Cleared Traditional

K811367 - KALLESTAD ANTISERA TO PHENOBARBITAL

K811367 is the FDA 510(k) clearance for KALLESTAD ANTISERA TO PHENOBARBITAL by Kallestad Laboratories, Inc.. It is a Class 2 Chemistry device (product code DLZ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811367 · Kallestad Laboratories, Inc. · Chemistry device
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May 1981
Decision
15d
Days
Class 2
Risk

K811367 is an FDA 510(k) clearance for the KALLESTAD ANTISERA TO PHENOBARBITAL. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 29, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3660 - 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: 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K811367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1981
Decision Date May 29, 1981
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 Chemistry 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 K811367.
A-GENT PHENOBARBITAL
K832457 · Abbott Laboratories · Sep 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · Syva Co. · Aug 1983
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621 · Syva Co. · Jun 1981
PHENOBARBITAL REAGENT TEST KIT
K802039 · Beckman Instruments, Inc. · Oct 1980
PHENOBARBITAL ANALYTICAL TEST PACKS
K770919 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1977