Cleared Traditional

K053401 - SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMI...

K053401 is an FDA 510(k) clearance for SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMI..., manufactured by Arkray, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K053401 · Arkray, Inc. · Chemistry device
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Mar 2006
Decision
108d
Days
Class 2
Risk

K053401 is an FDA 510(k) clearance for the SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on March 24, 2006 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Arkray, Inc. devices

FDA 510(k) Submission Details - K053401

510(k) Number K053401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2005
Decision Date March 24, 2006
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIC Device Classification - Class 2, Special Controls

Product Code CIC Cresolphthalein Complexone, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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.

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All 73
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