Special condition for use statement:
The BAR, BZO, TCA, OXY assay will yield preliminary positive results when BAR, BZO, TCA and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant and oxycodone in urine. The Multi Drug Cup 12 shows the drug was or was not present at the cutoff level. Drug Our 12 enows and 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 for most drugs (HPLC is the spectionely (Greatery method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

This device is not intended for workplace testing. This device is intended for Home Use.

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 - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided.

Device Description

The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tricyclic Antidepressants (TCA) and Oxycodone (OXY), 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 12 or the sample should be mailed in for confirmation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the First Check® Multi Drug Cup 12, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly defined by its intended use as a preliminary screening test and its claim of substantial equivalence to predicate devices. The "reported device performance" directly addresses the ability of lay users to correctly operate and interpret the test.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Description	Reported Device Performance
User Comprehension & Usability for Lay Users	The device should be usable by lay consumers (e.g., concerned parents) without special skills or training, allowing them to obtain immediate, preliminary information.	A consumer study demonstrates that the test exhibits "excellent overall performance in the hands of lay users." The data supports the conclusion that consumers can use the device to obtain immediate, preliminary information regarding possible drug use.
Qualitative Detection of Drugs at Specified Cut-off Concentrations	The device must qualitatively detect the presence or absence of the listed drugs and their metabolites in urine at the specified cut-off concentrations.	The device detects the following drugs at specified cut-off concentrations: - Marijuana (THC): 50 ng/mL - Cocaine (COC): 300 ng/mL - Amphetamine (AMP): 1000 ng/mL - Methamphetamine (MET): 1000 ng/mL - Ecstasy (MDMA): 500 ng/mL - Opiates (OPI): 2000 ng/mL - Phencyclidine (PCP): 25 ng/mL - Benzodiazepine (BZO): 300 ng/mL - Barbiturates (BAR): 300 ng/mL - Methadone (MTD): 300 ng/mL - Tri-cyclic Antidepressants (TCA): 1,000 ng/mL - Oxycodone (OXY): 100 ng/mL
Procedural Control Functionality	The device should include a procedural control to indicate correct test performance.	A colored line always appears at the control line region if the test has been performed properly. If not, results are invalid.
Specificity to Target Drugs	The test should react specifically with the target drugs and their metabolites.	Analytical studies of the identical Ameditech, Inc ImmuTest Drug Screen Cup (K050186) indicate that the drug test reacts specifically with the listed drugs and their metabolites.
Equivalence to Predicate Devices	The device's design, performance characteristics, materials, and manufacturing process should be substantially equivalent to legally marketed predicate devices.	The device is claimed to be identical to the Ameditech ImmuTest Drug Screen Cup (K050186) and substantially equivalent to the Accu-Stat Home Drug Test Cup and other commercially available drug screening tests.

Study Information

The document describes one distinct study (a consumer study) and references analytical studies of an identical predicate device.

Sample size used for the test set and data provenance:
- Consumer Study: The document states that a "consumer study" was conducted demonstrating performance in the hands of lay users. However, the sample size for the test set is NOT specified in the provided text. The data provenance (country of origin, retrospective/prospective) is also NOT specified. It is implied to be prospective for the purpose of evaluating lay user performance.
- Analytical Studies: Analytical studies for the "identical Ameditech, Inc ImmuTest Drug Screen Cup (K050186)" are referenced for specificity. The sample size and data provenance for these analytical studies are NOT provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is NOT provided for the consumer study, as the ground truth appears to be the observed performance of lay users. For the analytical studies, this information is also not provided, though it would typically involve laboratory analysis with established methods.
Adjudication method for the test set:
- For the consumer study, the adjudication method for determining "excellent overall performance" is NOT explicitly described. It likely involved observation of user adherence to instructions and correct interpretation of results.
- For the analytical studies, the adjudication method is NOT provided, but would typically be based on established laboratory analytical techniques.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was NOT done. This is a point-of-care, qualitative immunoassay for home use, not an AI-assisted diagnostic device requiring human reader interpretation in a complex medical imaging context. The "readers" are the lay users themselves.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, the device's inherent function is primarily standalone. The "algorithm" is the biochemical reaction and visual display. The "human-in-the-loop" is the consumer who performs the test and interprets the visual lines. The analytical studies (though referenced from a predicate) serve this purpose by confirming the device's ability to detect drugs at specific concentrations independent of user interpretation, focusing on the chemical performance. The consumer study then validates how well lay users can interact with this standalone device.
The type of ground truth used:
- Consumer Study: The ground truth for the consumer study appears to be human observation/assessment of lay user ability to correctly operate the device and interpret the visual results.
- Analytical Studies (referenced from predicate): The ground truth for the analytical studies would be established laboratory methods (e.g., using spiked urine samples or confirmed positive/negative clinical samples) to verify the presence and concentration of drugs.
The sample size for the training set: There is no mention of a training set in the context of machine learning or AI, as this is a biochemical immunoassay device, not an AI/ML product.
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model mentioned.

