(80 days)
The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine.
Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Opiates300, Pencyclidine, Barbiturates, Benzodiazepines, Methadone, Oxycodone, MDMA, Tricyclic Antidepressants.
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.
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The provided text is a 510(k) summary for the "Amedica Home Drug Test Cup," a device intended for over-the-counter (OTC) consumer use for detecting various drugs in human urine.
Acceptance Criteria and Device Performance:
The document does not explicitly state "acceptance criteria" in a table format with performance metrics. However, the core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, which implies that the performance of the Amedica Home Drug Test Cup is comparable to these predicates for the stated indications.
The key performance aspect mentioned is the detection of specific drugs at defined cutoff levels. The device is intended to provide a preliminary positive or negative result based on these cutoffs.
| Drug | Analyte | Cutoff | Reported Device Performance (Implied) |
|---|---|---|---|
| Marijuana | THC | 50 ng/mL | Detects THC at or above 50 ng/mL |
| Cocaine | Benzoecgonine | 300 ng/mL | Detects Benzoecgonine at or above 300 ng/mL |
| Amphetamine | Amphetamine | 1000 ng/mL | Detects Amphetamine at or above 1000 ng/mL |
| Methamphetamine | Methamphetamine | 1000 ng/mL | Detects Methamphetamine at or above 1000 ng/mL |
| Opiates | Morphine | 2000 ng/mL | Detects Morphine at or above 2000 ng/mL |
| Opiates300 | Morphine | 300 ng/mL | Detects Morphine at or above 300 ng/mL |
| Pencyclidine | Phencylidine | 25 ng/mL | Detects Phencylidine at or above 25 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL | Detects Secobarbital at or above 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL | Detects Oxazepam at or above 300 ng/mL |
| Methadone | Methadone | 300 ng/mL | Detects Methadone at or above 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL | Detects Oxycodone at or above 100 ng/mL |
| MDMA | MDMA | 500 ng/mL | Detects MDMA at or above 500 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL | Detects Nortriptyline at or above 1000 ng/mL |
Note: The document only lists the cutoffs and states the device's purpose is to detect these drugs at these cutoffs. It does not provide specific sensitivity, specificity, or accuracy data for the Amedica Home Drug Test Cup. The substantial equivalence claim implies that its performance is equivalent to legally marketed predicate devices, meaning it meets the generally accepted performance standards for point-of-care drug tests.
Study Information:
The provided text does not contain any details about a specific study (like a clinical trial or performance evaluation study) that proves the device meets acceptance criteria. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting full clinical trial data as would be required for a PMA (Premarket Approval) application.
Therefore, the following information points cannot be directly extracted from the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not mentioned. The "ground truth" for these types of tests is typically established through a more specific alternate chemical method (like GC/MS or HPLC), not expert consensus in the diagnostic imaging sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant or mentioned, as this is a device for drug detection and not an AI-assisted diagnostic imaging tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of generating a preliminary result. There's no "algorithm only" performance separate from the physical test cup.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The document specifies that for preliminary positive results, 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." This indicates that GC/MS or HPLC are the established ground truth methods.
- The sample size for the training set: Not mentioned. This type of device relies on chemical reactions, not machine learning or AI with training sets.
- How the ground truth for the training set was established: Not applicable, as there's no training set in the AI/ML sense.
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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
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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
§ 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).