Cleared Traditional

K811849 - ESKAFLOW TEST FOR GLUCOSE

K811849 is the FDA 510(k) clearance for ESKAFLOW TEST FOR GLUCOSE by Smithkline Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K811849 · Smithkline Diagnostics, Inc. · Chemistry device
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Jul 1981
Decision
14d
Days
Class 2
Risk

K811849 is an FDA 510(k) clearance for the ESKAFLOW TEST FOR GLUCOSE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1981 after a review of 14 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K811849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 15, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K811849.
ULTRACHEM E-GLU #64976 & 65040
K821470 · Emd Chemicals, Inc. · Jun 1982
ULTRA CHEM E-GLU #64976 & 65040
K812595 · Harleco · Sep 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303 · Boehringer Mannheim Corp. · Sep 1981
HEXOKINASE, GLUCOSE
K802810 · Beckman Instruments, Inc. · Dec 1980
F/LS MCA APPLICATION SOFTWARE
K801456 · Instrumentation Laboratory CO · Oct 1980
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765 · Reagents Applications, Inc. · Sep 1980