Cleared Traditional

K864612 - DART PHENOBARBITAL ASSAY SYSTEM

K864612 is an FDA 510(k) clearance for DART PHENOBARBITAL ASSAY SYSTEM, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Toxicology device with product code LFN cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K864612 · Coulter Electronics, Inc. · Toxicology device
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Jan 1987
Decision
50d
Days
Class 2
Risk

K864612 is an FDA 510(k) clearance for the DART PHENOBARBITAL ASSAY SYSTEM. Classified as Nephelometric Inhibition Immunoassay, Phenobarbital (product code LFN), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on January 13, 1987 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K864612

510(k) Number K864612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1986
Decision Date January 13, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFN Device Classification - Class 2, Special Controls

Product Code LFN Nephelometric Inhibition Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 Toxicology devices follow this clearance model.

Regulatory Peers - LFN Nephelometric Inhibition Immunoassay, Phenobarbital

Devices cleared under the same product code (LFN) and FDA review panel - the closest regulatory comparables to K864612.
QMS PHENOBARBITAL
K934388 · Seradyn, Inc. · Feb 1994
DUPONT PHENOBARBITAL CALIBRATOR
K860303 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1986
DUPONT PHENOBARBITAL ASSAY
K860304 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1986
IPA FOR DETECTION OF PHENOBARBITAL
K821543 · Electro-Nucleonics Laboratories, Inc. · Jun 1982