Cleared Traditional

K170079 - Tyson Bio HT100 Blood Glucose Monitorin...

K170079 is the FDA 510(k) clearance for Tyson Bio HT100 Blood Glucose Monitorin... by Tyson Bioresearch, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K170079 · Tyson Bioresearch, Inc. · Chemistry device
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Oct 2017
Decision
269d
Days
Class 2
Risk

K170079 is an FDA 510(k) clearance for the Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Gluc.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Tyson Bioresearch, Inc. (Chu-Nan, Miao-Li County, TW). The FDA issued a Cleared decision on October 6, 2017 after a review of 269 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 Tyson Bioresearch, Inc. devices

Submission Details

510(k) Number K170079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2017
Decision Date October 06, 2017
Days to Decision 269 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
181d slower than avg
Panel avg: 88d · This submission: 269d
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 Peers - NBW System, Test, Blood Glucose, Over The Counter

All 236
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