feb 5, 2001 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 5, 2001
Review
76 days
Class
Class II
Product code
LPS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared200020052010201520202025
  1. This deviceK003597 Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model…Diagnostic Products Corp. · 2001
  2. Descendant · cites it directly · 0 of its ownK121533 ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set…Tosoh Bioscience, Inc. · 2012 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K121533ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…Tosoh Bioscience, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003597Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2Diagnostic Products Corp.2001—
+1K121533ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack…Tosoh Bioscience, Inc.20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K003597, 2001–2012Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPS? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K121533ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…Tosoh Bioscience, Inc.20120

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, K121533 (Tosoh Bioscience, Inc., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LPS devices

LPS Urinary Homocystine (Nonquantitative) Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPS

1in 2013

2007: 22008: 22009: 12012: 42013: 1
2007high 4 (2012) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPS

141in 2012

2012: 141 days median
2007high 141 (2012)2026

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

Recalls per year · LPS

1in 2024

2007: 12011: 12012: 12013: 12018: 12019: 42024: 1
2007high 4 (2019) · low 0 (2008)2026

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

Adverse event reports per year · LPS

1in 2024

2014: 12015: 22016: 12017: 82021: 12024: 1
2007high 8 (2017) · low 0 (2007)2025

MAUDE reports naming product code LPS, 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—10
20082—00
20091—00
20100—00
20110—10
2012414110
20131—10
20140—01
20150—02
20160—01
20170—08
20180—10
20190—40
20200—00
20210—01
20220—00
20230—00
20240—11
20250—00
20260—0—

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in LPS

The LPS category page

  • K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc. · 2013
  • K121053Diazyme Homocysteine Poc Test KitDiazyme Laboratories · 2012
  • K121533ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine Control SetTosoh Bioscience, Inc. · 20122 recalls
  • K113793Homocysteine TestRoche · 20123 recalls
  • K112790Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012

https://510kreport.com/device/K003597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003597: Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003597

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026