Cleared Traditional

K943981 - IL TEST PHENOBARBITAL CALIBRATORS

K943981 is the FDA 510(k) clearance for IL TEST PHENOBARBITAL CALIBRATORS by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K943981 · Instrumentation Laboratory CO · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
225d
Days
Class 2
Risk

K943981 is an FDA 510(k) clearance for the IL TEST PHENOBARBITAL CALIBRATORS. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 18, 1995 after a review of 225 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K943981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date January 18, 1995
Days to Decision 225 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
138d slower than avg
Panel avg: 87d · This submission: 225d
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 28
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K943981.
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · Syva Co. · Jan 2000
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
PHENOBARBITAL ENZYME IMMUNOASSAY
K946210 · Diagnostic Reagents, Inc. · Feb 1995
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · Baxter Diagnostics, Inc. · Mar 1994
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · Syva Co. · Aug 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · Instrumentation Laboratory CO · Apr 1991