(145 days)
Not Found
No
The device description and performance studies indicate a traditional lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing algorithms.
No.
The device is described as an in vitro diagnostic test for detecting drugs/drug metabolites in human urine, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These tests provide visual qualitative results and are intended for in vitro diagnostic use only."
No
The device is a lateral flow immunoassay dipstick/dipcard, which is a physical, in-vitro diagnostic test kit, not a software-only device.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "These tests provide visual qualitative results and are intended for in vitro diagnostic use only."
- Nature of the Test: The device is a lateral flow immunoassay designed to detect specific substances (drugs and drug metabolites) in a biological sample (human urine). This is a hallmark of in vitro diagnostic testing, which involves examining samples taken from the body.
- Intended User and Setting: The text specifies that the device is for "prescription point-of-care use only" and "not intended for over-the-counter sale to non-professionals." This indicates it's intended for use by healthcare professionals in a clinical setting, which aligns with the typical use of IVDs.
N/A
Intended Use / Indications for Use
The Fastect® II PPX Drug Screen Dipstick is lateral flow immunoassay in vitro diagnostic screen test for qualitative detection of propoxyphene at or above 300ng/ml in human urine.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay in vitro diagnostic screen tests for the qualitative detection of cocaine (at or above 300ng/ml), opiates (at or above 300ng/ml), methamphetamine (at or above 500ng/ml), THC (at or above 50ng/ml), amphetamine (at or above 1000ng/ml), phencyclidine (at or above 25ng/ml), benzodiazepines (at or above 300ng/ml), barbiturates (at or above 300ng/ml), methadone (at or above 300ng/ml), tricyclic antidepressants (at or above 1000ng/ml), MDMA (at or above 500ng/ml), oxycodone (at or above 100ng/ml), buprenorphine (at or above 10ng/ml), or propoxyphene (at or above 300ng/ml) in human urine. It is for prescription point-of-care use and not intended for over-the-counter sale to non-professionals.
The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:
THC: 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid, 50 ng/ml
COC: Benzoylecgonine, 300 ng/ml
OPI: Morphine, 300 ng/ml
MET: Methamphetamine, 500 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
MDMA: 3,4-methylenedioxymethamphetamine, 500 ng/ml
OXY: Oxycodone, 100 ng/ml
BUP: Buprenorphine, 10 ng/ml
PPX: Propoxyphene, 300 ng/ml
Product codes (comma separated list FDA assigned to the subject device)
IXN, JXN
Device Description
The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites.
The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments.
A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription point-of-care use only and not intended for over-the-counter sale to non-professionals.
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)
The performance characteristics of the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard devices were based on evaluations by the following analytical performance studies:
- Stability .
- Optimal Read Time .
- Precision .
- Method Comparison .
- Specificity and Interference .
- Effect of pH and Specific Gravity .
The performance characteristics studies performed demonstrate substantial equivalency between the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, QuickTox® Drug Screen Dipcard and the predicate kit ACON™ Drug Screen test device with the same cutoff concentration of 300 ng/ml. We have demonstrated that the Fasted II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard are safe and effective for the qualitative detection of Propoxyphene at a cutoff concentration of 300ng/ml.
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.
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
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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
K1aa752
Image /page/0/Picture/1 description: The image shows a logo for BRANAN MEDICAL CORP. The logo features the letters "BMC" in a bold, sans-serif font, enclosed within a geometric shape that resembles a stylized house or shield. The word "BRANAN" is arched above the shape, and "MEDICAL CORP" is positioned below it. The logo is in black and white and appears to be slightly distressed or aged.
5.0 510(k) Summary
JAN 3 0 2013
510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Establishment Name and Address
Branan Medical Corporation 140 Technology Dr., Bldg. 400 Irvine, CA 92618 Tel: (949) 598-7166 Fax: (949) 598-7167
Contact Person: Olivia Chan Tel: (949) 598-7166 ext. 113 Email: olivia@brananmedical.com
Date Prepared: September 5, 2012
Proprietary and Trade Name
Fastect® II PPX Drug Screen Dipstick Fastect® II Drug Screen Dipstick QuickTox® Drug Screen Dipcard
Common Name
Immunochromatographic test for the qualitative detection of Propoxyphene in urine.
