510(k) · Cleared
ClearedBayer Diagnostics Advia Centaur Toxoplasma Igg Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Dec 27, 2001 as substantially equivalent to K922737 (Biomerieux Vitek, Inc., 1993) after a 168-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Dec 27, 2001
- Review
- 168 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922737 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK922737 Vidas Toxo IG6 Assay (TX6)Biomerieux Vitek, Inc. · 1993
- This deviceK012183 Bayer Diagnostics Advia Centaur Toxoplasma Igg AssayBayer Diagnostics Corp. · 2001
- Descendant · cites it directly · 0 of its ownK102681 Advia Centaur Toxoplasma Igg (Toxo G)Siemens Healthcare Diagnostics, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102681Advia Centaur Toxoplasma Igg (Toxo G)Siemens Healthcare Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922737 | Vidas Toxo IG6 Assay (TX6) | Biomerieux Vitek, Inc. | 1993 | — |
| 0 (this device) | K012183 | Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay | Bayer Diagnostics Corp. | 2001 | — |
| +1 | K102681 | Advia Centaur Toxoplasma Igg (Toxo G) | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K922737 | Vidas Toxo IG6 Assay (TX6)Summary page 1…e Information Manufacturer: Device Description Bayer Diagnostics ADVIA Centaur Toxoplasma IgG Immunoassay, Toxoplasma Gondii Class I 21 CFR 866. 3780 Vidas TOXO IgG K922737 bioMerieux Toxoplasma gondii is an intracellular parasitic protozoan that affects birds and mammals, with cats being the primary… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102681 | Advia Centaur Toxoplasma Igg (Toxo G) | 2011 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K102681 (Siemens Healthcare Diagnostics, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LGD devicesLGD 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGD
89in 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 ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct chemiluminometric immunoassay for the quantitative or qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur System. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's serological response from individuals including women of childbearing age. This…
Read the full statement (116 words)
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody
capture microparticle direct chemiluminometric immunoassay for the quantitative or
qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum
or plasma (EDTA, heparin) using the ADVIA Centaur System. The measurement of
Toxoplasma IgG may be used to aid in the assessment of a patient's serological response
from individuals including women of childbearing age. This assay may also be utilized
with an IgM Toxoplasma result to determine recent serological response to Toxoplasma..
Testing should not be performed as a screening procedure for the general population.
This assay has not been cleared or approved by the FDA for the screening of blood or
plasma donors.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012183: Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012183
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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