Cleared Traditional

K964004 - GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS

K964004 is an FDA 510(k) clearance for GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS, manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K964004

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.

CFR Device Classification - Class 2, Special Controls

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 137
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K964004.
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc., · Jul 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467 · Carolina Liquid Chemistries Corp. · Jun 1997
STC AUTO-LYTE URINARY GLUCOSE ASSAY
K962435 · OraSure Technologies, Inc. · Dec 1996
GLUCOSE (HEXOKINASE) KIT
K953210 · Randox Laboratories, Ltd. · Oct 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · Diagnostic Chemicals , Ltd. · Jun 1996