Cleared Traditional

K010148 - ENA SCREEN EIA KIT

K010148 is the FDA 510(k) clearance for ENA SCREEN EIA KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K010148 · The Binding Site, Ltd. · Immunology device
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Feb 2001
Decision
37d
Days
Class 2
Risk

K010148 is an FDA 510(k) clearance for the ENA SCREEN EIA KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 23, 2001 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K010148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2001
Decision Date February 23, 2001
Days to Decision 37 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
67d faster than avg
Panel avg: 104d · This submission: 37d
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 K010148.
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K983376 · Zeus Scientific, Inc. · Nov 1998