Cleared Traditional

K953847 - ROCHE REAGENT FOR GLUCOSE

K953847 is an FDA 510(k) clearance for ROCHE REAGENT FOR 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 181-day FDA review.

K953847 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1996
Decision
181d
Days
Class 2
Risk

K953847 is an FDA 510(k) clearance for the ROCHE REAGENT FOR 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 February 13, 1996 after a review of 181 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 - K953847

510(k) Number K953847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date February 13, 1996
Days to Decision 181 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
93d slower than avg
Panel avg: 88d · This submission: 181d
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 K953847.
GLUCOSE (HEXOKINASE) KIT
K953210 · Randox Laboratories, Ltd. · Oct 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · Diagnostic Chemicals , Ltd. · Jun 1996
HICHEM GLUCOSE/HK REAGENT KIT
K960084 · Hi Chem, Inc. · Apr 1996
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