Cleared Traditional

K951487 - DIASTAT ANTI-THYROID PEROXIDASE KIT

K951487 is the FDA 510(k) clearance for DIASTAT ANTI-THYROID PEROXIDASE KIT by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K951487 · Shield Diagnostics, Ltd. · Immunology device
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Jun 1995
Decision
91d
Days
Class 2
Risk

K951487 is an FDA 510(k) clearance for the DIASTAT ANTI-THYROID PEROXIDASE KIT. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on June 30, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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 K951487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1995
Decision Date June 30, 1995
Days to Decision 91 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
13d faster than avg
Panel avg: 104d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 - JZO System, Test, Thyroid Autoantibody

All 41
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K951487.
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695 · Diagnostic Products Corp. · Jan 1997
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · Immco Diagnostics, Inc. · Jun 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · Immco Diagnostics, Inc. · Jun 1996
QUANTA LITE(TM) THYROID M ELISA
K930485 · Inova Diagnostics, Inc. · Mar 1993
ELIAS TGAB
K925922 · Elias U.S.A., Inc. · Jan 1993
ELIAS TMAB
K925923 · Elias U.S.A., Inc. · Jan 1993