The Branan Medical Corporation Fastix Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Delta9-Tetrahydrocannabinol-9-carboxylic acid (a metabolite) and Benzoylecgonine in human urine. The cutoff concentrations are as follows: THC 50 ng/ml, COC 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.

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-Delta9-Tetrahydrocannabinol-9-carboxylic acid, Benzoylecgonine and D-Methamphetamine in human urine. The cutoff concentrations are as follows: THC 50 ng/ml, COC 300 ng/ml, MET 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.

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 cutoff concentrations are as follows: OPI 2000 ng/ml, MET 1000 ng/ml, THC 50 ng/ml, COC 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.

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 cutoff concentrations are as follows: OPI 2000 ng/ml, AMP 1000 ng/ml, THC 50 ng/ml, COC 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.

Device Description

Not Found

AI/ML Overview

This document outlines the Indications for Use and Cutoff Concentrations for several Fastix™ Drug Screen Dipstick Tests. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information from the given text.

The document primarily serves as a 510(k) premarket notification letter and describes the intended use and specific drug cutoffs for various configurations of the Fastix™ Drug Screen Dipstick Test. It indicates that the FDA has reviewed the submission and allows the device to be marketed.

Summary

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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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Page 2 -

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
---------------------------------------	--

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)

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)

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

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).