Cleared Traditional

K900147 - MODIFIED DSL-2300 ACTH RIA

K900147 is an FDA 510(k) clearance for MODIFIED DSL-2300 ACTH RIA, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K900147 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Mar 1990
Decision
49d
Days
Class 2
Risk

K900147 is an FDA 510(k) clearance for the MODIFIED DSL-2300 ACTH RIA. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 49 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.

FDA 510(k) Submission Details - K900147

510(k) Number K900147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1990
Decision Date March 01, 1990
Days to Decision 49 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
40d faster than avg
Panel avg: 89d · This submission: 49d
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 29
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K900147.
ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
K926396 · Nichols Institute · Jul 1993
ACTH IRMA KIT II MITSUBISHI YUKA
K915727 · Mitsubishi Yuka America, Inc. · Mar 1992
ACTH IRMA KIT MITSUBISHI YUKA
K910178 · Science Regulatory Services Intl. · May 1991
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · Nichols Institute Diagnostics · Aug 1988
ACTHK-PR RIA KIT
K860311 · Compagnie Oris Industrie, S.A. · Apr 1986
BACI 6 -ADRENOCORTICOTROOP HORMONE
K850053 · Euro-Diagnostics BV · Apr 1985
K900147 · MODIFIED DSL-2300 ACTH RIA
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