510(k) · Cleared

Cleared

Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCR

K092757510(k) SpecialCleared Oct 9, 200930-day reviewClass II21 CFR 866.5660

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

Thera-Test Laboratories, Inc. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Cleared on Oct 9, 2009 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Oct 9, 2009
Review: 30 days
Class: Class II
Product code: MSV
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K092757Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MSV? 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 MSV device

#1 K243979 Aptiva APS IgA Reagentscore 10.8 · 1 generation · no Class I recall

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All MSV devices

MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MSV

1in 2018

2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSV

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

Recalls per year · MSV

No recall names MSV since 2007.

Adverse event reports per year · MSV

No MAUDE report names MSV since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	1	—	0
2010	1	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	0	—	0
2015	2	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The TheraTest EL-f32GPI TM (IgM-IgG-IgA) is a set of in vitro diagnostic tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against serum beta 2-glycoprotein I (p32GPI). This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus. The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the…

Read the full statement (108 words)

The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the screening for autoantibodies in human serum directed against the serum glycoprotein beta 2-glycoprotein I (p32GPI). This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K092757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092757: Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092757

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026