Cleared Traditional

K111335 - ST AIA-PACK ACTH

K111335 is an FDA 510(k) clearance for ST AIA-PACK ACTH, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K111335 · Tosoh Bioscience, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
203d
Days
Class 2
Risk

K111335 is an FDA 510(k) clearance for the ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K111335

510(k) Number K111335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2011
Decision Date December 01, 2011
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
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 15
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K111335.
IDS ACTH II
K223867 · Immunodiagnostic Systems Limited · Aug 2023
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · Roche Diagnostics Corp. · May 2006
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990