The First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is a screening test for the rapid detection of one to seven of the above listed drugs in a variety of combinations in human urine. The designated cut-off concentrations of these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml.

This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing of the second step in the process, along with the materials for shipping the unne speciment o the laboratory, is provided.

Device Description

The First Check® Multi Drue Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP), like other commercially available drug screening tests, qualitatively detects the presence or absence of the above listed drugs and their metabolites in urine, using a one step. rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug complexes.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly. If a control line does not appear for any reason, the results are considered invalid and should not be interpreted. The sample should either be retested using a new First Check Multi Drug Cup 7 or the sample should be mailed in for confirmation.

AI/ML Overview

The K051966 submission describes the "First Check® Multi Drug Cup 7" for rapid screening of several drugs of abuse in urine for over-the-counter (OTC) consumer use. The device's performance relies on its substantial equivalence to a predicate device (Ameditech ImmuTest Drug Screen Cup) that was previously cleared for professional use, and a consumer study demonstrating effective use by lay users.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal "acceptance criteria" for precision, accuracy, sensitivity, or specificity in a table format. However, it strongly implies that the device's performance is acceptable because it is identical to a legally marketed professional-use device (Ameditech ImmuTest Drug Screen Cup, K040092 and K042975) and a consumer study demonstrated excellent overall performance with lay users.

The performance is implicitly tied to:

Qualitative detection: Presence or absence of drugs/metabolites.
Cut-off concentrations: Specific thresholds for each drug (e.g., Marijuana at 50 ng/ml).
Specific reactions: The analytical studies of the predicate device (Ameditech ImmuTest Drug Screen Cup) indicate that the drug test reacts specifically with the listed drugs and their metabolites.

Drug	Cut-off Concentration (ng/ml)	Acceptance Criteria (Implicit)	Reported Device Performance
Marijuana (THC)	50	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Cocaine (COC)	300	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Amphetamine (AMP)	1000	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Methamphetamine (MET)	1000	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Ecstasy (MDMA)	500	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Opiates (OPI)	2000	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Phencyclidine (PCP)	25	Qualitative detection of presence/absence at or above cut-off.	Device is identical to Ameditech ImmuTest Drug Screen Cup (K040092 & K042975) whose analytical studies indicated specific detection. Consumer study demonstrated "excellent overall performance in the hands of lay users" and "successful responses from the consumer study."
Overall Use (OTC)	N/A	Usability by lay users; ability to follow instructions and interpret results correctly; no safety/effectiveness issues for intended function.	"Excellent overall performance in the hands of lay users." "Successful responses from the consumer study." "No reports of consumer inability to follow instructions or interpret results over many years" for similar predicate devices. "No issue regarding the safety or effectiveness of the product to perform its intended function."

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

Test set sample size: The text mentions a "consumer study" but does not specify the sample size used for this study.
Data Provenance: The text does not explicitly state the country of origin. It relates to a US FDA 510(k) submission, suggesting it's relevant to the US market. The study appears to be prospective in nature, as it's a "consumer study using the First Check® Home Drug Test" to demonstrate its performance with lay users. This indicates data was collected specifically for this submission or related clearances.

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

The document does not describe a traditional expert-adjudicated test set for performance metrics like sensitivity/specificity against a ground truth. Instead, it relies on two primary lines of evidence:
- Analytical studies of the identical predicate device: These studies (from K040092 and K042975) would have established the analytical performance (specificity, cut-offs) in a laboratory setting. No details on experts for these specific studies are provided in this document.
- Consumer study: This study focused on user comprehension and ability to perform the test, rather than establishing diagnostic ground truth of the urine samples themselves. No experts are mentioned in relation to this consumer study's ground truth for drug presence.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for diagnostic performance. The consumer study likely assessed participant understanding and correct interpretation of results against a predefined correct outcome, but no multi-expert adjudication method is described. The analytical studies for the predicate device would have relied on laboratory standards and confirmatory methods, but adjudication methods are not detailed here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This device is a rapid, qualitative immunoassay, not a complex imaging or diagnostic interpretation system where MRMC studies are typically performed.

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

Yes, implicitly. The immunoassay itself performs the "algorithm" for detecting drugs. The analytical studies (mentioned regarding the predicate device K040092 and K042975) would represent the "standalone" performance of the test mechanics in a laboratory setting. The consumer study then assesses the human-in-the-loop (lay user) aspect.

7. The Type of Ground Truth Used

For the analytical performance (inherent to the immunoassay): The ground truth would typically be established by controlled spiking of drug metabolites into urine samples at known concentrations and/or confirmatory laboratory methods like Gas Chromatography/Mass Spectrometry (GC/MS) for naturally occurring samples. The document states that the predicate's analytical studies indicate specific reactions and the instruction for the device advises "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
For the consumer study (usability): The ground truth would be related to whether the lay users correctly followed instructions and interpreted the test lines (or lack thereof) as positive/negative according to known sample results (which would have been determined by analytical ground truth).

