Cleared Traditional

K864282 - GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA (FDA 510(k) Clearance)

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

K864282 · Medical Device Consultants, Inc. · Chemistry device
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May 1987
Decision
208d
Days
Class 2
Risk

K864282 is an FDA 510(k) clearance for the GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medical Device Consultants, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 208 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 Medical Device Consultants, Inc. devices

Submission Details

510(k) Number K864282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1986
Decision Date May 26, 1987
Days to Decision 208 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 88d · This submission: 208d
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.

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