Cleared Traditional

K854260 - CHEMPRO 1000

K854260 is the FDA 510(k) clearance for CHEMPRO 1000 by Sen Tech Medical Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K854260 · Sen Tech Medical Corp. · Chemistry device
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Nov 1985
Decision
27d
Days
Class 2
Risk

K854260 is an FDA 510(k) clearance for the CHEMPRO 1000. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Sen Tech Medical Corp. (Arden Hills, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 27 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 Sen Tech Medical Corp. devices

Submission Details

510(k) Number K854260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date November 19, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 198
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K854260.
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
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · Miles Laboratories, Inc. · Aug 1985
ACCU-CHEK II
K851456 · Boehringer Mannheim Corp. · Aug 1985