(89 days)
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No
The device description and performance studies describe a standard immunoassay with visual interpretation, and there are no mentions of AI, ML, or image processing.
No.
The device is an in vitro diagnostic test for detecting amphetamine in urine, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine..."
No
The device description clearly indicates it is a "Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection," which describes a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine..." This is the most direct indicator.
- Nature of the Test: The test analyzes a biological sample (human urine) outside of the body to detect a substance (Amphetamine) that indicates a physiological state or condition (drug use). This is the core function of an IVD.
- Professional Use: While not exclusively for IVDs, the indication for use by "healthcare professionals" and "professional use" aligns with the typical distribution and use of many IVD devices.
- Preliminary Result: The fact that it provides a preliminary result and requires confirmation by a more specific method (like GC/MS) is common for screening IVDs.
The description clearly fits the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
DKZ
Device Description
Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 1000 ng/ml.
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97% agreement with GC/MS results.
Predicate Device(s)
Rapid Amphetamine Test Rapid Diagnostics, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
023/04
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 |
1
Predicate kit:
Rapid Amphetamine Test Rapid Diagnostics, Inc.
2
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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Page
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)