Cleared Traditional

K180209 - Diazyme 1,5-AG Assay (FDA 510(k) Clearance)

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

K180209 · Diazyme Laboratories, Inc. · Chemistry device
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Oct 2018
Decision
253d
Days
Class 2
Risk

K180209 is an FDA 510(k) clearance for the Diazyme 1,5-AG Assay. Classified as Assay, 1,5-anhydroglucitol (15ag) (product code NOZ), Class II - Special Controls.

Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on October 4, 2018 after a review of 253 days - an extended review cycle.

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.

View all Diazyme Laboratories, Inc. devices

Submission Details

510(k) Number K180209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date October 04, 2018
Days to Decision 253 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
165d slower than avg
Panel avg: 88d · This submission: 253d
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.