Cleared Traditional

K842267 - C-PEP-RIA-100

K842267 is the FDA 510(k) clearance for C-PEP-RIA-100 by Institut National Des Radioelements. It is a Class 1 Chemistry device (product code JKD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K842267 · Institut National Des Radioelements · Chemistry device
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Sep 1984
Decision
90d
Days
Class 1
Risk

K842267 is an FDA 510(k) clearance for the C-PEP-RIA-100. Classified as Radioimmunoassay, C-peptides Of Proinsulin (product code JKD), Class I - General Controls.

Submitted by Institut National Des Radioelements (Walker, US). The FDA issued a Cleared decision on September 6, 1984 after a review of 90 days - within the typical 510(k) review window.

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 Institut National Des Radioelements devices

Submission Details

510(k) Number K842267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1984
Decision Date September 06, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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.

Regulatory Peers - JKD Radioimmunoassay, C-peptides Of Proinsulin

All 7
Devices cleared under the same product code (JKD) and FDA review panel - the closest regulatory comparables to K842267.
IMMULITE C-PEPTIDE
K943767 · Diagnostic Products Corp. · Mar 1995
DSL C-PEPTIDE RIA (DSL #7000)
K896420 · Diagnostic Systems Laboratories, Inc. · May 1990
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
K854066 · Diagnostic Products Corp. · Nov 1985
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
K820666 · Immuno Nuclear Corp. · Jul 1982
RIA QUANT C-PEPTIDE KIT
K812689 · Mallinckrodt Critical Care · Oct 1981
C-PEPTICE REAGENTS
K810718 · Calbiochem-Behring Corp. · Mar 1981