(223 days)
Instant-View Anıphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect amphetamine in human urine at a cutoff level of 1000 ng/ml. It is intended for health care professional use only.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
The Instant-View™ Amphetamine Urine Cassette Test is a qualitative immunoassay device manufactured by Alfa Scientific Designs, Inc. It is intended for health care professionals to detect Amphetamine in human urine at a cutoff level of 1000 ng/ml.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like minimum sensitivity or specificity percentages). However, based on the Discussion and Conclusion section, we can infer the performance targets assessed during the comparison study.
| Acceptance Criterion (Inferred) | Reported Device Performance | Met? |
|---|---|---|
| Correlation with Predicate Device | Higher than 94.6% correlation with the legally marketed test device. | Yes |
| Agreement across POL sites | 95.0% agreement across all three POL sites. | Yes |
| Accuracy (Clinical Lab & POL) | 92.2% agreement with expected results. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "Clinical Laboratory and the three Physician's Offices Laboratory" but doesn't quantify the number of samples.
The data provenance is likely retrospective as it involves comparison with a "legally marketed test device." The "three POL sites" and "Clinical Laboratory" suggest the data was collected in a clinical setting. The country of origin is not explicitly stated, but given the submitter's address in San Diego, CA, and the FDA's involvement, it can be inferred that the data primarily originates from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. It only mentions that the "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected." This suggests that the ground truth was established by laboratory personnel or healthcare professionals in those settings, but their specific qualifications or the number involved are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
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 described focuses on the device's performance compared to a predicate device and accuracy against expected results, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was implicitly done. The Instant-View™ Amphetamine Urine Cassette Test is a qualitative immunoassay device, which means it provides a result directly without requiring human interpretation that would be enhanced by AI. The "Accuracy Evaluation" and "Correlation of results" compare the device's output to established truths or another device's output, indicating a standalone assessment of its performance.
7. The Type of Ground Truth Used
The ground truth used appears to be a combination of:
- Reference Device Output: The "legally marketed test device" (QuikStrip OneStep Amphetamine Test, K971218) served as a comparative ground truth for correlation.
- Expected Results: For the "Accuracy Evaluation," the device's results were compared to "results expected," which likely refers to confirmatory laboratory methods (such as GC/MS, as mentioned in the "Indications For Use" as the preferred confirmatory method) or known concentrations of amphetamine in urine samples.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This device is a biochemical immunoassay, not a machine learning or AI-based algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no "training set," and therefore, no ground truth needed to be established for a training set. The device's performance is based on its intrinsic chemical and immunological properties.
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Alfa Scientific Designs, Inc.
11494 Sorrento Valley Road, Suite M San Diego, CA 92121
510(K) Summary
In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92.
| Submitter | Name: Alfa Scientific Designs, Inc.Address: 11494 Sorrento Valley Road, Suite MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net |
|---|---|
| Device Name | Trade Name: Instant-View™ Amphetamine Urine Cassette TestCommon Name: Amphetamine TestClassification Name: 21 CFR 862.3100, Class II |
| Predicate Device | The Instant-View™ Amphetamine Urine Cassette Test issubstantially equivalent to other legally marketed devicesfor the similar intended use. The device used forcomparison study is QuikStrip OneStep Amphetamine Test,manufactured by Syntron Bioresearch, Inc. with 510(K) #:K971218, Date of Approval: 05/30/97. |
| Device Description | This test is a one-step lateral flow chromatographicimmunoassay. |
| Intended Use | The Instant-View™ Amphetamine Urine Cassette Test is aqualitative immunoassay device intended to be used fordetecting Amphetamine in human urine at a cutoff level of1000 ng/ml. It is for health care professional use only. |
| Summary of theSimilarities to thePredicate Device | • Intended Use:Both devices are intended to detect amphetamine inhuman urine at a cutoff level of 1000 ng/ml.• Interpretation of results:The appearance of only one line - C line, indicates apositive result, and that the amphetamine level is at acutoff level of 1000 ng/ml or higher. And, the |
| appearance of two lines - both C line and T line indicates a negative result, and that the amphetamine level is below 1000 ng/ml.Technological Characteristics:Both devices are one step, qualitative, competitive binding immunoassay test, utilizing the basic immunochemical sandwich assay principle of recognition and formation of specific Amphetamine/Antibody/Amphetamine complexes. | |
| Discussion and Conclusion | • The correlation of results from the Instant-ViewTM Amphetamine Urine Cassette Test, and the legally marketed test device compared, is higher than 94.6%. The results from all three POL sites agreed 95.0 %.• The Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected.• Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-ViewTM Amphetamine Urine Cassette Test is suitable for use by health care professionals with diverse educational backgrounds and work experiences, and it is substantially equivalent to the existing legally marketed device. |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 7 2000
Ms. Rhoda Filipina QA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
K994395 Re:
Trade Name: Instant-View Amphetamine Urine Cassette Test -Regulatory Class: II Product Code: DKZ Dated: June 30, 2000 Received: July 6, 2000
Dear Ms. Filipina:
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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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 packeted 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 Camplia.ce 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" (21CFR 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/cdrlv/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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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K994395 510(k) Number (if known):
Device Name: Instant-View Amphetamine Urine Cassette Test
Indications For Use:
Instant-View Anıphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect amphetamine in human urine at a cutoff level of 1000 ng/ml. It is intended for health care professional use only.
This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
(Division Sign-Off)
Division of Clinical Lat
510(k) Number: K994359
(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
§ 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).