Cleared Traditional

RID SYSTEM-HUMAN C-REACTIVE PROTEIN (K780325) - FDA 510(k) Clearance

Class I Immunology device.

K780325 · Icl Scientific · Immunology device
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Mar 1978
Decision
18d
Days
Class 1
Risk

K780325 is an FDA 510(k) clearance for the RID SYSTEM-HUMAN C-REACTIVE PROTEIN. Classified as Alpha-1-t-glycoprotein, Antigen, Antiserum, Control (product code DEN), Class I - General Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5420 - 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 Icl Scientific devices

Submission Details

510(k) Number K780325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1978
Decision Date March 17, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DEN Alpha-1-t-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
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.