(104 days)
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| 6-Acetylmorphine | 6-monoacetylmorphine | 10 |
| Amphetamine | d-Amphetamine | 500 |
| Amphetamine | d-Amphetamine | 1,000 |
| Secobarbital | Secobarbital | 300 |
| Oxazepam | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 10 |
| EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 |
| Cocaine | Benzoylecgonine | 150 |
| Cocaine | Benzoylecgonine | 300 |
| Ecstasy | d,l-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 1,000 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 20 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | d/l-Methadone | 300 |
| Opiates | Morphine | 300 |
| Opiates | Morphine | 2,000 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencyclidine | 25 |
| Propoxyphene | Propoxyphene | 300 |
| Nortriptyline | Nortriptyline | 1,000 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only.
The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
For prescription use, the devices consist of:
- a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests
- b. Package Insert
- c. Procedure Card
Here's a breakdown of the acceptance criteria and study details for the ATTEST Drug Screen Cup and Dip Card, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate, quantitative target for each metric before presenting the results. Instead, it presents the performance data and implies that these results demonstrate the device's suitability. The primary performance metric presented is agreement with gold-standard methods (GC/MS, LC/MS or equivalent), and for most categories, the reported agreement is 100% or very close to it.
For the purpose of this analysis, I will infer the "acceptance criteria" from the reported performance, assuming that the FDA's acceptance is based on these high agreement rates, especially at or further from the cutoff concentrations.
| Characteristic | Acceptance Criteria (Inferred from data) | Reported Device Performance (Agreement with Gold Standard) - ATTEST Cup & Dip Card |
|---|---|---|
| Precision/Reproducibility | >99% correlation at +/-50% of each assay cutoff across multiple sites. | >99% correlation (across Advin Biotech and 3 external sites). |
| Analytical Specificity | No or minimal cross-reactivity for structurally similar compounds; no positive interference from chemically dissimilar compounds, endogenous agents, or pH/specific gravity variations. | Detailed tables provided showing specific cross-reactivity percentages (e.g., d-Amphetamine 100%, l-Amphetamine 1%), and non-interference for numerous substances, pH (4-9), and specific gravity (1.003-1.030). |
| Method Comparison/Accuracy | High agreement with gold-standard methods (GC/MS, LC/MS) across drug-free, near-cutoff, and beyond-cutoff concentrations. | Generally 93.2% - 100% agreement for negative and positive results, with specific discordant cases identified and quantified relative to the cutoff. |
| Read Time Stability | Stable results expected for a reasonable reading window (e.g., up to 75 minutes). | Test results stable for up to 75 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
-
Sample Size for Test Set: The method comparison/accuracy study (which serves as the "test set" for performance evaluation) uses the following sample sizes per drug test/cutoff combination:
- Drug-free: 40 samples
- -50% C/O to <-25% C/O: Varies (e.g., 4 for 6-AM/10, 22 for THC/20)
- -25% C/O to C/O: Varies (e.g., 1 for 6-AM/10, 6 for THC/20)
- C/O to +25% C/O: Varies (e.g., 1 for 6-AM/10, 2 for THC/20)
- >+25% C/O to +50% C/O: Varies (e.g., 4 for 6-AM/10, 5 for THC/20)
- >+50% C/O: Varies (e.g., 35 for 6-AM/10, 46 for THC/20)
- Total samples per drug test/cutoff category appears to be around 80-100 samples.
-
Data Provenance: The document states that the studies used "clinical urine specimens previously quantitated for the target drugs of abuse by gold-standard methods (GC/MS, LC/MS or equivalent)." There is no explicit mention of the country of origin for these clinical specimens or if they were retrospective or prospective. Given the context of a 510(k) submission, these are typically retrospective studies using archived, de-identified clinical samples.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
- The document does not mention the use of human experts to establish the ground truth for the test set.
- Ground truth for the method comparison/accuracy study was established by "gold-standard methods (GC/MS, LC/MS or equivalent)", which are analytical laboratory techniques, not expert human interpretation.
4. Adjudication Method for the Test Set
- Since the ground truth was established by instrumental analytical methods (GC/MS, LC/MS), there was no human adjudication (e.g., 2+1, 3+1) involved in determining the "true" presence or absence of drugs for the test set. The results from the gold-standard methods served as the definitive determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The ATTEST Drug Screen Cup and Dip Card are qualitative lateral flow immunoassays and function as standalone diagnostic devices. Their performance is evaluated against chemical reference methods, not against human readers. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance evaluation was done. The ATTEST Drug Screen Cup and Dip Card are designed to be used as standalone qualitative tests. The performance data presented (precision, analytical specificity, and method comparison/accuracy tables) directly reflect the device's diagnostic capability without human in-the-loop interaction for result interpretation, beyond simply reading a positive or negative line visually as designed by a qualitative immunoassay. The results are based on the device's output (presence or absence of control/test lines).
