Cleared Traditional

K922811 - ROCHE COBAS FUTURA GLUCOSE

K922811 is the FDA 510(k) clearance for ROCHE COBAS FUTURA GLUCOSE by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K922811 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jan 1993
Decision
231d
Days
Class 2
Risk

K922811 is an FDA 510(k) clearance for the ROCHE COBAS FUTURA GLUCOSE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 231 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K922811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1992
Decision Date January 27, 1993
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
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 102
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K922811.
IL TEST GLUCOSE
K931402 · Instrumentation Laboratory CO · Oct 1993
GLUCOSE-HK TEST
K931890 · Em Diagnostic Systems, Inc. · Jul 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
K926361 · Heraeus Kulzer, Inc. · Jun 1993
OLYMPUS GLUCOSE REAGENT
K924601 · Olympus Corp. · Dec 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572 · Em Diagnostic Systems, Inc. · Nov 1992
ENCORE TEST STRIPS
K923018 · Heraeus Kulzer, Inc. · Sep 1992