Cleared Traditional

K962601 - NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE

K962601 is an FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE ADR..., 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 175-day FDA review.

K962601 · Nichols Institute Diagnostics · Chemistry device
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Dec 1996
Decision
175d
Days
Class 2
Risk

K962601 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on December 24, 1996 after a review of 175 days - an extended review cycle.

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 - K962601

510(k) Number K962601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1996
Decision Date December 24, 1996
Days to Decision 175 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 88d · This submission: 175d
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 K962601.
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
K050748 · Scantibodies Laboratory, Inc. · May 2005
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · Scantibodies Laboratory, Inc. · Jun 2002
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608 · Sangui Biotech, Inc. · Aug 1998
MICRO HAEMATOCRIT CENTRIFUGE
K960491 · Hawksley & Sons , Ltd. · Oct 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994