(99 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 a diagnostic test for the presence of phencyclidine and does not treat or alleviate any condition.
Yes
Explanation: The device is described as a "qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine," which is a diagnostic purpose. It provides a "preliminary analytical result" for the presence of a substance in a biological sample.
No
The device description clearly states it is an "immunochromatographic based one step in vitro test," which is a physical test kit, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's used to "screen human urine for the presence of phencyclidine". This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description directly states "The Redi-Test PCP is an immunochromatograpic based one step in vitro test." The term "in vitro" is a key indicator of an IVD.
The other sections, while providing details about the device and its performance, further support its classification as an IVD by describing a diagnostic test and its evaluation.
N/A
Intended Use / Indications for Use
The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/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
LCM
Device Description
The Redi-Test PCP 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
human urine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The tests demonstrated >99% correlation when 100 specimens (50 negative and 50 positive, over the entire assay range) were compared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
The DRI, Phencyclidine Enzyme Immunoassay
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
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N/A
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AUG 25
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.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
- Date of summary:
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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 PCP
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Device Classification: Class II, Panel 91 Toxicology
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Device description: The Redi-Test PCP is an immunochromatograpic based one step in vitro test.
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Intended Use: The Redi-Test PCP is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the phencyclidine at a cut off concentration of 25 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an altemate methodology preferably. GC/MS.
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Substantial Equivalence: The Redi-Test PCP was found substantially equivalent to the DRI, Phencyclidine Enzyme Immunoassay. Both products are immunoassays and use specific antibodies to detect phencyclidine. 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 phencyclidine at a cut off concentration of 25 no/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 PCP Enzyme Immunoassay and the Redi-Test PCP are substantially equivalent in performance characteristics. The correlation of the two tests was >99%.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 25 1999
Redwood Biotech Inc. c/o Ms. Janis Freestone Advantage Diagnostics Corporation 2440 Leghorn Street Mountain View. California 94043
Re: K991698
Trade Name: Redi-Test PCP Regulatory Class: II Product Code: LCM Dated: August 17, 1999 Received: August 18, 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 (OS) 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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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/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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510k Number:
Device Name: Redi-Test PCP
Indications for Use:
The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
P. Berhaut (for J. Cooper, ovm)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991698
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