Cleared Traditional

K920616 - DIASTAT ANTI-HISTONE KIT

K920616 is the FDA 510(k) clearance for DIASTAT ANTI-HISTONE KIT by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K920616 · Shield Diagnostics, Ltd. · Immunology device
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Jul 1992
Decision
154d
Days
Class 2
Risk

K920616 is an FDA 510(k) clearance for the DIASTAT ANTI-HISTONE KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on July 14, 1992 after a review of 154 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 K920616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date July 14, 1992
Days to Decision 154 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
50d slower than avg
Panel avg: 104d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 39
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K920616.
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K924087 · Bio-Rad Laboratories, Inc. · Nov 1992
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K915272 · Hemagen Diagnostics, Inc. · Mar 1992
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K894894 · Diamedix Corp. · Aug 1989