Cleared Traditional

K931890 - GLUCOSE-HK TEST

K931890 is the FDA 510(k) clearance for GLUCOSE-HK TEST by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K931890 · Em Diagnostic Systems, Inc. · Chemistry device
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Jul 1993
Decision
98d
Days
Class 2
Risk

K931890 is an FDA 510(k) clearance for the GLUCOSE-HK TEST. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 98 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K931890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1993
Decision Date July 22, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
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 K931890.
OLYMPUS GLUCOSE REAGENT
K944406 · Olympus America, Inc. · Mar 1995
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · Heraeus Kulzer, Inc. · Dec 1993
IL TEST GLUCOSE
K931402 · Instrumentation Laboratory CO · Oct 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
K926361 · Heraeus Kulzer, Inc. · Jun 1993
ROCHE COBAS FUTURA GLUCOSE
K922811 · Roche Diagnostic Systems, Inc. · Jan 1993
OLYMPUS GLUCOSE REAGENT
K924601 · Olympus Corp. · Dec 1992