The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

AMP Amphetamine 500 ng/ml
BAR Secobarbital 300 ng/ml
BUPG Buprenorphine Glucuronide 10 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 150 ng/ml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
MET Methamphetamine 500 ng/ml
MTD Methadone 300 ng/ml
OPI Morphine 300 ng/ml
OXY Oxycodone 100 ng/ml
PCP Phencyclidine 25 ng/ml
PPX Propoxyphene 300 ng/ml
TCA Nortriptyline 1000 ng/ml
THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in single drug analyte cassette dip format and/or double drug analyte cassette dip format. It is intended for prescription point-of-care and overthe-counter consumer use.

These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, 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 result, particularly when a preliminary positive result is indicated.

Device Description

The ToxCup® Drug Screen Cup is based on the principle of highly specific immunochemical reactions between antigens and antibodies. It utilizes a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. The ToxCup® Drug Screen Cup device consists of individual test strips, in single drug analyte cassette dip format and/or double analyte cassette dip format, assembled into separate chambers of a plastic insert and can detect up to 14 drugs in human urine at various cutoff concentrations. The presence of a color band at a specific test region indicates a negative result for that particular test. The absence of a color band at a specific test region indicates presumptive positive result for that particular test.

A control band at the control region should always appear regardless of the presence of the drug or its metabolites. The presence of the control band during testing serves as a built in control which indicates that the test has completed and is valid.

AI/ML Overview

The provided text describes the ToxCup® Drug Screen Cup, a qualitative lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine. The acceptance criteria and the study performance reported are based on Method Comparison studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion specified for the Method Comparison is a total % agreement of ≥ 95%. The text states that the predicate device (Amedica Home Drug Test Cup) had a total % agreement of ≥ 93%. While the specific percentages for the ToxCup® Drug Screen Cup are not detailed in the provided excerpt, the "Differences" table (Page 5) implies that the new device meets or exceeds this threshold, as it lists "≥ 95%" for "Method Comparison Total % agreement". The conclusion explicitly states: "The performance characteristics studies performed demonstrate substantial equivalency between the ToxCup® Drug Screen Cup, the predicate kit Amedica Home Drug Test Cup."

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Method Comparison Total % Agreement	≥ 95%	Not explicitly stated as a specific numerical value, but claimed to be ≥ 95% and demonstrate substantial equivalency.

Important Note: The provided text only explicitly states the acceptance criterion for "Method Comparison Total % agreement" in the "Differences" table between the subject device and the predicate device. It does not provide specific numerical results for each drug analyte or for other performance characteristics like stability, optimal read time, precision/reproducibility, or specificity/interference, beyond listing that these studies were performed.

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

The provided summary does not explicitly state the sample size used for the test set in the Method Comparison study, nor does it mention the country of origin of the data or whether the study was retrospective or prospective.

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

The document does not provide information about experts used to establish ground truth for the test set. Drug screening tests like this typically use laboratory-confirmed quantitative methods (e.g., GC/MS) as the gold standard for ground truth, rather than expert interpretation of the rapid test results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This type of device provides a visual qualitative result (presence or absence of a color band) and the "ground truth" is typically established by an independent, more definitive laboratory method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study (MRMC) is generally more relevant for imaging devices where human interpretation is a primary factor. The ToxCup® is a rapid immunoassay for drugs in urine.

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

The device itself is a standalone, qualitative lateral flow immunoassay. Its performance characteristics, such as the Method Comparison, are evaluated based on the device's ability to produce a correct visual result (positive or negative) compared to a gold standard. Human interpretation of the result is part of how the device is used (reading the presence or absence of a color band), but the performance studies focus on the accuracy of the test itself. There is no "algorithm only" component in the traditional sense of AI/image analysis without human-in-the-loop performance, as the device's output is the visual result.

7. The Type of Ground Truth Used

The ground truth for preliminary positive results is established by a "more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS)." This is explicitly stated: "For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used." This is a gold standard laboratory method for drug detection and quantification.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. Immunoassays like the ToxCup® are designed and optimized through a development process, but they don't typically involve "training sets" in the same way machine learning algorithms do. The performance studies described (Precision/reproducibility, Method Comparison, Specificity and Interference, Consumer Study, etc.) are verification and validation studies of the developed product.

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

As there is no mention of a "training set" in the context of machine learning, there is no description of how ground truth for such a set was established. The development of such an immunoassay would involve standard laboratory practices and analytical chemistry to determine appropriate antibody and antigen concentrations and reaction conditions to achieve desired sensitivity and specificity.

Summary

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K122633

FEB

7 2013

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 hexagon with a pointed top. The words "BRANAN" are arched above the shape, and "MEDICAL CORP" is written below it in a smaller, bold font.

