(89 days)
The Amedica Drug Screen Amphetamine Test is a immunochromatographic assay for the rapid detection of Amphetamine in human urine at a cutoff concentration of 1000 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.
The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine at a cutoff of 1000 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 cutoff is 1000 ng/ml.
Acceptance Criteria and Study for Amedica Drug Screen Amphetamine Test
This document outlines the acceptance criteria for the Amedica Drug Screen Amphetamine Test and the study proving its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Agreement with GC/MS | Not explicitly stated (implied to be high, comparable to predicate) | > 97% |
| Qualitative Detection (Clinical Site Study) | Not explicitly stated (implied to be effective and usable by professionals) | Demonstrated that the device can be used by professionals for visual, qualitative detection of drugs of abuse. |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (Rapid Amphetamine Test - Rapid Diagnostics, Inc.) | Demonstrated substantial equivalence to the predicate device. |
Note: The provided text does not explicitly state numerical acceptance criteria for agreement or qualitative detection. The "Performance" section describes the study results as demonstrating the device meets the intended purpose and is comparable to a predicate.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The study used "blind-labeled clinical specimens" and was a "correlation study."
- Data Provenance:
- Country of Origin: Not explicitly stated, but the manufacturer is based in Hayward, CA, and the FDA's address is in Rockville, MD, suggesting a US-centric study.
- Retrospective or Prospective: Not explicitly stated. The use of "blind-labeled clinical specimens" could suggest either if they were collected for another purpose and then retrospectively analyzed, or if they were collected prospectively for this study. The term "correlation study" doesn't clarify this either.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable, as the primary ground truth for the correlation study was established by GC/MS, an analytical chemical method, not human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis, not subject to human adjudication for its results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test with a visual qualitative result, not an image-based or complex diagnostic system typically requiring MRMC studies. The "clinical site study" mentioned involved professionals using the device, but it was to demonstrate usability and qualitative detection, not to measure improvement with AI assistance or compare human readers.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Yes, in essence, the "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" represents a standalone performance evaluation of the device itself. The device is a "membrane based one-step, lateral flow, competitive immunoassay," which operates as a standalone diagnostic without human interpretation beyond reading the visual result. The >97% agreement refers to the device's inherent performance compared to a gold standard.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the primary correlation study was Gas Chromatography/Mass Spectrometry (GC/MS). The text states, "This study produced > 97% agreement with GC/MS results," indicating GC/MS served as the reference standard. This is an objective, highly accurate analytical method for drug detection and quantification in urine.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a chemical immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. Its design and performance are based on chemical reactions and physical properties.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device. The immunoassay's specificity and sensitivity are inherent to its chemical design.
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3. Summary of Safety and Effectiveness ( As required by 21CFR 807.92(c))
DEC 1 6 2002
Device name: Amedica Drug Screen Amphetamine Test
Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 1000 ng/ml.
Intended Use: The Amedica Drug Screen Amphetamine Test is a immunochromatographic assay for the rapid detection of Amphetamine in human urine at a cutoff concentration of 1000 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 Amphetamine 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 amphetamine concentration in the urine is below 1000 ng/ml, it is not enough to saturate all of the binding sites of the antibodycoated colored particles in the test strip. The unsaturated antibody-coated particles will then be captured by amphetamine conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the amphetamine level is above 1000 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 amphetamine 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 > 97% agreement with GC/MS results. In addition, clinical site study was performed at two certified laboratories and demonstrated that Amedica Biotech Drug Screen Amphetamine 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 amphetamine test demonstrated that Amedica Biotech Drug Screen Amphetamine Test is substantially equivalent to the predicate kit.
| Manufacturer: | Amedica Biotech, Inc. |
|---|---|
| 28301 Industrial Blvd. Suite K | |
| Hayward, CA 94545 | |
| Phone: | (510) 785-5980 |
| Fax: | (510) 785-5973 |
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Predicate kit:
Rapid Amphetamine Test Rapid Diagnostics, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
DEC 1 6 2002
Mr. Jeff Chen President Amedica Biotech Inc. 28301 Industrial Blvd. - Suite K Hayward, CA 94545
Re:
K023104 Trade/Device Name: Amedica Drug Screen Amphetamine Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: November 12, 2002 Received: November 19, 2002
Dear Mr. Chen:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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O
510(k) Number (if known):
023104
Amedica Drug Screen Amphetamine Test Device Name:
Indications For Use:
The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine at a cutoff of 1000 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.
Conger
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Nurnber K023104
(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)
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).