(190 days)
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No
The device description and performance studies describe a standard immunoassay test, with no mention of AI or ML technologies.
No
The device is an immunoassay intended to detect morphine in human urine, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is described as an "immunoassay device intended to detect morphine only in human urine," and the "Intended Use / Indications for Use" section specifies its purpose in detecting a substance indicative of drug use. This qualitative detection of a specific marker in the body for the purpose of identifying a health condition (morphine presence) aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "one-step lateral flow chromatographic immunoassay," which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative immunoassay device intended to detect morphine only in human urine". This clearly indicates it's used to test a sample taken from the human body (in vitro) to diagnose or provide information about a health condition (detecting the presence of morphine).
- Anatomical Site: The anatomical site is "human urine", which is a biological sample taken from a human.
- Device Description: The description of it being a "one-step lateral flow chromatographic immunoassay" is a common type of technology used in IVD tests.
- Intended User / Care Setting: While it's for "health care professional use only", this doesn't preclude it from being an IVD. Many IVDs are designed for use by trained professionals in a healthcare setting.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
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.
Product codes
DPK
Device Description
This test is a one-step lateral flow chromatographic immunoassay.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
health care professional use only.
Clinical Laboratory and three Physician's Offices
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- The correlation of results from the Instant-View ™ Morphine Urine Cassette Test, and the legally marketed test device compared, is higher than 91.6 %.
- The results from all three POL sites agreed 92.5%.
- 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.
- Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Morphine Urine Cassette Test is suitable for use by health care professionals with diverse educational backgrounds and work experiences, and is substantially equivalent to the existing legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation: higher than 91.6%
Agreement (POL sites): 92.5%
Accuracy: 96.5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
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 M | |
| San Diego, CA 92121 | ||
| Telephone: (858) 350-9798 | ||
| Fax: (858) 350-9709 | ||
| Email: 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 is | |
| substantially equivalent to other legally marketed devices | ||
| for the similar intended use. The device used for | ||
| comparison 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 chromatographic | |
| immunoassay. | ||
| Intended Use | The 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. | ||
| Summary of the | ||
| Similarities to the | ||
| Predicate Device | • Intended Use: | |
| Both devices are intended to detect morphine in human | ||
| urine at a cutoff level of 300 ng/ml. | ||
| • Interpretation of results: | ||
| The appearance of only a C line indicates a positive | ||
| result, and that the morphine level is at a cutoff level of | ||
| 300 ng/ml or higher. And, the appearance of two lines – | ||
| both C line and T line indicates a negative result, and the |
1
| morphine level is below 300 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 the specific Morphine/ |
| Antibody/Morphine complexes. |
| Discussion and Conclusion |
| • The correlation of results from the Instant-View ™ |
| Morphine Urine Cassette Test, and the legally |
| marketed test device compared, is higher than 91.6 %. |
| The results from all three POL sites agreed 92.5%. |
| • 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. |
| • Based on the results of the Performance Characteristics |
| and Comparison Studies, it may be concluded that the |
| Instant-View™ Morphine Urine Cassette Test is suitable |
| for use by health care professionals with diverse |
| educational backgrounds and work experiences, and is |
| substantially equivalent to the existing legally marketed |
| device. |
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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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Page 2
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