Cleared Traditional

K952521 - CARDIOLIPIN IGM EIA TEST SYSTEM

K952521 is an FDA 510(k) clearance for CARDIOLIPIN IGM EIA TEST SYSTEM, manufactured by Immunoprobe, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K952521 · Immunoprobe, Inc. · Immunology device
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Feb 1996
Decision
253d
Days
Class 2
Risk

K952521 is an FDA 510(k) clearance for the CARDIOLIPIN IGM EIA TEST SYSTEM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Immunoprobe, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on February 9, 1996 after a review of 253 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 Immunoprobe, Inc. devices

FDA 510(k) Submission Details - K952521

510(k) Number K952521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1995
Decision Date February 09, 1996
Days to Decision 253 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 105d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
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 - MID System, Test, Anticardiolipin Immunological

All 74
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K952521.
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469 · American Laboratory Products Co., Ltd. · Sep 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · Shield Diagnostics, Ltd. · May 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449 · American Laboratory Products Co., Ltd. · May 1996
CARDIOLIPIN G EIA TEST SYSTEM
K946215 · Hogan & Hartson · Jan 1996
CARDIOLIPIN A EIA TEST SYSTEM
K946216 · Hogan & Hartson · Jan 1996
CARDIOLIPIN M EIA TEST SYSTEM
K946217 · Hogan & Hartson · Jan 1996