Cleared Traditional

K882741 - ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES

K882741 is an FDA 510(k) clearance for ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130..., 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 60-day FDA review.

K882741 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
60d
Days
Class 2
Risk

K882741 is an FDA 510(k) clearance for the ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 60 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 - K882741

510(k) Number K882741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date August 30, 1988
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
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 K882741.
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
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990
ACTHK-PR RIA KIT
K860311 · Compagnie Oris Industrie, S.A. · Apr 1986
BACI 6 -ADRENOCORTICOTROOP HORMONE
K850053 · Euro-Diagnostics BV · Apr 1985
ACTH II BY RADIOIMMUNOASSAY
K850882 · Immuno Nuclear Corp. · Mar 1985
K882741 · ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
Download PDF Nichols Institute Dia…