Cleared Traditional

K922811 - ROCHE COBAS FUTURA GLUCOSE

K922811 is an FDA 510(k) clearance for ROCHE COBAS FUTURA GLUCOSE, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K922811

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.

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 134
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
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129 · King Diagnostics, Inc. · Nov 1992