7. Type of Ground Truth Used
- The ground truth used was analytical gold-standard methods: Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS), and their tandem mass-spectrometer versions. The document explicitly states these are the "preferred confirmatory methods."
8. Sample Size for the Training Set
- The document does not specify the sample size used for the training set. As this device is a rapid lateral flow immunoassay (a chemical test, not an AI/machine learning algorithm), the concept of a "training set" in the context of predictive modeling is not directly applicable in the same way. The device's components and antibodies are developed and optimized through laboratory work and validation, rather than "training" on a large dataset of results in the way an AI algorithm would be.
9. How the Ground Truth for the Training Set Was Established
-
Given that this is a chemical immunoassay, the concept of a "training set" for ground truth establishment, as it pertains to AI/machine learning, is not directly relevant. The "ground truth" during the development and optimization of such assays would involve:
- Known concentrations of target analytes and potential cross-reactants: Used to optimize antibody binding, cutoff concentrations, and minimize false positives/negatives.
- Control samples: Including negative urine samples (drug-free) and positive urine samples spiked with known drug concentrations.
- Reference materials: Calibrators and controls with established values, often verified by GC/MS or LC/MS.
The "precision/reproducibility" and "analytical specificity" studies described in the document reflect parts of the characterization and validation process that would inform the final design and performance claims of the device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 17, 2020
Advin Biotech, Inc. Daniel Hsu Director of QA/QC/RA 10237 Flanders Ct San Diego, CA 92121
Re: K201494
Trade/Device Name: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DKZ, DIO, LCM, NGG, JXM, DIS, LDJ, JXN, DJR, LFG, DJC Dated: August 7, 2020 Received: August 10, 2020
Dear Daniel Hsu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201494
Device Name ATTEST Drug Screen Cup
ATTEST Drug Screen Dip Card
Indications for Use (Describe)
The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| 6-Acetylmorphine | 6-monoacetylmorphine | 10 |
| Amphetamine | d-Amphetamine | 500 |
| Amphetamine | d-Amphetamine | 1,000 |
| Secobarbital | Secobarbital | 300 |
| Oxazepam | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 10 |
| EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 |
| Cocaine | Benzoylecgonine | 150 |
| Cocaine | Benzoylecgonine | 300 |
| Ecstasy | d,l-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 500 |
| Methamphetamine | d-Methamphetamine | 1,000 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 20 |
| Marijuana | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | d/l-Methadone | 300 |
| Opiates | Morphine | 300 |
| Opiates | Morphine | 2,000 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencyclidine | 25 |
| Propoxyphene | Propoxyphene | 300 |
| Nortriptyline | Nortriptyline | 1,000 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only.
The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date: | September 17, 2020 |
|---|---|
| Submitter: | Advin Biotech, Inc.10237 Flanders Ct.,San Diego, California 92121 |
| Contact: | Daniel HsuTelephone: 858-866-8382, ext. 100Email: daniel.hsu@advinbio.com |
A. 510(k) Number:
B. Purpose for Submission:
- a. Addition of Marijuana 20 to a previously cleared device (K182123)
C. Measurand:
6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH
D. Type of Test:
Qualitative lateral-flow immunoassay
E. Applicant:
Advin Biotech, Inc.