5.0 510(k) Summary

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., Bidg. 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: August 24, 2012

Proprietary and Trade Name

ToxCup® Drug Screen Cup

Common Name

Qualitative Lateral Flow Immunoassay

Classification Panel

Toxicology (91)

140 Technology Dr, Suite 400, Irvine, CA 92618 e-mail: info@brananmedical.com · www.brananmedical.com phone: 949-598-7166 · fax 949-598-7167

Page 13 of 223

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Image /page/1/Picture/0 description: The image shows a logo for BRANAN BMC MEDICAL CORP. The logo features the letters "BMC" in a bold, stylized font, with a horizontal line above and below the letters. The word "BRANAN" is arched above the letters, and the words "MEDICAL CORP." are below. The logo is black and white.

MEDICAL CORP

Device	Panel	Product Code	Classification	Regulation Section	Description
THC	Toxicology (91)	LDJ	II	862.3870	Cannabinoid Test System
COC	Toxicology (91)	DIO	II	862.3250	Cocaine and CocaineMetabolite Test System
OPI	Toxicology (91)	DJG	II	862.3650	Opiates Test System
MET	Toxicology (91)	DJC	II	862.3610	Methamphetamine TestSystem
AMP	Toxicology (91)	DKZ	II	862.3100	Amphetamine Test System
BZO	Toxicology (91)	JXM	II	862.3170	Benzodiazepine TestSystem, Over The Counter
BAR	Toxicology (91)	DIS	II	862.3150	Barbiturate Test System
MTD	Toxicology (91)	DJR	II	862.3620	Methadone Test System
BUPG	Toxicology (91)	DJG	II	862.3650	Opiates (Buprenorphine)Test System
TCA	Toxicology (91)	LFG	II	862.3910	Tricyclic AntidepressantDrugs Test System
MDMA	Toxicology (91)	DJC	II	862.3610	Methamphetamine(MDMA) Test System,Over The Counter
OXY	Toxicology (91)	DJG	II	862.3650	Opiates (Oxycodone) TestSystem, Over the Counter
PCP	Toxicology (91)	LCM	II	862.3100	Enzyme immunoassayPhencyclidine
PPX	Toxicology (91)	IXN	II	862.3700	Propoxyphene Test System

Product Code and Regulation Number

Device Classification

Class II .

Substantially Equivalent Devices

K082898 – Amedica Home Drug Test Cúp

Page 14 of 223

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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, stacked on top of each other. The letters are enclosed in a hexagon shape. The words "BRANAN" are arched above the letters, and the words "MEDICAL CORP" are below the hexagon.

Device Description

Intended Use

The ToxCup® Drug Screen Cup in single drug analyte cassette dip format and/or double analyte cassette dip format is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

AMP	Amphetamine	500 ng/ml
BAR	Secobarbital	300 ng/ml
BUPG	Buprenorphine Glucuronide	10 ng/ml
BZO	Oxazepam	300 ng/ml
COC	Benzoylecgonine	150 ng/ml
MDMA	3,4-methylenedioxymethamphetamine	500 ng/ml
MET	Methamphetamine	500 ng/ml
MTD	Methadone	300 ng/ml
OPI	Morphine	300 ng/ml
OXY	Oxycodone	100 ng/ml
PCP	Phencyclidine	25 ng/ml
PPX	Propoxyphene	300 ng/ml
TCA	Nortipltyline	1000 ng/ml
THC	11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid	50 ng/ml

140 Technology Dr, Suite 400, Irvine, CA 92618 e-mail: info@brananmedical.com · www.brananmedical.com phone: 949-598-7166 · fax 949-598-7167

Page 15 of 223

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Image /page/3/Picture/0 description: The image shows a logo for Branan Medical Corp. The logo features the word "BRANAN" in a curved, block-letter font at the top. Below "BRANAN" is the acronym "BMC" in a bold, sans-serif font, enclosed within a geometric shape that resembles a stylized roof or shield. The words "MEDICAL CORP" are printed in a bold, sans-serif font at the bottom of the logo.

Indications for Use

The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

AMP	Amphetamine	500 ng/ml
BAR	Secobarbital	300 ng/ml
BUPG	Buprenorphine Glucuronide	10 ng/ml
BZO	Oxazepam	300 ng/ml
COC	Benzoylecgonine	150 ng/ml
MDMA	3,4-methylenedioxymethamphetamine	500 ng/ml
MET	Methamphetamine	500 ng/ml
MTD	Methadone	300 ng/ml
OPI	Morphine	300 ng/ml
OXY	Oxycodone	100 ng/ml
PCP	Phencyclidine	25 ng/ml
PPX	Propoxyphene	300 ng/ml
TCA	Nortriptyline	1000 ng/ml
THC	11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid	50 ng/ml

-140 Technology Dr, Suite 400, Irvine, CA 92618 e-mail: info@brananmedical.com · www.brananmedical.com phone: 949-598-7166 · fax 949-598-7167

Page 16 of 223

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Image /page/4/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 geometric shape resembling a hexagon with a pointed top. The word "BRANAN" is arched above the shape, and the words "MEDICAL CORP" are printed below the shape.

