Cleared Traditional

K864322 - MPX SYSTEM

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

K864322 · Lifescan, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 133
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K864322.
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · Miles Laboratories, Inc. · Dec 1987
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
FAST GLUCOSE
K870631 · Sclavo, 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