FIRST CHECK HOME DRUG TEST PANEL 3 by WORLDWIDE MEDICAL CORP.

The First Check® Home Drug Test Panel 3 is an educational screening test for the rapid detection of marijuana, cocaine, methamphetamine and/or their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL and 1,000 ng/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 three drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

Device Description

The First Check® Home Drug Test Panel 3, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, methamphetamine and/or their metabolites in urine, using a one stee, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drog/anibody complexes. The cut-off concentration for THC is 50ng/mL. The out-off concentration for COC is 300ng/mL. The cut-off concentration four MET is 1,000ng/mL.

AI/ML Overview

This document is a 510(k) summary for a home drug test panel. It claims substantial equivalence to previously marketed devices and focuses on the intended use, technological characteristics, safety, and effectiveness in comparison to those predicates. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way requested for a medical AI/software device.

The provided text describes a qualitative immunoassay device, not an AI/software device. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device.

For completeness, I can extract the relevant information that is present:

Device: First Check® Home Drug Test Panel 3

Intended Use: An educational screening test for the rapid, qualitative detection of marijuana, cocaine, and methamphetamine and/or their metabolites in human urine at specified cut-off levels (50ng/mL for THC, 300ng/mL for COC, and 1,000ng/mL for MET). It's intended for consumer use as the first step in a two-step process, with information provided for confirmatory testing.

Acceptance Criteria and Device Performance:
The document implies acceptance criteria by claiming substantial equivalence to predicate devices and stating that its performance characteristics are identical to one predicate (Applied Biotech SureStep™ Drug Screen Multi Test). However, it does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity or specificity values) with corresponding reported device performance metrics.

Instead, the argument for safety and effectiveness is based on:

Identicality to a legally marketed predicate: "Because the First Check® Home Drug Test Panel 3 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425..."
Lack of special skills for use: "...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..."
Substantial equivalence of labeling and consumer use history: "Because the labeling of the First Check® Home Drug Test Panel 3 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the Phamatecchi 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."

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The document relies on proving substantial equivalence to existing devices rather than presenting new performance data against pre-defined acceptance metrics for this specific device.

Regarding the other requested points (which are generally for AI/Software devices):

Sample size used for the test set and the data provenance: Not applicable. This is not a study reporting on a test set for an AI/software device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay. Its performance is inherent to its design, not a separate algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of test would be confirmed analytical methods, often Gas Chromatography coupled with Mass Spectrometry (GC/MS) or Liquid Chromatography coupled with Mass Spectrometry (LC/MS), which are the gold standards for drug confirmation in urine. However, this document does not detail any such validation study for this specific device, instead relying on equivalence to a predicate.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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JUN 2 3 2000

K994138

CORPORATION

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

I. Submitter:
- A. Name: Worldwide Medical Corporation
- B. Address: 199 Technology Drive, Suite 150, Irvine, California 92618
- C. Phone and Fax Numbers: Phone: 949/727-0711 Fax: 949/727-0602
- D. Contact Person: H. Thad Morris
II. Date of Preparation of this Summary: November 30, 1999
Trade Name: First Check® Home Drug Test Panel 3 III.
IV. Common Name: At home drugs of abuse rapid screening test for marijuana, cocaine and methamphetamine 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® Home Drug Test Panel 3 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 3 is substantially equivalent to the listed products; it is a preliminary, rapid screening test for the detection of marijuana, cocaine 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 three 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 19-727-0711 ・・・・ 800-788-57 ic Fox: 949-727-0602 www.wwmed.com

Stock symbol: WMED

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Discussion of Technological Characteristics: The First Check® Home VIII. Drug Test Panel 3, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, methamphetamine and/or their metabolites in urine, using a one stee, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drog/anibody complexes. The cut-off concentration for THC is 50ng/mL. The out-off concentration for COC is 300ng/mL. The cut-off concentration four MET is 1,000ng/mL.
Safety and Effectiveness: Because the First Check® Home Drug Test IX. Panel 3 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 3 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the Phamatecchi 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 Brite State 150 14. 44 60 30 3 Fox 949 121 0602 www.wwmed com Store Timber WMED

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JUN 2 3 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

Re: K994138

Trade Name: First Check® Home Drug Test Panel 3 Regulatory Class: II Product Code: LDJ, DIO, LAF Dated: May 23, 2000 Received: May 23, 2000

Dear Mr. Pilot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found 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 (OS) 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning 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.

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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 marketed 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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

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SECTION A

Page 1 of 1

510(k) Number (if known): K994138

Device Name: First Check® Home Drug Test Panel 3

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluatu 510(k) Number

OVER-THE-COONTER USE

199 Technology Brive Suite 50 Irvine, CA 92618 49 727 0711 SUD 758 31 3 fox: 949-727-0602 www.wwned.com Stock symbol WHED

(Optional Format 3-10-98)

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).