Cleared Traditional

K946216 - CARDIOLIPIN A EIA TEST SYSTEM

K946216 is an FDA 510(k) clearance for CARDIOLIPIN A EIA TEST SYSTEM, manufactured by Hogan & Hartson. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K946216 · Hogan & Hartson · Immunology device
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Jan 1996
Decision
399d
Days
Class 2
Risk

K946216 is an FDA 510(k) clearance for the CARDIOLIPIN A EIA TEST SYSTEM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on January 24, 1996 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hogan & Hartson devices

FDA 510(k) Submission Details - K946216

510(k) Number K946216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date January 24, 1996
Days to Decision 399 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
295d slower than avg
Panel avg: 104d · This submission: 399d
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 55
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K946216.
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
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · Elias U.S.A., Inc. · Oct 1995
QUANTA LITE IGA ACA (HRP)
K953366 · Inova Diagnostics, Inc. · Sep 1995
QUANTA LITE ACA SCREEN (HRP)
K953291 · Inova Diagnostics, Inc. · Aug 1995