Cleared Special

K092757 - THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR

K092757 is an FDA 510(k) clearance for THERATEST EL-BETA2GPI (IGM-IGG-IGA), manufactured by Thera-Test Laboratories, Inc.. The device is a Class 2 Immunology device with product code MSV cleared through the Special 510(k) pathway after a 30-day FDA review.

K092757 · Thera-Test Laboratories, Inc. · Immunology device
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Oct 2009
Decision
30d
Days
Class 2
Risk

K092757 is an FDA 510(k) clearance for the THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Thera-Test Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092757

510(k) Number K092757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date October 09, 2009
Days to Decision 30 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 105d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MSV Device Classification - Class 2, Special Controls

Product Code MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

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K092757 · THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
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