Cleared Traditional

K160038 - UniStrip1 Generic Blood Glucose Test Strips

K160038 is an FDA 510(k) clearance for UniStrip1 Generic Blood Glucose Test Strips, manufactured by Ok Biotech Co., Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K160038 · Ok Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
204d
Days
Class 2
Risk

K160038 is an FDA 510(k) clearance for the UniStrip1 Generic Blood Glucose Test Strips. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ok Biotech Co., Ltd. (Hsinchu City, TW). The FDA issued a Cleared decision on July 29, 2016 after a review of 204 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 Ok Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K160038

510(k) Number K160038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2016
Decision Date July 29, 2016
Days to Decision 204 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
116d slower than avg
Panel avg: 88d · This submission: 204d
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 273
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K160038.
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
K161738 · Taidoc Technology Corporation · Nov 2016
Wireless Smart Gluco-Monitoring System
K153278 · Andon Health Co, Ltd. · Aug 2016
iHealth Align Gluco-Monitoring system
K153286 · Andon Health Co, Ltd. · Aug 2016
StatStrip Xpress Blood Glucose Monitoring System
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