Cleared Traditional

K002638 - FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

K002638 is an FDA 510(k) clearance for FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT, manufactured by Future Diagnostics B.V.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K002638 · Future Diagnostics B.V. · Chemistry device
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Jan 2001
Decision
146d
Days
Class 2
Risk

K002638 is an FDA 510(k) clearance for the FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Future Diagnostics B.V. (San Diego, US). The FDA issued a Cleared decision on January 17, 2001 after a review of 146 days - within the typical 510(k) review window.

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 Future Diagnostics B.V. devices

FDA 510(k) Submission Details - K002638

510(k) Number K002638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2000
Decision Date January 17, 2001
Days to Decision 146 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
58d slower than avg
Panel avg: 88d · This submission: 146d
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 21
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K002638.
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
K060585 · Roche Diagnostics Corp. · May 2006
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
K050748 · Scantibodies Laboratory, Inc. · May 2005
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · Scantibodies Laboratory, Inc. · Jun 2002
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608 · Sangui Biotech, Inc. · Aug 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
MICRO HAEMATOCRIT CENTRIFUGE
K960491 · Hawksley & Sons , Ltd. · Oct 1996