(46 days)
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No
The device description and intended use indicate a simple in vitro diagnostic test cup for visual, qualitative results, with no mention of AI, ML, image processing, or complex data analysis that would typically involve such technologies.
No
This device is an in vitro diagnostic test used to detect various substances in human urine. It provides a preliminary qualitative result and is not involved in treating or preventing any disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. propoxyphene and oxycodone in human urine..."
No
The device description and intended use clearly describe an in vitro diagnostic test kit that detects substances in urine, indicating a physical test component, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test for the rapid detection of [various substances] in human urine".
- In Vitro: The test is performed on a sample (human urine) taken from the body, rather than directly on the body itself.
- Diagnostic: The test is used to detect the presence of specific substances, which can be used to aid in diagnosis or assessment.
The description clearly aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. propoxyphene and oxycodone in human urine at the following cutoff concentration:
| THC | 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic | 50 ng,ml |
|---|---|---|
| COC | Benzoylecgonine | 300 ng,ml |
| OPI | Morphine | 2000 ng,ml |
| OPI | Morphine | 300 ng,ml |
| AMP | Amphetamine | 1000 ng,ml |
| MET | Methamphetamine | 1000 ng,ml |
| PCP | Phencyclidine | 25 ng,ml |
| MDMA | 3,4 methylenedioxymethamphetamine | 500 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |
| PPX | Propoxyphene | 300 ng/ml |
| OXY | Oxycodone | 300 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
LDJ, DIO, DJG, DKZ, LAF, LCM, DJC, DIS, JXM, DJR, MLK, JXN, DJG
Device Description
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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
human urine
Indicated Patient Age Range
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Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "U.S. Department of Health & Human Services, Washington, D.C." are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
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
JUL 2 1 2006
Re: K061556
Trade/Device Name: Amedica Drug Screen Test Cup THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Regulation Number: 21 CFR8862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO, DJG, DKZ, LAF, LCM, DJC, DIS, JXM, DJR, MLK, JXN, DJG Dated: July 14, 2006 Received: July 17, 2006
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 fisting (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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K061556 510(k) Number:
- Amedica Drug Screen Test Cup Device Name: THC,COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,MTD,TCA,PPX,OXY
Indications For Use:
The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. propoxyphene and oxycodone in human urine at the following cutoff concentration:
| THC | 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic | 50 ng,ml |
|---|---|---|
| COC | Benzoylecgonine | 300 ng,ml |
| OPI | Morphine | 2000 ng,ml |
| OPI | Morphine | 300 ng,ml |
| AMP | Amphetamine | 1000 ng,ml |
| MET | Methamphetamine | 1000 ng,ml |
| PCP | Phencyclidine | 25 ng,ml |
| MDMA | 3,4 methylenedioxymethamphetamine | 500 ng/ml |
| BAR | Secobarbital | 300 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |
| PPX | Propoxyphene | 300 ng/ml |
| OXY | Oxycodone | 300 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro-Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety