Cleared Traditional

K940682 - AXSYM(TM) QUINIDINE

K940682 is an FDA 510(k) clearance for AXSYM(TM) QUINIDINE, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LGI cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K940682 · Abbott Laboratories · Chemistry device
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Jun 1994
Decision
131d
Days
Class 2
Risk

K940682 is an FDA 510(k) clearance for the AXSYM(TM) QUINIDINE. Classified as Fluorescence Polarization Immunoassay, Carbamazepine (product code LGI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - 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.

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FDA 510(k) Submission Details - K940682

510(k) Number K940682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date June 21, 1994
Days to Decision 131 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 88d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGI Device Classification - Class 2, Special Controls

Product Code LGI Fluorescence Polarization Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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.