AT HOME DRUG TEST, MODEL 9069 by PHAMATECH INC.

A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of any of the following drugs of abuse in urine: Methamphetamine, MDMA.

Device Description

The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: Methamphetamine, MDMA; 500 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the "At Home Drug Test (Model 9069)":

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets. Instead, the document frames the device's performance in terms of "substantial equivalence" to existing commercially available tests and a high percentage of accuracy. The key performance indicators mentioned are:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices	Stated as "substantially equivalent to the reported performance characteristics of other commercially available tests".
High correlation with laboratory methods (EMIT II, GC/MS)	">99% correlation when compared to the Behring EMIT II and GC/MS methodology."
High overall accuracy (professional users)	"excellent overall accuracy (>98%) in the hands of professional users."
High accuracy (consumer interpretation)	"Consumer interpretation of the methamphetamine test showed accuracy to be 428/444 or 96.4%."

Study Details

Sample Size and Data Provenance:
- Test Set Sample Size:
  - Clinical sample correlation study: Not explicitly stated, but "clinical specimens" are mentioned.
  - Blind labeled spiked study: Not explicitly stated.
  - Clinical studies (professional users): Not explicitly stated, but "performed at two independent laboratories."
  - Consumer study (methamphetamine accuracy): 444 samples.
- Data Provenance: Not explicitly stated as retrospective or prospective. It implies prospective data collection for the "clinical sample correlation study," "blind labeled spiked study," "clinical studies," and "consumer study." The countries of origin for the data are not specified beyond the locations of the manufacturers (San Diego, CA, USA for Phamatech; Cupertino, CA, USA for Behring EMIT II).
Number of Experts and Qualifications:
- The document implies the use of "professional users" in the "clinical studies" and comparison to "SAMHSA certified laboratory" for confirmation. However, the specific number of experts involved in establishing ground truth for the test set and their qualifications are not explicitly stated.
Adjudication Method:
- The document mentions "Correlation studies... when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." This suggests that the EMIT II and GC/MS results served as the reference or adjudicating methods, rather than a human consensus approach among the "professional users." No specific human adjudication method (e.g., 2+1, 3+1) is mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is explicitly mentioned. The study focuses on comparing the device's performance to predicate devices and laboratory methods, and on consumer interpretation, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic tool for human interpretation.
Standalone Performance:
- Yes, a standalone performance was done. The entire performance section describes the results of the device (an immunoassay) detecting drugs/metabolites, both when compared to laboratory standards and when interpreted by consumers. This represents the algorithm's (immunoassay's) standalone performance.
Type of Ground Truth Used:
- The ground truth for the "clinical sample correlation study" was established using Behring EMIT II and GC/MS methodology, which are highly regarded laboratory analytical methods.
- For the "blind labeled spiked study" and "clinical studies," the ground truth is implicitly the known spiked concentrations or the results from the EMIT II/GC/MS comparisons.
- For the "consumer study," the accuracy is reported against an assumed established ground truth, likely the EMIT II/GC/MS results or a confirmed positive/negative status.
Training Set Sample Size:
- The document does not specify a separate "training set" sample size. As this is a rapid immunoassay, it typically doesn't involve a machine learning training phase in the same way an AI algorithm would. The development of such a test relies on chemical and biological design, optimization, and then validation studies (the "performance" section describes these validation studies, effectively the "test set" for regulatory purposes).
Ground Truth for Training Set:
- Since a distinct "training set" for an AI algorithm is not applicable here, the concept of establishing ground truth for a training set in the AI sense is not relevant or described. The development of the immunoassay involves establishing its chemical and biological parameters to accurately detect the target analytes at the specified cut-off, which is a different process than "training" an AI model.

Summary

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DEC 0 6 2001

510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

013412

Identification: At Home Drug Test (Model 9069)

Description: Immunoassay for the qualitative detection of methamphetamine, MDMA in urine.

Name Of Manufacturer:	Phamatech9530 Padgett Street,Suite #101San Diego, California 92126, USA
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Intended Use: The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: Methamphetamine, MDMA; 500 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.

The At Home Drug Test, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC (Ancramdale, NY) and the Applied Biotech SureStep Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.

The product performance characteristics of the At Home Drug Test were Performance: evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech at Home Drug Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine. Correlation studies, using clinical specimens, produced a >99% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology. Clinical studies, performed at two independent laboratories, were also performed. In them the Phamatech At Home Drug Test exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed, in it the At Home Drug Test exhibited excellent overall accuracy. Consumer interpretation of the methamphetamine test showed accuracy to be 428/444 or 96.4%

For the reasons mentioned above, it may be concluded that the Phamatech At Conclusion: Home Drug Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 0 6 2001

Mr. Carl Mongiovi Vice President Phamatech, Inc. 9530 Padgett Street, Suite 101 San Diego, CA 92126

Re: K013412

Trade/Device Name: At Home Drug Test (Model 9069) Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: MVO Dated: November 15, 2001 Received: November 19, 2001

Dear Mr. Mongiovi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manative perice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device America commence prior to May 20, 1976, the exactions of the Federal Food. Drug, devices mat have occh recassinod in asses approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosmetic Act (71ct) that to her request of the general controls provisions of the Act. The Tou may, dicierole, market the device, books of the mount registration, listing of gencial controls provisions of the revelop 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 If your device is classified (300 above) this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controlier Litters, or Parts 800 to 898. In addition, FDA may be found in the Code of Peachar Regarning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a succements.
that FDA has made a determination that your device complies with other requirements of the Act that IDA has made a actorinmation administered by other Federal agencies. You must of ally it catal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the 70€ 31equirements, as and manufacturing practice requirements as set CTN Fart 807), ademig (21 CFR Part 800), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 noutication. THE I Dr Intention 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 1 IT you desire specific acrices diagnostic devices), please contact the Office of Compliance at additionally 007.10 for mirrous and advertising on the promotion and advertising of your device, (301) 594-4500. Traditionally and (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 Information on your responsible in the sumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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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K013412/5'

ម័រ ទី១/។ ប្រទេស

INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known): K013412

Device Name: At Home Drug Test (Model 9069)

Indications for Use:

A home drug screening, and if needed, confirmation service. This kit provides a A nomic arage coroching, at a may of the following drugs of abuse in urine: Methamphetamine. MDMA.

Shauws C. Muts for Jeave cooper
(Division Sign-Off)

vision of Clinical Laboratory Devices 510(k) Number

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of the CDRH Office of Device Evaluation (ODE)

Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:

Prescription Use:_ Per 21 CFR 801.1099 Over the Counter:_

Regulation Number and Section

N/A