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

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, 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.

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.

AI/ML Overview

The provided document describes the Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, and QuickTox® Drug Screen Dipcard devices, which are lateral flow immunoassays for the qualitative detection of Propoxyphene (PPX) and other drugs in human urine at specified cutoff concentrations.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on Propoxyphene as it's the new analyte):

The document does not explicitly state "acceptance criteria" through numerical thresholds for sensitivity, specificity, or accuracy in a traditional sense. Instead, the acceptance criterion for regulatory approval appears to be demonstrating substantial equivalency to a predicate device (ACON® multi-CLINTM Drug Screen Test Device K041685) for the detection of Propoxyphene at a 300 ng/ml cutoff. The "Performance Specifications" section outlines the types of analytical studies conducted to establish this equivalency.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (Summary from Conclusion)
Functional Equivalence	Detect Propoxyphene in human urine.	All devices mentioned (Fastect® II PPX Drug Screen Dipstick, Fastect® II Drug Screen Dipstick, QuickTox® Drug Screen Dipcard) detect Propoxyphene.
Cut-off Concentration	Detect Propoxyphene at or above 300 ng/ml.	All devices are standardized to detect Propoxyphene at a cutoff concentration of 300 ng/ml.
Test Principle	Utilize competitive immunoassay.	All devices are based on the principle of highly specific immunochemical reactions between antigens and antibodies and utilize a competitive immunoassay procedure.
Analytical Performance	Demonstrate performance comparable to predicate for:	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." Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in this summary, but the studies listed (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) were conducted to support this conclusion.
	- Stability
	- Optimal Read Time
	- Precision
	- Method Comparison
	- Specificity and Interference
	- Effect of pH and Specific Gravity
Safety and Effectiveness	Safe and effective for qualitative detection of Propoxyphene.	"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."

2. Sample Size Used for the Test Set and Data Provenance:

The document lists the types of performance characteristic studies performed (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) but does not provide details on the sample sizes used for these test sets.

The data provenance (e.g., country of origin, retrospective or prospective) is not specified in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For drug screening tests like these, ground truth is typically established through a reference method (like GC/MS or LC/MS), not through a panel of experts interpreting results.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. When a reference method like GC/MS is used to establish ground truth, there isn't typically an "adjudication method" involving multiple human readers interpreting the output of the reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study evaluates the performance of human readers, sometimes with and without AI assistance. The described devices are in vitro diagnostic tests that provide a visual qualitative result, intended for direct use by a professional without a complex interpretation process that would typically involve multiple readers. The document highlights the need for confirmation by GC/MS or LC/MS for preliminary positive results, indicating that human interpretation of the dipstick is a preliminary step, not a diagnostic endpoint requiring complex reader studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the performance studies described are essentially standalone performance evaluations. The devices are immunochromatographic tests that yield a visual result (presence or absence of a line). The "performance characteristics studies" (Stability, Optimal Read Time, Precision, Method Comparison, Specificity and Interference, Effect of pH and Specific Gravity) evaluate the inherent analytical performance of the device itself, independent of human interpretation variability after the preliminary visual reading. The device's "algorithm" is the biochemical reaction and the visual readout mechanism.

7. The Type of Ground Truth Used:

The document states: "All preliminary positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS or LC/MS confirmatory analysis." This strongly implies that Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) would be the gold standard or "ground truth" used to validate the performance of these devices in a method comparison study. These are highly sensitive and specific analytical techniques for drug detection and quantification.

8. The Sample Size for the Training Set:

This information is not provided as these are not machine learning/AI devices in the traditional sense that require a "training set." The development of such immunoassay devices involves laboratory testing and optimization of reagents, antibodies, and manufacturing processes, rather than training on a dataset in the way an AI algorithm would be trained.

9. How the Ground Truth for the Training Set Was Established:

As these are not traditional AI devices with a "training set," this question is not directly applicable. The "ground truth" for optimizing the assay's performance during development would rely on known concentrations of propoxyphene and its metabolites, confirmed by highly accurate analytical methods like GC/MS or LC/MS.

Summary

{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}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo for Branen Medical Corp. The logo features the letters "BMC" in a bold, sans-serif font, stacked vertically and enclosed within a geometric shape resembling a stylized hexagon. The words "BRANAN" are arched above the shape, and "MEDICAL CORP" is written below it.

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

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.

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

{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

・

. .

・

: 上一篇:

. . . . .

Similarities
Feature	Subject Devices(Fastect® II PPX Drug ScreenDipstick, Fastect® II DrugScreen Dipstick, andQuickTox® Drug ScreenDipcard)	Predicate Device(ACON® multi-CLINTM DrugScreen 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-vitrodiagnostic use	For professional, in-vitrodiagnostic use
Shelf Life	24 Months	24 Months
Testing Method	Lateral Flow Immunoassay	Lateral Flow Immunoassay
Antibody/Antigen	Mouse monoclonal antibodyPPX Ag	Mouse monoclonal antibodyPPX Ag

Differences
Feature	Subject Devices	Predicate Device
	(Fastect® II PPX Drug ScreenDipstick, Fastect® II DrugScreen Dipstick, andQuickTox® Drug ScreenDipcard)	(ACON® multi-CLINTM DrugScreen Test Device K041685)
Used in Professional orPoint-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 ProceduralControls	Negative control line	Positive and negative controllines

phone: 949-598-7166 • fax 949-598-7167 ·

: 上一篇:

{4}------------------------------------------------

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.

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 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)

Regulation Number and Section

§ 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).