(80 days)
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No
The summary describes a simple in vitro diagnostic test cup for drug detection in urine, with no mention of AI, ML, image processing, or complex data analysis that would typically involve such technologies.
No
The device is an in vitro diagnostic test designed to detect drugs in human urine, providing information about the presence or absence of certain substances. It is not intended for treating or alleviating any medical condition, which is the purpose of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine."
No
The device is described as an "in vitro diagnostic test" and a "test cup," which strongly implies a physical hardware component (the cup and test strips/reagents) is integral to its function, not just software.
Yes, based on the provided information, the Amedica Home Drug Test Cup 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".
- Sample Type: It is designed to detect drugs in "human urine", which is a biological sample tested in vitro (outside the body).
- Purpose: The purpose is to provide information about the presence or absence of specific substances (drugs or their metabolites) in the sample, which is a core function of IVD tests.
The fact that it's intended for "over-the-counter (OTC) consumer use" and is the "first step in a two step process" does not negate its classification as an IVD. It simply describes the intended user and how the test fits into a larger process.
N/A
Intended Use / Indications for Use
The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine.
This test is intended for over-the-counter (OTC) consumer use 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 drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multi-drug 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 (comma separated list FDA assigned to the subject device)
NGL, NFT, NFY, NGG, DIS, NFV, DJR, LCM, LFG, NFW
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
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Indicated Patient Age Range
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Intended User / Care Setting
Over-The-Counter 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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Amedica Biotech, Inc. c/o Mr. Jeff Chen 28301 Industrial Blvd., Suite K Hayward, CA 94545
DEC 1 9 2008
K082898 Trade Name: Amedica Home Drug Test Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: NGL, NFT, NFY, NGG, DIS, NFV, DJR, LCM, LFG, NFW Dated: September 29, 2008 Received: September 30, 2008
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 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 10gally marketed predicate device results in a classification for your device and thus, perrorts 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) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 the more the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known):
Device Name: Amedica Home Drug Test Cup
Indications For Use:
The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine.
| Drug | Analyte | Cutoff | Device Code |
|---|---|---|---|
| Marijuana | THC | 50 ng/mL | THC |
| Cocaine | Benzoecgonine | 300 ng/mL | COC |
| Amphetamine | Amphetamine | 1000 ng/mL | AMP |
| Methamphetamine | Methamphetamine | 1000 ng/mL | MET |
| Opiates | Morphine | 2000 ng/mL | OPI |
| Opiates300 | Morphine | 300 ng/mL | OPI300 |
| Pencyclidine | Phencylidine | 25 ng/mL | PCP |
| Barbiturates | Secobarbital | 300 ng/mL | BAR |
| Benzodiazepines | Oxazepam | 300 ng/mL | BZD |
| Methadone | Methadone | 300 ng/mL | MTD |
| Oxycodone | Oxycodone | 100 ng/mL | OXY |
| MDMA | MDMA | 500 ng/mL | MDMA |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL | TCA |
This test is intended for over-the-counter (OTC) consumer use 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 drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multi-drug 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) |
AND/OR
Over-The-Counter Use (21 CFR 801 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
iagnostic Device
1082899