(90 days)
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Not Found
No
The summary describes a simple in vitro diagnostic test for drug detection in urine, 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 for the detection of drugs in urine, not a device used for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is an in vitro diagnostic test."
No
The device is an in vitro diagnostic test that analyzes human urine, indicating it is a physical test kit and 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 the following drugs in human urine".
- Sample Type: The test is performed on "human urine", which is a biological sample tested in vitro (outside of the body).
- Purpose: The purpose is to detect the presence of specific substances (drugs or their metabolites) within that sample, which is a core function of IVD devices.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine:
THC 11-nor-Δ -Tetrahydrocannabinol-9-carboxylic 50 ng/ml
COC Benzoylecgonine 300 ng/ml
OPI Morphine 300 ng/ml
OPI Morphine 2000 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
OXY Oxycodone 300 ng/ml
This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will yield preliminary positive results when prescription I one 10. Pressed, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multidrug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Product codes
NGL, DIS, DJR, LCM, LFG, NFT, NFV, NFW, NFY, NGG
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
Not Found
Intended User / Care Setting
over-the-counter (OTC) consumers
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
§ 862.3650 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, positioned above two wavy lines. The eagle and lines are black. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Amedica Biotech Inc. c/o Mr. Jeff Chen 28301 Industrial Blvd Suite K Hayward, CA 94545 USA
APR 1 4 2010
Re: K100108 Trade/Device Name: Amedica Drug Test Cup Regulation Number: 21 CFR 862.3650 Regulatory Class II Product Code: NGL, DIS, DJR, LCM, LFG, NFT, NFV, NFW, NFY, NGG Dated: March 25, 2010 Received: March 26, 2010
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Signature
Courtney C. Harper, 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
510(k) Number: K100108
Device Name: Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZ0/MTD/TCA/OXY
Indications for Use: The Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine
THC 11-nor-Δ -Tetrahydrocannabinol-9-carboxylic 50 ng/ml COC Benzoylecgonine 300 ng/ml OPI Morphine 300 ng/ml OPI Morphine 2000 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 OXY Oxycodone 300 ng/ml
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Livision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
100/08
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This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will yield preliminary positive results when prescription I one 10. Pressed, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multidrug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Prescription Use
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Levision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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