(42 days)
Not Found
Not Found
No
The device description and performance studies indicate a standard immunochromatographic assay, with no mention of AI or ML technologies.
No.
The device is for qualitative determination of cannabinoids and its metabolites in human urine. It is a diagnostic test, not a therapeutic device.
Yes
Explanation: The device is described as being for "qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens" and providing a "preliminary analytical result," which are characteristics of a diagnostic test to identify the presence of a specific substance in the body.
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 explicitly states "qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to diagnose or screen for a condition (presence of THC).
- Device Description: The device description states "The Redi-Test THC is an immunochromatograpic based one step in vitro test." The term "in vitro test" directly indicates it is an IVD.
- Sample Type: The test uses "human urine specimens," which are biological samples analyzed in vitro.
- Purpose: The purpose is to "screen human urine for the presence of cannabinoids," which is a diagnostic or screening function performed on a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Redi-Test is designed for the qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens. The presence of 11nor-Δ°-ΤΗC-9-COOH in human urine as low as 50 ng/ml can be detected. This test is for use in clinical laboratories by health care professionals and forensic professionals only.
The Redi-Test THC is a rapid immunochromatographic competitive assay used to screen human urine for the presence of cannabinoids at a cutoff concentration of 50ng/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 (comma separated list FDA assigned to the subject device)
LDJ
Device Description
The Redi-Test THC is an immunochromatograpic based one step in vitro test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories by health care professionals and forensic professionals only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The tests demonstrated 99% correlation when 100 specimens (50 positive and 50 negative) were compared. The tests are similar in sensitivity, specificity, accuracy and precision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The sensitivity of the tests are similar, the DRI test detects 11-Hydroxy-μ-THC at a cut off of 20ng/mL and the Redi-Test detects this metabolite at a cut off of 50ng/mL.
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.
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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.
Not Found
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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§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
4/27/99
510(k) Summary
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.
K 990870 The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
- Date of summary: February 18, 1999
Redwood Biotech 3573 Westwind Blvd. Santa Rosa, CA 95403 2. Submitted by: TEL 707-577-7959 FAX 707-577-0365 Contact: Robert Mount
Redi-Test THC 3. Device Name:
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Device Classification: Class II. 862.3650, Panel 91 Toxicology
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Device description: The Redi-Test THC is an immunochromatograpic based one step in vitro test.
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Intended Use: The Redi-Test is designed for the qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens. The presence of 11nor-Δ°-ΤΗC-9-COOH in human urine as low as 50 ng/ml can be detected. This test is for use in clinical laboratories by health care professionals and forensic professionals only.
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Substantial Equivalence: The Redi-Test was found substantially equivalent to the DRI. Cannabinoids Enzyme Immunoassav. Both products are immunoassays and use specific antibodies to detect the major metabolite of cannabinoids. 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 test detects 11-Hydroxy-മീ-THC at a cut off of 20ng/mL and the Redi-Test detects this metabolite at a cut off of 50ng/mL. GC/MS confirmed that both tests identified samples below 24.7ng/mL negative and above 31ng/mL positive.
The tests demonstrated 99% correlation when 100 specimens (50 positive and 50 negative) were compared. The tests are similar in sensitivity, specificity, accuracy and precision.
Conclusion:
The Cannabinoid Enzyme Immunoassay and the Redi-Test THC are substantially equivalent in performance characteristics. The correlation of the two tests was 99%.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/10 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem of three stylized human profiles forming the shape of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1999
Redwood Biotech Inc. C/O Ms. Janis Freestone Advantage Diagnostics Corporation 520 Weddell Drive, Suite B Sunnyvale, California 94089
Re: K990870 Trade Name: Redi-Test THC Regulatory Class: II Product Code: LDJ Dated: March 10, 1999 Received: March 16, 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/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
3
510k Number: K940870
Device Name: Redi-Test THC
Indications for Use:
The Redi-Test THC is a rapid immunochromatographic competitive assay used to screen human urine for the presence of cannabinoids at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed by an alternate methodology preferably GC/MS.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
990870 510(k) Number
(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)
.
C