Cleared Traditional

K842264 - VENTREZYME PHENOBARBITAL KIT IMMUNO

K842264 is the FDA 510(k) clearance for VENTREZYME PHENOBARBITAL KIT IMMUNO by Ventrex Laboratories, Inc.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K842264 · Ventrex Laboratories, Inc. · Toxicology device
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Aug 1984
Decision
68d
Days
Class 2
Risk

K842264 is an FDA 510(k) clearance for the VENTREZYME PHENOBARBITAL KIT IMMUNO. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1984 after a review of 68 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K842264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1984
Decision Date August 14, 1984
Days to Decision 68 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
19d faster than avg
Panel avg: 87d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLZ Enzyme 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 - DLZ Enzyme Immunoassay, Phenobarbital

All 31
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K842264.
DETERMINATION OF PHENOBARBITAL
K860046 · Clinical Data, Inc. · Jan 1986
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · Miles Laboratories, Inc. · Sep 1985
ENDAB PHENOBARBITAL
K852995 · Immunotech Corp. · Aug 1985
CHEM KIT PHENOBARBITAL
K833796 · Abbott Laboratories · Jan 1984
EMIT QST PHENOBARBITAL ASSAY
K834216 · Syva Co. · Jan 1984
A-GENT PHENOBARBITAL
K832457 · Abbott Laboratories · Sep 1983