Cleared Traditional

K983504 - PRECISION XTRA ADVANCED DIABETES MANAGE...

K983504 is the FDA 510(k) clearance for PRECISION XTRA ADVANCED DIABETES MANAGE... by Medisense, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K983504 · Medisense, Inc. · Chemistry device
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Jul 1999
Decision
276d
Days
Class 2
Risk

K983504 is an FDA 510(k) clearance for the PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE T.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medisense, Inc. (Bedford, US). The FDA issued a Cleared decision on July 9, 1999 after a review of 276 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 Medisense, Inc. devices

Submission Details

510(k) Number K983504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1998
Decision Date July 09, 1999
Days to Decision 276 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
188d slower than avg
Panel avg: 88d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K983504.
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · Lifescan, Inc. · Dec 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · Roche Diagnostics Corp. · Sep 2000
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp. · Feb 2000
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
K990649 · Bayer Corp. · Jul 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · Bayer Corp. · Jun 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344 · Dade Behring, Inc. · Jun 1999