F. Proprietary and Established Names:
- a. ATTEST Drug Screen Cup
- b. ATTEST Drug Screen Dip Card
G. Regulatory Information:
| Assay | PRODUCTCODE | CLASSIFICATION | REGULATIONNUMBER/DESCRIPTION | PANEL |
|---|---|---|---|---|
| 6-AM | DJG | II | 862.3650/EnzymeImmunoassay, Opiates | Toxicology |
| AMP | DKZ | II | 862.3100/ EnzymeImmunoassay, Amphetamine | Toxicology |
| COC | DIO | II | 862.3250/EnzymeImmunoassay, Cocaine andcocaine metabolites | Toxicology |
| BUP | DJG | II | 862.3650/EnzymeImmunoassay, Opiates | Toxicology |
| EDDP | DJR | II | 862.3620/EnzymeImmunoassay, Methadone | Toxicology |
| MDMA | NGG | II | 862.3610/MethamphetamineTest System | Toxicology |
| MET | DJC | II | 862.3610/MethamphetamineTest System | Toxicology |
| MTD | DJR | II | 862.3620/EnzymeImmunoassay, Methadone | Toxicology |
| OPI | DJG | II | 862.3650/EnzymeImmunoassay, Opiates | Toxicology |
| BZO | JXM | II | 862.3170/BenzodiazepinesTest System | Toxicology |
| OXY | DJG | II | 862.3650/EnzymeImmunoassay, Opiates | Toxicology |
| PCP | LCM | N/A | Unclassified/ EnzymeImmunoassay, Phencyclidine | Toxicology |
| PPX | JXN | II | 862.3700/EnzymeImmunoassay, Propoxyphene | Toxicology |
| BAR | DIS | II | 862.3150/Barbiturates TestSystem | Toxicology |
| TCA | LFG | II | 862.3910/TricyclicAntidepressant drugs testsystem | Toxicology |
| THC | LDJ | II | 862.3870/Cannabinoids TestSystem | Toxicology |
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H. Intended Use
The Advin Biotech ATTEST Drug Screens are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:
| Assay | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| 6-Acetylmorphine | 6AM | 6-monoacetylmorphine | 10 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Secobarbital | BAR | Secobarbital | 300 |
| Oxazepam | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl-3-3-diphenylpyrrolidine | 300 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 20 |
| Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 50 |
| Methadone | MTD | d/l-Methadone | 300 |
| Opiates | OPI | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Nortriptyline | TCA | Nortriptyline | 1,000 |
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The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format or in the cup format. Only one cutoff concentration per analyte will be included per device. The druq screen tests are intended for prescription use only.
The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
-Device Descriptions:
For prescription use, the devices consist of:
- a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests
- b. Package Insert
- c. Procedure Card
J. Substantial Equivalence Information:
- a. Predicate device names:
- i. Advin Biotech Multi-Drug Screen Test Cup
- ii. Advin Biotech Multi-Drug Screen Test Dip Card
- b. Predicate 510(k) number(s):
- i. K122809
- c. Comparisons with predicates:
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Predicate Similarities and Differences Table for All Assays
| Characteristic | Predicate (K122809) | Candidate Devices | ||||
|---|---|---|---|---|---|---|
| Indications for use | Qualitative detection of drugs of abuseand/or their metabolites in humanurine | Same | ||||
| Methodology | Lateral flow immunochromatographicassay based on competitive binding | Same | ||||
| Specimen | Human urine | Same | ||||
| Analytes,calibrators,cutoffs | Assay | Calibrator | Cutoff(ng/mL) | |||
| Amphetamine | d-amphetamine | 500 | Same except the additions of: | |||
| Barbiturates | Secobarbital | 300 | Assay | Calibrator | cutoff | |
| Benzodiazepine | Oxazepam | 300 | 6-AM | 6-acetylmorphine | 10 | |
| Buprenorphine | Buprenorphine | 10 | Amphetamine | d-amphetamine | 1000 | |
| Cocaine | Benzoylecgonine | 150 | Cocaine | Benzoylecgonine | 300 | |
| EDDP | 2-ethylidene-1,5- dimethyl-3,3- diphenyl-pyrrolidine | 300 | Methamphetamine | d-meth-amphetamine | 1000 | |
| Ecstasy | d/l-methylene-dioxy-meth- | 500 | Marijuana | THC-COOH | 20 | |
| Methamphetamine | d-meth-amphetamine | 500 | Update formulation of Opiate 300from K122809 | |||
| Methadone | d/l-methadone | 300 | Assay | Calibrator | cutoff | |
| Morphine | Morphine | 300 | Opiates | Morphine | 300 | |
| Opiates | Morphine | 2,000 | ||||
| Oxycodone | Oxycodone | 100 | ||||
| Phencyclidine | Phencyclidine | 25 | ||||
| Propoxyphene | d-propoxyphene | 300 | ||||
| Tricyclics | Nortriptyline | 1,000 | ||||
| Marijuana | THC-COOH | 50 |
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| Test formats | Cup, Dip Card, Cassette | Cup and Dip Card only |
|---|---|---|
| Intended use | For Prescription Use and OTC Use | For Prescription Use Only |
K. Standard/Guidance Document Referenced (if applicable):
Not applicable.
L. Test Principle:
The Advin Biotech ATTEST Drug Screen Cup and Dip Card are rapid lateral flow immunoassays in which drug-protein conjugates compete for limited antibody sites with drugs or drug metabolites that may be present in the urine. Each test strip consists of one or two drug-protein conjugates which are printed on nitrocellulose membrane in the test (T) regions. The anti-drug antibody-colloidal gold conjugates are dried onto a pad which is located beneath the nitrocellulose membrane bearing the test line(s). If target drugs are present in the urine specimen below the cut-off concentration of the assay, the solution of the colored antibody-colloidal gold conjugate that has been rehydrated by the urine sample migrates by capillary action across the immobilized drug-protein conjugate zone on the test (T) region. The colored antibody-gold conjugate then binds with the drug-protein conjugate to form visible lines in the test (T) regions. The formation of a visible line in the test (T) region on any strip indicates a negative result, regardless of the intensity of the visible line.
