510(k) · Cleared

Cleared

Access Immunoassay System Toxo Igm II Assay

K031506510(k) SpecialCleared Jun 2, 200319-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

Beckman Coulter, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Cleared on Jun 2, 2003 as substantially equivalent to K003259 (Beckman Coulter, Inc., 2001) after a 19-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jun 2, 2003
Review: 19 days
Class: Class II
Product code: LGD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003259 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003259 Access Toxo Igm II Reagents for Use on the Access Immunoassay…Beckman Coulter, Inc. · 2001
This deviceK031506 Access Immunoassay System Toxo Igm II AssayBeckman Coulter, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003259	Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model…	Beckman Coulter, Inc.	2001	—
0 (this device)	K031506	Access Immunoassay System Toxo Igm II Assay	Beckman Coulter, Inc.	2003	—

FIG. 1 — Lineage of K031506, 2001–2003Source: 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
*	K003259	Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model… Summary page 1 …~~ Legally Marketed (Unmodified) Access Toxo IgM I1 Reagents for use on the Access Device Immunoassay System (K003259, cleared 6113/01) Device Description The Access Toxo IgM II reagents consist of reagent packs, controls, QC, substrate and wash…	Beckman Coulter, Inc.	2001	—
†	K023764	Unicel Dxi 800 Access Immunoassay System, Model 973100	Beckman Coulter, Inc.	2003	31

Also cleared against K003259: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K003259.

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

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 Access Toxo IgM II assay is a paramagnetic-particle,chemiluminescent immunoassay for the qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma, using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031506 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031506: Access Immunoassay System Toxo Igm II Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031506

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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