Cleared Traditional

K952437 - DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

K952437 is the FDA 510(k) clearance for DMA GLUCOSE HEXOKINASE U.V. PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K952437 · Data Medical Associates, Inc. · Chemistry device
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Oct 1995
Decision
131d
Days
Class 2
Risk

K952437 is an FDA 510(k) clearance for the DMA GLUCOSE HEXOKINASE U.V. PROCEDURE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on October 3, 1995 after a review of 131 days - within the typical 510(k) review window.

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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K952437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date October 03, 1995
Days to Decision 131 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
43d slower than avg
Panel avg: 88d · This submission: 131d
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 109
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K952437.
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
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HICHEM GLUCOSE/HK REAGENT KIT
K960084 · Hi Chem, Inc. · Apr 1996
ROCHE REAGENT FOR GLUCOSE
K953847 · Roche Diagnostic Systems, Inc. · Feb 1996
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
OLYMPUS GLUCOSE REAGENT
K944406 · Olympus America, Inc. · Mar 1995