Cleared Traditional

K864322 - MPX SYSTEM, GLUCOSE TEST SYSTEM

K864322 is an FDA 510(k) clearance for MPX SYSTEM, manufactured by Lifescan, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K864322 · Lifescan, Inc. · Chemistry device
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Feb 1987
Decision
114d
Days
Class 2
Risk

K864322 is an FDA 510(k) clearance for the MPX SYSTEM, GLUCOSE TEST SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Lifescan, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 114 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.

View all Lifescan, Inc. devices

FDA 510(k) Submission Details - K864322

510(k) Number K864322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date February 25, 1987
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
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 285
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K864322.
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
FAST GLUCOSE
K870631 · Sclavo, Inc. · Mar 1987
GLUCOSE OXIDASE REAGENT
K870616 · Intersect Systems, Inc. · Mar 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · Miles Laboratories, Inc. · Feb 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · Abbott Laboratories · Jan 1987
TRACKER SYSTEM
K860948 · Boehringer Mannheim Corp. · Dec 1986