QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61

K022355 · Branan Medical Corp. · DIO · Jul 30, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022355
• Device Name: QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
• Applicant: Branan Medical Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Device Story

QuickTox™ Multiple Drug Dipcard is a lateral flow chromatographic immunoassay for qualitative detection of drugs of abuse in human urine. Device consists of a dipcard format containing multiple test strips; each strip utilizes specific antibodies to detect target drug metabolites at defined cutoff concentrations. Professional users immerse the dipcard into a urine specimen; results appear as visual lines on the test strips within a specified timeframe. The presence or absence of colored lines indicates a qualitative positive or negative result for each drug analyte. Used in clinical or professional settings to provide rapid preliminary screening results to assist healthcare providers in identifying potential drug use. Does not provide quantitative results; positive results require confirmation by alternative chemical methods.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance characteristics, including sensitivity and specificity evaluations for each drug analyte compared to established cutoff concentrations.

Technological Characteristics

Lateral flow chromatographic immunoassay; visual qualitative readout. Device utilizes specific antibodies for cocaine, morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and nortriptyline. Cutoff concentrations range from 25 ng/ml to 2000 ng/ml depending on the analyte. Form factor is a multi-strip dipcard for urine immersion. No electronic components, software, or external energy sources required.

Indications for Use

Indicated for professional in vitro diagnostic screening of human urine for the presence of cocaine, morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and nortriptyline metabolites.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 3 0 2002

Mr. Raphael Wong President Branan Medical Corporation 10015 Muirlands Road. - Suite E Irvine. CA 92618

Re: k022355

Trade/Device Name: QuickTox™ Multiple Drug Dipcard-COC/MOR/MET/THC/AMP/ PCP/BZO/BAR/MTD/TCA Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO; DJG; DJC; LDJ; DKZ; LCM; JXM; DIS; DJR; LFH Dated: July 5, 2002 Received: July 19, 2002

Dear Mr. Wong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact.the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known):

## KO22355

## QuickTox™ Multiple Drug Dipcard -Device Name: COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA

Indications For Use:

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:

| COC | Benzoylecgonine | 300 ng/ml |
|-----|--------------------------------------------------------------|------------|
| MOR | Morphine | 2000 ng/ml |
| MET | Methamphetamine | 1000 ng/ml |
| THC | 11-nor- $$\Delta^9$$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| AMP | Amphetamine | 1000 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |

The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

Cooper
in Sign-Off)
of Clinical Laboratory Devices
:mber K022355