Cleared Traditional

K934388 - QMS PHENOBARBITAL

K934388 is an FDA 510(k) clearance for QMS PHENOBARBITAL, manufactured by Seradyn, Inc.. The device is a Class 2 Toxicology device with product code LFN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K934388 · Seradyn, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
169d
Days
Class 2
Risk

K934388 is an FDA 510(k) clearance for the QMS PHENOBARBITAL. Classified as Nephelometric Inhibition Immunoassay, Phenobarbital (product code LFN), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Seradyn, Inc. devices

FDA 510(k) Submission Details - K934388

510(k) Number K934388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date February 25, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 87d · This submission: 169d
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 K934388.
DART PHENOBARBITAL ASSAY SYSTEM
K864612 · Coulter Electronics, Inc. · Jan 1987
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