MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET

K012541 · Branan Medical Corp. · LDJ · Sep 4, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012541
• Device Name: MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
• Applicant: Branan Medical Corp.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Sep 4, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Branan Medical Corporation Fastix™ Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid and Benzoylecgonine in human urine. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons. The Branan Medical Corporation Fastix™ Drug Screen THC/COC/MET Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid, Benzoylecgonine, and D-Methamphetamine in human urine. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons. The Branan Medical Corporation Fastix™ Drug Screen OPI/MET/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Methamphetamine, THC, and Cocaine in human urine. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons. The Branan Medical Corporation Fastix™ Drug Screen OPI/AMP/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Amphetamine, THC and Cocaine in human urine. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.

Device Story

Fastix™ Drug Screen Dipstick tests are lateral flow immunoassays for rapid, qualitative detection of drug metabolites in human urine. Input: urine sample; Output: visual color change on dipstick indicating presence or absence of specific drug metabolites above defined cutoff concentrations. Used in professional clinical settings; operated by healthcare professionals. Provides rapid screening results to assist in clinical decision-making regarding substance use. Benefits include quick, point-of-care identification of drug presence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay dipstick format. Qualitative visual readout. Detects drug metabolites in urine at specified cutoff concentrations (e.g., 50 ng/ml for THC, 300 ng/ml for COC, 1000 ng/ml for MET/AMP, 2000 ng/ml for OPI).

Indications for Use

Indicated for professional in vitro rapid qualitative detection of drugs of abuse (THC, COC, MET, OPI, AMP) in human urine. Not for over-the-counter use.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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).

Predicate Devices

• K004034

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

SEP - 4 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K012541 Re:

K012541
Trade/Device Name: Fastix™ Drug Screen THC/COC Dipstick Test, Fastix™ Drug Screen THC/COC/MET Dipstick Test, Fastix™ Drug Screen OPI/MET/THC/COC, Dipstick Test, and Fastix™ Drug Screen OPI/AMP/THC/COC Dipstick Test Regulation Number: 21 CFR 862.3870, 862.3250, 862.3610, 862.3640, 862.3100 Regulatory Class: II Product Code: LDJ, DIO, LAF, DKZ, DJG Dated: August 1, 2001 Received: August 7, 2001

Dear Mr. Wong:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have formed your booulen b r (2) == == == == == == == == == == == == == == == == == == == == == == == == == == == == == == == == == == interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Anticluments, or to devices marilie Act (Act). You may, therefore, market the device, subject to 1 casin I oon rog, and sions of the Act. The general controls provisions of the Act include the general connois provision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket rippt of ally our din the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing A substantially equiraleral (GMP) regulation (21 CFR Part 820) and that, through r ractive GMP inspections, the Food and Drug Administration (FDA) will verify such periodio one mailure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Dri may pathis response to your premarket notification submission does not affect region. Free you might have under sections 531 through 542 of the Act for devices under the any or diation your madiation Control provisions, or other Federal laws or regulations.

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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 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

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1 4 Page

510(k) Number (if known): K004034 KC12541

#### Fastix™ Drug Screen THC/COC Dipstick Test Device Name:

Indications For Use:

The Branan Medical Corporation Fastix 141 Drug Screen THC/COC Dipstick Test is an in The Branan Medical Corporation Fastis - Drag - C - Tetrahydrocanabind-9-1ville screen test for the rapia deceeded on ametabolite) in human urine. The cutoff concentrations are as follows:

| THC | 11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
|-----|------------------------------------------------------------|-----------|
| COC | Benzoylecgonine | 300 ng/ml |

The test kit is used to obtain a visual, qualitative result and is intended for professional use I ne test in as assended 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) | |
|-----------------------------------------------|--|
|-----------------------------------------------|--|

(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K012541 |
|---------------|---------|
|---------------|---------|

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Page ನ of 4

8004039 KO12541 510(k) Number (if known):

#### Fastix TM Drug Screen THC/COC/MET Dipstick Test Device Name:

Indications For Use:

The Branan Medical Corporation Fastix™ Drug Screen THC/COC/MET Dipstick Test is I the Dranan Medical Corporation Fasces and Methamphetamine in an in no of the cutoff concentrations are as follows:

| THC | 11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
|-----|------------------------------------------------------------|------------|
| COC | Benzoylecgonine | 300 ng/ml |
| MET | D-Methamphetamine | 1000 ng/ml |

The test kit is used to obtain a visual, qualitative result and is intended for professional 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)

Kesia Alexander Jr. Joan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012541

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ന 4 Page of

K004034 KO12541 510(k) Number (if known):

#### Fastix™ Drug Screen OPI/MET/THC/COC Dipstick Test Device Name:

Indications For Use:

The Branan Medical Corporation Fastix™ Drug Screen OPVMET/THC/COC Dipstick The branan witchear Oorporation the rapid detection of Opiate, Methamphetamine THC, and Cocaine in human urine. The cutoff concentrations are as follows:

| OPI | Morphine | 2000 ng/ml |
|-----|--------------------------------------------------|------------|
| MET | D-Methamphetamine | 1000 ng/ml |
| THC | 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| COC | Benzoylecgonine | 300 ng/ml |

The test kit is used to obtain a visual, qualitative result and is intended for professional 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)

Desia Alexander M. Chan Lopez

Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number.

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4 Page 4 of

510(k) Number (if known): KOO4034 KO12541

Fastix™ Drug Screen OPI/AMP/THC/COC Dipstick Test Device Name:

Indications For Use:

The Branan Medical Corporation Fastix™ Drug Screen OPVAMP/THC/COC Dipstick The in and in vitro screen test for the rapid detection of Opiate, Amphetamine, THC and Cocaine in human urine. The cutoff concentrations are as follows:

| OPI | Morphine | 2000 ng/ml |
|-----|------------------------------------------------------------|------------|
| AMP | Amphetamine | 1000 ng/ml |
| THC | 11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
| COC | Benzoylecgonine | 300 ng/ml |

The test kit is used to obtain a visual, qualitative result and is intended for professional 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) Over-The-Counter Use __ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

atory Devices 510(k) Number