Cleared Traditional

K073492 - DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073492 · Tyson Bioresearch, Inc. · Chemistry device
Apr 2008
Decision
118d
Days
Class 2
Risk

K073492 is an FDA 510(k) clearance for the DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLU.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Tyson Bioresearch, Inc. (Chun-Nan, Miao-Li County, TW). The FDA issued a Cleared decision on April 8, 2008 after a review of 118 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. 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.

Submission Details

510(k) Number K073492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2007
Decision Date April 08, 2008
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 234d · This submission: 118d
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 14
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K073492.
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · ACON Laboratories, Inc. · Oct 2025
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · Bionime Corporation · Nov 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · Bionime Corporation · Jan 2024
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · I-Sens, Inc. · Aug 2023
GlucoSure ADVANCE Link Blood Glucose Monitoring System
K222234 · Apex BioTechnology Corp. · Dec 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
K220421 · Apex BioTechnology Corp. · Nov 2022