Cleared Traditional

K032076 - SENOVA(R) BLOOD GLUCOSE MONITOR

K032076 is an FDA 510(k) clearance for SENOVA BLOOD GLUCOSE MONITOR, manufactured by Chdiagnostics, LLC. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K032076 · Chdiagnostics, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
85d
Days
Class 2
Risk

K032076 is an FDA 510(k) clearance for the SENOVA(R) BLOOD GLUCOSE MONITOR. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Chdiagnostics, LLC (Rockville, US). The FDA issued a Cleared decision on September 30, 2003 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chdiagnostics, LLC devices

FDA 510(k) Submission Details - K032076

510(k) Number K032076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date September 30, 2003
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, Glucose
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 - LFR Glucose Dehydrogenase, Glucose

All 68
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K032076.
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ACCU-CHEK COMPACT TEST STRIP
K031755 · Roche Diagnostics Corp. · Jul 2003
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
K022941 · Abbott Laboratories · Oct 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · Abbott Laboratories · Aug 2002