If the target drug level exceeds the cutoff concentration of the drug/metabolite antigen in the urine will bind to and saturate the limited antibody sites during the capillary migration up the strip. The saturated antibody sites will be unavailable to the drug-protein conjugate on the membrane, so no visible lines will appear. Therefore, absence of a visible line in the test (T) region indicates a preliminary positive result. A separate antibody-antigen reaction forms control (C) lines which must appear on the strip to interpret the results. The lack of a visible control (C) line indicates an insufficient specimen volume or improper test technique and the test must be repeated.
M. Performance Characteristics:
- a. Analytical performance:
- i. Precision/Reproducibility:
The precision, reproducibility and sensitivity of the ATTEST Drug Screen Cup and Dip card were evaluated at Advin Biotech and at three (3) external testing sites. Data obtained at all testing sites across the intended use populations indicate >99% correlation at +/-50% of each assay cutoff.
- ii. Linearity/Assay Reportable Range: Not applicable. Devices intended for qualitative determinations only.
- iii. Traceability, Stability, Expected Values (controls, calibrators, methods):
-
- Stability: Device stability has been or will be determined using accelerated stress testing and real-time studies. All accelerated studies have been completed. The devices are stable at 2 - 30°C for 24 months based on
-
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accelerated stability studies. Real-time stability studies for the THC20 assay are ongoing.
-
- Controls: Devices have been evaluated with various 3d party commercial controls. FDA-cleared controls manufactured by Biochemical Diagnostics, Inc. (a Kova International company) are recommended by Advin Biotech, Inc. for use in verifying the performance of the assays.
- iv. Detection Limit/sensitivity:
Assays contained within the devices bear the cutoff levels shown in the table in section H above. Field studies demonstrate the sensitivity of the assays in the hands of intended professional users and are summarized in section M.a.i. above.
- v. Analytical Specificity:
The specificity of each assay was determined through the testing of contrived solutions made by spiking certified standards of chemically-related or structurallysimilar compounds into drug free urine. The relative cross-reactivity (if any) represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay.
| Assay/Cutoff | Compound | Concentration(ng/mL) | Relative cross-reactivity (%) |
|---|---|---|---|
| 6-AM10 | 6-acetylmorphine | 10 | 100 |
| Diacetylmorphine (heroin) | 300 | 3.3 | |
| Morphine | >100,000 | <0.1 | |
| Codeine | >100,000 | <0.1 | |
| Oxycodone | >100,000 | <0.1 | |
| Oxymorphone | >100,000 | <0.1 | |
| AMP500 | d-Amphetamine | 500 | 100 |
| l-Amphetamine | 50,000 | 1 | |
| MDA | 8,000 | 6.5 | |
| Phentermine | 45,000 | 1.1 | |
| AMP1000 | d-Amphetamine | 1,000 | 100 |
| l-Amphetamine | 100,000 | 1 | |
| MDA | 15,000 | 6.7 | |
| Phentermine | 100,000 | 1.0 | |
| BAR | Secobarbital | 300 | 100 |
| 300 | Amobarbital | 2,500 | 12 |
| Aprobarbital | 500 | 60 | |
| Butabarbital | 100 | 300 | |
| Butalbital | 300 | 100 | |
| Cyclopentobarbital | 500 | 60 | |
| Pentobarbital | 250 | 120 | |
| Phenobarbital | 300 | 100 | |
| Oxazepam | 300 | 100 | |
| Alprazolam | 200 | 150 | |
| α-Hydroxyalprazolam | 1,900 | 15.8 | |
| Bromazepam | 1,000 | 30 | |
| Clobazam | 200 | 150 | |
| Clonazepam | 1,500 | 20 | |
| 7-Aminoclonazepam | >100,000 | <0.3 | |
| Clorazepate | 750 | 40 | |
| BZO | Desalkylflurazepam | 1,200 | 25 |
| 300 | Diazepam | 1,000 | 30 |
| Flunitrazepam | 250 | 120 | |
| Lorazepam | 3,900 | 7.7 | |
| Lorazepam glucuronide | 5,000 | 6 | |
| Nitrazepam | 250 | 120 | |
| Norchlordiazepoxide | 500 | 60 | |
| Nordiazepam | 390 | 76.9 | |
| Temazepam | 150 | 200 | |
| Triazolam | 2,500 | 12 | |
| Buprenorphine | 10 | 100 | |
