Cleared Traditional

K831826 - ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY

K831826 is an FDA 510(k) clearance for ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY, manufactured by Damon Corp.. The device is a Class 2 Microbiology device with product code CKG cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K831826 · Damon Corp. · Microbiology device
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Jul 1983
Decision
41d
Days
Class 2
Risk

K831826 is an FDA 510(k) clearance for the ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Damon Corp. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1025 - the FDA microbiology 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 Damon Corp. devices

FDA 510(k) Submission Details - K831826

510(k) Number K831826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date July 18, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CKG Device Classification - Class 2, Special Controls

Product Code CKG Radioimmunoassay, Acth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - CKG Radioimmunoassay, Acth

All 21
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K831826.
DPC ACTH KIT
K840018 · Diagnostic Products Corp. · Mar 1984
ACTH RIA
K833849 · Syncor Intl. Corp. · Jan 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
K833471 · Nichols Institute Diagnostics · Jan 1984
ACTH RIA SYSTEM-DSI 2300
K830893 · Diagnostic Systems Laboratories, Inc. · Apr 1983
SERAGAN ACTH125 I-RIA KIT
K822115 · Seragen Diagnostics, Inc. · Oct 1982
ACTH RADIOIMMUNOASSAY KIT
K811565 · Immuno Nuclear Corp. · Jun 1981