Cleared Traditional

K943980 - IL TEST PHENYTION CALIBRATORS

K943980 is an FDA 510(k) clearance for IL TEST PHENYTION CALIBRATORS, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Toxicology device with product code DIP cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K943980 · Instrumentation Laboratory CO · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
328d
Days
Class 2
Risk

K943980 is an FDA 510(k) clearance for the IL TEST PHENYTION CALIBRATORS. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 1, 1995 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - 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. Elevated predicate reliance profile. 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 - K943980

510(k) Number K943980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date May 01, 1995
Days to Decision 328 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
241d slower than avg
Panel avg: 87d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIP Device Classification - Class 2, Special Controls

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - DIP Enzyme Immunoassay, Diphenylhydantoin

All 39
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K943980.
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · Syva Co. · Jan 2000
ACE PHENYTOIN REAGENT, AED CALIBRATORS
K973414 · Schiapparelli Biosystems, Inc. · Nov 1997
CEDIA PHENYTOIN II ASSAY
K963840 · Boehringer Mannheim Corp. · Nov 1996
PHENYTION EIA TEST
K945725 · Diagnostic Reagents, Inc. · Feb 1995
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
K944085 · Schiapparelli Biosystems, Inc. · Dec 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142 · Eastman Kodak Company · Jun 1994