Cleared Traditional

K961337 - EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM

K961337 is an FDA 510(k) clearance for EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM, 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 74-day FDA review.

K961337 · Medisense, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
74d
Days
Class 2
Risk

K961337 is an FDA 510(k) clearance for the EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medisense, Inc. (Waltham, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medisense, Inc. devices

FDA 510(k) Submission Details - K961337

510(k) Number K961337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date June 21, 1996
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K961337.
CHEMCARD GLUCOSE TEST
K943503 · Chem-Elec, Inc. · Jul 1996
LXN BLOOD GLUCOSE TEST SYSTEM
K960034 · Lxn Corp. · Jun 1996
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
K960053 · Selfcare, Inc. · Jun 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459 · Boehringer Mannheim Corp. · Apr 1996
GLUCOCHEK POCKETLAB
K951457 · Clinical Diagnostics, Inc. · Feb 1996