Cleared Traditional

K982303 - PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST

K982303 is an FDA 510(k) clearance for PRECISION PCX POINT OF CARE MANAGEMENT ..., manufactured by Medisense, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K982303 · Medisense, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
160d
Days
Class 2
Risk

K982303 is an FDA 510(k) clearance for the PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYST.... 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 December 8, 1998 after a review of 160 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

FDA 510(k) Submission Details - K982303

510(k) Number K982303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date December 08, 1998
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K982303.
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