Cleared Traditional

K953847 - ROCHE REAGENT FOR GLUCOSE

K953847 is the FDA 510(k) clearance for ROCHE REAGENT FOR 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 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

Submission Details

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.

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 101
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