(104 days)
No
The device is a rapid lateral flow immunoassay, which is a chemical test that does not involve computational analysis or image processing typically associated with AI/ML in medical devices. The description focuses on the chemical detection of substances and standard analytical performance studies.
No
This device is a diagnostic tool used to detect the presence of certain substances in human urine; it does not treat or cure any medical condition.
Yes
The device is a rapid lateral flow immunoassay for the qualitative detection of various substances in human urine, providing preliminary results for diagnostic purposes.
No
The device description explicitly states that the devices consist of physical test cups or dip cards, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "qualitative detection of [various drugs] in human urine." This indicates that the device is used to perform tests on biological specimens (human urine) outside of the body (in vitro).
- Device Description: The device description details the components used for testing (test cups or dip cards).
- Performance Studies: The document describes performance studies conducted using "clinical urine specimens," further confirming the use of biological samples.
These characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DKZ, DIO, LCM, NGG, JXM, DIS, LDJ, JXN, DJR, LFG, DJC
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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 drugs 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:
For each drug test/cutoff concentration (ng/mL), the following categories of samples were reported:
- Drug-free samples
- Samples with drug quantitation by gold-standard method relative to assay cutoff level including:
- -50% C/O to +25% C/O to +50% C/O
-
+50% C/O
Total number of samples per drug test/cutoff in the "Drug-free" category is 40.
Total number of samples per drug test/cutoff in the "Drug quantitation by gold-standard method relative to assay cutoff level" varies per category and per drug test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical Performance (Precision/Reproducibility, Analytical Specificity, Method Comparison/Accuracy Studies)
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.
Analytical Specificity:
The specificity of each assay was determined through the testing of contrived solutions made by spiking certified standards of chemically-related or structurally-similar 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.
Additionally, the potential interference from compounds chemically dissimilar to target drugs, known endogenous agents, urine pH, and specific gravity variances was determined. Testing was performed by spiking 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.
Advin Biotech also 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 certain drugs (Rantidine, Sertraline, Naproxen, Pantoprazole, Gabapentin, Pregabalin, Atomoxetine) and found no false positive results.
The effect of urine pH (4.0 to 9.0) and specific gravity (1.003 to 1.030) on assays was evaluated and demonstrated no effect on the results.
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 drugs of abuse by gold-standard methods (GC/MS, LC/MS or equivalent). Data for previously-cleared assays (K122809 and K182123) are included. The study presents agreement between the ATTEST Drug Screen Cup/Dip Card results (Negative/Positive) and the drug quantitation by gold-standard method relative to the assay cutoff level.
Key Results (Agreement for ATTEST Drug Screen Cup format):
- 6-AM/10: 100% agreement for both Negative (45 samples) and Positive (40 samples)
- AMP/500: 97.7% agreement for Negative (43 samples), 100% agreement for Positive (50 samples)
- AMP/1000: 100% agreement for both Negative (46 samples) and Positive (46 samples)
- BAR/300: 95.2% agreement for Negative (42 samples), 100% agreement for Positive (45 samples)
- BUP/10: 95.5% agreement for Negative (42 samples), 100% agreement for Positive (42 samples)
- BZO/300: 93.2% agreement for Negative (41 samples), 100% agreement for Positive (44 samples)
- COC/150: 97.70% agreement for Negative (43 samples), 100% agreement for Positive (59 samples)
- COC/300: 100% agreement for both Negative (45 samples) and Positive (40 samples)
- EDDP/300: 93.2% agreement for Negative (41 samples), 100% agreement for Positive (43 samples)
- MDMA/500: 95.5% agreement for Negative (42 samples), 100% agreement for Positive (42 samples)
- MET/500: 93.2% agreement for Negative (41 samples), 100% agreement for Positive (58 samples)
- MET/1000: 100% agreement for both Negative (46 samples) and Positive (45 samples)
- MTD/300: 95.5% agreement for Negative (42 samples), 100% agreement for Positive (43 samples)
- OPI/300: 97.72% agreement for Negative (43 samples), 100% agreement for Positive (51 samples)
- OPI/2000: 93.2% agreement for Negative (41 samples), 100% agreement for Positive (49 samples)
- OXY/100: 93.2% agreement for Negative (41 samples), 100% agreement for Positive (44 samples)
- PCP/25: 97.7% agreement for Negative (43 samples), 100% agreement for Positive (45 samples)
- PPX/300: 95.3% agreement for Negative (41 samples), 100% agreement for Positive (42 samples)
- TCA/1000: 95.5% agreement for Negative (42 samples), 100% agreement for Positive (42 samples)
- THC/20: 98.55% agreement for Negative (68 samples), 96.30% agreement for Positive (53 samples)
- THC/50: 97.7% agreement for Negative (43 samples), 100% agreement for Positive (56 samples)
Similar agreement percentages were found for the ATTEST Drug Screen Dip Card format.
