Cleared Traditional

K152493 - POGO Automatic Blood Glucose Monitoring System

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) Official FDA 510(k) Summary (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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Regulatory Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02333864 Completed Observational Industry-sponsored

POGO® Automatic Blood Glucose Monitoring System Clinical Study

287
Patients (actual)
2
Sites
Condition studied Diabetes Mellitus
Eligibility All sexes · 18 Years+
Sponsor Intuity Medical, Inc (industry)
Started 2014-12-01 → Primary completion 2015-03-01
Primary outcome
Accuracy Validation of the POGO® BGMS: Minimum outcome of 95% of results within 20% of reference measurement.
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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

All 510
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K152493.
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
K153201 · Sd Biosensor · Jun 2016
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
K160430 · Ascensia Diabetes Care U.S., Inc. · Jun 2016
StatStrip Xpress Blood Glucose Monitoring System
K160156 · Nova Biomedical Corporation · Jun 2016
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
K152365 · Agamatrix, Inc. · Apr 2016
TRUE METRIX GO Self Monitoring Blood Glucose System
K143548 · Trividia Health, Inc. · Apr 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · Abbott Diabetes Care, Inc. · Feb 2016