AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ by AMEDICA BIOTECH, INC.

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.

Device Description

Not Found

AI/ML Overview

The provided text describes the AmediCheck Drug Screen Test, an in vitro diagnostic test for the rapid detection of various drugs in human urine. It also includes information regarding its FDA 510(k) clearance (K080872). However, the document does not contain specific information about the acceptance criteria and the study that proves the device meets those criteria in the format requested (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, details of comparative effectiveness studies, or standalone performance data).

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the drugs detected, their cut-off concentrations, and the intended use (professional, not over-the-counter, provides preliminary results, GC/MS for confirmation).

Therefore, I cannot populate most of the requested fields based on the provided text.

Here's what can be extracted and a clear indication of what is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The document only lists the cutoff concentrations for each drug.

Drug	Substance Detected	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

Reported Device Performance: Not reported in the document (e.g., sensitivity, specificity, accuracy). The FDA letter indicates substantial equivalence, implying that its performance is comparable to its predicates, but specific data is not provided here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document is an FDA clearance letter, not the detailed study report itself.

3. 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 applicable/Not provided. For drug screens, ground truth is typically established by definitive chemical methods (like GC/MS), not by expert consensus on visual interpretation for the test set itself. The document mentions "professional use" and that "Clinical consideration and professional judgment should be applied," but this refers to the interpretation of results, not the establishment of ground truth for device validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are typically relevant for studies where multiple human readers interpret data, and their disagreements need resolution. This is less common for a chemical assay like a drug screen where definitive lab methods provide the ground truth for performance validation.

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 an in vitro diagnostic drug screen, not an AI-powered diagnostic imaging tool that requires human reader interpretation that could be augmented by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a rapid diagnostic test providing a visual, qualitative result. While the test itself operates "stand-alone" in terms of producing a result, its performance is evaluated against definitive chemical methods, not typically as an algorithm requiring separate 'standalone' vs. 'human-in-the-loop' analysis in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that Gas chromatography/mass spectrometers (GC/MS) is the preferred confirmatory method for preliminary positive results. This strongly suggests that GC/MS would have been used as the ground truth for validating the device's performance.

8. The sample size for the training set

Not provided. The document does not refer to a "training set" as this is not an AI/machine learning device. For assay development, there would be development samples, but those details are not in this FDA clearance.

9. How the ground truth for the training set was established

Not applicable/Not provided. As stated above, this is not an AI/machine learning device with a "training set" in that context.

Summary

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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).

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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) 276-0490. 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

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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:

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.

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
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Regulation Number and Section

§ 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).