Cleared Traditional

K971276 - GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER

K971276 is the FDA 510(k) clearance for GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER by Bayer Corp.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K971276 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
70d
Days
Class 2
Risk

K971276 is an FDA 510(k) clearance for the GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 70 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 Bayer Corp. devices

Submission Details

510(k) Number K971276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date June 16, 1997
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 K971276.
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999
GLU
K981185 · Abbott Laboratories · May 1998
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc., · Jul 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004 · Bayer Corp. · Feb 1997
GLUCOSE (HEXOKINASE) KIT
K953210 · Randox Laboratories, Ltd. · Oct 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · Diagnostic Chemicals , Ltd. · Jun 1996