Predicate Device Comparison

Similarities
Feature	Subject Devices (ToxCup® Drug Screen Cup)	Predicate Device (Amedica Home Drug Test Cup)
Intended Use	Screening Device	Screening Device
Matrix	Human Urine	Human Urine
Test Principle	Competitive immunoassay	Competitive immunoassay
Analytes and Cut-Off	THC 50ng/mlMorphine 300ng/mlPhencyclidine 25ng/mlSecobarbital 300ng/mlBenzodiazepines 300ng/mlMethadone 300ng/mlOxycodone 100ng/mlMDMA 500ng/mlNortriptyline 1000ng/ml	THC 50ng/mlMorphine 300ng/mlPhencyclidine 25ng/mlSecobarbital 300ng/mlBenzodiazepines 300ng/mlMethadone 300ng/mlOxycodone 100ng/mlMDMA 500ng/mlNortriptyline 1000ng/ml
Housing	Plastic lid and cup base	Plastic lid and cup base
Internal Procedural Controls	Control line	Control line
Intended User	Over The Counter Consumer	Over The Counter Consumer
Testing Method	Lateral Flow Immunoassay	Lateral Flow Immunoassay

140 Technology Dr, Suite 400, Irvine, CA 92618 -e-mail: info@brananmedical.com • www.brananmedical.com phone: 949-598-7166 • fax 949-598-7167

Page 17 of 223

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Image /page/5/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 words "BRANAN" are arranged in an arc above the hexagon, and the words "MEDICAL CORP" are placed below the hexagon.

Differences
Feature	Subject Devices(ToxCup® Drug ScreenCup)	Predicate Device(Amedica Home Use DrugTest Cup)
Test Strip	Test up to 14 drugs	Test up to 12 drugs
Analytes and Cut-Off	Benzoylecgonine 150ng/mlAmphetamine 500ng/mlMethamphetamine 500ng/mlBuprenorphine Glucuronide10ng/mlPropoxyphene 300ng/ml	Benzoylecgonine 300ng/mlAmphetamine 1000ng/mlMethamphetamine 1000ng/ml
MethodComparison Total% agreement	≥ 95%	≥ 93%
Storage	Sealed pouch at 15-30°C	Sealed pouch at 2-30°C
Intended User	Over The CounterConsumer and PrescriptionPoint-of-Care use	Over The CounterConsumer
Reading Time	5 - 8 minutes	4 - 5 minutes

Test Summary:

Performance Specifications

The performance characteristics of the ToxCup® Drug Screen Cup were based on evaluations by the following analytical performance studies:

Stability .
Optimal Read Time .
`Precision/reproducibility .
Method Comparison .
Specificity and Interference .
. Consumer Study

Conclusion

The performance characteristics studies performed demonstrate substantial equivalency between the ToxCup® Drug Screen Cup, the predicate kit Amedica Home Drug Test Cup.

140 Technology Dr, Suite 400, Irvine, CA 92618 e-mail: info@brananmedical.com · www.brananmedical.com phone: 949-598-7166 · fax 949-598-7167

Page 18 of 223

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

February 7, 2013

Branan Medical Corporation c/o Olivia Chan 140 Technology Dr. Suite 400 Irvine, CA 92618

Re: K122633

Trade/Device Name: ToxCup® Drug Screen Cup Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DIO, DJG, DJC, DKZ, JXM, DIS, DJR, LFG, LCM, JXN Dated: January 18, 2013 Received: January 22, 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 forth in the quality systems (OS) 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/CDRH0ffices/ucm115809.htm for

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Page 2-Ms. Chan '

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

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Indications for Use

510(k) Number (if known): K122633

ToxCup® Drug Screen Cup Device Name:

Indications for Use:

The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

AMP Amphetamine	500 ng/ml
BAR Secobarbital	300 ng/ml
BUPG Buprenorphine Glucuronide	10 ng/ml
BZO Oxazepam	300 ng/ml
COC Benzoylecgonine	150 ng/ml
MDMA 3,4-methylenedioxymethamphetamine	500 ng/ml
MET Methamphetamine	500 ng/ml
MTD Methadone	300 ng/ml
OPI Morphine	300 ng/ml
OXY Oxycodone	100 ng/ml
PCP Phencyclidine	25 ng/ml
PPX Propoxyphene	300 ng/ml
TCA Nortriptyline	1000 ng/ml
THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid	50 ng/ml

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in double drug analyte cassette dip format. It is intended for prescription point-of-care use and over-the-counter consumer use.

(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 2013.02.05 15:21:38 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K122633 510(k)

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Indications for Use

510(k) Number (if known): K122633

ToxCup® Drug Screen Cup Device Name:

Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (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 2013.02.05 15:21:59 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K122633 510(k)

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).