Cleared Traditional

K050748 - ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT

K050748 is an FDA 510(k) clearance for ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K050748 · Scantibodies Laboratory, Inc. · Chemistry device
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May 2005
Decision
59d
Days
Class 2
Risk

K050748 is an FDA 510(k) clearance for the ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on May 20, 2005 after a review of 59 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 Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K050748

510(k) Number K050748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2005
Decision Date May 20, 2005
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 18
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K050748.
IDS ACTH II
K223867 · Immunodiagnostic Systems Limited · Aug 2023
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
K111335 · Tosoh Bioscience, Inc. · Dec 2011
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · Roche Diagnostics Corp. · May 2006
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · Scantibodies Laboratory, Inc. · Jun 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996