Cleared Traditional

K030702 - IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

K030702 is an FDA 510(k) clearance for IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2G..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K030702 · Immco Diagnostics, Inc. · Immunology device
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Sep 2003
Decision
187d
Days
Class 2
Risk

K030702 is an FDA 510(k) clearance for the IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 9, 2003 after a review of 187 days - an extended review 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: 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K030702

510(k) Number K030702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date September 09, 2003
Days to Decision 187 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
82d slower than avg
Panel avg: 105d · This submission: 187d
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 45
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K030702.
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
K040451 · Pharmacia Deutschland GmbH · May 2004
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
K040452 · Pharmacia Deutschland GmbH · May 2004
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · Immco Diagnostics, Inc. · Sep 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · Corgenix, Inc. · Jul 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · Axis-Shield Diagnostics, Ltd. · Jun 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
K030397 · Hycor Biomedical , Ltd. · Mar 2003