Cleared Traditional

K942963 - GLUCOSE QVET

K942963 is an FDA 510(k) clearance for GLUCOSE QVET, manufactured by Prisma Systems. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K942963 · Prisma Systems · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
189d
Days
Class 2
Risk

K942963 is an FDA 510(k) clearance for the GLUCOSE QVET. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 189 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 Prisma Systems devices

FDA 510(k) Submission Details - K942963

510(k) Number K942963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 29, 1994
Days to Decision 189 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
101d slower than avg
Panel avg: 88d · This submission: 189d
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 K942963.
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
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K945908 · Sigma Diagnostics, Inc. · May 1995
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
GLUCOSE-HK TEST
K931890 · Em Diagnostic Systems, Inc. · Jul 1993