Cleared Traditional

K855178 - DIATRON BLOOD GLUCOSE METER

K855178 is the FDA 510(k) clearance for DIATRON BLOOD GLUCOSE METER by Dextron, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K855178 · Dextron, Inc. · Chemistry device
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Aug 1986
Decision
221d
Days
Class 2
Risk

K855178 is an FDA 510(k) clearance for the DIATRON BLOOD GLUCOSE METER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Dextron, Inc. (Natick, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 221 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 Dextron, Inc. devices

Submission Details

510(k) Number K855178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date August 04, 1986
Days to Decision 221 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 88d · This submission: 221d
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 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K855178.
GLUCOSE OXIDASE
K863926 · Tech-Co, Inc. · Nov 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · Abbott Laboratories · Nov 1986
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 HK PROCEDURE
K861653 · Data Medical Associates, Inc. · May 1986