Cleared Traditional

GLYCOMARK (K031604) - FDA 510(k) Clearance

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

K031604 · Tomen America, Inc. · Chemistry device
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Sep 2003
Decision
123d
Days
Class 2
Risk

K031604 is an FDA 510(k) clearance for the GLYCOMARK. Classified as Assay, 1,5-anhydroglucitol (15ag) (product code NOZ), Class II - Special Controls.

Submitted by Tomen America, Inc. (New York, US). The FDA issued a Cleared decision on September 22, 2003 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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.

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Submission Details

510(k) Number K031604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2003
Decision Date September 22, 2003
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NOZ Assay, 1,5-anhydroglucitol (15ag)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
Definition The Test Provides Quantitative Measurement Of 1,5-anhydroglucitol (15ag) In Patient's Blood. The Test Is For Professional Use, And Is Indicated For The Monitoring Of Glycemic Control In People With Diabetes.
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.