(46 days)
The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. 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 is needed to obtain a confirmed result.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
Not Found
This FDA 510(k) clearance document for the Amedica Drug Screen Test Cup does not contain the detailed study information required to answer many of your questions. This document is a clearance letter, essentially stating that the device is substantially equivalent to legally marketed predicate devices, not a detailed technical report of the studies performed.
Therefore, I can only provide limited information based on the text provided.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a typical table format that would include metrics like sensitivity, specificity, or accuracy. Instead, it defines the "indications for use" by listing the specific drugs detected and their respective cutoff concentrations. The "reported device performance" is not detailed in terms of performance metrics but rather by stating that the device detects these substances at the given cutoffs. An explicit comparison of performance against pre-defined acceptance criteria is not present in this document.
| Drug Name | Cutoff Concentration (ng/ml) | Device Performance (as stated in document) |
|---|---|---|
| 11-nor-Δ⁹-Tetrahydrocannabinol-9-carboxylic (THC) | 50 | Detects THC at 50 ng/ml |
| Benzoylecgonine (COC) | 300 | Detects COC at 300 ng/ml |
| Morphine (OPI) | 2000 | Detects OPI at 2000 ng/ml |
| Morphine (OPI) | 300 | Detects OPI at 300 ng/ml |
| Amphetamine (AMP) | 1000 | Detects AMP at 1000 ng/ml |
| Methamphetamine (MET) | 1000 | Detects MET at 1000 ng/ml |
| Phencyclidine (PCP) | 25 | Detects PCP at 25 ng/ml |
| 3,4 methylenedioxymethamphetamine (MDMA) | 500 | Detects MDMA at 500 ng/ml |
| Secobarbital (BAR) | 300 | Detects BAR at 300 ng/ml |
| Oxazepam (BZO) | 300 | Detects BZO at 300 ng/ml |
| Methadone (MTD) | 300 | Detects MTD at 300 ng/ml |
| Nortriptyline (TCA) | 1000 | Detects TCA at 1000 ng/ml |
| Propoxyphene (PPX) | 300 | Detects PPX at 300 ng/ml |
| Oxycodone (OXY) | 300 | Detects OXY at 300 ng/ml |
Note: The document only states that the device detects these substances at the specified cutoff concentrations. It does not provide metrics like sensitivity or specificity, nor does it explicitly list quantitative acceptance criteria in terms of performance. The "acceptance criteria" here are implied by the cutoff concentrations for detection.
2. Sample size used for the test set and the data provenance
Not specified in the document. This document is a regulatory clearance letter, not a full study report. Information on sample size for testing or data provenance (e.g., country of origin, retrospective/prospective) is not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For a rapid drug screen test, the "ground truth" is typically established by laboratory confirmation methods (e.g., GC/MS), not by human expert consensus or interpretation of images/signals. The document does not describe the methodologies or personnel involved in establishing such ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of complex data (e.g., medical images). For a diagnostic device that provides a qualitative result based on a chemical reaction, such adjudication is not relevant. The document does not mention any adjudication method for its performance evaluation.
5. 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 applicable. This device is a rapid in vitro diagnostic test cup, not an AI-powered system or a device that requires human "readers" in the context of image analysis or complex interpretation where an MRMC study would be relevant. There is no mention of AI assistance or human-in-the-loop performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. This is a standalone diagnostic test cup. Its performance is evaluated purely based on its ability to detect the specified substances at the given cutoffs without any human interpretation enhancement (like an algorithm would provide in image analysis). The device provides a "visual, qualitative result" intended for professional use, but this referes to reading the test lines, not complex diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Implicitly, laboratory confirmation methods (e.g., a reference standard like GC/MS). For in vitro diagnostic drug tests, the ground truth for presence/absence of a drug and its concentration is typically established using highly accurate analytical chemistry methods performed in a laboratory, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). The document describes the test cup providing a "preliminary result" and states that "A more specific alternative chemical method is needed to obtain a confirmed result," which reinforces that laboratory-based analytical methods would be the ground truth.
8. The sample size for the training set
Not applicable/Not specified. This is a chemical immunoassay test, not a machine learning or AI-based device that would require a "training set" in the computational sense. The document does not describe any training set data.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not utilize a training set in the AI/machine learning sense.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "U.S. Department of Health & Human Services, Washington, D.C." are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jeff Chen President Amedica Biotech, Inc. 28301 Industrial Blvd. Suite K Hayward, CA 94545
JUL 2 1 2006
Re: K061556
Trade/Device Name: Amedica Drug Screen Test Cup THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Regulation Number: 21 CFR8862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO, DJG, DKZ, LAF, LCM, DJC, DIS, JXM, DJR, MLK, JXN, DJG Dated: July 14, 2006 Received: July 17, 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 fisting (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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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 G. A.
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
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Indications for Use
K061556 510(k) Number:
- Amedica Drug Screen Test Cup Device Name: THC,COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,MTD,TCA,PPX,OXY
Indications For Use:
The Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, MDMA. 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 is needed to obtain a confirmed result.
Prescription Use (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
§ 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).