Cleared Traditional

K040332 - POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

K040332 is an FDA 510(k) clearance for POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER, manufactured by Arkray, Inc.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K040332 · Arkray, Inc. · Chemistry device
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Jun 2004
Decision
127d
Days
Class 1
Risk

K040332 is an FDA 510(k) clearance for the POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 16, 2004 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 - K040332

510(k) Number K040332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2004
Decision Date June 16, 2004
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 35
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