| BUP | Buprenorphine-3-β-glucuronide | 3.5 | 286 |
| 10 | Norbuprenorphine | 7.5 | 133 |
| Norbuprenorphine glucuronide | 35 | 28 | |
| COC150 | Benzoylecgonine | 150 | 100 |
| COC150 | Cocaethylene | 50,000 | 0.3 |
| COC150 | Cocaine | 5,000 | 3 |
| COC150 | Ecgonine | 50,000 | 0.3 |
| COC300 | Benzoylecgonine | 300 | 100 |
| COC300 | Cocaethylene | 100,000 | 0.3 |
| COC300 | Cocaine | 10,000 | 3 |
| COC300 | Ecgonine | 100,000 | 0.3 |
| EDDP300 | 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | 100 |
| EDDP300 | d/l-Methadone | >100,000 | <0.3 |
| MET500 | d-Methamphetamine | 500 | 100 |
| MET500 | I-Methamphetamine | 15,000 | 3.3 |
| MET500 | d-Amphetamine | 50,000 | 1 |
| MET500 | I-Amphetamine | 50,000 | 1 |
| MET500 | 1R, 2S(-)-Ephedrine | 100,000 | <0.5 |
| MET500 | MDEA | 30,000 | 1.7 |
| MET500 | MDMA | 3,500 | 14.3 |
| MET500 | Mephentermine | 75,000 | 0.7 |
| MET1000 | d-Methamphetamine | 1,000 | 100 |
| MET1000 | I-Methamphetamine | 30,000 | 3.3 |
| MET1000 | d-Amphetamine | 100,000 | 1 |
| MET1000 | I-Amphetamine | 100,000 | 1 |
| MET1000 | 1R, 2S(-)-Ephedrine | >100,000 | <0.5 |
| MET1000 | MDEA | 60,000 | 1.7 |
| MET1000 | MDMA | 8,000 | 12.5 |
| MET1000 | Mephentermine | 100,000 | 1 |
| MDMA500 | (+/-)-methylenedioxymethamphetamine(MDMA) | 500 | 100 |
| (+/-)-methylenedioxyamphetamine(MDA) | 3,900 | 12.8 | |
| (+/-)-methylenedioxyethylamphetamine(MDEA) | 500 | 100 | |
| MTD | d/l-Methadone | 300 | 100 |
| 300 | EDDP | >100,000 | <0.3 |
| Morphine | 300 | 100 | |
| 6-Acetylmorphine (6-AM) | 400 | 75 | |
| Codeine | 100 | 300 | |
| Codeine-6-β-glucuronide | 150 | 200 | |
| Ethylmorphine | 150 | 200 | |
| OPI | Diacetylmorphine (heroin) | 900 | 33.3 |
| 300 | Hydrocodone | 500 | 60 |
| Hydromorphone | 600 | 50 | |
| Levorphanol | 10,000 | 3 | |
| Morphine-3-glucuronide | 450 | 66.7 | |
| Norcodeine | 30,000 | 1 | |
| Oxycodone | 70,000 | <0.5 | |
| Thebaine | 20,000 | 1.5 | |
| Morphine | 2,000 | 100 | |
| 6-Acetylmorphine (6-AM) | 700 | 286 | |
| Codeine | 1,800 | 111 | |
| Codeine-6-β-glucuronide | 1,250 | 160 | |
| OPI | Ethylmorphine | 1,500 | 133 |
| 2000 | Diacetylmorphine (heroin) | 11,000 | 18.2 |
| Hydrocodone | 5,000 | 40 | |
| Hydromorphone | 5,000 | 40 | |
| Levorphanol | >100,000 | <2 | |
| Morphine-3-glucuronide | 2,600 | 77 | |
| Norcodeine | >100,000 | <2 | |
| Oxycodone | 70,000 | 3 | |
| Thebaine | 95,000 | 2.1 | |
| Oxycodone | 100 | 100 | |
| Codeine | 50,000 | 0.2 | |
| OXY | Ethylmorphine | 50,000 | 0.2 |
| 100 | Hydrocodone | 5,000 | 2 |
| Hydromorphone | 25,000 | 0.4 | |
| Oxymorphone | 12,500 | 0.8 | |
| PCP | Phencyclidine | 25 | 100 |
| 25 | 4-OH-Phencyclidine | 1,500 | 1.7 |
| PPX | d-Propoxyphene | 300 | 100 |
| 300 | Norpropoxyphene | 300 | 100 |
| Nortriptyline | 1,000 | 100 | |
| Amitriptyline | 4,000 | 25 | |
| Clomipramine | 2,000 | 50 | |
| TCA | Desipramine | 500 | 200 |
| 1000 | Doxepine | 1,000 | 100 |
| Imipramine | 1,000 | 100 | |
| Promethazine | 1,000 | 100 | |
| Trimipramine | 5,000 | 20 | |
| 11-nor-Δ9-THC-COOH | 20 | 100 | |
| (±)-11-Hydroxy-Δ9-THC | 10,000 | 0.2 | |
| THC | Δ8-THC | >100,000 | <0.02 |
| 20 | Δ9-THC | 25,000 | 0.08 |
| Cannabinol | >100,000 | <0.02 | |
| Cannabidiol (CBD) | >100,000 | <0.02 | |
| THC | 11-nor-Δ9-THC-COOH | 50 | 100 |
| 50 | (±)-11-Hydroxy-Δ9-THC | 5,000 | 1 |
| Δ8-THC | 20,000 | 0.3 | |
| Δ9-THC | 20,000 | 0.3 | |
| Cannabinol | >100,000 | <0.1 | |
| Cannabidiol (CBD) | >100,000 | <0.1 |
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
The potential interference (whether positive) from compounds chemically dissimilar to target drugs, known endogenous agents, urine pH and specific gravity variances was also determined. Testing of compounds and endogenous agents was performed by spiking the substances into pooled urine containing target drugs at near-cutoff concentrations. Unless otherwise indicated, substances were tested for potential interference at concentrations of 100 ug/mL.
