Cleared Traditional

K863468 - EXACTECH(TM)

K863468 is an FDA 510(k) clearance for EXACTECH(TM), manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K863468 · Travenol Laboratories, S.A. · Chemistry device
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Dec 1986
Decision
91d
Days
Class 2
Risk

K863468 is an FDA 510(k) clearance for the EXACTECH(TM). Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on December 8, 1986 after a review of 91 days - within the typical 510(k) review window.

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 Travenol Laboratories, S.A. devices

FDA 510(k) Submission Details - K863468

510(k) Number K863468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1986
Decision Date December 08, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

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 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K863468.
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TRACKER SYSTEM
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GLUCOMETER-E
K863102 · J. D. Assoc. · Nov 1986
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K863926 · Tech-Co, Inc. · Nov 1986
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K863948 · Abbott Laboratories · Nov 1986