(62 days)
The Amedica Drug Screen THC Test is an in vitro diagnostic test for the rapid detection of THC in human urine at a cutoff of 50 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.
This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 50 ng/ml.
Here's a detailed breakdown of the Amedica Drug Screen THC Test's acceptance criteria and the study that proves its performance, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Agreement with GC/MS | Not explicitly stated; implied high agreement | > 96% agreement with GC/MS results |
| Clinical Site Study | Not explicitly stated; implied satisfactory performance for professional use | "demonstrated that Amedica Biotech Drug Screen THC Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse" |
| Substantial Equivalence | Equivalence to predicate device (Rapid THC Test) | Demonstrated equivalence to the Rapid Diagnostics THC Test |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "blind-labeled clinical specimens," but the number of specimens is not provided.
- Data Provenance: The data came from "blind-labeled clinical specimens" and "clinical site study...at two certified laboratories." The country of origin is not specified, but given the FDA submission, it's highly likely to be the USA. The study design is retrospective, as it uses "clinical specimens that have been measured by GC/MS."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a definitive analytical method, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done in the context of improving human reader performance with AI. The device is a standalone immunoassay, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the entire performance evaluation described is for the standalone device. The device is an "immunochromatographic assay for the rapid detection of THC in human urine" that provides a "visual, qualitative detection." Its performance is measured directly against GC/MS. While a human does read the visual result, the "algorithm" here refers to the chemical reaction and visual readout mechanism of the test strip itself, not a separate AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The primary ground truth for the correlation study was GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and commonly accepted reference method for confirming the presence and concentration of substances in urine.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Amedica Drug Screen THC Test is a competitive immunoassay, not an AI-based device that requires a training set in the conventional sense. Its "training" is inherent in its chemical design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as it's not an AI-based device. The device itself is designed based on known chemical principles and the specificity of antibodies to THC metabolites.
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NOV 6 2002
KO 22955
Summary of Safety and Effectiveness ( As required by 21CFR 807.92(c))
Device name: Amedica Drug Screen THC Test
Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 50 ng/ml.
Intended Use: The Amedica Drug Screen THC Test is a immunochromatographic assay for the rapid detection of THC in human urine at a cutoff concentration of 50 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
Test Principle and Description: The Amedica Drug Screen THC Test is based on the principle of highly specific competitive immunochemical reactions between and antibodies for the analysis of specific substances in urine. During testing, a urine specimen moves along membrane on the strip by capillary action. When THC concentration in the urine is below 50 ng/ml, it is not enough to saturate all of the binding sites of the antibody-coated colored particles in the test strip. The unsaturated antibody-coated particles will then be captured by THC conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the THC level is above 50 ng/ml, it is sufficient to occupy all of the binding sites on the antibody-coated particles. The saturated antibody-coated particles will not be captured by THC conjugate coated on the strip. The colored line will not form in the test region. The test result is positive. The device also provides a built-in control with a different antigen/antibody reaction at the control region. This control line should always appear whether or not the drugs or metabolites are present. If the control line does not appear the test result is invalid. This means that negative urine will produce two colored bands, and positive urine will produce only one band at control region.
Performance: The product performance was evaluated by correlation study using blind-labeled clinical specimens that have been measured by GC/MS. This study produced > 96% agreement with GC/MS results. In addition, clinical site study was performed at two certified laboratories and demonstrated that Amedica Biotech Drug Screen THC Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse. The results of these study and comparison with Rapid Diagnostics THC test demonstrated that Amedica Biotech Drug Screen THC Test is substantially equivalent to the predicate kit.
| Manufacturer: | Amedica Biotech, Inc.28301 Industrial Blvd. Suite KHayward, CA 94545Phone: (510) 785-5980Fax: (510) 785-5973 |
|---|---|
| Predicate kit: | Rapid THC TestRapid Diagnostics, Inc. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
ood and Drug Administration 198 Gaither Road Rockville MD 20850
6 2002 NOV
Mr. Jeff Chen President Amedica Biotech, Inc. 28301 Industrial Blvd., Suite K Hayward. CA 94545
K022955 Trade/Device Name: Amedica Drug Screen THC Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: August 30, 2002 Received: September 5, 2002
Dear Mr. Chen:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 g 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/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
Enclosure
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510(k) Number (if known):
Device Name: Amedica Drug Screen THC Test
Indications For Use:
The Amedica Drug Screen THC Test is an in vitro diagnostic test for the rapid detection of THC in human urine at a cutoff of 50 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.
This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
Jean Leogn
(Division Sign-Off)
Division of Clinical Laboratory Device.
510(k) Number: K022955
(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
Page
(Optional Format 1-2-96)
§ 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).