Cleared Special

K182046 - Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182046 · Tyson Bioresearch, Inc. · Chemistry device
Nov 2018
Decision
122d
Days
Class 2
Risk

K182046 is an FDA 510(k) clearance for the Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Gluc.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Tyson Bioresearch, Inc. (Zhunan Township, TW). The FDA issued a Cleared decision on November 30, 2018 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K182046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2018
Decision Date November 30, 2018
Days to Decision 122 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 234d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 14
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