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K Number
K182123
Device Name
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Manufacturer
Advin Biotech, Inc.
Date Cleared
2019-03-29

(235 days)

Product Code
DJGDIODJCDKZ
Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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-Ampletamine, 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 | | Barbiturates | Secobarbital/Pentobarbital | 300 | | Benzodiazepines | 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 | 50 | | Methadone | d/l-Methadone | 300 | | Opiates | Morphine | 300 | | Opiates | Morphine | 2,000 | | Oxycodone | Oxycodone | 100 | | Phencyclidine | Phencyclidine | 25 | | Propoxyphene | Propoxyphene | 300 | | Tricyclic Antidepressants | 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. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. 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.
Device Description
For professional 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
More Information

K122809

Not Found

No
The device is described as a rapid lateral flow immunoassay, which is a traditional biochemical testing method and does not involve AI or ML for its operation or interpretation.

No.
The device is a rapid lateral flow immunoassay for the qualitative detection of various drugs in human urine, providing only a preliminary result for diagnostic purposes, not for treatment.

Yes

The device qualitatively detects substances in human urine, which provides information for diagnosis or detection of drug use. The text explicitly states it provides a "preliminary result" for presumptive positive detection, characteristic of a diagnostic device.

No

The device description explicitly states that the devices consist of physical components: test cups or dip cards. These are hardware components, not software.

Based on the provided information, 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 involves testing a biological sample (human urine) in vitro (outside the body) to obtain diagnostic information (presence or absence of drugs).
  • Device Description: The device is described as a "rapid lateral flow immunoassay," which is a common type of IVD test.
  • Performance Studies: The document describes performance studies using "clinical urine specimens" and comparing results to "gold-standard methods (GC/MS, LC/MS or equivalent)." This is typical for the validation of IVD devices.
  • Predicate Device: The mention of predicate devices with K numbers (K122809) indicates that this device is being compared to previously cleared IVD devices by a regulatory body like the FDA.

Therefore, all the key characteristics point to this device being an In Vitro Diagnostic.

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-Ampletamine, 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:

AnalyteCalibratorCutoff (ng/mL)
6-Acetylmorphine6-monoacetylmorphine10
Amphetamined-Amphetamine500
Amphetamined-Amphetamine1,000
BarbituratesSecobarbital/Pentobarbital300
BenzodiazepinesOxazepam300
BuprenorphineBuprenorphine10
EDDP2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine300
CocaineBenzoylecgonine150
CocaineBenzoylecgonine300
Ecstasyd,l-Methylenedioxymethamphetamine500
Methamphetamined-Methamphetamine500
Methamphetamined-Methamphetamine1,000
Marijuana11-nor-Δ9-THC-9-COOH50
Methadoned/l-Methadone300
OpiatesMorphine300
OpiatesMorphine2,000
OxycodoneOxycodone100
PhencyclidinePhencyclidine25
PropoxyphenePropoxyphene300
Tricyclic AntidepressantsNortriptyline1,000

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. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. 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, DJC

Device Description

For professional 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

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical performance:

  • Precision/Reproducibility: The precision, reproducibility and sensitivity of the ATTEST Drug Screen Cup and the ATTEST Drug Screen 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.
  • Linearity/Assay Reportable Range: Not applicable. Devices intended for qualitative determinations only.
  • Traceability, Stability, Expected Values (controls, calibrators, methods):

    • Traceability: The assays shown in the table below are harmonized with the DHHS/SAMHSA screening cutoffs for drugs of abuse in urine (Federal Register Notice, Volume 82. No.13, January 23, 2017):

      Assay NameAbbreviationCalibrator DrugCutoff level (ng/mL)
      6-AM6AM6-monoacetylmorphine10
      AmphetamineAMPd-amphetamine500
      CocaineCOCBenzoylecgonine150
      MethamphetamineMETd-methamphetamine500
      MDMAMDMAd/l-methylenedioxymethamphetamine500
      Opiates 2000OPIMorphine (free)2000
      OxycodoneOXYOxycodone100
      PCPPCPPhencyclidine25
      THCTHCTHC-COOH50

    • Stability: Device stability has been or will be determined using accelerated stress testing and real-time studies. All accelerated studies have been completed. Real-time stability testing in room temperature conditions have been completed for Amphetamine 1000, Cocaine 300 and Methamphetamine 1000 assays. In real-time, room temperature conditions, devices in both formats are stable for 28 months when stored at room temperature in sealed foil. Real-time stability studies for the 6-AM assay and the reformulated OPI 300 assay are ongoing.

    • Controls: Devices have been evaluated with various 3rd 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.

