Cleared Traditional

K964004 - GLUCOMETER ENCORE BLOOD GLUCOSE TEST ST...

K964004 is the FDA 510(k) clearance for GLUCOMETER ENCORE BLOOD GLUCOSE TEST ST... by Bayer Corp.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K964004 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
126d
Days
Class 2
Risk

K964004 is an FDA 510(k) clearance for the GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 126 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 Bayer Corp. devices

Submission Details

510(k) Number K964004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date February 10, 1997
Days to Decision 126 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
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K964004.
GLU
K981185 · Abbott Laboratories · May 1998
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc., · Jul 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997
GLUCOSE (HEXOKINASE) KIT
K953210 · Randox Laboratories, Ltd. · Oct 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · Diagnostic Chemicals , Ltd. · Jun 1996
HICHEM GLUCOSE/HK REAGENT KIT
K960084 · Hi Chem, Inc. · Apr 1996