Cleared Traditional

K030397 - AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

K030397 is an FDA 510(k) clearance for AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA..., manufactured by Hycor Biomedical , Ltd.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K030397 · Hycor Biomedical , Ltd. · Immunology device
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Mar 2003
Decision
43d
Days
Class 2
Risk

K030397 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Hycor Biomedical , Ltd. (Penicuik, Midlothian, GB). The FDA issued a Cleared decision on March 21, 2003 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hycor Biomedical , Ltd. devices

FDA 510(k) Submission Details - K030397

510(k) Number K030397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2003
Decision Date March 21, 2003
Days to Decision 43 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
62d faster than avg
Panel avg: 105d · This submission: 43d
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 36
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K030397.
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
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K031208 · Corgenix, Inc. · Jul 2003
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K031177 · Axis-Shield Diagnostics, Ltd. · Jun 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · Hycor Biomedical, Inc. · Dec 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · Hycor Biomedical, Inc. · Dec 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · Diamedix Corp. · Jan 2002