Cleared Traditional

DIRECT (K852960) - FDA 510(k) Clearance

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

K852960 · University of Wisconsin · Chemistry device
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Jun 1986
Decision
339d
Days
Class 2
Risk

K852960 is an FDA 510(k) clearance for the DIRECT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by University of Wisconsin (Madison, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 339 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K852960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1985
Decision Date June 16, 1986
Days to Decision 339 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 88d · This submission: 339d
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 73
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K852960.
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · Abbott Laboratories · Nov 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · Miles Laboratories, Inc. · Jul 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · Miles Laboratories, Inc. · Jul 1986
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