Cleared Special

K033334 - PROFILE -ER

K033334 is an FDA 510(k) clearance for PROFILE -ER, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Special 510(k) pathway after a 25-day FDA review.

K033334 · Medtox Diagnostics, Inc. · Toxicology device
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Nov 2003
Decision
25d
Days
Class 2
Risk

K033334 is an FDA 510(k) clearance for the PROFILE -ER. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on November 10, 2003 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033334

510(k) Number K033334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2003
Decision Date November 10, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 99
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K033334.
RANDOX BARBITURATE ASSAY
K041143 · Randox Laboratories, Ltd. · Nov 2004
'RAPIDTEC 4' TEST
K041712 · American Bio Medica Corp. · Nov 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc. · May 2004
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · Lin-Zhi International, Inc. · Nov 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946 · ACON Laboratories, Inc. · Feb 2003
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089 · Sun Biomedical Laboratories, Inc. · Apr 2002
K033334 · PROFILE -ER
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