Cleared Traditional

K944406 - OLYMPUS GLUCOSE REAGENT

K944406 is the FDA 510(k) clearance for OLYMPUS GLUCOSE REAGENT by Olympus America, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K944406 · Olympus America, Inc. · Chemistry device
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Mar 1995
Decision
188d
Days
Class 2
Risk

K944406 is an FDA 510(k) clearance for the OLYMPUS GLUCOSE REAGENT. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 188 days - an extended review 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: 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 Olympus America, Inc. devices

Submission Details

510(k) Number K944406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1994
Decision Date March 15, 1995
Days to Decision 188 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
100d slower than avg
Panel avg: 88d · This submission: 188d
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 109
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K944406.
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
K952437 · Data Medical Associates, Inc. · Oct 1995
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
K951058 · Heraeus Kulzer, Inc. · Jun 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
K945908 · Sigma Diagnostics, Inc. · May 1995
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · Heraeus Kulzer, Inc. · Dec 1993
IL TEST GLUCOSE
K931402 · Instrumentation Laboratory CO · Oct 1993
GLUCOSE-HK TEST
K931890 · Em Diagnostic Systems, Inc. · Jul 1993