Cleared Traditional

K882262 - GLUCOSE-SUPER FAST 4983050 AND 4983500

K882262 is an FDA 510(k) clearance for GLUCOSE-SUPER FAST 4983050 AND 4983500, manufactured by American Research Products Co.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K882262 · American Research Products Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
247d
Days
Class 2
Risk

K882262 is an FDA 510(k) clearance for the GLUCOSE-SUPER FAST 4983050 AND 4983500. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on February 2, 1989 after a review of 247 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 American Research Products Co. devices

FDA 510(k) Submission Details - K882262

510(k) Number K882262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date February 02, 1989
Days to Decision 247 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
159d slower than avg
Panel avg: 88d · This submission: 247d
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 305
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K882262.
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989
ROCHE CHLORIDE ELECTRODE
K890528 · Roche Diagnostic Systems, Inc. · Mar 1989
GLUCOSE (GOD) REAGENT
K890336 · Alpkem Corp. · Feb 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · Heraeus Kulzer, Inc. · Jan 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · American Research Products Co. · Jan 1989
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · Boehringer Mannheim Corp. · Dec 1988