TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC by BRANAN MEDICAL CORP.

The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:

AMP d-Amphetamine 1000 ng/ml
COC Benzoylecgonine 300 ng/ml
MET500 d-Methamphetamine 500 ng/ml
OPI2000 Morphine 2000 ng/ml
OPI300* Morphine 300 ng/ml
PCP Phencyclidine 25 ng/ml
THC 11-nor-Delta^9 -Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml

*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.

The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Device Description

Not Found

AI/ML Overview

This looks like information from a 510k submission to the FDA for a drug screening cup. The document is primarily an FDA clearance letter and an "Indications For Use" statement. It does not contain the detailed study information needed to describe acceptance criteria and device performance in the way requested.

Specifically, the document does not provide:

A table of acceptance criteria and reported device performance beyond the cutoff concentrations. While it lists the cutoff concentrations, it doesn't give sensitivity, specificity, accuracy, or other performance metrics against these cutoffs.
Sample sizes for the test set or data provenance.
Number or qualifications of experts for ground truth.
Adjudication method.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance (this is a physical test device, not an algorithm).
The specific type of ground truth used (e.g., confirmatory lab results).
Sample size or ground truth establishment for a training set (again, this is a physical test, not an AI/ML algorithm).

The only relevant information that can be extracted related to "acceptance criteria" (in the sense of target concentrations for detection) is from the "Indications For Use" table:

1. Table of Acceptance Criteria (Cutoff Concentrations) and Reported Device Performance (Implied target for detection):

Drug	Analyte (if specified)	Acceptance Criteria (Cutoff Concentration)	Reported Device Performance (Implied to meet these cutoffs for qualitative detection)
AMP	d-Amphetamine	1000 ng/ml	Detects d-Amphetamine at or above 1000 ng/ml
COC	Benzoylecgonine	300 ng/ml	Detects Benzoylecgonine at or above 300 ng/ml
MET500	d-Methamphetamine	500 ng/ml	Detects d-Methamphetamine at or above 500 ng/ml
OPI2000	Morphine	2000 ng/ml	Detects Morphine at or above 2000 ng/ml
OPI300*	Morphine	300 ng/ml	Detects Morphine at or above 300 ng/ml
PCP	Phencyclidine	25 ng/ml	Detects Phencyclidine at or above 25 ng/ml
THC	11-nor-$\Delta^9$-Tetrahydrocannabinol-9-carboxylic acid	50 ng/ml	Detects THC at or above 50 ng/ml
*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cut-off concentration indicated.

Regarding the other points, the document provides insufficient information:

Sample size used for the test set and the data provenance: Not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
Adjudication method for the test set: Not provided in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for this type of device (drug screening cup, not AI assistance for human readers).
If a standalone (i.e. algorithm only, without human-in-the loop performance) was done: Not applicable for this type of device (physical test, not an algorithm).
The type of ground truth used: Not explicitly stated, but for drug screens, it would typically be confirmed by a more precise analytical method like GC-MS.
The sample size for the training set: Not applicable/provided. This is not an AI/ML device that uses a "training set" in that sense.
How the ground truth for the training set was established: Not applicable/provided.

To get the detailed study information regarding sensitivity, specificity, positive predictive value, negative predictive value, exact sample sizes, and how ground truth was established (e.g., confirmatory GC-MS), one would typically need to refer to the full 510(k) submission document or the device's Instructions For Use (IFU). This document is just the FDA clearance letter and indications for use.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, with flowing lines above them. The profiles and lines are black. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", also in black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 1 2003

Ms. Chia Her Quality Manager Branan Medical Corporation 10015 Muirlands Road, Suite E Irvine, CA 92618

Re: K032057 Trade/Device Name: ToxCup™ Drug Screen Cup – AMP/COC/MET/OPI/PCP/THC Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO; DJG; DJC; LDJ; DKZ; LCM Dated: August 14, 2003 Received: August 15, 2003

Dear Ms. Her:

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. Isting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of

K032057 510(k) Number (if known):

Device Name:

Indications For Use:

AMP	d-Amphetamine	1000 ng/ml
COC	Benzoylecgonine	300 ng/ml
MET500	d-Methamphetamine	500 ng/ml
OPI2000	Morphine	2000 ng/ml
OPI300*	Morphine	300 ng/ml
PCP	Phencyclidine	25 ng/ml
THC	11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid	50 ng/ml

*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.

(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)
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OR
Over-The-Counter Use ______ (Optional Format 1-2-96)

Division Sign-Off
for Sean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)	K032057
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Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).