Classification Panel
Propoxyphene Test System
Product Code IXN
Classification Number 21 CFR, 862.3700
1
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Device Classification
The Propoxyphene test systems are classified as Class II devices with moderate complexity. The Fasted® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene are used to provide only a preliminary result. All preliminary positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis.
Substantially Equivalent Devices
K041685 - ACON MULTI-CLIN Drug Screen Test Device
Device Description
The Fastect® II Drug Screen Dipstick with Propoxyphene and QuickTox® Drug Screen Dipcard with Propoxyphene contain multiple drugs and drug metabolites in addition to Propoxyphene. Propoxyphene is added as a new analyte. The Fastect® II PPX Drug Screen Dipstick only contains the propoxyphene analyte. All dipstick and dipcard devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and all devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites.
The Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Propoxyphene in human urine at a cutoff concentration of 300 ng/ml. These tests can be performed without the use of any additional instruments.
A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.
Intended Use
The Fastect® II PPX Drug Screen Dipstick is lateral flow immunoassay in vitro diagnostic screen test for qualitative detection of propoxyphene at or above 300ng/ml in human urine.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay in vitro diagnostic screen tests for the qualitative detection of cocaine (at or above 300ng/ml), opiates (at or above 300ng/ml), methamphetamine (at or above 500ng/ml), THC (at or above 50ng/ml), amphetamine (at or above 1000ng/ml), phencyclidine (at or above 25ng/ml), benzodiazepines (at or above 300ng/ml), barbiturates (at or above 300ng/ml), methadone (at or above 300ng/ml), tricyclic antidepressants (at or above 1000ng/ml), MDMA (at or above 500ng/ml), oxycodone (at or above 100ng/ml), buprenorphine (at or above 10ng/ml), or propoxyphene (at or above 300ng/ml) in human urine. It is for prescription point-of-care use and not intended for over-the-counter sale to non-professionals.
140 Technology Dr, Suite 400, Invine, CA 92618 e-mail: info@brananmedical.com · www.brananmedical.com phone: 949-598-7166 · fax 949-598-7167
2
Image /page/2/Picture/0 description: The image shows a logo for Branan Medical Corp. The logo features the letters "BMC" in a bold, sans-serif font, enclosed within a hexagon shape. The word "BRANAN" is arched above the hexagon, and the words "MEDICAL CORP" are printed below the hexagon. The logo appears to be a black and white image.
Indications for Use
The Fastect® II Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propxyphene in human urine at or above 300 ng/mL.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:
| THC | 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
|---|---|---|
| COC | Benzoylecgonine | 300 ng/ml |
| OPI | Morphine | 300 ng/ml |
| MET | Methamphetamine | 500 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 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 ng/ml |
| OXY | Oxycodone | 100 ng/ml |
| BUP | Buprenorphine | 10 ng/ml |
| PPX | Propoxyphene | 300 ng/ml |
These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to nonprofessionals.
These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fasted® II Drug Screen Dipstick or Fasted® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.
3
Image /page/3/Picture/0 description: The image shows a logo for Branan Medical Corp. The logo features the letters "BMC" in a bold, sans-serif font, enclosed within a hexagon shape. The word "BRANAN" is arched above the hexagon, and the words "MEDICAL CORP" are below the hexagon.
