Cleared Traditional

K861653 - GLUCOSE HK PROCEDURE

K861653 is the FDA 510(k) clearance for GLUCOSE HK PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K861653 · Data Medical Associates, Inc. · Chemistry device
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May 1986
Decision
23d
Days
Class 2
Risk

K861653 is an FDA 510(k) clearance for the GLUCOSE HK PROCEDURE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 23 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 K861653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date May 23, 1986
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K861653.
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
K860682 · Gambro, Inc. · Aug 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · Miles Laboratories, Inc. · Jul 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · Miles Laboratories, Inc. · Jul 1986
GLUCOSE OXIDASE PROCEDURE
K861204 · Data Medical Associates, Inc. · Apr 1986
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · Clinical Data, Inc. · Nov 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · Sterling Diagnostics, Inc. · Nov 1985