(141 days)
Not Found
Not Found
No
The description indicates a visual, qualitative 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
The device is described as an "in vitro diagnostic test" for the rapid detection of various substances in human urine. It provides a preliminary, qualitative result and is not intended for treatment or therapy.
Yes
The document explicitly states that the device is "an in vitro diagnostic test."
No
The device is described as an in vitro diagnostic test kit for detecting substances in human urine, which is a hardware-based test.
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 AmediCheck Drug Screen Test is an "in vitro diagnostic test".
- Purpose: The test is designed to detect specific substances (drugs) in a biological sample (human urine) outside of the body ("in vitro").
- Diagnostic Nature: While it provides a preliminary result, its purpose is to aid in the diagnosis or detection of the presence of these substances, which falls under the scope of diagnostics.
The description clearly aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZQ/MDMA/OXY/MTD/ PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants 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 must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometers (GCMS) 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 used.
Product codes
LDJ, DIG, DKZ, LAF, LCM, DJC, DIS, JXM, DJR, MLR, JXN
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
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
Image /page/0/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The symbol in the center appears to be a stylized depiction of an eagle or other bird in flight. The text around the perimeter is difficult to read due to the image quality, but it seems to be in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Amedica Biotech, Inc. c/o Mr. Jeff Chen President 28301 Industrial Blvd. Suite K Hayward, CA 94545
AUG 1 9 2008
Re: K080872
Trade/Device Name: Amedicheck Drug Screen Test. THC/COC/OPI/AMP/MET/PCP/ BAR/BZO/MDMA/OXY/MTD/PPX/TCA Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid Test System. Regulatory Class: Class II Product Code: LDJ, DIG, DKZ, LAF, LCM, DJC, DIS, JXM, DJR, MLR, JXN Dated: July 18, 2008 Received: July 21, 2008
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
Page 2 -
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) 276-0490. 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 (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
510(k) Number: K080872
Device Name: AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZO/MDMA/OXY/MTD/PPX/TCA
Indications For Use:
The AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZQ/MDMA/OXY/MTD/ PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants 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 must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometers (GCMS) 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 used.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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
| 6 | 510(k) | K080872 |
|---|---|---|
| --- | -------- | --------- |