(190 days)
Instant-View™ Morphine Urine Cassette Test is a qualitative immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is for health care professional use only.
This test is a one-step lateral flow chromatographic immunoassay.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details:
Acceptance Criteria and Study Details for Instant-View™ Morphine Urine Cassette Test
1. Acceptance Criteria and Reported Device Performance
The provided text implies acceptance criteria for two key areas:
i) Correlation with a legally marketed predicate device, and
ii) Accuracy compared to expected results.
| Acceptance Criteria Category | Specific Metric (Implied) | Acceptance Threshold (Implied) | Reported Device Performance |
|---|---|---|---|
| Correlation with Predicate Device | Agreement/Correlation with predicate device | > 91.6% (implied from "higher than 91.6 %") | "higher than 91.6 %" |
| Agreement Across Different Testing Sites/Users | Agreement of results across multiple POL sites | Not explicitly stated | "The results from all three POL sites agreed 92.5%." |
| Accuracy (Comparison to Expected Results) | Accuracy compared to expected results (clinical and Physician's Offices) | Not explicitly stated | "agreed 96.5 % with the expected results." |
Note: The document states "The correlation of results from the Instant-View ™ Morphine Urine Cassette Test, and the legally marketed test device compared, is higher than 91.6 %." This phrasing can be interpreted as the acceptance criterion itself, and the device met it. Similarly, "The Accuracy evaluation results...agreed 96.5 % with the expected results" indicates the performance achieved.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact numerical sample size used for the test set. However, it mentions:
- "The correlation of results from the Instant-View ™ Morphine Urine Cassette Test, and the legally marketed test device compared, is higher than 91.6 %." This suggests a comparison was made on a set of samples.
- "The results from all three POL sites agreed 92.5%." This indicates testing was conducted at multiple Physician's Office Laboratories (POLs) on a set of samples.
- "The Accuracy evaluation results from the Clinical Laboratory and three Physician's Offices conducted by persons with diverse educational background and working experience agreed 96.5 % with the expected results." This implies a set of samples was tested in a clinical laboratory and at the three POLs.
Data Provenance: The data appears to be prospective in nature, as it describes a study conducted to evaluate the device. The country of origin is not explicitly stated within the provided text, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or followed U.S. regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions "persons with diverse educational background and working experience" conducted the accuracy evaluation, but these are presumably the test operators, not necessarily the experts establishing the ground truth if a confirmatory method was used.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. It mentions "The correlation of results" with a legally marketed device and "Accuracy evaluation results" with "expected results." This implies a gold standard or reference method was used to determine the "expected results" or for comparison with the predicate device, but the process of resolving discrepancies (adjudication) is not detailed. The intent for positive results is that "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." This suggests GC/MS would serve as the ultimate ground truth, but how initial discrepancies in the study were handled is not detailed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a qualitative immunoassay for detecting morphine in urine, intended for standalone use by healthcare professionals. The study focuses on its performance characteristics, correlation with a predicate, and accuracy against expected results. It does not involve human readers interpreting images, nor does it assess the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done. The Instant-View™ Morphine Urine Cassette Test is a "qualitative immunoassay device" designed for direct use to produce a result. The performance data presented (correlation, agreement across sites, accuracy) reflects the performance of the device itself, providing a direct interpretation (appearance of lines) without human interpretation beyond reading the indicated result. It is described as a "one-step lateral flow chromatographic immunoassay."
7. The Type of Ground Truth Used
The type of ground truth used is implied to be:
- Comparison with a predicate device: For the correlation study, the results from the predicate device (QuikStrip One Step Opiate Test) served as a reference.
- Expected results: For the accuracy evaluation, results were compared against "expected results," which, given the context of drug testing, would typically refer to results obtained from a highly accurate, quantitative reference method. The document explicitly states that for confirmation, "Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method," strongly suggesting that a similar method or a prepared reference standard was used to define these "expected results" for the study samples. This aligns with chemical analysis/quantitative reference method as the ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The Instant-View™ Morphine Urine Cassette Test is described as a "lateral flow chromatographic immunoassay," implying a chemical/biological test rather than a machine learning or AI-based algorithm that would require a distinct training set. The study detailed focuses on evaluating the performance of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of this immunoassay device, the method for establishing its ground truth is not applicable.
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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™ Morphine Urine Cassette Test | |
| Common Name: Opiate Test | ||
| Classification Name: 21 CFR 862.3650, Class II | ||
| Predicate Device | The Instant-View™ Morphine Urine Cassette Test issubstantially equivalent to other legally marketed devicesfor the similar intended use. The device used forcomparison study is QuikStrip One Step Opiate Test,manufactured by Syntron Bioresearch, Inc. with 510(K) #:K972571, Date of Approval: 08/20/97. | |
| Device Description | This test is a one-step lateral flow chromatographicimmunoassay. | |
| Intended Use | The Instant-View™ Morphine Urine Cassette Test is aqualitative immunoassay device intended to detect morphineonly in human urine at a cutoff level of 300 ng/ml. It is forhealth care professional use only. | |
| Summary of theSimilarities to thePredicate Device | • Intended Use:Both devices are intended to detect morphine in humanurine at a cutoff level of 300 ng/ml.• Interpretation of results:The appearance of only a C line indicates a positiveresult, and that the morphine level is at a cutoff level of300 ng/ml or higher. And, the appearance of two lines –both C line and T line indicates a negative result, and the |
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| morphine level is below 300 ng/ml. |
|---|
| Technological Characteristics:• Both devices are one step, qualitative, competitivebinding immunoassay test, utilizing the basicimmunochemical sandwich assay principle ofrecognition and formation of the specific Morphine/Antibody/Morphine complexes. |
| Discussion and Conclusion |
| • The correlation of results from the Instant-View ™Morphine Urine Cassette Test, and the legallymarketed test device compared, is higher than 91.6 %.The results from all three POL sites agreed 92.5%. |
| • The Accuracy evaluation results from the ClinicalLaboratory and three Physician's Offices conducted bypersons with diverse educational background andworking experience agreed 96.5 % with the expectedresults. |
| • Based on the results of the Performance Characteristicsand Comparison Studies, it may be concluded that theInstant-View™ Morphine Urine Cassette Test is suitablefor use by health care professionals with diverseeducational backgrounds and work experiences, and issubstantially equivalent to the existing legally marketeddevice. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 5 2000
Ms. Rhoda Filipina QA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
Re: K994404
Trade Name: Instant-View Morphine Urine Cassette Test Regulatory Class: II Product Code: DPK Dated: June 6, 2000 Received: June 8, 2000
Dear Ms. Filipina:
We have reviewed your Section 510(k) notification of intent to market the device referenced wo have have 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 provision 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 Costilette Pro (110). - The general controls provisions of the Act include requirements for annual provisions of the read of thees, 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 ( fecting 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 mopelwaith 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 This letter will anow you to objin allating of your device to a legally marketed nonification. The I Dr I mailing of Sication 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 If you desire spoently an in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, (201) 594-1568. Tracklendly) (1) 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/cdrl/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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K994404 510(k) Number (if known):
Instant-View Morphine Urine Cassette Test Device Name:
Indications For Use:
Instant-View Morphine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.
The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Morphine to be at a concentration of 2000 ng/ml.
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.
(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)
Kim Cooper 1/3/00
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 994404
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine 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).