(12 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: Methamphetamine, THC and Opiates
Immunoassay for the Qualitative Detection of Methamphetamine, THC and Opiates in Urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| For Professional Users: | |
| Overall accuracy for Methamphetamine | > 98% |
| Overall accuracy for THC | > 98% |
| Overall accuracy for Opiates | > 98% |
| Correlation with Behring EMIT II | > 99% |
| Correlation with GC/MS methodology | > 99% |
| For Lay Users (Consumers): | |
| Overall accuracy for Methamphetamine | > 96% |
| Overall accuracy for THC | > 96% |
| Overall accuracy for Opiates | > 96% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the numerical sample size for the test set. It mentions "clinical sample correlation study" and "blind labeled spiked study." It also notes "clinical studies, performed at two independent laboratories."
- Sample Size: Not specified.
- Data Provenance: Clinical specimens were used for the correlation studies. The clinical studies were performed at "two independent laboratories," suggesting external, potentially prospective data, though this is not explicitly stated. The "blind labeled spiked study" would involve controlled samples, likely prepared in a laboratory setting. The location of the clinical specimens is not explicitly stated (e.g., country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts. However, it indicates ground truth was established by:
- Comparison to the Behring EMIT II (another commercial immunoassay device).
- GC/MS methodology (Gas Chromatography/Mass Spectrometry), which is a "gold standard" analytical method for drug detection.
- "Professional users" and "lay users" were involved in the evaluation of the device performance, but not in establishing the ground truth methodology itself, beyond their correct application of the test.
4. Adjudication method for the test set
The document does not mention an adjudication method for the test set. Ground truth was established by comparison to other validated methods (Behring EMIT II and GC/MS).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the device's performance against established methods, and its accuracy in the hands of both professional and lay users, rather than comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an "At Home Drug Test" using "visual color sandwich one step immunoassay technology." It's a qualitative immunoassay. The performance described is inherently a "standalone" or "algorithm-only" performance in the sense that the test itself (the immunoassay) provides the direct result, which is then interpreted by a human (professional or lay user). There isn't an "algorithm" separate from the immunoassay technology that would then require human interpretation in a human-in-the-loop scenario. The "human-in-the-loop" aspect is the visual interpretation of the color change, not an AI algorithm generating a result that a human then reviews.
7. The type of ground truth used
The ground truth was established by:
- Reference Device Comparison: Behring EMIT II (a predicate immunoassay device).
- Gold Standard Analytical Method: GC/MS methodology.
- Spiked Samples: For the "blind labeled spiked study," the ground truth would be the known concentration of drugs added to the samples.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning. The device is an immunoassay, which does not typically involve traditional machine learning training sets in its development or validation as described here. The "training" in this context refers more to the development and optimization of the immunoassay reagents and design rather than algorithm training.
9. How the ground truth for the training set was established
As there's no explicitly mentioned machine learning "training set," this question is not directly applicable. If we consider the development of the immunoassay itself, the "ground truth" during its development would have been established through laboratory experiments using known concentrations of target drugs/metabolites, similar to how spiked samples are used in validation.
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JUL 13 1999
Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string is "KA992217".
む・リア
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: At Home Drug Test (9175)
Description: Immunoassay for the Qualitative Detection of Methamphetamine, THC and Opiates in Urine.
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The At Home Drug Test (model 9175) is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: methamphetamine; 500 ng/ml, THC; 50 ng/m, opiates; 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 certified laboratory.
The At Home Drug Test, like many commercially available drug screening Technology: test 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 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.
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. Correlations 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 Pharnatech 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 (>96%) in the hands of lay users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech At 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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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, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three curved lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration . 2098 Gaither Road Rockville MD 20850
JUL 17:3 19:3
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road #112-113 San Diego, CA 92126
Re: K992217
Trade Name: QuickScreen At Home Drug Test Model 9175 Regulatory Class: II Product Code: DJC, DJG, LDJ Dated: June 28, 1999 Received: July 1, 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. 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 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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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _K 9922222-
Device Name: At Home Drug Test (Model 9175)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a
nd if the success of the first for for conse of the following drugs of abuse in un A home drug screening, and it heeded, committiation oorwoor while:
preliminary result for the detection/presence of the following drugs of abuse in urine: Methamphetamine, THC and Opiates
ean Conger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992217
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:
OR Prescription Use: Per 21 CFR 801.109
Over the Counter:____
N/A