Cleared Traditional

K170587 - On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis (FDA 510(k) Clearance)

Class I Chemistry device.

K170587 · ACON Laboratories, Inc. · Chemistry device
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Jul 2017
Decision
128d
Days
Class 1
Risk

K170587 is an FDA 510(k) clearance for the On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strip.... Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 6, 2017 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K170587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2017
Decision Date July 06, 2017
Days to Decision 128 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
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
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.