Predicate Device Comparison
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| Similarities | ||
|---|---|---|
| Feature | Subject Devices | |
| (Fastect® II PPX Drug Screen | ||
| Dipstick, Fastect® II Drug | ||
| Screen Dipstick, and | ||
| QuickTox® Drug Screen | ||
| Dipcard) | Predicate Device | |
| (ACON® multi-CLINTM Drug | ||
| Screen Test Device K041685) | ||
| Intended Use | Screening Device | Screening Device |
| Matrix | Human Urine | Human Urine |
| Test Principle | Competitive immunoassay | Competitive immunoassay |
| Analytes | Propoxyphene | Propoxyphene |
| Cut-Off | 300ng/ml | 300ng/ml |
| Housing | Plastic strip holder and sleeve | Plastic strip holder and sleeve |
| Sample Volume | 10 ml | 10 ml |
| Target User Population | For professional, in-vitro | |
| diagnostic use | For professional, in-vitro | |
| diagnostic use | ||
| Shelf Life | 24 Months | 24 Months |
| Testing Method | Lateral Flow Immunoassay | Lateral Flow Immunoassay |
| Antibody/Antigen | Mouse monoclonal antibody | |
| PPX Ag | Mouse monoclonal antibody | |
| PPX Ag |
| Differences | ||
|---|---|---|
| Feature | Subject Devices | Predicate Device |
| (Fastect® II PPX Drug Screen | ||
| Dipstick, Fastect® II Drug | ||
| Screen Dipstick, and | ||
| QuickTox® Drug Screen | ||
| Dipcard) | (ACON® multi-CLINTM Drug | |
| Screen Test Device K041685) | ||
| Used in Professional or | ||
| Point-of-Care Setting | Used in point-of-care settings | Used in laboratory settings |
| Test Strip | Single Drug/Multi-Drug | Multi-Drug |
| Product Design | Dip method | Dip method and drop method |
| Storage | Sealed pouch at 15-30°C | Sealed pouch at 2-30°C |
| Reading Time | 5-30 min | 5-8 hrs |
| Internal Procedural | ||
| Controls | Negative control line | Positive and negative control |
| lines |
phone: 949-598-7166 • fax 949-598-7167 ·
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Image /page/4/Picture/0 description: The image is a black and white logo for BRANAN BMC MEDICAL CORP. The logo features the letters "BMC" in a bold, sans-serif font, enclosed within a hexagon shape. The word "BRANAN" is arched above the hexagon, and the words "MEDICAL CORP" are below the hexagon.
Performance Specifications
The performance characteristics of the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard devices were based on evaluations by the following analytical performance studies:
- Stability .
- Optimal Read Time .
- Precision .
- Method Comparison .
- Specificity and Interference .
- Effect of pH and Specific Gravity .
Conclusion
The performance characteristics studies performed demonstrate substantial equivalency between the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug . Screen Dipstick, QuickTox® Drug Screen Dipcard and the predicate kit ACON™ Drug Screen test device with the same cutoff concentration of 300 ng/ml. We have demonstrated that the Fasted II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard are safe and effective for the qualitative detection of Propoxyphene at a cutoff concentration of 300ng/ml.
5
Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The background is plain white.
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 30, 2013
Branan Medical Corporation c/o Ms. Olivia Chan 140 Technology Dr., Suite 400 Irvine, CA 92618
Re: K122752
Trade/Device Name: Fastect® II PPX Drug Screen Dipstick Fastect® II Drug Screen Dipstick OuickTox® Drug Screen Dipcard Regulation Number: 21 CFR 862.3700 ' Regulation Name: Propoxyphene test system Regulatory Class: II Product Code: JXN Dated: January 02, 2013 Received: January 03, 2013
Dear Ms. Chan:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2-Ms. Chan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D.
Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K122752
Device Name: ·
Fastect® II PPX Drug Screen Dipstick Test Fastect® II Drug Screen Dipstick Test QuickTox® Drug Screen Dipcard
Indications for Use:
The Fastect® II PPX Drug Screen Dipstick Test is a lateral flow immunoassay for the rapid detection of propoxyphene in human urine at or above 300 ng/mL.
The Fastect® II Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:
| THC | 1-1-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
|---|---|---|
| COC | Benzoylecgonine | 300 ng/ml |
| OPI | Morphine | 300 ng/ml |
| MET | Methamphetamine | 500 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 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 ng/ml |
| OXY | Oxycodone | 100 ng/ml |
| BUP | Buprenorphine | 10 ng/ml |
| PPX | Propoxyphene | 300 ng/ml |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.01.29 06:58:43 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health K122752 510(k) .
. –
8
These tests provide visual qualitative results and are intended for in vitro diagnostic use only. It is for prescription point-of-care use only and not intended for over-the-counter sale to non-professionals.
These tests provide only a preliminary test result. For a quantitative result or to confirm preliminary positive results obtained by the QuickTox® Drug Screen Dipcard, Fastect® II Drug Screen Dipstick or Fastect® II PPX Drug Screen Dipstick tests, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical Consideration and professional judgment should be applied to any drug of abuse test results, particularly when a preliminary positive result is indicated.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.01.29 06:59:15 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health K122752 510(k)