510(k) Report

510(k) · Cleared

Cleared

Toxoplasma Igm Elisa Test System

K913787510(k) TraditionalCleared Dec 18, 1991117-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

Zeus Scientific, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Cleared on Dec 18, 1991 after a 117-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Dec 18, 1991
Review
117 days
Class
Class II
Product code
LGD
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared1990200020102020
  1. This deviceK913787 Toxoplasma Igm Elisa Test SystemZeus Scientific, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK012075 Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000…Diagnostic Products Corp. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K012075Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model…Diagnostic Products Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K913787, 1991–2002Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, 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
K012075Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model…Diagnostic Products Corp.20020

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, K012075 (Diagnostic Products Corp., 2002) has gone furthest, with 0 descendants of its own.

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—

More from Zeus Scientific, Inc.

140 FDA decisions under this applicant name. See the company

  • K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc. · 2022
  • K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemZeus Scientific, Inc. · 2019
  • K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemZeus Scientific, Inc. · 2019
  • K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemZeus Scientific, Inc. · 2019
  • P150045Zeus Elisa Parvovirus B19 Igg Test SystemZeus Scientific, Inc. · 20171 recall

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/K913787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913787: Toxoplasma Igm Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913787

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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