-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KiguELo0v0v7b+rfp17OhVTNZIwnth0zDzuasyJNLZnXsTeXg/mSNzZ9Rt5nZKV7 KM8yaw6ATtv8uLDpLTXH5Q== 0000739944-09-000063.txt : 20090729 0000739944-09-000063.hdr.sgml : 20090729 20090729161600 ACCESSION NUMBER: 0000739944-09-000063 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090729 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090729 DATE AS OF CHANGE: 20090729 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDTOX SCIENTIFIC INC CENTRAL INDEX KEY: 0000739944 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 953863205 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11394 FILM NUMBER: 09970400 BUSINESS ADDRESS: STREET 1: 402 WEST COUNTY ROAD D CITY: ST PAUL STATE: MN ZIP: 55112 BUSINESS PHONE: 6126367466 MAIL ADDRESS: STREET 1: 402 WEST COUNTY ROAD D CITY: ST PAUL STATE: MN ZIP: 55112 FORMER COMPANY: FORMER CONFORMED NAME: EDITEK INC DATE OF NAME CHANGE: 19940902 FORMER COMPANY: FORMER CONFORMED NAME: ENVIRONMENTAL DIAGNOSTICS INC DATE OF NAME CHANGE: 19920703 8-K 1 form8-k072909.htm 8-K


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 29, 2009

 


 

MEDTOX SCIENTIFIC, INC.

(Exact name of registrant as specified in its charter)

 


 

 

 

 

 

 

Delaware

 

1-11394

 

95-3863205

(State or other jurisdiction

of incorporation)

 

(Commission File Number)

 

(IRS Employer

Identification No.)

 


 

 

 

 

 

402 West County Road D, St. Paul, Minnesota

 

55112

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (651) 636-7466

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 


 

1

 


Item 8.01.

Other Events

 

On July 29, 2009, MEDTOX Scientific, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its PROFILE®-V MEDTOXScan® Drugs-of-Abuse Test System with three additional drugs, as described in the press release attached as Exhibit 99.1.

 

 

 

2

 


Item 9.01.                Financial Statements and Exhibits.

(c)

Exhibits.

 

The following exhibit is filed as part of this report:

 

 

 

 

Exhibit No.

 

Description

99.1

 

MEDTOX Scientific, Inc. Press Release, dated July 29, 2009.

 

 

 

3

 


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

MEDTOX Scientific, Inc.

 

 

 

Date: July 29, 2009

By:

/s/ Richard J. Braun

 

Name:     Richard J. Braun

 

Title:

Chief Executive Officer

 

 

4

 


INDEX TO EXHIBITS

 

 

 

 

 

Exhibit No.

 

Description

99.1

 

MEDTOX Scientific, Inc. Press Release, dated July 29, 2009.

 

 

 

5

 

 

EX-99 2 ex99-1072909.htm EXHIBIT 99.1

Exhibit 99.1

MEDTOX Scientific, Inc.

402 West County Road D

St. Paul, MN 55112

Contact: Paula Perry (877) 715-7236

 

FOR IMMEDIATE RELEASE

 

MEDTOX SCIENTIFIC RECEIVES FDA 510(K) CLEARANCE FOR ADDITIONAL
THREE DRUGS ON THE PROFILE®-V MEDTOXScan®

DRUGS-OF-ABUSE TEST SYSTEM

 

ST. PAUL, July 29, 2009 – MEDTOX Scientific, Inc. (Nasdaq:MTOX), announced today that on July 24, 2009, it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its PROFILE®-V MEDTOXScan® Drugs-of-Abuse Test System with three additional drugs - Oxycodone, Propoxyphene and Tricyclic Anitidepressants.

 

The total number of drugs detectable on the system is now twelve. The MEDTOXScan® READER and expanded panel is the broadest panel with the lowest detection levels available with any FDA cleared reader in the market place.

 

The PROFILE®-V MEDTOXScan® Drugs-of-Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The Test Devices are one-step immunochromatographic tests for the rapid qualitative detection of one or more of the following drug classes and cutoff concentrations in human urine:

 

AMP

Amphetamine

500 ng/mL

BAR

Barbiturates

200 ng/mL

BZO

Benzodiazepines

150 ng/mL

COC

Cocaine

150 ng/mL

MAMP

Methamphetamine

500 ng/mL

MTD

Methadone

200 ng/mL

OPI

Opiates

100 ng/mL

PCP

Phencyclidine

25 ng/mL

THC

Cannabinoids

50 ng/mL

OXY

Oxycodone

100 ng/mL

PPX

Propoxyphene

300 ng/mL

TCA

Tricyclic Antidepressants

300 ng/mL

 

The Reader provides accurate, easy-to-use and cost effective testing for drugs-of-abuse. Results are available in 10 minutes for improved turn around time. There is an optional attached bar-code scanner for accurate entry of user ID, patient ID and lot number of the device. Test results will remain on the digital display until cleared by the operator. A printer provides a paper copy of the results for a permanent record. The Reader also has network integration capabilities and enhanced record storage of 1,000 results with improved record management.

 

 


The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The Positive and Negative QC Test Devices are intended to detect potential errors associated with the Reader such as a contaminated contact imaging sensor (CIS) and to verify the CIS cleaning procedure using the approved Cleaning Cassette which effectively removes any contamination.

 

The Test System is intended for professional use in a hospital laboratory setting. Currently MEDTOX has between 300 and 400 hospital clients utilizing MEDTOX’s PROFILE® visually read cassettes for drugs-of-abuse detection. The new Test System will be marketed not only to those clients, but to the broader hospital market which is estimated in excess of 2,500 hospitals.

 

 

MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high quality specialized laboratory testing services and on-site/point-of-collection testing (POCT) devices. The company also supports customers with complete logistics, data and program management services. MEDTOX is a leader in providing esoteric laboratory testing services to hospitals and laboratories nationwide. This includes both central laboratory and bio-analytical testing for pharmaceutical clinical trials. MEDTOX develops and manufactures diagnostic devices for quick and economical on-site/point-of-collection analysis for drugs-of-abuse, therapeutic drugs and biological and agricultural toxins and provides employment drug screening and occupational health testing. For more information see www.medtox.com.

 

 

 

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