(55 days)
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Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay, with no mention of AI or ML technologies.
No
The device is described as an in vitro diagnostic test for the rapid detection of morphine in human urine, which is used for diagnostic purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test for the rapid detection of morphine in human urine".
No
The device description clearly states 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: The "Intended Use / Indications for Use" section explicitly states that the Amedica Drug Screen Opiate Test is an "in vitro diagnostic test".
- Sample Type: It is designed to test "human urine", which is a biological sample.
- Purpose: It is used for the "rapid detection of morphine", which is a diagnostic purpose.
- Method: It is an "in vitro" test, meaning it is performed outside of the living body.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amedica Drug Screen Opiate Test is a immunochromatographic assay for the rapid detection of Opiate in human urine at a cutoff concentration of 2000 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 Opiate Test is an in vitro diagnostic test for the rapid detection of morphine in human urine at a cutoff of 2000 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 (comma separated list FDA assigned to the subject device)
DJG
Device Description
Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 2000 ng/ml.
The Amedica Drug Screen Opiate 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 morphine concentration in the urine is below 2000 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 morphine conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the morphine level is above 2000 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 morphine 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
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
professional use
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
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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 OPIATE 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 Opiate test demonstrated that Amedica Biotech Drug Screen Opiate Test is substantially equivalent to the predicate kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97% agreement with GC/MS results
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Rapid Opiates Test
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
ICO230417
NOV
3. Summary of Safetv and Effectiveness ( As required by 21CFR 807.92(c))
Device name: Amedica Drug Screen Opiate Test
Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 2000 ng/ml.
Intended Use: The Amedica Drug Screen Opiate Test is a immunochromatographic assay for the rapid detection of Opiate in human urine at a cutoff concentration of 2000 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 Opiate 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 morphine concentration in the urine is below 2000 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 morphine conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the morphine level is above 2000 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 morphine 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 OPIATE 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 Opiate test demonstrated that Amedica Biotech Drug Screen Opiate 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 | |
| Predicate kit: | Rapid Opiates Test |
| Rapid Diagnostics, Inc |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jeff Chen President Amedica Biotech, Inc. 28301 Industrial Blvd., Suite K Hayward. CA 94545
NOV 6 2002
Re: K023047 Trade/Device Name: Amedica Drug Screen Opiate Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: September 4, 2002 Received: September 12, 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 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 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/cdrb/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
3
Page of
510(k) Number (if known):
Device Name: Amedica Drug Screen Opiate Test
Indications For Use:
The Amedica Drug Screen Opiate Test is an in vitro diagnostic test for the rapid detection of morphine in human urine at a cutoff of 2000 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 Lager
(Division Sign-Off)
Division vices
510(k) Number K023047
(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)