(55 days)
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Immunoassay for the Qualitative Detection of Methamphetamine in Urine. The QuickScreenTM One Step Methamphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (methamphetamine) test kits, to qualitatively measure the presence of methamphetamine by visual color sandwich one step immunoassay technology.
The provided document describes the "QuickScreen™ One Step Methamphetamine Test," an immunoassay for the qualitative detection of methamphetamine in urine.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, and accuracy thresholds that the device must meet. Instead, it compares the device's performance to commercially available predicate devices.
| Performance Metric | Reported Device Performance (QuickScreen™) | Comparison to Predicate (Syva EMIT II) |
|---|---|---|
| Sensitivity | >95% | Substantially equivalent |
| Specificity | >99% | Substantially equivalent |
| Accuracy | >97% | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97%". While the exact total number of specimens isn't provided for these correlation studies, a subsequent statement notes: "Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125)." This indicates a total of 125 clinical specimens were collectively used across these two laboratory studies.
- Data Provenance: The studies used clinical specimens, implying a real-world, retrospective or prospective collection from individuals. The sites of clinical testing were Poison Laboratories, San Diego, CA, and Quest Diagnostics Incorporated, San Diego, CA, suggesting data from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth. It states the performance was compared to the Syva EMIT II, which served as the reference method or "ground truth" for the clinical correlation studies. The "excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125) in the hands of professional laboratory technicians" suggests experienced laboratory personnel operated the QuickScreen test, but it doesn't describe who established the ground truth for those 125 samples independent of the predicate method.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. The comparison was made against a predicate device (Syva EMIT II), which implies the results from the predicate device constituted the ground truth for comparison.
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 document describes a standalone performance evaluation against a predicate device and does not involve human readers as a variable or assessment of their improvement with AI assistance (as this is not an AI-assisted device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The QuickScreen™ One Step Methamphetamine Test is a qualitative immunoassay, and its performance was evaluated by directly comparing its results to those of the predicate device (Syva EMIT II) using clinical specimens. The reported sensitivity, specificity, and accuracy refer to the device's performance directly.
7. The Type of Ground Truth Used
The primary ground truth used for the correlation studies was the results obtained from the Syva EMIT II, another commercially available immunoassay for methamphetamine detection, which served as the reference method.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or "training data." As this is a traditional immunoassay, not an AI/machine learning algorithm, the concept of a training set as understood in AI development is not applicable. The device's design and calibration would have been established during its development, but this information is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model. For traditional immunoassays, development typically involves optimizing reagents and conditions against known positive and negative samples, but this is not a "ground truth for a training set" in the context of AI.
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SEP - 2 1997
10972556
510(k) SUMMARY As Required By Section 807.92(c)
QuickScreen™ One Step Methamphetamine Test
Immunoassay for the Qualitative Detection of Methamphetamine in Urine
| Name of Product: | QuickScreen™ One Step Methamphetamine Test |
|---|---|
| Name Of Packager: | Phamatech9265 Activity Road #112San Diego, California 92126USA |
| Name Of Manufacturer: | Phamatech9520 Padgett Street #108San Diego, California 92126USA |
| Site of Control Testing: | Phamatech9265 Activity Road #112San Diego, California 92126USA |
| Sites of Clinical Testing: | Poison Laboratories7272 Clairemont Mesa Blvd.San Diego, CA 92111Quest Diagnostics Incorporated7470 Mission Valley RoadSan Diego, CA 92108 |
Regulatory Control Number: 011
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510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: OuickScreen TM One Step Methamphetamine Screening Test (9065)
Description: Immunoassay for the Qualitative Detection of Methamphetamine in Urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA
Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose
The QuickScreenTM One Step Methamphetamine Test utilizes colloidal Technology: gold as the label like other commercially available immunoassays for drug of abuse (methamphetamine) test kits, to qualitatively measure the presence of methamphetamine by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego. CA 92121)and the Syntron Bioresearch Methamphetamine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / Methamphetamine / antibody / complexes.
Performance: The product performance characteristics of the QuickScreen™ One Step Methamphetamine Test was evaluated in a clinical sample correlation study and a blind labeled methamphetamine study. The results of these studies demonstrate the Phamatech QuickScreen™ One Step Methamphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of methamphetamine in urine. Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97% when compared to the Syva EMIT II (San Jose, CA 95161). Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125) in the hands of professional laboratory technicians.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step Methamphetamine ScreeningTest is substantially equivalent to a variety of qualitative methamphetamine tests currently in commercial distribution.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
SEP - 2 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tuan H. Pham President Phamatech, Inc. 9265 Activity Road, Suite 112-113 San Diego, California 92126
K972556 Re: QuickScreen™ One Step Methamphetamine Test Requlatory Class: II Product Code: LAF Dated: July 7, 1997 Received: July 9, 1997
Dear Tuan H. Pham:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. 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 requlations.
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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 requlation (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/dsmamain.html".
Sincerely yours,
Steven Litman
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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Fax:6196355843
INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known): 972556
Device Name. QuickScreen TM One Step Methamphetamine Test
Indications for Use:
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Denicas,
510(k) Number. 56
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:
| Prescription Use: | |
|---|---|
| Per 21 CFR 801.109 |
Over the Counter OR
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).