Cleared Traditional

K193340 - GoChek Blood Glucose Monitoring System

K193340 is the FDA 510(k) clearance for GoChek Blood Glucose Monitoring System by Microtech Medical, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K193340 · Microtech Medical, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2020
Decision
284d
Days
Class 2
Risk

K193340 is an FDA 510(k) clearance for the GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitori.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Microtech Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 11, 2020 after a review of 284 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 Microtech Medical, Inc. devices

Submission Details

510(k) Number K193340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date September 11, 2020
Days to Decision 284 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
196d slower than avg
Panel avg: 88d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Zi-medical, Inc.
Mingzi Hussey

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.

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