The following substances demonstrated no positive interference on the assays encompassed in this submission:
| Acetaminophen | Acetone | Acetylsalicylic acid(aspirin) |
|---|---|---|
| Albumin | Ampicillin | Ascorbic acid |
| Aspartame | Atropine | Benzocaine |
| Bilirubin | Caffeine | Chloroquine |
| Chlorpheniramine | Creatine | Dexbrompheniramine |
| Dextromethorphan | Dimethylaminoantipyrine | Diphenhydramine |
| Dimenhydrinate | Dopamine | Isoproterenol |
| (+)-Ephedrine | Erythromycin | Ethanol |
| Furosemide | Gabapentin | Glucose |
| Guaiacol glyceryl ether | Hemoglobin | Ibuprofen |
| Ketamine | Lidocaine | Methylephedrine |
| Naproxen | Niacinamide | Nicotine |
| Norephedrine | Oxalic acid | Pantoprazole |
| Penicillin-G | Pheniramine | Phenothiazine |
| I-Phenylephrine | B-Phenylethylamine | Pregabalin |
| Procaine | Quinidine | Ranitidine |
{16}------------------------------------------------
| Riboflavin | Sertraline | Sodium chloride |
|---|---|---|
| Sulindac | Theophylline | Tyramine |
In addition to the spiked testing described above, in light of industry-known interferences presumably arising from the metabolites of these drugs in human urine. Advin Biotech has evaluated its assays for potential false positive results using clinical urine specimens from donors taking self-reported prescription-level or OTC high-dose levels of each of the following drugs and found no false positive results:
- a. Rantidine (Zantac®)-donors taking high-doses per OTC instructions for use
- b. Sertraline (Zoloft®)-donor taking prescription dose (steady-state level)
- c. Naproxen (Aleve®)-donor taking high-dose per OTC instructions for use
- d. Pantoprazole (Protonix®)-donor taking high-dose per OTC instructions for use
- e. Gabapentin (Neurontin®)-donor taking high prescription doses of 900mg/dav
- Pregabalin (Lyrica®)-donor taking prescription dose f.
- g. Atomoxetine (Strattera®)-donor taking prescription dose
To evaluate the potential effect of variances in urine pH on the assays, pooled urine specimens containing target drugs at near-cutoff concentrations were pH adjusted from 4.0 to 9.0 in increments of 1.0 and tested in duplicate.
To evaluate the potential effect of variances of urine specific gravity on the assays, pooled urine specimens containing target drugs at near-cutoff concentrations were diluted using deionized water or concentrated using sodium chloride to achieve specific gravity results of 1.003, 1.010, 1.015, 1.020, 1.025 and 1.030. Each solution was tested in duplicate.
The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.003 to 1.030 do not affect the results of the assays. To mitigate the risk of specimen tampering, adulteration or substitution, the ATTEST Drug Screen Cup and Dip card can be constructed with specimen validity tests (SVT).