Summary

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K 052/15

DEC 2 9 2005

Section D

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

Submitter: I.

Address: 13 Spectrum Pointe Dr, Lake Forest, California 92630 B.

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

Contact Person: Kevin J. Gadawski D.
Date of Preparation of this Summary: July 29, 2005 II.
Trade Name: First Check® Multi Drug Cup 12, III.
Common Name: Home use drug's of abuse rapid screening test for Marijuana IV. (THC), Cocaine (COC), Ampethamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) in urine.
Classification Name: Immunoassay for the qualitative detection of drugs of abuse V. in urine.
The Marketed Products to Which Equivalence is Claimed: The First Check® VI. Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tricyclic Antidepressants and Oxycodone (OXY), 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.
Statement of Intended Use Compared to Other Products: The intended use of the VII. First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates

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(OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is substantially equivalent to the listed products; it is a preliminary, rapid screening test for the detection of up to twelve of the above listed drugs and their metabolites in urine. 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), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) and their metabolites in a urine sample. Information regarding the second step, confirmatory testing, is provided.

There are no uniformly recognized drug levels for Barbiturate (BAR), Benzodiazepine (BZO), Tri-cyclic Antidepressant (TCA) and Oxycodone (OXY) in urine. The Multi Drug Cup 12 shows the drug was or was not present at the cutoff level. The device is intended for home use. The device is not intended for workplace testing.

Discussion of Technological Characteristics: The First Check® Multi Drug Cup VIII. 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tricyclic Antidepressants (TCA) and Oxycodone (OXY), 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 12 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 (K050186) indicate that the drug test reacts specifically with the above listed drugs and their metabolites. A consumer study using the First Check® Multi Drug Cup 12 demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can

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use the First Check® Multi Drug Cup for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) to obtain immediate, preliminary information regarding the possible use of the above listed drugs. The cut-off concentration 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, Phencyclidine at 25 ng/ml, Benzodiazepine at 300 ng/ml, Barbiturates at 300 ng/ml, Methadone at 300 ng/ml, Tri-cyclic Antidepressants at 1,000 ng/ml and Oxycodone at 100 ng/ml.

Safety and Effectiveness: Because the First Check® Multi Drug Cup 12 for IX. Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepines (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is identical to the Ameditech ImmuTest Drug Screen Cup Test that is legally marketed under K050186, 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, PCP, BZO, BAR, MTD, TCA, OXY and their metabolite(s).
Because the labeling of the First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepines (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) 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, it should be concluded that the product can be used effectively by the lay user.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is composed of three curved lines that appear to be flowing or moving upwards. The text is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 9 2005

Mr. Kevin J. Gadawski President First Check Diagnostic LLC. 13 Spectrum Pointe Drive Lake Forest, CA 92630

., LOUS

K052115 Re:

R022119
Trade/Device Name: First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Rogulator y Chass. Class in
Product Code: DKZ, DJR, JXM, LDJ, LFG, LCM, DIO, DIS, DJC, DJG

Dated: November 28, 2005 Received: November 29, 2005

Dear Mr. Gadawski:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreated 77 the enactment date of the Medical Device Amendments, or to eonimores 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 rou may, merers, mains 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 I trass of acrised and I termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny Federal 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) I ms letter will and w you to oegin maing of substantial equivalence of your device to a legally promated netirate 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, r you desire specific mironion and advertising of your device, please contact the Office of In of quotions on the promostic 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 I ou may oother other generational 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,

Alberto Guts

Alberto Gutierrez, Ph.D. 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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Indications for Use

510(k) Number (if known): K052115

Device Name: First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COO), Device Name: 1 Trat Oncoke man. Barnine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY).

Indications For Use:

The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), (1 mir ), Hethine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants Dollaboundsome (DEO), Darshilans (eening test for the rapid detection of the twelve drugs listed (1 or your on human urine. The designated cut-off concentrations of these drugs are as follows: above in naman at 50 ng/mL, Amphetamine at 1000 ng/mL, Methamphetamine at 1000 ng/mL, Ecstasy at 500 ng/mL, Opiates at 2000 ng/mL, Phencyclidine at 25 ng/mL, at 1000 ng min., Barbiturates at 300 ng/mL, Methadone at 300 ng/mL, Tri-cyclic Antidepressants at 1,000 ng/mL and Oxycodone at 100 ng/mL.

Special condition for use statement:

The BAR, BZO, TCA, OXY assay will yield preliminary positive results when BAR, BZO, TCA and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant and oxycodone in urine. The Multi Drug Cup 12 shows the drug was or was not present at the cutoff level. Drug Our 12 enows and 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 for most drugs (HPLC is the spectionely (Greatery method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

This device is not intended for workplace testing. This device is intended for Home Use.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In \tjfgs of In \gjfff Page 1 of 1___________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

10-1115

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).