Cleared Traditional

K863259 - GLUCOSE HK PROCEDURE

K863259 is the FDA 510(k) clearance for GLUCOSE HK 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 32-day FDA review.

K863259 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
32d
Days
Class 2
Risk

K863259 is an FDA 510(k) clearance for the GLUCOSE HK 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 September 26, 1986 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Data Medical Associates, Inc. devices

Submission Details

510(k) Number K863259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date September 26, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K863259.
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · Abbott Laboratories · Aug 1988
GLUCOSE (HEXOKINASE)
K874846 · Tech-Co, Inc. · Mar 1988
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · Baxter Healthcare Corp · Nov 1987
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · Sterling Diagnostics, Inc. · Apr 1986
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)
K860724 · Trace Scientific , Ltd. · Apr 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · Diagnostic Chemicals, Ltd. (Usa) · Mar 1986