Cleared Traditional

K921265 - DIASTAT ANTI-CARDIOLIPIN KIT

K921265 is the FDA 510(k) clearance for DIASTAT ANTI-CARDIOLIPIN KIT by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K921265 · Shield Diagnostics, Ltd. · Immunology device
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Aug 1992
Decision
140d
Days
Class 2
Risk

K921265 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 August 3, 1992 after a review of 140 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K921265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date August 03, 1992
Days to Decision 140 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
36d slower than avg
Panel avg: 104d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K921265.
SYNELISA CARDIOLIPIN ANTIBODIES
K924421 · Elias U.S.A., Inc. · Nov 1992
QUANTA LITE(TM) IGA ACA
K922351 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE ACA SCREEN
K923320 · Inova Diagnostics, Inc. · Sep 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K921250 · Elias U.S.A., Inc. · Jun 1992
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661 · Immuno Concepts, Inc. · Dec 1991
QUANTA LITE(TM) ACA
K911680 · Inova Diagnostics, Inc. · Nov 1991