(89 days)
The Amedica Drug Screen Methamphetamine Test is a immunochromatographic assay for the rapid detection of methamphetamine 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.
Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 1000 ng/ml.
Here's an analysis of the provided text regarding the Amedica Drug Screen Methamphetamine Test, structured to address your specific points:
Acceptance Criteria and Study Details for Amedica Drug Screen Methamphetamine Test
The information provided is from a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance criteria against a predefined set of acceptance values. Therefore, the "acceptance criteria" for this device are implicitly tied to demonstrating performance comparable to the predicate device and achieving a high level of agreement with a confirmatory method (GC/MS).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High agreement with GC/MS (confirmatory method) | "> 94% agreement with GC/MS results" |
| Usability by professionals at clinical sites | "demonstrated that Amedica Biotech Drug Screen Methamphetamine Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse." |
| Substantial equivalence to predicate device | "comparison with Rapid Diagnostics methamphetamine test demonstrated that Amedica Biotech Drug Screen Methamphetamine Test is substantially equivalent to the predicate kit." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text mentions a "correlation study using blind-labeled clinical specimens" and a "clinical site study." However, the specific number of samples (sample size) for these test sets is not explicitly stated in the provided document.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. The use of "clinical specimens" implies a real-world context, but whether they were collected specifically for this study (prospective) or were pre-existing (retrospective) is not detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document implies that the ground truth for the correlation study was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "number of experts" is not directly applicable in this context.
- For the "clinical site study," human professionals (implied to be healthcare professionals working in certified laboratories) used the device. However, their role was to use the device, not to establish a separate ground truth against which the device was compared. The ground truth for this validation would still likely refer back to objective analytical methods or the predicate device's performance.
- Qualifications of Experts: Not applicable, as GC/MS is an instrumental method. For the clinical site study, the "professionals" were working in "two certified laboratories," implying they were qualified given the laboratory accreditation.
4. Adjudication Method for the Test Set
- None specified. The "correlation study" used GC/MS as the reference standard, which is an objective analytical method. There's no mention of multiple human readers or an adjudication process for the GC/MS results themselves or for the visual test results from the Amedica device to establish a consensus ground truth. The agreement was likely a direct comparison of the device's qualitative result (positive/negative) against the quantitative GC/MS result relative to the 1000 ng/ml cutoff.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or clearly conducted. The focus was on the device's performance against GC/MS and its substantial equivalence to a predicate device. While a "clinical site study" was performed, it describes the device being "use by professionals" rather than a formal MRMC study comparing human readers with and without AI assistance to measure an effect size.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in essence, the "correlation study" is a standalone evaluation of the device's analytical performance. The "Amedica Drug Screen Methamphetamine Test" is a lateral flow immunoassay that provides a visual qualitative result. While a human physically interprets the lines on the strip, the device itself is a "standalone" diagnostic rather than an AI algorithm that augments human interpretation. The reported agreement of "> 94% agreement with GC/MS results" directly reflects this standalone performance.
7. Type of Ground Truth Used
- Expert Consensus: No.
- Pathology: No (this is for drug detection, not tissue pathology).
- Outcomes Data: No.
- Other: The primary ground truth for evaluating the device's accuracy was Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly specific and sensitive analytical method considered the gold standard for drug confirmation.
8. Sample Size for the Training Set
- Not applicable / Not specified. This device is a competitive immunoassay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" in this context would refer to the development and optimization of the immunoassay reagents and manufacturing process, which doesn't typically involve a distinct data "training set" like AI models do.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As mentioned above, there isn't a "training set" in the machine learning sense for this type of device. The immunoassay's specificity and sensitivity are inherent in its chemical design and production, not learned from a dataset.
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K023/01
3. Summary of Safety and Effectiveness ( As required by 21CFR 807.92(c))
DEC 1 6 2002
Device name: Amedica Drug Screen Methamphetamine Test
Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is1000 ng/ml.
Intended Use: The Amedica Drug Screen Methamphetamine Test is a immunochromatographic assay for the rapid detection of methamphetamine 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 Methamphetamine Test is based on the principle of highly specific competitive immunochemical reactions between antigens 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 methamphetamine concentration in the urine is below 1000 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 methamphetamine conjugates immobilized on the strip and a colored line will appear in the test line region. The test result is negative. If the methamphetamine 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 methamphetamine 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 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 cartridge should be discarded. 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 > 94% agreement with GC/MS results. In addition, clinical site study was performed at two certified laboratories and demonstrated that Amedica Biotech Drug Screen Methamphetamine 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 methamphetamine test demonstrated that Amedica Biotech Drug Screen Methamphetamine Test is substantially equivalent to the predicate kit.
Manufacturer: Amedica Biotech, Inc. 28301 Industrial Blvd. Suite K Hayward, CA 94545 Phone: (510) 785-5980
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Fax: (510) 785-5973
Predicate kit:
Rapid Methamphetamine Test Rapid Diagnostics, Inc.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jeff Chen President Amedica Biotech Inc. 28301 Industrial Blvd. - Suite K Havward. CA 94545
FC 1 6 2002
K023101 Trade/Device Name: Amedica Drug Screen Methamphetamine Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF Dated: November 12, 2002 Received: November 19, 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 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 vour 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 (OS) 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 Sutman
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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Page
510(k) Number (if known):
Amedica Drug Screen Methamphetamine Test Device Name:
Indications For Use:
The Amedica Drug Screen Methamphetamine Test is an in vitro diagnostic test for the rapid detection of methamphetamine 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.
Alan Cooper
(Division Sign-Off)
Division of Clinical Laboratory 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)
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).