Cleared Traditional

K972790 - THE THERATEST EL-B2GP1 (IGM

K972790 is the FDA 510(k) clearance for THE THERATEST EL-B2GP1 (IGM by Theratest Laboratories, Inc.. It is a Class 2 Immunology device (product code MSV) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K972790 · Theratest Laboratories, Inc. · Immunology device
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Dec 1997
Decision
130d
Days
Class 2
Risk

K972790 is an FDA 510(k) clearance for the THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Chicago, US). The FDA issued a Cleared decision on December 5, 1997 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Theratest Laboratories, Inc. devices

Submission Details

510(k) Number K972790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1997
Decision Date December 05, 1997
Days to Decision 130 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 104d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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)

All 23
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K972790.
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241 · Hemagen Diagnostics, Inc. · Aug 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243 · Hemagen Diagnostics, Inc. · Aug 1999
QUANTA LITE B2 GPI SCREEN
K980230 · Inova Diagnostics, Inc. · Mar 1998
QUANTA LITE B2 GPI IGA
K973006 · Inova Diagnostics, Inc. · Oct 1997
QUANTA LITE B2GPI IGM
K973014 · Inova Diagnostics, Inc. · Oct 1997
QUANTA LITE B2GPI IGG
K970551 · Inova Diagnostics, Inc. · Jun 1997