Cleared Traditional

K833471 - ADRENOCOR TICOTROPIC HORMONE RADIOIMM

K833471 is an FDA 510(k) clearance for ADRENOCOR TICOTROPIC HORMONE RADIOIMM, manufactured by Nichols Institute Diagnostics. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K833471 · Nichols Institute Diagnostics · Chemistry device
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Jan 1984
Decision
97d
Days
Class 2
Risk

K833471 is an FDA 510(k) clearance for the ADRENOCOR TICOTROPIC HORMONE RADIOIMM. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Walker, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 97 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 Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K833471

510(k) Number K833471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1983
Decision Date January 11, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CKG Radioimmunoassay, Acth

All 20
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K833471.
ACTH NORMAL RANGE
K842249 · Diagnostic Systems Laboratories, Inc. · Aug 1984
DPC ACTH KIT
K840018 · Diagnostic Products Corp. · Mar 1984
ACTH RIA
K833849 · Syncor Intl. Corp. · 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