Cleared Traditional

C-PEPTIDE RADIOIMMUNOASSAY TEST KIT (K833396) - FDA 510(k) Clearance

Class I Chemistry device.

K833396 · Serono Diagnostics, Inc. · Chemistry device
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Apr 1984
Decision
196d
Days
Class 1
Risk

K833396 is an FDA 510(k) clearance for the C-PEPTIDE RADIOIMMUNOASSAY TEST KIT. Classified as Radioimmunoassay, C-peptides Of Proinsulin (product code JKD), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 196 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1135 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K833396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date April 13, 1984
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKD Radioimmunoassay, C-peptides Of Proinsulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1135
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.