Cleared Traditional

K994403 - INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST

K994403 is an FDA 510(k) clearance for INSTANT-VIEW COCAINE (BENZYLECGONINE) U..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K994403 · Alfa Scientific Designs, Inc. · Toxicology device
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Aug 2000
Decision
230d
Days
Class 2
Risk

K994403 is an FDA 510(k) clearance for the INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on August 14, 2000 after a review of 230 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K994403

510(k) Number K994403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date August 14, 2000
Days to Decision 230 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
143d slower than avg
Panel avg: 87d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 116
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K994403.
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K994398 · Alfa Scientific Designs, Inc. · Jul 2000
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K001197 · OraSure Technologies, Inc. · May 2000
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K000467 · Dade Behring, Inc. · Apr 2000