  • 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.
  • 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. (Detailed tables of cross-reactivity for various compounds are provided in the source document). Additionally, the compounds listed previously in the document demonstrated no positive or negative interference.
    • The potential effect of variances in urine pH on the assays was evaluated by pH adjusting pooled urine specimens (containing target drugs at near-cutoff concentrations) from 4.0 to 9.0 in increments of 1.0 and testing in duplicate.
    • The potential effect of variances of urine specific gravity on the assays was evaluated by diluting pooled urine specimens (containing target drugs at near-cutoff concentrations) using deionized water or concentrating them 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.
    • Key Results: 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.

Method Comparison/Accuracy Studies:
Advin Biotech performed a method comparison study of the ATTEST Drug Screen Cup and the ATTEST Drug Screen 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 detailed tables in the source document.
Clinical Studies:

  • Clinical sensitivity: refer to accuracy table shown in section M.b. above
  • Clinical specificity: refer to accuracy table show in section M.b. above
  • Other clinical supportive data (when i and ii are not applicable): N/A

Read Time:
To evaluate the reading time flexibility, the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card and 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics are presented in the "Method Comparison/Accuracy Studies" section through tables detailing "Agreement" for Negative and Positive results across various drug concentrations relative to the cutoff, for both the Cup and Dip Card formats. For instance, for 6-AM/10, both Neg and Pos results showed 100% agreement. For AMP/500, Neg showed 97.7% agreement and Pos showed 100% agreement. These tables provide counts of samples in different concentration ranges (e.g., "Drug-free", "-50% C/O to

§ 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).

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March 29, 2019

Advin Biotech, Inc. Daniel Hsu Senior QA/RA Manager 10340 Camino Santa Fe, Suite G San Diego, CA 92121

Re: K182123

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, DJC Dated: February 7, 2019 Received: February 12, 2019

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.

1

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

Courtney H. Lias, Ph.D. for Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182123

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-Ampletamine, 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:

AnalyteCalibratorCutoff (ng/mL)
6-Acetylmorphine6-monoacetylmorphine10
Amphetamined-Amphetamine500
Amphetamined-Amphetamine1,000
BarbituratesSecobarbital/Pentobarbital300
BenzodiazepinesOxazepam300
BuprenorphineBuprenorphine10
EDDP2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine300
CocaineBenzoylecgonine150
CocaineBenzoylecgonine300
Ecstasyd,l-Methylenedioxymethamphetamine500
Methamphetamined-Methamphetamine500
Methamphetamined-Methamphetamine1,000
Marijuana11-nor-Δ9-THC-9-COOH50
Methadoned/l-Methadone300
OpiatesMorphine300
OpiatesMorphine2,000
OxycodoneOxycodone100
PhencyclidinePhencyclidine25
PropoxyphenePropoxyphene300
Tricyclic AntidepressantsNortriptyline1,000

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. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Date:March 28, 2019
Submitter:Advin Biotech, Inc.
10340 Camino Santa Fe, Suite G
San Diego, California 92121
Contact:Daniel Hsu
Telephone: 858-866-8382, ext. 100
Email: daniel.hsu@advinbio.com

A. 510(k) Number:

K182123

B. Purpose for Submission:

  • a. Addition of Amphetamine 1000, Cocaine 300, Methamphetamine 1000 and 6-Acetylmorphine 10 to a previously cleared device (K122809)
  • b. Update formulation of Opiate 300 assay from the same previously cleared device

C. Measurand:

d-Methamphetamine 6-Acetylmorphine, d-Amphetamine, Benzoylecqonine, and Morphine

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 |

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| MET | DJC | II | 862.3610/Methamphetamine
Test System | Toxicology |
|-----|-----|----|-----------------------------------------|------------|
| OPI | DJG | II | 862.3650/Enzyme
Immunoassay, Opiates | Toxicology |

H. Intended 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, Buprenorphine, EDDP, dll-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, 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:

| Assay | Abbreviation | Calibrator | Cutoff
Concentration
(ng/mL) |
|-------------------------|--------------|-------------------------------------------------------|------------------------------------|
| 6-Acetylmorphine | 6AM | 6-monoacetylmorphine | 10 |
| Amphetamine 500 | AMP500 | d-Amphetamine | 500 |
| Amphetamine 1000 | AMP1000 | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl-3-3-
diphenylpyrrolidine | 300 |
| Cocaine 150 | COC150 | Benzoylecgonine | 150 |
| Cocaine 300 | COC 300 | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-
Methylenedioxymethamphetamine | 500 |
| Methamphetamine 500 | MET500 | d-Methamphetamine | 500 |
| Methamphetamine
1000 | MET1000 | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 50 |
| Methadone | MTD | d/l-Methadone | 300 |
| Opiates 300 | OPI300 | Morphine | 300 |
| Opiates 2000 | OPI2000 | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |

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PhencyclidinePCPPhencyclidine25
PropoxyphenePPXPropoxyphene300
Tricyclic
AntidepressantsTCANortriptyline1,000

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 dip card format or in the cup format. Only one cutoff concentration per analyte will be included per device. The drug screen tests are intended for prescription use only.

