510(k) · Cleared

Cleared

Advia Centaur Toxoplasma Igg (Toxo G)

K102681510(k) TraditionalCleared May 4, 2011229-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

Siemens Healthcare Diagnostics, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Cleared on May 4, 2011 as substantially equivalent to K012183 (Bayer Diagnostics Corp., 2001) after a 229-day review. Its family tree reaches back 2 generations to 1993.

Decided: May 4, 2011
Review: 229 days
Class: Class II
Product code: LGD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K922737 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK922737 Vidas Toxo IG6 Assay (TX6)Biomerieux Vitek, Inc. · 1993
1 generation backK012183 Bayer Diagnostics Advia Centaur Toxoplasma Igg AssayBayer Diagnostics Corp. · 2001
This deviceK102681 Advia Centaur Toxoplasma Igg (Toxo G)Siemens Healthcare Diagnostics, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922737	Vidas Toxo IG6 Assay (TX6)	Biomerieux Vitek, Inc.	1993	—
−1	K012183	Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay	Bayer Diagnostics Corp.	2001	—
0 (this device)	K102681	Advia Centaur Toxoplasma Igg (Toxo G)	Siemens Healthcare Diagnostics, Inc.	2011	—

FIG. 1 — Lineage of K102681, 1993–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K242022 Access Toxo IgGscore 9.7 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K012183	Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay Summary page 1 …Assay Manufacturer- Siemens Healthcare Diagnostics Inc. (previously Bayer Diagnostics Corp.) 510(k) Number- K012183 Siemens Healthcare Diagnostics Inc., Tarrytown, NY Page 1 of 4 Special 51 0(k) for ADVIA Centaur…	Bayer Diagnostics Corp.	2001	—

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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
None of the 2 ancestors has a recall.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · LGD

1in 2025

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	4
2008	2	—	1	14
2009	1	—	0	91
2010	0	—	1	71
2011	2	—	0	115
2012	0	—	0	75
2013	2	—	0	35
2014	0	—	0	22
2015	1	—	0	121
2016	0	—	0	140
2017	1	—	0	173
2018	0	—	0	100
2019	0	—	0	59
2020	0	—	0	87
2021	0	—	1	38
2022	1	—	0	73
2023	0	—	0	118
2024	2	—	0	81
2025	1	—	0	89
2026	0	—	0	—

What is it indicated for?

The AD VIA Centaur Toxoplasma lgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of lgG antibodies to the Toxoplasma gondil parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma lgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102681: Advia Centaur Toxoplasma Igg (Toxo G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102681

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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