Cleared Traditional

K880294 - DART PHENYTOIN

K880294 is an FDA 510(k) clearance for DART PHENYTOIN, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Chemistry device with product code LFO cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K880294 · Coulter Electronics, Inc. · Chemistry device
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May 1988
Decision
123d
Days
Class 2
Risk

K880294 is an FDA 510(k) clearance for the DART PHENYTOIN. Classified as Nephelometric Inhibition Immunoassay, Diphenylhydantoin (product code LFO), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - 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 Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K880294

510(k) Number K880294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date May 27, 1988
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFO Device Classification - Class 2, Special Controls

Product Code LFO Nephelometric Inhibition Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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.