Cleared Traditional

K152493 - POGO Automatic Blood Glucose Monitoring...

K152493 is an FDA 510(k) clearance for POGO Automatic Blood Glucose Monitoring..., manufactured by Intuity Medical, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K152493 · Intuity Medical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
237d
Days
Class 2
Risk

K152493 is an FDA 510(k) clearance for the POGO Automatic Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Intuity Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 25, 2016 after a review of 237 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Intuity Medical, Inc. devices

FDA 510(k) Submission Details - K152493

510(k) Number K152493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date April 25, 2016
Days to Decision 237 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
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 308
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K152493.
Wireless Smart Gluco-Monitoring System
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iHealth Align Gluco-Monitoring system
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K160156 · Nova Biomedical Corporation · Jun 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · Abbott Diabetes Care, Inc. · Feb 2016
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · Abbott Laboratories · Dec 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
K150833 · Andon Health Co, Ltd. · Dec 2015