- ﻗ Method Comparison/Accuracy Studies
Advin Biotech performed a method comparison study of the ATTEST Drug Screen Cup and Dip card using clinical urine specimens previously quantitated for the target druqs of abuse by gold-standard methods (GC/MS, LC/MS or equivalent). The results are shown in the table below. Data for previously-cleared assays (K122809 and K182123) are taken from that submission and presented in combination with the new assays below:
| DrugTest/Cutoff(ng/mL) | Result | Drug-free | Drug quantitation by gold-standard method relative to assay cutoff level | Agreement | ||||
|---|---|---|---|---|---|---|---|---|
| -50% C/O to<-25% C/O | -25% C/Oto C/O | C/O to+25% C/O | >+25% C/Oto +50% C/O | >+50%C/O | ||||
| 6-AM/10 | Neg | 40 | 4 | 1 | 0 | 0 | 0 | 100% |
| 6-AM/10 | Pos | 0 | 0 | 0 | 1 | 4 | 35 | 100% |
| AMP/500 | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% |
| AMP/500 | Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% |
ATTEST Drug Screen Cup format
{17}------------------------------------------------
| AMP/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% |
|---|---|---|---|---|---|---|---|---|
| Pos | 0 | 0 | 0 | 3 | 3 | 40 | 100% | |
| BAR/300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% |
| Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% | |
| BUP/10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% | |
| Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | |
| BZO/300 | Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% |
| COC/150 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.70% |
| Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% | |
| COC/300 | Neg | 40 | 3 | 2 | 0 | 0 | 0 | 100% |
| Pos | 0 | 0 | 0 | 2 | 3 | 35 | 100% | |
| EDDP/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% | |
| Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | |
| MDMA/500 | Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% |
| MET/500 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% | |
| Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% | |
| MET/1000 | Pos | 0 | 0 | 0 | 2 | 3 | 40 | 100% |
| Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | |
| MTD/300 | Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% |
| OPI/300 | Neg | 40 | 2 | 1 | 0 | 0 | 0 | 97.72% |
| Pos | 0 | 0 | 1 | 3 | 1 | 46 | 100% | |
| OPI/2000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% | |
| OXY/100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% | |
| PCP/25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% |
| Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% | |
| PPX/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% |
| Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% | |
| Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | |
| TCA/1000 | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% |
| THC/20 | Neg | 40 | 22 | 6 | 2 | 0 | 0 | 98.55% |
| Pos | 0 | 0 | 1 | 1 | 5 | 46 | 96.30% | |
| Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% | |
| THC/50 | Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% |
Summary of Discordant Results, ATTEST Cup format
| Drug Test/Cutoff (ng/ml) | ATTEST Cup Result | Result w/ GC/MS or LC/MS | |
|---|---|---|---|
| AMP/500 | Positive | 477 | Amphetamine |
| BAR/300 | Positive | 265 | Barbital |
| BAR/300 | Positive | 286 | Barbital |
| BUP/10 | Positive | 8 | Buprenorphine |
| BUP/10 | Positive | 9 | Buprenorphine |
| BZO/300 | Positive | 244 | Oxazepam |
| BZO/300 | Positive | 252 | Oxazepam |
| BZO/300 | Positive | 295 | Oxazepam |
| COC/150 | Positive | 146 | Benzoylecgonine |
| EDDP/300 | Positive | 250 | EDDP |
| EDDP/300 | Positive | 263 | EDDP |
| EDDP/300 | Positive | 275 | EDDP |
| MDMA/500 | Positive | 368 | MDMA |
| MDMA/500 | Positive | 381 | MDMA |
{18}------------------------------------------------
| MET/500 | Positive | 394 | Methamphetamine |
|---|---|---|---|
| Positive | 461 | Methamphetamine | |
| Positive | 478 | Methamphetamine | |
| OPI/300 | Positive | 289 | Morphine |
| Positive | 266 | Methadone | |
| MTD/300 | Positive | 273 | Methadone |
| Positive | 1,898 | Morphine | |
| OPI/2000 | Positive | 1,990 | Morphine |
| OXY/100 | Positive | 88 | Oxycodone |
| Positive | 98 | Oxycodone | |
| Positive | 99 | Oxycodone | |
| PCP/25 | Positive | 22.9 | Phencyclidine |
| PPX/300 | Positive | 242 | Norpropoxyphene |
| Positive | 285 | Norpropoxyphene | |
| TCA/1000 | Positive | 786 | Nortriptyline |
| Positive | 859 | Nortriptyline | |
| THC/20 | Positive | 17.4 | 11-nor-Δ9-THC-9-COOH |
| Negative | 21.11 | 11-nor-Δ9-THC-9-COOH | |
| Negative | 22.55 | 11-nor-Δ9-THC-9-COOH | |
| THC/50 | Positive | 49 | 11-nor-Δ9-THC-9-COOH |
ATTEST Drug Screen Dip Card format
| DrugTest/Cutoff(ng/mL) | Result | Drug-free | Drug quantitation by gold-standard method relative to assay cutoff level | Agreement | ||||
