Cleared Traditional

GLU (K981185) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 60
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K981185.
WAKO L-TYPE GLUCOSE 2
K024281 · Wako Chemicals USA, Inc. · Feb 2003
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
K001403 · Sigma Diagnostics, Inc. · Aug 2000
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999
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K953210 · Randox Laboratories, Ltd. · Oct 1996
ROCHE REAGENT FOR GLUCOSE
K953847 · Roche Diagnostic Systems, Inc. · Feb 1996
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
K951058 · Heraeus Kulzer, Inc. · Jun 1995