The First Check Home Drug Test (THC) is an educational screening test for the rapid detection of THC (and its metabolites) in human urine at a cut off for the rapid dececeion of the (antended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned a two seep process to provious concerning the presence of THC (and its parents, with information obliozing is beneficial to consumer metabolices) in a arine baspeable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.

Device Description

The First Check® Home Drug Test (THC), like many commercially available drug screening tests, qualitatively measures the presence or absence of THC and its 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.

AI/ML Overview

This 510(k) summary does not contain the detailed criteria or study information typically found in a standalone performance study report. Instead, it relies on substantial equivalence to legally marketed predicate devices.

As such, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor detailed information on sample sizes, ground truth establishment methods, or multi-reader multi-case studies.

However, I can extract the following relevant information:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "First Check® Home Drug Test (THC) is identical to the Applied Biotech SureStep™ Drug Screen THC Test in terms of intended use, product design, performance characteristics, materials of construction, and manufacturing process." It also claims substantial equivalence to "other commercially available drug screening tests which qualitatively measure the presence of target drugs or metabolites by visual color one step immunoassay technology."

The core performance characteristic mentioned is the cut-off concentration for THC, which is 50ng/mL. The device is intended for the qualitative detection of THC and its metabolites.

Since the submission relies on substantial equivalence rather than a new performance study demonstrating specific sensitivity/specificity metrics, a table of novel acceptance criteria and reported device performance for this specific device would not be present in this type of submission. The performance is assumed to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the given 510(k) summary for the "First Check® Home Drug Test (THC)". The submission instead refers to the predicate device K960744 (Applied Biotech SureStep™ Drug Screen THC test) as being "legally marketed". It likely means that the performance data for K960744 was previously established. The current submission focuses on demonstrating equivalence.

The text does mention: "there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months the product has been purchased by the general public and used in quantities exceeding 87,000 tests". This refers to real-world usage of a similar product (the Phamatech QuickScreen™ At Home Drug Test), not a formal test set for the device in question.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the given 510(k) summary. The nature of the device (a home drug test) and its reliance on substantial equivalence to a predicate device suggests that a complex expert-adjudicated ground truth for a new test set was likely not established for this specific 510(k) submission. For drug tests, ground truth is typically established by confirmatory laboratory methods (e.g., GC/MS).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given 510(k) summary.

5. 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:

This device is a rapid screening immunoassay for drug detection, not an AI-assisted diagnostic device for human readers. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance would be not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is a standalone rapid screening test that provides a visual result. It is not an algorithm, but a physical immunoassay device. Its performance is inherent to the device itself. The product is intended for lay users "to follow instructions or interpret results," implying a human-in-the-loop, but the "standalone performance" of the device itself (its ability to detect the analyte at the specified cut-off) is fundamental to its design. However, a formal "standalone (algorithm only)" study as typically understood in AI/software medical devices is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

While not explicitly stated for a new study in this document, for drug screening tests like this, the ground truth is typically established by confirmatory laboratory methods, such as Gas Chromatography/Mass Spectrometry (GC/MS). This is implied by the mention of "confirmatory testing" as the "second step" to follow the home test.

8. The sample size for the training set:

This information is not provided in the 510(k) summary. As this is an immunoassay device, not a machine learning algorithm, the concept of a "training set" as used in AI development is not applicable in the same way. The device is manufactured based on established chemical and biological principles.

9. How the ground truth for the training set was established:

As mentioned above, the concept of a "training set" for this type of immunoassay device is not applicable. The performance characteristics are based on the chemical and biological design of the test, and validation would involve testing against known positive and negative samples, with ground truth established by confirmatory lab methods.

Summary

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JUN 2 3 2000

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

I. Submitter:
- Name: Worldwide Medical Corporation A.
- Address:199 Technology Drive, Suite 150, Irvine, California B. 92618
- Phone and Fax Numbers: Phone: 949/727-0711 C. Fax: 949/727-0602
- Contact Person: H. Thad Morris D.
Date of Preparation of this Summary: September 29, 1999 II.
III. Trade Name: First Check® Home Drug Test (THC)
Common Name: At home drugs of abuse rapid screening test for THC in IV. urine
Classification Name: Immunoassay for the qualitative detection of THC in V. urine
The Marketed Products to Which Equivalence is Claimed: The First VI. Check® Home Drug Test (THC) that is the subject of this submission is identical to the Applied Biotech SureStep™ Drug Screen THC 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.
Statement of Intended Use Compared to Other Products: The intended use VII. of the First Check® Home Drug Test (THC) is substantially equivalent to the listed products; it is a preliminary, rapid screening test for the detection of THC and its 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 THC (and its metabolites) in a urine sample. Information regarding the second step, confirmatory testing, is provided.

199 Technology Drive Suite 150 Irvine, CA 92618 ·49-727-0711 800-788-5716 Fax: 949-727-0602 www.wwmed.com

Stock symbo : WMED

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Discussion of Technological Characteristics: The First Check® Home VIII. Drug Test (THC), like many commercially available drug screening tests, qualitatively measures the presence or absence of THC and its 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.
IX. Safety and Effectiveness: Because the First Check® Home Drug Test (THC) is identical to the Applied Biotech SureStep™ Drug Screen THC test that is legally marketed under K960744, 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 THC and its metabolites. Because the labeling of the First Check® Home Drug Test (THC) 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 the product has been purchased by the general public and used in quantities exceeding 87,000 tests, it is concluded that the product can be used effectively by the lay user.

199 Technology D. ... : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : - 2 ( 2 0 2 ) 3 Fer 949 721 Coll www.wwmed.com Stock symbol WMED

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 3 2000

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: K993663

Trade Name: First Check® Home Drug Test (THC) Regulatory Class: II Product Code: LDJ 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 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). 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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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 Gutman

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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510(k) Number (if known):_K993663

First Check Home Drug Test (THC) Device Name:

Indications For Use:

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993663

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OVER-The -COUNTA USE

(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).