Cleared Traditional

HUMAN (IGG) SUBCLASS (EIA) KIT (K895600) - FDA 510(k) Clearance

Class I Immunology device.

K895600 · The Binding Site, Ltd. · Immunology device
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Nov 1989
Decision
51d
Days
Class 1
Risk

K895600 is an FDA 510(k) clearance for the HUMAN (IGG) SUBCLASS (EIA) KIT. Classified as Igg (fc Fragment Specific), Antigen, Antiserum, Control (product code DAS), Class I - General Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5530 - 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 K895600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1989
Decision Date November 08, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 104d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.