The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result if the donor doesn't admit use or anytime required by testing procedures. 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.

The tests are not intended to differentiate between illicit and prescription use of benzodiazepines, barbiturates, buprenorphine, oxycodone, propoxyphene and tricyclic antidepressants. There are no uniformly recognized cutoff levels for these drugs in urine.

I. Device Descriptions:

For professional 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 Multi-Drug Screen Test Cup
    • ii. Advin Multi-Drug Screen Test Dipcard

  • b. Predicate 510(k) number(s): i. K122809

  • c. Comparisons with predicates:
CharacteristicPredicate (K122809)Candidate Devices
Indications for useQualitative detection of drugs of abuse
and/or their metabolites in human
urineSame

Predicate Similarities and Differences Table for All Assays

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MethodologyLateral flow immunochromatographic assay based on competitive bindingSame
SpecimenHuman urineSame
Analytes, calibrators, cutoffsAssayCalibratorCutoff (ng/mL)
Amphetamined-amphetamine500
BarbituratesSecobarbital300
BenzodiazepineOxazepam300
BuprenorphineBuprenorphine10
CocaineBenzoylecgonine150
EDDP2-ethylidene-1,5-dimethyl-3-3-diphenyl-pyrrolidine300
Ecstasyd/l-methylene-dioxy-meth-amphetamine500
Methamphetamined-meth-amphetamine500
Methadoned/l-methadone300
MorphineMorphine300
OpiatesMorphine2,000
OxycodoneOxycodone100
PhencyclidinePhencyclidine25
Propoxyphened-propoxyphene300
TricyclicsNortriptyline1,000
MarijuanaTHC-COOH50
Same except the additions of:AssayCalibratorcutoff
6-AM6-acetyl-morphine
Amphetamined-amphetamine
CocaineBenzoylecgonine300
Meth-amphetamined-meth-amphetamine1,000
Test formatsCup, Dip Card, CassetteCup and Dip Card only

K. Standard Referenced:

Cutoffs shown in the table below are harmonized with DHHS/SAMHSA screening cutoffs for drugs of abuse in urine (Federal Register Notice, Volume 82. No.13, January 23, 2017):

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| Assay Name | Abbreviation | Calibrator Drug | Cutoff
level
(ng/mL) |
|-----------------|--------------|---------------------------------------|----------------------------|
| 6-AM | 6AM | 6-monoacetylmorphine | 10 |
| Amphetamine | AMP | d-amphetamine | 500 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Methamphetamine | MET | d-methamphetamine | 500 |
| MDMA | MDMA | d/l-
methylenedioxymethamphetamine | 500 |
| Opiates 2000 | OPI | Morphine (free) | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| PCP | PCP | Phencyclidine | 25 |
| THC | THC | THC-COOH | 50 |

L. Test Principle:

The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays in which drug-protein conjuqates 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 antibodycolloidal qold conjuqate that has been rehydrated by the urine sample migrates by capillary action across the membrane to 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 tarqet druq level exceeds the cutoff concentration of the druq/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 bind to the drugprotein 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 antibodyantigen 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 the ATTEST Drug Screen 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.

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  • ii. Linearity/Assav Reportable Range: Not applicable. Devices intended for qualitative determinations only.
  • iii. Traceability, Stability, Expected Values (controls, calibrators, methods):
      1. Traceability: The assays shown in the table below are harmonized with the DHHS/SAMHSA screening cutoffs for drugs of abuse in urine (Federal Register Notice, Volume 82. No.13, January 23, 2017):

| Assay Name | Abbreviation | Calibrator Drug | Cutoff
level
(ng/mL) |
|-----------------|--------------|---------------------------------------|----------------------------|
| 6-AM | 6AM | 6-monoacetylmorphine | 10 |
| Amphetamine | AMP | d-amphetamine | 500 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Methamphetamine | MET | d-methamphetamine | 500 |
| MDMA | MDMA | d/l-
methylenedioxymethamphetamine | 500 |
| Opiates 2000 | OPI | Morphine (free) | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| PCP | PCP | Phencyclidine | 25 |
| THC | THC | THC-COOH | 50 |

