Cleared Traditional

K915727 - ACTH IRMA KIT II MITSUBISHI YUKA

K915727 is an FDA 510(k) clearance for ACTH IRMA KIT II MITSUBISHI YUKA, manufactured by Mitsubishi Yuka America, Inc.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K915727 · Mitsubishi Yuka America, Inc. · Chemistry device
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Mar 1992
Decision
73d
Days
Class 2
Risk

K915727 is an FDA 510(k) clearance for the ACTH IRMA KIT II MITSUBISHI YUKA. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Mitsubishi Yuka America, Inc. (Washington, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mitsubishi Yuka America, Inc. devices

FDA 510(k) Submission Details - K915727

510(k) Number K915727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date March 02, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
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 21
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K915727.
MICRO HAEMATOCRIT CENTRIFUGE
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INCSTAR ACTH IRMA
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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