510(k) Report

510(k) · Cleared

Cleared

Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6

K012075510(k) TraditionalCleared Jan 10, 2002192-day reviewClass II21 CFR 866.3780

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

Diagnostic Products Corp. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Cleared on Jan 10, 2002 as substantially equivalent to K923166 (Biomerieux Vitek, Inc., 1993) and 1 other predicate after a 192-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jan 10, 2002
Review
192 days
Class
Class II
Product code
LGD
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K913787 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestorK913787 · Toxoplasma Igm Elisa Test System · Zeus Scientific, Inc. · 199119901992199419961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K913787 · Toxoplasma Igm Elisa Test System · Zeus Scientific, Inc. · 19910
  1. Root · 1 generation backK913787 Toxoplasma Igm Elisa Test SystemZeus Scientific, Inc. · 1991
  2. This deviceK012075 Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000…Diagnostic Products Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913787Toxoplasma Igm Elisa Test SystemZeus Scientific, Inc.1991—
0 (this device)K012075Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm…Diagnostic Products Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
FIG. 1 — Lineage of K012075, 1991–2002Source: 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 LGD? 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 LGD device

  1. #1 K242022 Access Toxo IgGscore 9.7 · 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? (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
*K923166Vidas Toxoplasma Gondii Igm Asssay
Summary page 1
…Los Angeles, CA 90045 (The Quality System of Diagnostic Products Corporation is registered to ISO 9001:19%94) DPC’s Registration Number 2017183 Vidas (ELFA) Toxo IgM (K923166) Zeus Scientific Toxo IgM ELISA Test System (K913787) IMMULITE and IMMULITE 2000 Toxoplasma IgM are clinical devices for use wi…
Biomerieux Vitek, Inc.1993—
*K913787Toxoplasma Igm Elisa Test System
Summary page 1
…ic Products Corporation is registered to ISO 9001:19%94) DPC’s Registration Number 2017183 Vidas (ELFA) Toxo IgM (K923166) Zeus Scientific Toxo IgM ELISA Test System (K913787) IMMULITE and IMMULITE 2000 Toxoplasma IgM are clinical devices for use with their respective IMMULITE and IMMULITE 2000 Automat…
Zeus Scientific, Inc.1991—

Also cleared against K923166: 5 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?

  • None of the 2 ancestors has a recall.
  • 5 other devices also cite its predicate K923166.

How does its category compare?

All LGD devices

LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGD

1in 2025

2008: 22009: 12011: 22013: 22015: 12017: 12022: 12024: 22025: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LGD

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

Recalls per year · LGD

1in 2021

2007: 22008: 12010: 12021: 1
2007high 2 (2007) · low 0 (2009)2026

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

Adverse event reports per year · LGD

89in 2025

2007: 42008: 142009: 912010: 712011: 1152012: 752013: 352014: 222015: 1212016: 1402017: 1732018: 1002019: 592020: 872021: 382022: 732023: 1182024: 812025: 89
2007high 173 (2017) · low 4 (2007)2025

MAUDE reports naming product code LGD, 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—24
20082—114
20091—091
20100—171
20112—0115
20120—075
20132—035
20140—022
20151—0121
20160—0140
20171—0173
20180—0100
20190—059
20200—087
20210—138
20221—073
20230—0118
20242—081
20251—089
20260—0—

What is it indicated for?

IMMULITE® Toxoplasma IgM - For in vitro diagnostic use with the IMMULITE® Analyzers — for the presumptive qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, particularly for women of childbearing age. When performed in conjunction with a Toxoplasma IgG assay, the IMMULITE® Toxoplasma IgM can be used as an aid in the presumptive diagnosis of acute, recent or reactive Toxoplasma gondii infection. This product has not been…

Read the full statement (159 words)

IMMULITE® Toxoplasma IgM - For in vitro diagnostic use with the IMMULITE® Analyzers — for the presumptive qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, particularly for women of childbearing age. When performed in conjunction with a Toxoplasma IgG assay, the IMMULITE® Toxoplasma IgM can be used as an aid in the presumptive diagnosis of acute, recent or reactive Toxoplasma gondii infection. This product has not been cleared/approved by the FDA for blood/plasma donor screening.

IMMULITE® 2000 Toxoplasma IgM - For in vitro diagnostic use with the MMULITE® 2000 Analyzers — for the presumptive qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, particularly for women of childbearing age. When performed in conjunction with a Toxoplasma IgG assay, the IMMULITE® 2000 Toxoplasma IgM can be used as an aid in the presumptive diagnosis of acute, recent or reactive Toxoplasma gondii infection. This product has not been cleared/approved by the FDA for blood/plasma donor screening.

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

Also cleared against K923166

5 other devices cite the same predicate.

  • K233932Alinity i Toxo IgMAbbott Laboratories · 2024
  • K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics · 2017
  • K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control SetBio-Rad Laboratories · 2017
  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic…Biomerieux · 20154 recalls
  • K101946Vidas Toxo Igg AviditybioMerieux, Inc. · 20111 recall

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 LGD

The LGD category page

  • K242022Access Toxo IgGBeckman Coulter, Inc. · 2025
  • K242095Access Toxo IgM IIBeckman Coulter, Inc. · 2024
  • K233932Alinity i Toxo IgMAbbott Laboratories · 2024
  • K210596ARCHITECT Toxo IgGAbbott Laboratories · 2022
  • K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics · 2017

https://510kreport.com/device/K012075 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012075: Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012075

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026