(15 days)
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Cocaine (benzoylecgonine).
The At Home Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: Cocaine (benzoylecgonine): 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a certified laboratory. The At Home 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: At Home Drug Test (Model 9073)
Intended Use: Rapid, qualitative immunoassay for the detection of Cocaine (benzoylecgonine) in urine, intended for home use to assist in the prevention of drug abuse, with a mechanism for anonymous confirmation testing.
Target Analyte & Cut-off: Cocaine (benzoylecgonine): 300 ng/ml
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance benchmarks for "excellent overall accuracy" and "correlation" to established methods.
| Acceptance Criteria (Stated Goal / Implicit) | Reported Device Performance (Cocaine) |
|---|---|
| Excellent Overall Accuracy (Professional Users) | >97% overall accuracy |
| Excellent Overall Accuracy (Lay Users) | 96.65% overall accuracy (all drugs) / 97.24% (Cocaine) |
| Correlation to Behring EMIT II and GC/MS | >98% correlation |
2. Sample Size Used for the Test Set and Data Provenance
The text describes three main types of studies:
-
Clinical Sample Correlation Study:
- Sample Size: Not explicitly stated, but implicitly a sufficient number of clinical specimens to achieve >98% correlation.
- Data Provenance: Not explicitly stated (e.g., country of origin). It used "clinical specimens," suggesting real-world samples. The study involved "two independent laboratories," implying a multi-site approach. The study compared the device to Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology, which are established laboratory methods.
- Nature: Retrospective, as it used existing "clinical specimens."
-
Blind Labeled Spiked Study:
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified, but involved "spiked" samples, meaning known concentrations of the drug were added to urine.
- Nature: Prospective (controlled experimental conditions).
-
Consumer Study (Lay Users):
- Sample Size: 4715 total interpretations across all drugs, with 943 interpretations for Cocaine specific accuracy.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it involved "lay users," suggesting a broader consumer population.
- Nature: Prospective, simulating home-use conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Clinical Sample Correlation Study: The ground truth was established by Behring EMIT II and GC/MS methodology. These are considered gold standard laboratory methods for drug detection. The "experts" in this context would be the laboratory personnel operating and interpreting these instruments, assumed to be qualified professionals in clinical chemistry/toxicology, but their specific number or qualifications are not provided in the summary.
- Blind Labeled Spiked Study: The ground truth was established by the known concentration of the spiked samples. No human expert interpretation was needed to establish the ground truth for spiked samples, as the concentration is predetermined.
- Consumer Study: The ground truth likely derived from the results obtained by "professional users" (as mentioned in a separate phase of the evaluation) or from laboratory confirmation (e.g., GC/MS) of the samples used in the consumer study. The summary doesn't explicitly state how the ground truth for the consumer study was established, but it would logically be based on a definitive laboratory method rather than expert consensus on the device's reading itself.
4. Adjudication Method for the Test Set
- Clinical Sample Correlation Study: Not explicitly an "adjudication" in the typical sense of multiple human readers resolving disagreements. Instead, the device's results were correlated directly with the results from two established analytical methods (Behring EMIT II and GC/MS). Discrepancies would likely be investigated, but the primary method is direct comparison.
- Blind Labeled Spiked Study: No adjudication method described as the ground truth is simply the known spiked concentration.
- Consumer Study: The summary does not describe any specific adjudication method for reconciling consumer interpretations or establishing a gold standard for discrepancies. The accuracy figures are reported directly from the consumer interpretations against the assumed true positive/negative status of the samples.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study, in the sense of comparing human readers' performance with and without AI assistance, was not done. This device is a standalone diagnostic kit, not an AI-assisted diagnostic tool for human readers. It does involve multiple "readers" (professional users and lay users) but not in a comparative effectiveness setup with/without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies effectively evaluate the "standalone" performance of the device, although it's not an algorithm but a rapid immunoassay.
- The "clinical sample correlation study" and the "blind labeled spiked study" assess the device's ability to accurately detect the drug in samples against established laboratory methods or known concentrations, independent of human interpretation variability.
- The phase involving "professional users" is also a standalone assessment of the device's performance when used by trained personnel.
- The "consumer study" assesses the device's standalone performance including the human-in-the-loop (lay user interpretation) directly, which is crucial given its intended point-of-care, home-use application.
7. The Type of Ground Truth Used
- Expert Consensus: Not explicitly stated as the primary ground truth method.
- Pathology: Not applicable for a drug test.
- Outcomes Data: Not applicable for a drug test.
- Other:
- Established Laboratory Methods: For the clinical correlation study, the ground truth was established by Behring EMIT II and GC/MS methodology, considered reference standards in toxicology.
- Known Spiked Concentrations: For the blind labeled spiked study, the ground truth was the predetermined concentration of the drug in the spiked urine samples.
8. The Sample Size for the Training Set
The provided text does not mention any training set or machine learning components. This device is described as an immunoassay, which is a chemical and biological test, not a software algorithm that requires a training set. Therefore, this question is not applicable to the information provided.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, this question is not applicable.
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510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At Home Drug Test (Model 9073) ldentification:
Description: Immunoassay for the qualitative detection of Cocaine (benzoylecgonine) in urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The At Home Drug Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: Cocaine (benzoylecgonine): 300 ng/ml. This assay is intended for use in the home to assist in the prevention of drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a certified laboratory.
The At Home 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 QuickScreen At Home Drug Test 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.
Performance: The product performance characteristics of the At Home 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 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 >98% 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 QuickScreen" exhibited excellent overall accuracy (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Druq Test exhibited excellent overall accuracy (4557/4715 correct or 96.65%) in the hands of lay users. Consumer interpretation of the Cocaine test in this study showed accuracy to be 917/943 or 97.24%.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech At Home Drug Test Model 9073 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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 3 0 1999
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego, California 92126
Re: K994219
Trade Name: At Home Drug Test (Model 9073) Regulatory Class: II Product Code: DIO Dated: August 25, 1999 Received: December 15, 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 (QS) 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. Failurs 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/cdrl/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):
Device Name: At Home Drug Test (Model 9073)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Cocaine (benzoylecgonine).
Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994219
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:
Over the Counter:_ Prescription Use: OR Per 21 CFR 801.109
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).