Theratest EL-BETA2GPI (Igm-igg-iga), Theratest EL--BETA2GPI Scr
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092757 FDA 510(k)
- FDA Product Code
- MSV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Theratest El-beta2gpi (Igm-igg-iga), Theratest El--beta2gpi Scr is an in vitro diagnostic test system for human serum that measures IgM, IgG, and IgA autoantibodies against beta 2-glycoprotein I (β2GPI). It is used in clinical laboratories to aid in the diagnosis of antiphospholipid antibody syndrome (APS) or autoimmune thrombotic disorders, such as those secondary to systemic lupus erythematosus.
The device is supplied for use in clinical laboratory settings and has received FDA 510(k) clearance under K092757 with product code MSV. It is classified as a Class 2 device under regulation 866.5660, with a special clearance type and substantially equivalent decision. The device is intended for use by trained laboratory personnel and is not indicated for point-of-care or home use.
Frequently asked questions
What is the Theratest El-beta2gpi test system used for?
The Theratest El-beta2gpi test system is used to measure IgM, IgG, and IgA autoantibodies against beta 2-glycoprotein I (β2GPI) in human serum. It aids in the diagnosis of antiphospholipid antibody syndrome (APS) or autoimmune thrombotic disorders, such as those associated with systemic lupus erythematosus, by detecting specific immune markers linked to these conditions.
Who is intended to use the Theratest El-beta2gpi test system and where is it used?
The device is intended for use by trained laboratory personnel in clinical laboratory settings. It is not indicated for point-of-care or home use, as it requires specialized training and equipment to perform the assay accurately and interpret results within the context of autoimmune disease diagnostics.
What regulatory clearance does the Theratest El-beta2gpi test system have and under what classification?
The Theratest El-beta2gpi test system has received FDA 510(k) clearance under submission K092757. It is classified as a Class 2 medical device under regulation 866.5660, with product code MSV, and was determined to be substantially equivalent to a predicate device through a special clearance pathway.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Theratest El-beta2gpi (Igm-igg-iga), Theratest El--beta2gpi Scr, THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR 510 (k ..., TheraTest | Revenue Enhancement Solutions | United States
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092757 | Class II | Active |
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Manufacturer
- Manufacturer
- Thera-Test Laboratories, Inc
- FDA Applicant
- Thera-Test Laboratories, Inc.
Sources (1)
- FDA 510(k) K092757 24 fields · synced Oct 6, 2026