Cleared Traditional

K812288 - HUMAN C-PEPTIDE REAGENTS

K812288 is an FDA 510(k) clearance for HUMAN C-PEPTIDE REAGENTS, manufactured by Immunex Radiochemical Diagnostics. The device is a Class 1 Chemistry device with product code JKD cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812288 · Immunex Radiochemical Diagnostics · Chemistry device
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Aug 1981
Decision
18d
Days
Class 1
Risk

K812288 is an FDA 510(k) clearance for the HUMAN C-PEPTIDE REAGENTS. Classified as Radioimmunoassay, C-peptides Of Proinsulin (product code JKD), Class I - General Controls.

Submitted by Immunex Radiochemical Diagnostics (Walker, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 18 days - a notably fast clearance 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: 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 Immunex Radiochemical Diagnostics devices

FDA 510(k) Submission Details - K812288

510(k) Number K812288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1981
Decision Date August 31, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JKD Device Classification - Class 1, General Controls

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 8
Devices cleared under the same product code (JKD) and FDA review panel - the closest regulatory comparables to K812288.
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
K833396 · Serono Diagnostics, Inc. · Apr 1984
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