Summary of Discordant Results (ATTEST Cup and Dip Card formats):
For THC/20, there were 2 negative results where the GC/MS or LC/MS concentration was above the cutoff (21.11 ng/ml and 22.55 ng/ml). All other discordant results where the ATTEST device was Positive but the GC/MS or LC/MS result was below the cutoff. These included various analytes like AMP/500 (477 ng/ml), BAR/300 (265, 286 ng/ml), BUP/10 (8, 9 ng/ml), BZO/300 (244, 252, 295 ng/ml), COC/150 (146 ng/ml), EDDP/300 (250, 263, 275 ng/ml), MDMA/500 (368, 381 ng/ml), MET/500 (394, 461, 478 ng/ml), MTD/300 (266, 273 ng/ml), OPI/300 (289 ng/ml), OPI/2000 (1898, 1990 ng/ml), OXY/100 (88, 98, 99 ng/ml), PCP/25 (22.9 ng/ml), PPX/300 (242, 285 ng/ml), TCA/1000 (786, 859 ng/ml), and THC/50 (49 ng/ml).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and Specificity are described qualitatively as percentages of agreement between the device results and gold-standard methods (GC/MS, LC/MS). Exact sensitivity, specificity, PPV, NPV values are not explicitly stated, but are inferred from the agreement percentages provided, especially under Method Comparison/Accuracy Studies.
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.
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
§ 862.3650 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).
0
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
1
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
2
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)
3
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4
510(k) Summary
| Date: | September 17, 2020 |
|---|---|
| Submitter: | Advin Biotech, Inc. |
| 10237 Flanders Ct., | |
| San Diego, California 92121 | |
| Contact: | Daniel Hsu |
| Telephone: 858-866-8382, ext. 100 | |
| Email: 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 | PRODUCT
CODE | CLASSIFICATION | REGULATION
NUMBER/DESCRIPTION | PANEL |
|-------|-----------------|----------------|--------------------------------------------------------------------|------------|
| 6-AM | DJG | II | 862.3650/Enzyme
Immunoassay, Opiates | Toxicology |
| AMP | DKZ | II | 862.3100/ Enzyme
Immunoassay, Amphetamine | Toxicology |
| COC | DIO | II | 862.3250/Enzyme
Immunoassay, Cocaine and
cocaine metabolites | Toxicology |
| BUP | DJG | II | 862.3650/Enzyme
Immunoassay, Opiates | Toxicology |
| EDDP | DJR | II | 862.3620/Enzyme
Immunoassay, Methadone | Toxicology |
| MDMA | NGG | II | 862.3610/Methamphetamine
Test System | Toxicology |
| MET | DJC | II | 862.3610/Methamphetamine
Test System | Toxicology |
| MTD | DJR | II | 862.3620/Enzyme
Immunoassay, Methadone | Toxicology |
| OPI | DJG | II | 862.3650/Enzyme
Immunoassay, Opiates | Toxicology |
| BZO | JXM | II | 862.3170/Benzodiazepines
Test System | Toxicology |
| OXY | DJG | II | 862.3650/Enzyme
Immunoassay, Opiates | Toxicology |
| PCP | LCM | N/A | Unclassified/ Enzyme
Immunoassay, Phencyclidine | Toxicology |
| PPX | JXN | II | 862.3700/Enzyme
Immunoassay, Propoxyphene | Toxicology |
| BAR | DIS | II | 862.3150/Barbiturates Test
System | Toxicology |
| TCA | LFG | II | 862.3910/Tricyclic
Antidepressant drugs test
system | Toxicology |
| THC | LDJ | II | 862.3870/Cannabinoids Test
System | Toxicology |
5
6
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 |
7
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:
8
Predicate Similarities and Differences Table for All Assays
| Characteristic | Predicate (K122809) | Candidate Devices | ||||
|---|---|---|---|---|---|---|
| Indications for use | Qualitative detection of drugs of abuse | |||||
| and/or their metabolites in human | ||||||
| urine | Same | |||||
| Methodology | Lateral flow immunochromatographic | |||||
| assay 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 300 | |||
| from 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 |
9
| 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
-
10
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-AM
10 | 6-acetylmorphine | 10 | 100 |
| | Diacetylmorphine (heroin) | 300 | 3.3 |
| | Morphine | >100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | +25% C/O
to +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
| Drug
Test/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 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% |
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| 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 |
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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.