(28 days)
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Not Found
No
The description explicitly states the test provides a "visual, qualitative result" and is a "dipstick test," indicating a simple chemical reaction read visually, not requiring complex computational analysis like AI/ML.
No.
The device is an in vitro screen test for detecting illicit substances, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "in vitro screen test for the rapid detection" of specific substances in human urine, which falls under the definition of a diagnostic device used to identify the presence of certain conditions or substances.
No
The device description is not provided, but the intended use clearly describes "dipstick tests" which are physical, in vitro diagnostic devices, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statements explicitly state that the devices are "in vitro screen test[s]" for the detection of substances in human urine. This aligns directly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
N/A
Intended Use / Indications for Use
The Branan Medical Corporation Fastix™ Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of THC (11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid) and COC (Benzoylecgonine) in human urine. The cutoff concentrations are 50 ng/ml for THC and 300 ng/ml for COC. 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 THC (11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid), COC (Benzoylecgonine) and Methamphetamine (D-Methamphetamine) in human urine. The cutoff concentrations are 50 ng/ml for THC, 300 ng/ml for COC, and 1000 ng/ml for MET. 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 (Morphine), Methamphetamine (D-Methamphetamine), THC (11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid), and Cocaine (Benzoylecgonine) in human urine. The cutoff concentrations are 2000 ng/ml for OPI, 1000 ng/ml for MET, 50 ng/ml for THC, and 300 ng/ml for COC. 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 (Morphine), Amphetamine (Amphetamine), THC (11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid) and Cocaine (Benzoylecgonine) in human urine. The cutoff concentrations are 2000 ng/ml for OPI, 1000 ng/ml for AMP, 50 ng/ml for THC, and 300 ng/ml for COC. 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.
Product codes (comma separated list FDA assigned to the subject device)
LDJ, DIO, LAF, DKZ, DJG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use only. Not intended for over-the-counter sale to lay persons.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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 |
|---|---|
| --------------- | --------- |
3
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
4
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.
5
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