Cleared Traditional

K940271 - INCSTAR ACTH IRMA

K940271 is an FDA 510(k) clearance for INCSTAR ACTH IRMA, manufactured by Incstar Corp.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K940271 · Incstar Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
193d
Days
Class 2
Risk

K940271 is an FDA 510(k) clearance for the INCSTAR ACTH IRMA. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 193 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 Incstar Corp. devices

FDA 510(k) Submission Details - K940271

510(k) Number K940271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date August 02, 1994
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
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 K940271.
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
MICRO HAEMATOCRIT CENTRIFUGE
K960491 · Hawksley & Sons , Ltd. · Oct 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
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 II BY RADIOIMMUNOASSAY
K850882 · Immuno Nuclear Corp. · Mar 1985