(33 days)
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Not Found
No
The device description and intended use indicate a simple in vitro diagnostic test that provides a visual, qualitative result. There is no mention of AI, ML, image processing, or any complex data analysis that would suggest the use of these technologies.
No
The device is described as an in vitro diagnostic test for the rapid detection of various substances in human urine. It is used to obtain a visual, qualitative result and provides only a preliminary result, indicating it is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states that the device is "an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, propoxyphene and oxycodone in human urine". This explicitly identifies it as a diagnostic test.
No
The device is described as an "in vitro diagnostic test" and a "test kit" for detecting substances in human urine, which inherently involves physical components for sample collection and analysis, not just software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states "The Amedica Drug Screen Test Cup II... is an in vitro diagnostic test".
- Purpose: It is designed to detect specific substances (drugs) in a biological sample (human urine) in vitro (outside of the living body).
- Professional Use: While it's for professional use, this doesn't preclude it from being an IVD. Many IVDs are intended for use by trained professionals in a laboratory or clinical setting.
N/A
Intended Use / Indications for Use
The Amedica Drug Screen Test Cup II THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, 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 must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN
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
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
Not Found
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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 the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jeff Chen Amedica Biotech, Inc. 28301 Industrial Blvd, Suite K Hayward, CA 94545
DEC 1 1 2006
Re: K063379 Trade/Device Name: Amedica Drug Screen Test Cup II Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN Dated: October 30, 2006
Received: November 8, 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 listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) 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) 276-0484. 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 Gutierrez, Ph.D.
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
2
Indications for Use
510(k) Number: K063379
Device Name: Amedica Drug Screen Test Cup II THC,COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,MTD,TCA,PPX,OXY
Indications For Use:
The Amedica Drug Screen Test Cup II THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, 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 must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) 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 (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
510(k) K063379