Cleared Traditional

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (K050748) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.