(42 days)
The Redi-Test THC 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.
The Redi-Test THC is an immunochromatograpic based one step in vitro test.
Acceptance Criteria and Study Details for Redi-Test THC (K990870)
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation | Not explicitly stated, but high correlation with predicate is implied for substantial equivalence. | 99% correlation with the predicate device (DRI Cannabinoids Enzyme Immunoassay). |
| Sensitivity | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Detected 11-Hydroxy-Δ⁹-THC at a cutoff of 50ng/mL. Predicate detected at 20ng/mL. |
| Specificity | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Found to be similar to the predicate device. |
| Accuracy | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Found to be similar to the predicate device. |
| Precision | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Found to be similar to the predicate device. |
| Cutoff | The device needs to detect 11-nor-Δ⁹-ΤΗC-9-COOH at a specified cutoff. | Detects 11-nor-Δ⁹-ΤΗC-9-COOH as low as 50 ng/ml. |
Note: The acceptance criteria were not explicitly defined as numerical thresholds in this 510(k) summary but were implied by the claim of "substantial equivalence" to the predicate device in terms of sensitivity, specificity, accuracy, and precision, and the 99% correlation.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 100 specimens
- 50 positive samples
- 50 negative samples
- Data Provenance: Not specified (e.g., country of origin). The data is retrospective, as existing specimens were used for comparison.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not described. The ground truth was established by GC/MS confirmation and comparison to a legally marketed predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is an in vitro diagnostic (IVD) assay, not an imaging-based AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes. The study directly assessed the performance of the Redi-Test THC device by comparing its results to the predicate device and GC/MS confirmation on 100 specimens. The device's performance was evaluated independently in this context.
7. Type of Ground Truth Used
- Type of Ground Truth:
- External Reference Standard: Gas Chromatography/Mass Spectrometry (GC/MS) confirmation was used for objective determination of positive and negative samples below 24.7ng/mL and above 31ng/mL.
- Comparison to Predicate Device: The DRI Cannabinoids Enzyme Immunoassay served as a comparative ground truth for evaluating correlation, sensitivity, specificity, accuracy, and precision.
8. Sample Size for the Training Set
- Sample Size: Not applicable. As an immunochromatographic assay, the Redi-Test THC does not involve a "training set" in the context of machine learning or AI algorithms. Its performance is based on its chemical and biological reactions.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
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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%.
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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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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: 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
§ 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).