Cleared Traditional

K925118 - EN TYPING CIE KIT FOR DIAGNOSTIC USE

K925118 is the FDA 510(k) clearance for EN TYPING CIE KIT FOR DIAGNOSTIC USE by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K925118 · The Binding Site, Ltd. · Immunology device
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Feb 1993
Decision
162d
Days
Class 2
Risk

K925118 is an FDA 510(k) clearance for the EN TYPING CIE KIT FOR DIAGNOSTIC USE. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on February 2, 1993 after a review of 162 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K925118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date February 02, 1993
Days to Decision 162 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
58d slower than avg
Panel avg: 104d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 116
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K925118.
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K924262 · The Binding Site, Ltd. · Dec 1992
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K924898 · Inova Diagnostics, Inc. · Dec 1992
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