Cleared Traditional

K170587 - On Call Ketone Reagent Strips for Urina...

K170587 is an FDA 510(k) clearance for On Call Ketone Reagent Strips for Urina..., manufactured by ACON Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K170587

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

JIN Device Classification - Class 1, General Controls

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.

Regulatory Peers - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 11
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K170587.
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URS-1K (KETONE TESST)
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ABBOTT BREATH ACETONE ANALYZER
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