Cleared Traditional

RETINOL BINDING PROTEIN RBP RID KIT (K973189) - FDA 510(k) Clearance

Class I Immunology device.

K973189 · The Binding Site, Ltd. · Immunology device
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Sep 1997
Decision
35d
Days
Class 1
Risk

K973189 is an FDA 510(k) clearance for the RETINOL BINDING PROTEIN RBP RID KIT. Classified as Retinol-binding Protein, Antigen, Antiserum, Control (product code CZS), Class I - General Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 29, 1997 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5765 - 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 K973189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date September 29, 1997
Days to Decision 35 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
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CZS Retinol-binding Protein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5765
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.