|---|---|---|---|---|---|---|---|---|
| -50% C/O to <-25% C/O | -25% C/O to C/O | C/O to +25% C/O | >+25% C/O to +50% C/O | >+50% C/O | ||||
| 6-AM/10 | Neg | 40 | 4 | 1 | 0 | 0 | 0 | 100% |
| Pos | 0 | 0 | 0 | 1 | 4 | 35 | 100% | |
| AMP/500 | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% |
| Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% | |
| AMP/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% |
| Pos | 0 | 0 | 0 | 3 | 3 | 40 | 100% | |
| BAR/300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% |
| Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% | |
| BUP/10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% | |
| BZO/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% | |
| COC/150 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.70% |
| Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% | |
| COC/300 | Neg | 40 | 3 | 2 | 0 | 0 | 0 | 100% |
| Pos | 0 | 0 | 0 | 2 | 3 | 35 | 100% | |
| EDDP/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% | |
| MDMA/500 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% | |
| MET/500 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% | |
| MET/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% |
| Pos | 0 | 0 | 0 | 2 | 3 | 40 | 100% | |
| MTD/300 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% | |
| OPI/300 | Neg | 40 | 2 | 1 | 0 | 0 | 0 | 97.72% |
| Pos | 0 | 0 | 1 | 3 | 1 | 46 | 100% |
{19}------------------------------------------------
| OPI/2000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
|---|---|---|---|---|---|---|---|---|
| Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% | |
| OXY/100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% | |
| PCP/25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% |
| Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% | |
| PPX/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% |
| Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% | |
| TCA/1000 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% | |
| THC/20 | Neg | 40 | 22 | 6 | 2 | 0 | 0 | 98.55% |
| Pos | 0 | 0 | 1 | 1 | 5 | 46 | 96.30% | |
| THC/50 | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% |
| Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% |
Summary of Discordant Results, ATTEST Dip Card format
| Drug Test/Cutoff (ng/ml) | ATTEST Dip Card Result | Drug Concentration (ng/ml) | Analyte |
|---|---|---|---|
| AMP/500 | Positive | 477 | Amphetamine |
| BAR/300 | Positive | 265 | Barbital |
| Positive | 286 | Barbital | |
| BUP/10 | Positive | 8 | Buprenorphine |
| Positive | 9 | Buprenorphine | |
| BZO/300 | Positive | 244 | Oxazepam |
| Positive | 252 | Oxazepam | |
| Positive | 295 | Oxazepam | |
| COC/150 | Positive | 146 | Benzoylecgonine |
| EDDP/300 | Positive | 250 | EDDP |
| Positive | 263 | EDDP | |
| Positive | 275 | EDDP | |
| MDMA/500 | Positive | 368 | MDMA |
| Positive | 381 | MDMA | |
| MET/500 | Positive | 394 | Methamphetamine |
| Positive | 461 | Methamphetamine | |
| Positive | 478 | Methamphetamine | |
| MTD/300 | Positive | 266 | Methadone |
| Positive | 273 | Methadone | |
| OPI/300 | Positive | 289 | Morphine |
| OPI/2000 | Positive | 1,898 | Morphine |
| Positive | 1,990 | Morphine | |
| OXY/100 | Positive | 88 | Oxycodone |
| Positive | 98 | Oxycodone | |
| Positive | 99 | Oxycodone | |
| PCP/25 | Positive | 22.9 | Phencyclidine |
| PPX/300 | Positive | 242 | Norpropoxyphene |
| Positive | 285 | Norpropoxyphene | |
| TCA/1000 | Positive | 786 | Nortriptyline |
| Positive | 859 | Nortriptyline | |
| THC/20 | Positive | 17.4 | 11-nor-Δ9-THC-9-COOH |
| Negative | 21.11 | 11-nor-Δ9-THC-9-COOH | |
| Negative | 22.55 | 11-nor-Δ9-THC-9-COOH | |
| THC/50 | Positive | 49 | 11-nor-Δ9-THC-9-COOH |
{20}------------------------------------------------
c. Clinical Studies
- i. Clinical sensitivity: refer to accuracy table shown in section M.b. above
- ii. Clinical specificity: refer to accuracy table show in section M.b. above
- iii. Other clinical supportive data (when i and ii are not applicable): N/A
d. Read Time
To evaluate the reading time flexibility, Advin ATTEST Drug Screen Dip Card and Cup were tested with drug standards at the concentration of 0, -50% and +50% cutoff level. The result was read and recorded at 4, 5, 10, 30, 60 and 75 minutes. Each solution was tested in duplicate. Data showed that the test results were stable for up to 75 minutes.
N. Proposed Labeling
The proposed labeling is deemed sufficient based on the outcomes of all intended user studies and meets the requirements of 21 CFR 809.10.
O. Conclusions
The data submitted in this premarket notification is complete and supports a substantial equivalence determination.
§ 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).