510(k) Report

510(k) · Cleared

Recalled · 2003

Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg

K000463510(k) TraditionalCleared Jun 1, 2000111-day reviewClass I21 CFR 866.3110Recalls 1

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

Diagnostic Products Corp. · LYR Helicobacter Pylori

Cleared on Jun 1, 2000 after a 111-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Jun 1, 2000
Review
111 days
Class
Class I
Product code
LYR
Recalls
1
Predicates
0

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

Descendants, by year cleared 2016: 1 descendant cleared2004: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK000463 Immulite H. Pylori Igg and Immulite 2000 H. Pylori IggDiagnostic Products Corp. · 2000
  2. Descendant · cites it directly · 1 of its ownK161139 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016
  3. Descendant · 2 generations on · 0 of its ownK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018
  4. Descendant · cites it directly · 0 of its ownK041238 Helicobacter Pylori Igg ElisaBiohit Plc · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016 · cites it directly1descendant
  • K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018 · 2 generations on0descendants
  • K041238Helicobacter Pylori Igg ElisaBiohit Plc · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000463Immulite H. Pylori Igg and Immulite 2000 H. Pylori IggDiagnostic Products Corp.2000—
+1K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc.2016—
+2K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.2018—
+1K041238Helicobacter Pylori Igg ElisaBiohit Plc2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201610
201810
FIG. 1 — Lineage of K000463, 2000–2018Source: 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 LYR? 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 LYR device

  1. #1 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (3)

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

NumberDeviceApplicantDecidedDescendants
K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc.20161
K041238Helicobacter Pylori Igg ElisaBiohit Plc20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 31, 2003Not classifiedZ-1219-03OtherKits had parts in them that did not belong in the kit.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K161139 (DiaSorin, Inc., 2016) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LYR devices

LYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYR

2in 2023

2012: 22015: 22016: 22018: 42019: 12020: 12023: 2
2007high 4 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYR

86in 2018

2018: 86 days median
2007high 86 (2018)2026

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

Recalls per year · LYR

2in 2025

2008: 22010: 12022: 32023: 12025: 2
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LYR

2in 2023

2010: 12011: 22015: 22016: 42017: 12020: 42021: 12023: 2
2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code LYR, 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
20080—20
20090—00
20100—11
20110—02
20122—00
20130—00
20140—00
20152—02
20162—04
20170—01
201848600
20191—00
20201—04
20210—01
20220—30
20232—12
20240—00
20250—20
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 LYR

The LYR category page

  • K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023
  • K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
  • K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc. · 2020
  • K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc. · 2019
  • K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018

https://510kreport.com/device/K000463 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000463: Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000463

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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