Cleared Traditional

K925118 - EN TYPING CIE KIT FOR DIAGNOSTIC USE

K925118 is an FDA 510(k) clearance for EN TYPING CIE KIT FOR DIAGNOSTIC USE, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K925118

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
57d slower than avg
Panel avg: 105d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

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 146
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K925118.
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