(105 days)
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No
The summary describes a standard immunochromatographic assay for drug screening, with no mention of AI or ML technologies.
No
The device is described as an immunochromatographic competitive assay used to screen human urine for the presence of opiate compounds, providing only a preliminary analytical result. This indicates a diagnostic or screening purpose, not a therapeutic one.
Yes
The device screens human urine for the presence of opiate compounds, providing a "preliminary analytical result" which is indicative of its use in diagnosing or identifying a condition.
No
The device description explicitly states it is an "immunochromatographic based one step in vitro test," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is used to "screen human urine for the presence of the opiate compounds". This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The "Device Description" section clearly labels it as an "immunochromatograpic based one step in vitro test". The term "in vitro" directly indicates it's an IVD.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of the opiate compounds including morphine at a cut off concentration of 300 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
Product codes
DJG
Device Description
The Redi-Test Opiates is an immunochromatograpic based one step in vitro test.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
The tests demonstrated >99% correlation when 100 specimens (50 negative and 50 positive, over the entire assay range) were compared.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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) Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
991883 The assigned 510(k) number is: /
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Date of summary: May 20, 1999
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Submitted by: Redwood Biotech Inc. 3573 Westwind Blvd. Santa Rosa, CA 95403 TEL 707-577-7959 FAX 707-577-0365 Contact: Robert Mount
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Device Name: Redi-Test Opiates
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Device Classification: CFR 21 862.3650, Class II, Panel 91 Toxicology
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Device description: The Redi-Test Opiates is an immunochromatograpic based one step in vitro test.
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Intended Use: The Redi-Test Opiates is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the opiate compounds including morphine at a cut off concentration of 300 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
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Substantial Equivalence: The Redi-Test Opiates was found substantially equivalent to the DRI, Opiate Enzyme Immunoassay. Both products are immunoassays and use specific antibodies to detect various opiate compounds including morphine. Both assays are preliminary screens for human urine and require confirmation with altemate methods such as GC/MS. The sensitivity of the tests are similar, the DRI and Redi-Test both detect morphine and codeine at a cut off concentration of 300 ng/mL. The tests demonstrated >99% correlation when 100 specimens (50 negative and 50 positive, over the entire assay range) were compared. The tests are similar in sensitivity, specificity, accuracy and precision.
Conclusion:
The Opiate Enzyme Immunoassay and the Redi-Test Opiates are substantially equivalent in performance characteristics. The correlation of the two tests was >99%.
1
Image /page/1/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 with three lines extending from its body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 5 1999
Advantage Diagnostics Corp. c/o Ms. Janis Freestone Redwood Biotech Inc. 3573 Westwind Blvd. Santa Rosa, California 95403
Re: K991883 Trade Name: Redi-Test Opiates Regulatory Class: II Product Code: DJG Dated: August 19, 1999 Received: August 20, 1999
Dear Ms. Freestone:
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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Page 2
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 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) 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"(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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
3
510k Number:
Device Name: Bedi-Test Opiates
Indications for Use:
Indications for Use.
The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive
States of the secon buman urine for the presence of opiates are a The Redi-Test Opiates is a qualitative, one step, imminounion in the Redi-Test The Redi-1 est Oplates is urine for the presence of oplates are only a prefits.
assay used to sceen human urine for the presence of provides only a preferably assay used to scech handa
concentration of 300ngml.. The test is qualitative and provides only of profiliance for
analytical result, which must be confirmed by an alternate GC/MS.
Jean Cooper
(Division Sign-Off)
carpry Levices Division of Clinical 510(k) Number.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the counter use_