Cleared Traditional

K833934 - ADRENOCORTICOTROPIC HORMONE TEST

K833934 is the FDA 510(k) clearance for ADRENOCORTICOTROPIC HORMONE TEST by Clinetics Corp.. It is a Class 2 Chemistry device (product code CKG) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K833934 · Clinetics Corp. · Chemistry device
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Apr 1984
Decision
142d
Days
Class 2
Risk

K833934 is an FDA 510(k) clearance for the ADRENOCORTICOTROPIC HORMONE TEST. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Clinetics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1025 - 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 Clinetics Corp. devices

Submission Details

510(k) Number K833934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date April 04, 1984
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - CKG Radioimmunoassay, Acth

All 11
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K833934.
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · Nichols Institute Diagnostics · Aug 1988
ACTH NORMAL RANGE
K842249 · Diagnostic Systems Laboratories, Inc. · Aug 1984
DPC ACTH KIT
K840018 · Diagnostic Products Corp. · Mar 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
K833471 · Nichols Institute Diagnostics · Jan 1984
ACTH RIA SYSTEM-DSI 2300
K830893 · Diagnostic Systems Laboratories, Inc. · Apr 1983