Cleared Traditional

K962601 - NICHOLS ADVANTAGE CHEMILUMINESCENCE ADR...

K962601 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE ADR... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (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

Submission Details

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.

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 10
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K962601.
IDS ACTH II
K223867 · Immunodiagnostic Systems Limited · Aug 2023
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · Roche Diagnostics Corp. · May 2006
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994
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