FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY

K052115 · First Check Diagnostics, LLC · DKZ · Dec 29, 2005 · Clinical Toxicology

Device Facts

• Record ID: K052115
• Device Name: FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
• Applicant: First Check Diagnostics, LLC
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Dec 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

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), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is a screening test for the rapid detection of the twelve drugs listed above 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, 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. 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. This assay 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 for most drugs (HPLC is the preferred confirmatory 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. 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 Story

The First Check® Multi Drug Cup 12 is a rapid, one-step chromatographic immunoassay for qualitative detection of drugs of abuse in urine. The device uses a cup-based format where urine samples are collected and tested simultaneously for up to twelve target drugs. The principle of operation relies on competitive binding between drug metabolites in the urine and drug-conjugates immobilized on the test membrane; a positive result (presence of drug) is indicated by the absence of a colored line in the test region, while a negative result is indicated by the presence of a colored line. A control line confirms proper test performance. Designed for home use by lay users (e.g., parents), the device provides preliminary results that require follow-up confirmatory testing (e.g., GC/MS or HPLC) for definitive identification. The device benefits patients/consumers by providing immediate, preliminary information regarding potential drug use, facilitating the first step in a two-step screening process.

Clinical Evidence

Consumer study (n=250) evaluated performance and labeling comprehension. Participants interpreted 5,760 assays; 99.5% (5,731/5,760) were interpreted correctly. 480 unique tests performed using spiked urine samples at 0%, 50%, 75%, 125%, 150%, and 200% of target concentrations. Recovery for non-TCA drugs confirmed by GC/MS (85.3-138.0%); TCA confirmed by HPLC (84.3-121.2%). Questionnaire confirmed 95.2% found test easy to run/read and 94.7% understood positive results for prescription drugs do not confirm abuse.

Technological Characteristics

Two-piece plastic specimen collection cup with integrated test strips. Nitrocellulose membrane pre-coated with drug-protein conjugate or antibody; colloidal gold conjugate pad. Competitive binding immunoassay principle. No external energy source. Standalone device.

Indications for Use

Indicated for home use by consumers as a rapid, preliminary screening test for the qualitative detection 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) in human urine. Not for workplace testing.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Ameditech Immutest Drug Screen Cup (k050186)

Submission Summary (Full Text)

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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: [phone] |
|----|------------------------|-----------------------|
| | | Fax: [phone] |

- 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 [phone]. 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 [phone] or [phone] 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.

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.

| 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

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