Cleared Traditional

K981185 - GLU

K981185 is an FDA 510(k) clearance for GLU, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K981185 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
35d
Days
Class 2
Risk

K981185 is an FDA 510(k) clearance for the GLU. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 7, 1998 after a review of 35 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K981185

510(k) Number K981185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date May 07, 1998
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 111
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K981185.
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics · Feb 2000
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999
N-ASSAY GLU-UL
K980883 · Crestat Diagnostics, Inc. · Sep 1998
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc., · Jul 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004 · Bayer Corp. · Feb 1997