Cleared Traditional

K943981 - IL TEST PHENOBARBITAL CALIBRATORS

K943981 is an FDA 510(k) clearance for IL TEST PHENOBARBITAL CALIBRATORS, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K943981

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.

DLZ Device Classification - Class 2, Special Controls

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 33
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
PHENOBARBITAL FLEX REAGENT CARTRIDGE
K944932 · Dupont Medical Products · Dec 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · Schiapparelli Biosystems, Inc. · Oct 1994
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · Baxter Diagnostics, Inc. · Mar 1994