QUICKTOX MULTIPLE DRUG DIPCARD

K023489 · Branan Medical Corp. · DIO · Dec 16, 2002 · Clinical Toxicology

Device Facts

• Record ID: K023489
• Device Name: QUICKTOX MULTIPLE DRUG DIPCARD
• Applicant: Branan Medical Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Dec 16, 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 cutoff concentrations are as follow: COC Benzoylecgonine 300 ng/ml MOR2000 Morphine 2000 2000 ng/ml MOR300 Morphine 300 300 ng/ml MET1000 Methamphetamine 1000 1000 ng/ml MET500 Methamphetamine 500 500 ng/ml THC 11-nor- Δ9 -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.

Device Story

QuickTox Multiple Drug Dipcard is a lateral flow chromatographic immunoassay for rapid, qualitative detection of drugs of abuse in human urine. Device consists of a dipcard format containing multiple test strips. User immerses the card into a urine specimen; capillary action draws the sample across the membrane. Competitive binding between drug in the sample and drug-conjugate on the test line determines the presence of the analyte. Results are interpreted visually by a healthcare professional based on the presence or absence of colored lines. The device provides a preliminary analytical test result; clinical consideration and professional judgment are required for interpretation. Intended for professional use in clinical settings to screen for drug presence; aids in identifying potential substance use.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to demonstrate analytical performance, including sensitivity, specificity, and cutoff verification for the specified drug analytes.

Technological Characteristics

Lateral flow chromatographic immunoassay. Device format is a multi-panel dipcard. Employs competitive binding principle with drug-specific antibodies and drug-conjugates. Visual readout via colored lines. Standalone, non-electronic, single-use diagnostic device.

Indications for Use

Indicated for professional in vitro diagnostic use for the rapid, qualitative detection of drugs of abuse and their metabolites in human urine. Target analytes include cocaine, morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and nortriptyline at specified cutoff concentrations.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. Inside the circle is a symbol that appears to be three stylized, curved lines stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Chia Her Quality Manager Branan Medical Corporation 10015 Muirlands Road - Suite E Irvine, CA 92618

DEC 1.6 2002

Re: k023489

Trade/Device Name: QuickTox TM 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; LFG Dated: November 21, 2002 Received: December 3, 2002

Dear Ms. Her:

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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K023489

## Device Name: QuickTox™ Multiple Drug Dipcard -· 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 |
|---------|------------------------------------------------------------|------------|
| MOR2000 | Morphine 2000 | 2000 ng/ml |
| MOR300 | Morphine 300 | 300 ng/ml |
| MET1000 | Methamphetamine 1000 | 1000 ng/ml |
| MET500 | Methamphetamine 500 | 500 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<br>(Per 21 CFR 801.109)<br>✓ | OR | Over-The-Counter Use<br>(Optional Format 1-2-) |

Jean Cooper

510(k) Number: K023489