Cleared Traditional

K972790 - THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR

K972790 is an FDA 510(k) clearance for THE THERATEST EL-B2GP1 (IGM, manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K972790

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 105d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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)

All 35
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K972790.
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · Corgenix, Inc. · Dec 1998
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879 · Shield Diagnostics, Ltd. · Oct 1998
QUANTA LITE B2 GPI SCREEN
K980230 · Inova Diagnostics, Inc. · Mar 1998
EL-B2GP1SCR
K973882 · Theratest Laboratories, Inc. · Dec 1997
QUANTA LITE B2 GPI IGA
K973006 · Inova Diagnostics, Inc. · Oct 1997
QUANTA LITE B2GPI IGM
K973014 · Inova Diagnostics, Inc. · Oct 1997