(195 days)
Instant-View™ Morphine Urine Dip Strip 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.
Instant-View Morphine Urine Dip Strip Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.
This test is a one-step lateral flow chromatographic immunoassay.
Here's a breakdown of the acceptance criteria and study information for the Instant-View™ Morphine Urine Dip Strip Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Criteria/Method | Reported Device Performance |
|---|---|---|
| Correlation with Predicate | Comparison to predicate device (QuikStrip One Step Opiate Test) | Higher than 91.3% correlation with the legally marketed test device. |
| Agreement across POL sites | 92.5% agreement across all three POL sites. | |
| Accuracy (Overall Agreement) | Agreement with expected results | 96.2% agreement with expected results. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the test set. It mentions "results from the Clinical Laboratory and three Physician's Offices." Without specific numbers, it is not possible to determine the precise sample size.
Regarding data provenance:
- Country of Origin: Not specified, but likely the USA given the FDA 510(k) submission.
- Retrospective or Prospective: Not explicitly stated. The phrasing "results from the Clinical Laboratory and three Physician's Offices" suggests a prospective study, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the number of experts used to establish ground truth or their specific qualifications. It only states that the accuracy evaluation was "conducted by persons with diverse educational background and working experience." This implies that the "expected results" (ground truth) were established by a reference method rather than expert consensus on interpretation of the test device results.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. The accuracy was determined by comparing the device's results to "expected results," which likely implies a single reference method result was used as the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test (lateral flow immunoassay) for detecting morphine, not an AI-assisted diagnostic tool that aids human interpretation of complex medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone, qualitative immunoassay. The performance described (correlation and accuracy) is its intrinsic performance for detecting morphine in urine. There is no "algorithm" in the traditional sense of AI, but rather a biochemical reaction. The "standalone" performance here refers to the test strip's ability to produce a result without further human interpretation beyond reading the C and T lines.
7. The Type of Ground Truth Used
The ground truth used for accuracy evaluation was referred to as "expected results." While not explicitly stated, for drug screening devices, this typically refers to:
- Known concentrations: Spiking urine samples with known concentrations of morphine both above and below the cutoff.
- Reference method: Comparison to a gold standard analytical method like Gas Chromatography/Mass Spectrophotometry (GC/MS), which is explicitly mentioned as the "preferred confirmatory method" for preliminary positive results.
8. The Sample Size for the Training Set
The document does not provide information about a "training set." This type of immunoassay device does not typically involve a machine learning training phase in the same way an AI algorithm would. Its development is based on biochemical principles and validation.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information on how a ground truth for such a set was established.
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Alfa Scientific Designs, Inc.
11494 Sorrento Valley Road, Suite San Diego, CA 9212
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 Dip Strip Test |
| Common Name: | Opiate Test | |
| Classification Name: | 21 CFR 862.3650, Class II | |
| Predicate Device | The Instant-View™ Morphine Urine Dip Strip 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 Dip Strip 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 |
510(K) #: K994409 Summary: Instant-View™ Morphine Urine Dip Strip Test
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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 Dip Strip Test, and the legallymarketed test device compared, is higher than 91.3 %.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 96.2 % with the expectedresults. |
| • Based on the results of the Performance Characteristicsand Comparison Studies, it may be concluded that theInstant-View™ Morphine Urine Dip Strip Test issuitable for use by health care professionals withdiverse educational backgrounds and work experiences,and is substantially equivalent to the existing legallymarketed device. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a winding pattern representing snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 0 2000
Ms. Rhoda Filipina QA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
K994409 Re:
Trade Name: Instant-View Morphine Urine Dip Strip 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 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 particed 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 a 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/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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K99440p
Page 1 of 1
K994409 510(k) Number (if known):
Instant-View Morphine Urine Dip Strip Test Device Name:
Indications For Use:
Instant-View Morphine Urine Dip Strip Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used 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. س
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K994409 |
(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)
§ 862.3640 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).