FIRST CHECK HOME DRUG TEST PANEL 4

K993852 · Worldwide Medical Corp. · LAF · Nov 29, 2000 · Clinical Toxicology

Device Facts

• Record ID: K993852
• Device Name: FIRST CHECK HOME DRUG TEST PANEL 4
• Applicant: Worldwide Medical Corp.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Nov 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The First Check® Home Drug Test Panel 4 is an educational screening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/mL respectively. The test is intended for 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 four drugs concerned. This information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

Device Story

First Check® Home Drug Test Panel 4 is a rapid, one-step chromatographic immunoassay for qualitative detection of drugs of abuse in urine. Device utilizes antibody/target drug/antibody complex formation to identify presence of marijuana, cocaine, morphine/opiates, and methamphetamine. User applies urine sample to test card well; results interpreted visually by user. Intended for home use by lay persons (e.g., parents) as preliminary screening tool. Positive results require secondary confirmatory testing. Provides consumers with information regarding drug presence to assist in compliance with laws or societal expectations.

Clinical Evidence

No clinical data provided. Device relies on substantial equivalence to legally marketed predicate devices using established chromatographic immunoassay technology.

Technological Characteristics

One-step rapid chromatographic immunoassay. Principle: recognition and formation of specific antibody/target drug/antibody complexes. Cut-off concentrations: THC 50ng/mL, COC 300ng/mL, OPI 300ng/mL, MET 1,000ng/mL. Form factor: test card with sample well. Standalone device; no connectivity.

Indications for Use

Indicated for consumers, including parents, for rapid, preliminary qualitative screening of human urine for marijuana, cocaine, morphine/opiates, and methamphetamine and their metabolites. Intended as the first step in a two-step testing process; requires confirmatory testing for positive results.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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

• Applied Biotech SureStep™ Drug Screen Multi Test (K972425)
• Phamatech QuickScreen™ At Home Drug Test

Submission Summary (Full Text)

{0}------------------------------------------------

NOV 2 9 2000

Image /page/0/Picture/3 description: The image shows a pattern of alternating dark and light triangles. The dark triangles are arranged in a row, and the light triangles are positioned between them. The pattern is repeated across the image, creating a visually interesting design. The contrast between the dark and light triangles makes the pattern stand out.

Section D 510(k) Summary 21 C.F.R. § 807.92

- Submitter: I.
- Name: Worldwide Medical Corporation A.
- Address: 199 Technology Drive, Suite 150, Irvine, California B. 92618
- C. Phone and Fax Numbers: Phone: [phone] Fax:
- Contact Person: H. Thad Morris D.
- Date of Preparation of this Summary: November 8, 1999 II.
- Trade Name: First Check® Home Drug Test Panel 4 III.
- Common Name: At home drugs of abuse rapid screening test for IV. marijuana, cocaine, morphine/opiates and methamphetamine in urine.
- Classification Name: Immunoassay for the qualitative detection of drugs V. of abuse in urine.
- VI. The Marketed Products to Which Equivalence is Claimed: The First Check® Home Drug Test Panel 4 that is the subject of this submission is identical to the Applied Biotech SureStep™ Drug Screen Multi Test in terms of intended use, product design, performance characteristics, materials of construction, and manufacturing process. It is also substantially equivalent to the Phamatech QuickScreen™ At Home Drug Test and other commercially available drug screening tests which 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® Home Drug Test Panel 4 is substantially equivalent to the listed products; it is a preliminary, rapid screening test for the detection of marijuana, cocaine, morphine/opiates and methamphetamine and/or their metabolites in urine. This product is intended to be the first step in a two step process to provide consumers, including concerned parents, with information regarding the presence or absence of these four drugs and/or their metabolites in a urine sample. Information regarding the second step, confirmatory testing, is provided.

199 Technology Drive Suite 150 Irvine, CA 92618 949-727-0711 800-788-5716 949-727-0602 .wwwmed.com

Stock symhol: WMED

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white photograph of a patterned surface. The pattern appears to be a repeating design of dark shapes against a lighter background. The shapes are somewhat geometric, possibly triangles or similar angular forms, arranged in a grid-like fashion. The overall effect is a textured or tessellated appearance, with the contrast between the dark shapes and the light background creating a visually interesting pattern.

- Discussion of Technological Characteristics: The First Check® Home VIII. Drug Test Panel 4, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine and/or 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/antibody complexes. The cut-off concentration for THC is 50ng/mL. The cut-off concentration for COC is 300ng/mL. The cut-off concentration for OPI is 300ng/mL. The cut-off concentration for MET is 1,000ng/mL.
- IX. Safety and Effectiveness: Because the First Check® Home Drug Test Panel 4 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425, and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into the test card well, 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 the listed drugs and their metabolites. Because the labeling of the First Check® Home Drug Test Panel 4 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the Phamatech QuickScreen™ At Home Drug Test, and there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months in which the product line has been purchased by the general public and used in quantities exceeding 200,000 tests, it is concluded that the product can be used effectively by the lay user.

199 Technology Drive Suite 150 Irvine, CA 92618 949-727-0711 800-788-5716 949-727-0602 .rw.wwmed.com Stock symbol: WMED

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

NOV 2 9 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Worldwide Medical Corporation c/o Mr. Larry R. Pilot McKenna & Cueno, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108

K993852 Re:

Trade Name: First Check® Home Drug Test Panel 4 Regulatory Class: II Product Code: LAF, DIO, DJG, LDJ Dated: October 30, 2000 Received: October 30, 2000

Dear Mr. Pilot:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have toviewed your betermined the equivalent (for the indications for use above and we nave determinent in marketed predicate devices marketed in interstate commerce surved in the energians, to renactment 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). You may, therefore, market the device, subject to the general controls Cosments of the Act. The general controls provisions of the Act include requirements for annual provisions of the Fee. "The generod 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to may with the GMP regulation may result in regulatory action. In addition, FDA may publish compry with the CHI reoncerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally partited predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

SECTION A

Page 1 of 1

# 510(k) Number (if known): _ 1 993852

Device Name: First Check® Home Drug Test Panel 4

Indications for Use:

- The First Check® Home Drug Fest Panel 4 is an educational sereening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/mL respectively. The test is intended for 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 four drugs concorned parchib, was not information is beneficial to consumer offorts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

\$_\$ over the-counter DS

(Optional Format 3-10-98)

199 Technology Drive Suite 150 Irvine, CA 92618 949-727-0711 800-788-5716 949-727-0602 .wwwmed.com Stock symbol: WMED