(52 days)
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of the following drugs of abuse in urine: Cocaine.
Immunoassay for the qualitative detection of benzoylecgonine in urine. 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: cocaine; 300 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 kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
This document describes the regulatory submission for the At Home Drug Test (Model 9074) by Phamatech, an immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in urine.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "correlation" and "accuracy" thresholds achieved in the studies. Given the context of a 510(k) submission, the implicit acceptance criterion is "substantial equivalence" to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Professional Use | >95% Accuracy | >98% overall accuracy |
| Clinical Specimen Correlation | >95% Correlation | >99% correlation with Behring EMIT II and GC/MS |
| Consumer Use Accuracy | >95% Accuracy | 97.2% (917/943) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Clinical Sample Correlation Study: The text does not explicitly state the sample size for this study. It mentions using "clinical specimens."
- Data Provenance: Not explicitly stated, but "clinical specimens" suggest a real-world origin, likely retrospective from patients. The study was performed at "two independent laboratories."
-
Blind Labeled Spiked Study: The text does not explicitly state the sample size for this study.
- Data Provenance: This is a prospective study where samples are "spiked" with known concentrations of the analyte.
-
Consumer Study:
- Sample Size: 943 cases (implied by 917/943 accurate interpretations).
- Data Provenance: Prospective, as it involved consumer interpretation of the test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
-
Clinical Sample Correlation Study:
- Number of Experts: Not explicitly stated. The comparison was against "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." GC/MS is a highly accurate laboratory method, implying a high level of expertise in running and interpreting these sophisticated tests. The reference to "two independent laboratories" performing clinical studies suggests multiple professional users/experts were involved.
- Qualifications: "Professional users" are mentioned, implying trained laboratory personnel or clinical staff experienced with drug testing, GC/MS, and EMIT II assays. Specific qualifications (e.g., years of experience, specific certifications) are not provided.
-
Blind Labeled Spiked Study:
- Number of Experts: Not explicitly stated, but the performance was evaluated in "professional users," similar to the clinical study.
- Qualifications: As above, "professional users" would be experienced laboratory personnel.
-
Consumer Study: Ground truth for this study was likely established by the manufacturer, comparing consumer results to the expected result of the spiked or clinical samples. No "experts" were used to establish ground truth for the consumer interpretation itself, but rather to establish the "true" status of the samples given to consumers.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The performance is reported based on direct comparison with established methods (Behring EMIT II, GC/MS) for professional use, and consumer interpretation compared to a known result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study for human readers with/without AI assistance was not done. This device is a standalone diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance studies ("Clinical sample correlation study" and "Blind labeled spiked study" for professional users) represent the standalone performance of the device when used by trained professionals. The consumer study evaluates its standalone performance in the hands of lay users.
7. The Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth was established by comparison with a predicate device (Behring EMIT II) and a gold standard laboratory method (GC/MS methodology).
- Blind Labeled Spiked Study: The ground truth was established by known concentrations of the target analyte (cocaine) spiked into urine samples.
- Consumer Study: The ground truth was established by the known status of the samples provided to consumers (based on spiking or professional lab results).
8. The Sample Size for the Training Set
The document does not provide any information about a training set. This is an immunoassay (a chemical test), not a machine learning or AI-based device that typically requires a training set. The "studies" described are performance validation studies, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or an algorithm that requires training, this question is not applicable to the provided text.
{0}------------------------------------------------
DEC 0 6 2001
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: At Home Drug Test (Model 9074)
Description: Immunoassay for the qualitative detection of benzoylecgonine in urine.
| Name Of Manufacturer: | Phamatech.9530 Padgett Street,Suite #101San Diego, California 92126, USA |
|---|---|
| ----------------------- | -------------------------------------------------------------------------------------- |
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: cocaine; 300 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 cocaine test showed accuracy to be 917/943 or 97.2%
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.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right.
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
K013409 Re: Trade/Device Name: At Home Drug Test (Model 9074) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and Cocaine Metablite 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 becamed 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 conninered pror to May 2017 3)
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic 710- (110-) that to nevice, subject to the general controls provisions of the Act. The r ou may, diererey maxis of the Act include requirements for annual registration, listing of general controls proving practice, 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 elaboried to controls. Existing major regulations affecting your device can may be subject to back adders as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actived that i Dr over device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I caeral statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinny by of the every of (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
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 1 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 International and Consumer 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
{3}------------------------------------------------
INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _หุดเวนด9
Device Name: At Home Drug Test (Model 9074)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a A none drug screening, and if noodou, committeen of the following drugs of abuse in urine: Cocaine.
Thomas C. Scott for Jeanne Cooper
(Division Sign-Off)
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 OR
Over the Counter: X
N/A