(41 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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are 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.
The QuickScreenTM One Step Amphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine by visual color sandwich one step immunoassay technology.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the QuickScreen™ One Step Amphetamine Screening Test:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "must achieve >X% sensitivity"). Instead, it compares the device's performance to established methods as evidence of substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation | Must demonstrate high correlation (e.g., >97%) with established laboratory methods (Syva EMIT II and GC/MS). | >97% correlation when compared to Syva EMIT II and GC/MS. |
| Sensitivity | Must exhibit excellent sensitivity in the hands of professional laboratory technicians. | 83/84 (98.8%) |
| Specificity | Must exhibit excellent specificity in the hands of professional laboratory technicians. | 40/40 (100%) |
| Accuracy | Must exhibit excellent accuracy in the hands of professional laboratory technicians. | 123/124 (99.2%) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The summary mentions two types of studies:
- "Clinical sample correlation study"
- "Blind labeled amphetamine study"
- "Two clinical laboratory studies"
- Sample Size:
- For the sensitivity calculation: 84 samples (83 true positive detections).
- For the specificity calculation: 40 samples (40 true negative detections).
- For the accuracy calculation: 124 samples (123 correct detections).
- The total number of samples used in the "clinical sample correlation study" is not explicitly stated, only the correlation percentage.
- Data Provenance: The data is from "clinical specimens" and "clinical laboratory studies," implying human urine samples.
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, but "clinical sample correlation study" and "blind labeled amphetamine study" typically imply prospective or a mix of prospective/retrospective samples with a known status. The clinical laboratory studies would likely involve testing samples in a controlled lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth was established by comparison to the Syva EMIT II and GC/MS methodology. These are considered gold standard methods for drug detection.
- The summary does not specify a number of human experts for establishing ground truth, rather relying on established laboratory methods.
- The studies were performed "in the hands of professional laboratory technicians," implying qualified clinical laboratory personnel were involved in performing both the experimental device tests and likely the comparator tests (Syva EMIT II, GC/MS). Their specific qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
- The summary does not describe a formal adjudication method (e.g., 2+1 adjudicator scheme).
- Ground truth was based on the results from the Syva EMIT II and GC/MS methods. Discrepancies between the Phamatech QuickScreen™ and these methods would be resolved by the established methods being the "truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly described.
- This device is a qualitative immunoassay for amphetamine and its performance assessment focuses on its standalone accuracy against established lab methods, not on human reader improvement with AI assistance. The concept of "AI assistance" is not relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- Yes, the performance metrics (sensitivity, specificity, accuracy) are reported for the device in standalone mode. The device itself performs the detection, with professional laboratory technicians performing the test according to its instructions and interpreting the visual color change. While human interpretation of the color change is involved, the reported metrics reflect the device's intrinsic capability to produce the correct visual signal.
7. Type of Ground Truth Used
- The ground truth used was based on established laboratory methods:
- Syva EMIT II: An immunoassay that serves as a predicate device or a common comparative method in clinical toxicology.
- GC/MS (Gas Chromatography/Mass Spectrometry): Considered the gold standard confirmatory method for drug testing, providing highly accurate and specific identification and quantification of substances.
8. Sample Size for the Training Set
- The 510(k) summary does not provide information on the training set size. Regulatory submissions for such immunoassay devices typically focus on the performance of the final, locked-down device rather than detailing the internal development and training data if an "AI" or machine learning component isn't explicitly part of the submission. The device uses "colloidal gold technology" following "immunochemical sandwich assay principle," which is a biochemical assay, not an AI-driven device.
9. How the Ground Truth for the Training Set Was Established
- Since there's no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's underlying technology (immunoassay) is based on chemical reactions, not on learning from a dataset. The "development" of such a device would involve optimizing reagents and assay parameters based on known concentrations and interferences, not "training" an algorithm in the modern sense.
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KA72577
AUG 20 1997
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreenTM One Step Amphetamine Screening Test (9060) Identification:
Immunoassay for the Qualitative Detection of Amphetamine in Urine Description:
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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are 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.
The QuickScreenTM One Step Amphetamine Test utilizes colloidal Technology: gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine 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 Amphetamine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / AMP / antibody / complexes.
The product performance characteristics of the QuickScreen TM Performance: One Step Amphetamine Test was evaluated in a clinical sample correlation study and a blind labeled amphetamine study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Amphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of amphetamine in urine. Correlation studies, using clinical specimens, produced a >97% correlation when compared to the Syva EMIT II (San Jose, CA 95161) and the GC/MS methodology. Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (83/84), specificity (40/40), and accuracy (123/124) in the hands of professional laboratory technicians.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step AmphetamineTest is substantially equivalent to a variety of qualitative amphetamine tests currently in commercial distribution.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Carl A. Mongiovi Director of Operations Phamatech 9265 Activity Roads Suite 112-113 San Diego, California 92126 ... .....
AUG 20 1997
K972577 Re:
Trade Name: QuickScreen™ One Step Amphetamine Screening Test Requlatory Class: II Product Code: DIT Dated: July 7, 1997 Received: July 10, 1997
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 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 requirement, 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 requlatory 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 i 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) Additionally, for questions on the promotion and 594-4588. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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): _ K972577
Device Name: QuickScreen IM One Step AmphetamineTest
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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use and overdose.
PLEASE DO NOT WRITE BELOW THIS LINE
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972577 |
| Division Sign-Off | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number: | |
| Prescription Use: | ✓ |
| OR Over the Counter | |
| Per 21 CFR 801.109 |
§ 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).