Cleared Traditional

K955303 - DIASTAT ANTI-CARDIOLIPIN KIT

K955303 is an FDA 510(k) clearance for DIASTAT ANTI-CARDIOLIPIN KIT, manufactured by Shield Diagnostics, Ltd.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K955303 · Shield Diagnostics, Ltd. · Immunology device
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May 1996
Decision
192d
Days
Class 2
Risk

K955303 is an FDA 510(k) clearance for the DIASTAT ANTI-CARDIOLIPIN KIT. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on May 30, 1996 after a review of 192 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 Shield Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K955303

510(k) Number K955303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date May 30, 1996
Days to Decision 192 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
87d slower than avg
Panel avg: 105d · This submission: 192d
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 76
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K955303.
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · Hemagen Diagnostics, Inc. · Jun 1997
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
K962926 · American Laboratory Products Co., Ltd. · Oct 1996
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469 · American Laboratory Products Co., Ltd. · Sep 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449 · American Laboratory Products Co., Ltd. · May 1996
CARDIOLIPIN IGM EIA TEST SYSTEM
K952521 · Immunoprobe, Inc. · Feb 1996
CARDIOLIPIN IGA EIA TEST SYSTEM
K952522 · Immunoprobe, Inc. · Feb 1996