TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC

K032057 · Branan Medical Corp. · DIO · Aug 21, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032057
• Device Name: TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
• Applicant: Branan Medical Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations: AMP (d-Amphetamine) 1000 ng/ml; COC (Benzoylecgonine) 300 ng/ml; MET500 (d-Methamphetamine) 500 ng/ml; OPI2000 (Morphine) 2000 ng/ml; OPI300 (Morphine) 300 ng/ml; PCP (Phencyclidine) 25 ng/ml; THC (11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid) 50 ng/ml. The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cut-off concentration indicated. The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-of-abused in human 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

ToxCup™ Drug Screen Cup; in vitro diagnostic device for professional use. Input: human urine sample. Principle: chromatographic immunoassays. Output: visual, qualitative results for presence of drugs of abuse (AMP, COC, MET, OPI, PCP, THC). Used in clinical settings by healthcare professionals. Provides rapid screening to assist in identifying drug presence; results are qualitative and intended for professional use only.

Clinical Evidence

No clinical data provided; device relies on bench testing of chromatographic immunoassay performance at specified cutoff concentrations.

Technological Characteristics

In vitro diagnostic test strips; cup-based form factor; visual qualitative detection; chemical assay principle.

Indications for Use

Indicated for use as a diagnostic test for the qualitative detection of drugs of abuse in human urine.

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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Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 1 2003

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

Re: k032057 Trade/Device Name: ToxCup™ Drug Screen Cup – AMP/COC/MET/OPI/PCP/THC 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 Dated: August 14, 2003 Received: August 15, 2003

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. Isting 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). You may obtain other general information on your responsibilities under the Act 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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K032057 510(k) Number (if known):

## Device Name:

Indications For Use:

The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:

| AMP | d-Amphetamine | 1000 ng/ml |
|---------|------------------------------------------------------------|------------|
| COC | Benzoylecgonine | 300 ng/ml |
| MET500 | d-Methamphetamine | 500 ng/ml |
| OPI2000 | Morphine | 2000 ng/ml |
| OPI300* | Morphine | 300 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| THC | 11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |

*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.

The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;"> <img alt="Tick" src="tick.png" style="width:20px; height:auto; vertical-align:middle;"/> </div> |
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OR
Over-The-Counter Use ______ (Optional Format 1-2-96)

Division Sign-Off
for Sean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K032057 |
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