(14 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: amphetamine
Immunoassay for the qualitative detection of amphetamine in urine
The Phamatech At Home Drug Test (Model 9063) is a rapid, qualitative immunoassay for the detection of amphetamine in urine.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Amphetamine Detection Accuracy (Expert Users) | Not explicitly stated, but generally high accuracy is expected for medical devices. | >97% overall accuracy |
| Amphetamine Detection Accuracy (Lay Users) | Accuracy in the hands of lay users should be high enough to ensure safe and effective home use. | 97.2% (917/943 correct) |
| Correlation with Predicate Device (Behring EMIT II) | High correlation expected for substantial equivalence. | >98% correlation |
| Correlation with Confirmatory Method (GC/MS) | High correlation expected for reliable detection. | >98% correlation |
Note: The document implicitly assumes that "correlation" and "accuracy" are the primary indicators of performance for this type of test, and that a high percentage (e.g., >97-98%) is considered acceptable for substantial equivalence.
2. Sample Size and Data Provenance
- Test Set Sample Size: The document provides specific numbers for lay user studies (943 consumer interpretations for amphetamine specific, 4715 total interpretations across drugs). For professional users and correlation studies, it states "clinical specimens" but does not specify exact numbers.
- Data Provenance: The studies were performed in "two independent laboratories" and involved "clinical specimens" and "spiked study" data. The country of origin is not explicitly stated but can be inferred to be the USA, given the manufacturer's location and FDA submission. The studies were likely a combination of retrospective (clinical specimens) and prospective (blind labeled spiked study, consumer study).
3. Number of Experts and Qualifications for Ground Truth
- The document implies the use of "professional users" in some studies. However, it does not specify the exact number of experts, their qualifications (e.g., specific medical degrees, years of experience), or their role in establishing the ground truth for any of the studies.
- Clinical studies comparing the device to the Behring EMIT II and GC/MS were conducted, suggesting that the results of these established methods were considered the ground truth, which would have been interpreted by trained laboratory professionals.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method such as 2+1 or 3+1. Given that the ground truth for the clinical and correlation studies relied on established laboratory methods (Behring EMIT II and GC/MS), it's likely that a single, definitive result from these methods served as the ground truth. For the consumer study, the accuracy was measured against presumably pre-determined correct results, but the method of establishing those initial correct results (e.g., through a consensus of experts or a gold standard method) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was described. This device is a standalone in-vitro diagnostic test for home use, without an AI component in the described functionality.
6. Standalone Performance
Yes, a standalone performance study was done. The document reports the performance of the "At Home Drug Test" itself, both in the hands of professional users and lay users, and its correlation with predicate devices and GC/MS. This directly reflects the algorithm's (immunoassay's) standalone performance.
7. Type of Ground Truth Used
The ground truth used for the studies appears to be a combination of:
- Predicate Device Performance: Correlation studies were performed against the Behring EMIT II.
- Confirmatory Method: Correlation studies were performed against GC/MS methodology, which is a gold standard for drug detection.
- Pre-determined Correct Results: For the consumer study, the accuracy was reported against "correct" results, implying a comparison to an established ground truth, likely derived from the confirmatory methods or expert analysis.
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" sample size. As an immunoassay, the device itself is not a machine learning algorithm that requires a training set in the conventional sense. The "training" for such devices typically involves the optimization of reagents and protocols during development, rather than a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not utilize a machine learning algorithm with a conventional training set. The development of the immunoassay involves chemical and biological optimization, not data-driven training.
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DEC 3 0 1999
994237
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At Home Drug Test (Model 9063) ldentification:
Description: Immunoassay for the qualitative detection of amphetamine 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: amphetamine:(1000 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 / 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. 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, 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 Drug Test exhibited excellent overall accuracy (4557/4715 correct or 96.65%) in the hands of lay users. Consumer interpretation of the amphetaminetest in this study showed accuracy to be 917/943 or 97.2%.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Test Model 9063 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 eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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: K994237
Trade Name: At Home Drug Test (Model 9063) Regulatory Class: II Product Code: DKZ Dated: December 14, 1999 Received: December 16, 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 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
16994237 510 (k) Number (if known): __
Device Name: At Home Drug Test (Model 9063)
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: amphetamine
Han
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Nuraiber K994237
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: OR Per 21 CFR 801.109
U Over the Counter:
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§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).