AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C by PHAMATECH

A workplace drug screening and confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Phencyclidine (PCP), Amphetamine, THC (marijuana), Cocaine and Opiates.

Device Description

At Work Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Phencyclidine (PCP); 25 ng/ml, amphetamine; 1000 ng/ml, cocaine; 300 ng/ml and opiates; #9145 25C at 300 ng/ml and 9177 25C at 2000 ng/ml. This assay is intended for use in the workplace assist in the prevention of drug abuse. This kit, as supplied, incorporates a mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory. The At Work Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Cut-off Concentrations)	Reported Device Performance
Phencyclidine (PCP): 25 ng/ml	>97% overall accuracy
Amphetamine: 1000 ng/ml
Cocaine: 300 ng/ml
Opiates (Model 9145 25C): 300 ng/ml
Opiates (Model 9177 25C): 2000 ng/ml
Substantially equivalent to predicate devices	Yes, claimed "substantially equivalent"
Correlation with Behring EMIT II and GC/MS	>98% correlation
Accuracy in professional use	>97% overall accuracy
Accuracy in lay use (via "At Home Drug Test")	>96.4% overall accuracy

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated. The document mentions "clinical samples" for the correlation study and "clinical studies" performed at two independent laboratories. For the consumer study, it refers to "a consumer study" without specifying the number of participants.
Data provenance: Not explicitly stated, but the mention of "clinical samples" and "clinical studies... at two independent laboratories" suggests real-world urine samples. No information on country of origin or whether it was retrospective or prospective is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not explicitly stated.
Qualifications of experts: The "Performance" section mentions that the Phamatech At Work Drug Test "exhibited excellent overall accuracy (>97%) in the hands of professional users." This implies that the validation of the device's performance against the ground truth was assessed by professionals, but their specific qualifications (e.g., medical technologists, toxicologists, years of experience) are not detailed.

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

Adjudication method: Not explicitly stated. The document mentions "GC/MS methodology" as a comparative method and a "mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory." This implies that GC/MS was used as a confirmatory "gold standard" for the ground truth, but the process of how results were reconciled if initial screening conflicted with GC/MS is not described.

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:

MRMC study: Not applicable. This device is an immunoassay drug test, not an AI-assisted diagnostic tool for human readers. No mention of AI assistance or human reader involvement in interpreting results (beyond visual observation for the test's color changes) is made. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

Standalone performance: Yes, in essence, the "At Work Drug Test" is a standalone device. It's a "rapid, qualitative immunoassay" that provides a visual result. While it's used by "professional users" and "lay users," the device itself generates the result without interpretation assistance from a complex algorithm or AI. The stated accuracy numbers (>97% professional, >96.4% lay user) reflect its standalone performance.

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

Type of ground truth: Gas Chromatography-Mass Spectrometry (GC/MS) methodology. The document states: "Correlations studies, using clinical specimens. produced a >98% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." This clearly indicates GC/MS as the gold standard.

8. The sample size for the training set:

Sample size for training set: Not applicable/not provided. This is a traditional immunoassay device, not a machine learning model. Therefore, there is no "training set" in the context of AI. The development of the device would have involved an R&D phase with various experiments and optimization, but not a distinct "training set" as understood in AI studies.

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

Ground truth for training set: Not applicable, as there is no training set for this type of device. The development and validation of the immunoassay would rely on established analytical chemistry principles and comparison to recognized gold standards (like GC/MS) to ensure its accuracy against known drug concentrations in samples.

Summary

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

At Work Drug Test (Model 9145 25C and 9177 25C) ldentification:

Description: Immunoassay for the qualitative detection Phencyclidine (PCP), Amphetamine, THC, Cocaine and Opiates in urine

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 San Diego, California 92126, USA

Intended Use: At Work Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Phencyclidine (PCP); 25 ng/ml, amphetamine; 1000 ng/ml, cocaine; 300 ng/ml and opiates; #9145 25C at 300 ng/ml and 9177 25C at 2000 ng/ml. This assay is intended for use in the workplace assist in the prevention of drug abuse. This kit, as supplied, incorporates a mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory.

The At Work Drug Test, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech QuickScreen At Home Drug Test and the Phamatech QuickScreen Pro Multi Drug Screening Test. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.

Performance: The product performance characteristics of the At Work Drug Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech At Work 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. Correlations studies, using clinical specimens. produced a >98% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology. Clinical studies were also performed at two independent laboratories. In them the Phamatech At Work Drug Test™ exhibited excellent overall accuracy (>97%) in the hands of professional users.

A comsumer study using the At Home Drug Test, which utilizes identical formulation and, like the At Work Drug Screening Test, includes GC/MS confirmation testing as a component, was performed. In the hands of lay users the test exhibited excellent overall accuracy (>96.4%).

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Work 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved strokes representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 6 1999

Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego. California 92126

Re: K994093

Trade Name: At Work Drug Test (Models 9145-25C and 9177-25C) Regulatory Class: II Product Code: LCL, DKZ, LDJ, DJG, DIO Dated: December 1, 1999 Received: December 3, 1999

Dear Mr. Mongiovi:

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 OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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"(21 CFR 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 Sutman

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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INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known): _K 994097

Device Name: At Work Drug Test (Models 9145-25C and 9177-25C)

Indications for Use:

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994093

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 801.109

V Over the Counter:

Regulation Number and Section

N/A