Cleared Traditional

MED-PEN/MED-POINT (K853733) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853733 · Garid, Inc. · Chemistry device
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Dec 1986
Decision
454d
Days
Class 2
Risk

K853733 is an FDA 510(k) clearance for the MED-PEN/MED-POINT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Garid, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Garid, Inc. devices

Submission Details

510(k) Number K853733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date December 04, 1986
Days to Decision 454 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
366d slower than avg
Panel avg: 88d · This submission: 454d
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 61
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K853733.
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · Abbott Laboratories · Jan 1987
TRACKER SYSTEM
K860948 · Boehringer Mannheim Corp. · Dec 1986
EXACTECH(TM)
K863468 · Travenol Laboratories, S.A. · Dec 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · Abbott Laboratories · Nov 1986
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
ACCU-CHEK II
K851456 · Boehringer Mannheim Corp. · Aug 1985