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this is a chemical immunoassay device, not a machine learning algorithm that typically requires explicit training datasets. The device's underlying technology and performance characteristics would have been established through extensive R&D and analytical validation (e.g., cross-reactivity studies, precision studies) over time, which do not fit the common definition of a "training set" in AI/ML contexts.

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

As above, a "training set" in the AI/ML context is not applicable here. The device's design and manufacturing rely on established immunoassay principles, and its performance characteristics (specificity, accuracy against known concentrations) would have been validated through standard laboratory analytical methods using controlled samples (e.g., spiked urine samples, confirmed positive/negative clinical samples).

Summary

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K051966

Section D

510(k) Summary [As required by 21 CFR 807.92]

I. Submitter:

Name: Worldwide Medical LLC A.
B. Address: 13 Spectrum Pointe Drive, Lake Forest. California 92630

C.	Phone and Fax Numbers:	Phone: (949) 598-8378 X20-
		Fax: (949) 334-6006

D. Contact Person: Kevin J. Gadawski
Date of Preparation of this Summary: July15, 2005 II.
III. Trade Name: First Check® Multi Drug Cup 7 for Marijuana (THC). Cocaine (COC), Ampethamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP).
IV. Common Name: Home use drug of abuse rapid screening test for Marijuana (THC), Cocaine (COC), Ampethamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) in urine.
V. Classification Name: Immunoassay for the qualitative detection of drugs of abuse in urine.
VI. The Marketed Products to Which Equivalence is Claimed: The First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP), that is the subject of this submission is identical to the Ameditech ImmuTest Drug Screen Cup in terms of product design, performance characteristics, materials of construction and manufacturing process. It is also substantially equivalent to the Accu-Stat Home Drug Test Cup, and other commercially available drug screening tests, that qualitatively measure the presence of target drugs or metabolites by visual color one-step immunoassay technology.
VII. Statement of Intended Use Compared to Other Products: The intended use of the First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is substantially equivalent to the listed products; it

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is a preliminary, rapid screening test for the detection of between one and seven of the above listed drugs and their metabolites in urine (depending on configuration). This product is intended to be the first step in a two step process to provide consumers, including but not limited to concerned parents, with information regarding the presence of Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) and their metabolites in a urine sample, Information regarding the second step, confirmatory testing, is provided. The First Check Multi Drug Cup 7 utilizes the following cut-off concentrations: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The predicate device (Ameditech ImmuTest Drug Screen Cup) is intended for professional use while the First Check® Multi Drug Cup 7 is intended for OTC use.

VIII. Discussion of Technological Characteristics: The First Check® Multi Drue Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP), like other commercially available drug screening tests, qualitatively detects the presence or absence of the above listed drugs and their metabolites in urine, using a one step. rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug complexes.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly. If a control line does not appear for any reason, the results are considered invalid and should not be interpreted. The sample should either be retested using a new First Check Multi Drug Cup 7 or the sample should be mailed in for confirmation.

Examples of predicate devices include the First Check® Home Drug Tests using a single or multi-drug display and the Accu-Stat Drugs of Abuse Home Test Cup. The analytical studies of the identical Ameditech, Inc ImmuTest Drug Screen Cup (K040092 and K042975) indicate that the drug test reacts specifically with the above listed drugs and their metabolites. A consumer study using the First Check® Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the First Check® Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) to obtain immediate,

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preliminary information regarding the possible use of THC, COC, AMP, MET, MDMA, OPI and PCP.

IX. Safety and Effectiveness: Because the First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is identical to the Ameditech ImmuTest Drug Screen Cup Test that is legally marketed for professional use under K040092 and K042975, and because no special skills, training, education, or licensure are required to collect a urine sample and activate the test, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of THC, COC, AMP, MET, MDMA, OPI or PCP and their metabolite(s).
Because the labeling of the First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the First Check Home Drug Test Kit, the Phamatech At Home™ Drug Test Cup and the Accu-Stat Home Drug Test Cup, and there have been no reports of consumer inability to follow instructions or interpret results over the many years in which these products have been purchased by the general public, and due to the successful responses from the consumer study for the First Check® Multi Drug Cup 7, it should be concluded that the product can be used effectively by the lay user.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines suggesting movement or connection. The text is arranged in a circular fashion around the symbol.

Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Kevin J. Gadawski President Worldwide Medical, LLC 13 Spectrum Pointe Drive Lake Forest, California 92630

Received: July 20, 2005

SEP = 7 2005

K051966 Trade/Device Name: First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) Regulation Number: 21 CFR § 862.3100 Regulation Name: Enzyme Immunoassay, Amphetamine Regulatory Class: II Product Code: DKZ, LDJ, DIO, LAF, DJG and LCM Dated: July 15, 2005

Dear Mr. Gadawski:

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.

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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Page 2 –

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours.

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section A

Page 1 of 1

510(k) Number (if known): K 05 / 9 6

Device Name: First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP)

Indications for Use:

Special condition for use statement:

Prescription Use
Use X
(Part 21 CFR 801 Subpart D)

Over-The-Counter

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.)

AND/OR

Division Sicritar

Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of In Vitr Diagnostic Device Evaluation and . Listy

510(k) K051966

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).