    1. Stability: Device stability has been or will be determined using accelerated stress testing and real-time studies. All accelerated studies have been completed. Real-time stability testing in room temperature conditions have been completed for Amphetamine 1000, Cocaine 300 and Methamphetamine 1000 assays. In realtime, room temperature conditions, devices in both formats are stable for 28 months when stored at room temperature in sealed foil. Real-time stability studies for the 6-AM assay and the reformulated OPI 300 assay are ongoing.
    1. Controls: Devices have been evaluated with various 3rd 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 structurally-similar compounds into drug free urine. The relative cross

10

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 | +25% C/O to +50% C/O | >+50% C/O | Agreement |
|--------------------------|--------|-----------|-----------------------|-----------------|-----------------|-----------------------|-----------|-----------|
| 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% |
| AMP/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% |
| AMP/1000 | Pos | 0 | 0 | 0 | 3 | 3 | 40 | 100% |
| BAR/300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% |
| BAR/300 | Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% |
| BUP/10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| BUP/10 | Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% |
| BZO/300 | 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% |
| COC/150 | Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% |
| COC/300 | Neg | 40 | 3 | 2 | 0 | 0 | 0 | 100% |
| COC/300 | Pos | 0 | 0 | 0 | 2 | 3 | 35 | 100% |
| EDDP/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| EDDP/300 | Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% |
| MDMA/500 | 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% |
| MET/500 | Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% |
| MET/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% |
| MET/1000 | Pos | 0 | 0 | 0 | 2 | 3 | 40 | 100% |
| MTD/300 | 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% |
| OPI/300 | Pos | 0 | 0 | 1 | 3 | 1 | 46 | 100% |
| OPI/2000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| OPI/2000 | Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% |
| OXY/100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| OXY/100 | Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% |
| PCP/25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% |
| PCP/25 | Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% |
| PPX/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% |
| PPX/300 | Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% |
| TCA/1000 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| TCA/1000 | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% |
| THC/50 | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% |
| THC/50 | Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% |

The ATTEST Drug Screen Cup format

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| Drug Test/

Cutoff (ng/ml)ATTEST Cup ResultResult w/ GC/MS or LC/MS
Drug Concentration (ng/ml)Analyte
AMP/500Positive477Amphetamine
BAR/300Positive265Barbital
Positive286Barbital
BUP/10Positive8Buprenorphine
Positive9Buprenorphine
BZO/300Positive244Oxazepam
Positive252Oxazepam
Positive295Oxazepam
COC/150Positive146Benzoylecgonine
EDDP/300Positive250EDDP
Positive263EDDP
Positive275EDDP
MDMA/500Positive368MDMA
Positive381MDMA
MET/500Positive394Methamphetamine
Positive461Methamphetamine
Positive478Methamphetamine
OPI/300Positive289Morphine
MTD/300Positive266Methadone
Positive273Methadone
OPI/2000Positive1,898Morphine
Positive1,990Morphine
OXY/100Positive88Oxycodone
Positive98Oxycodone
Positive99Oxycodone
PCP/25Positive22.9Phencyclidine
PPX/300Positive242Norpropoxyphene
Positive285Norpropoxyphene
TCA/1000Positive786Nortriptyline
Positive859Nortriptyline
THC/50Positive4911-nor-Δ9-THC-9-COOH

Summary of Discordant Results, ATTEST Cup format

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DrugDrug-Drug quantitation by gold-standard method relative to assay cutoff level
Test/Cutoff
(ng/mL)Resultfree-50% C/O to +25% C/O to +50% C/O>+50% C/OAgreement
6-AM/10Neg4041000100%
Pos0001435100%
AMP/500Neg403000097.7%
Pos0012245100%
AMP/1000Neg4033000100%
Pos0003340100%
BAR/300Neg401100095.2%
Pos0025236100%
BUP/10Neg401100095.5%
Pos0028032100%
BZO/300Neg400100093.2%
Pos0031634100%
COC/150Neg400300097.70%
Pos0014153100%
COC/300Neg4032000100%
Pos0002335100%
EDDP/300Neg400100093.2%
Pos0035233100%
MDMA/500Neg401100095.5%
Pos0025134100%
MET/500Neg401000093.2%
Pos0031351100%
MET/1000Neg4033000100%
Pos0002340100%
MTD/300Neg400200095.5%
Pos0024037100%
OPI/300Neg402100097.72%
Pos0013146100%
OPI/2000Neg401000093.2%
Pos0024340100%
OXY/100Neg401000093.2%
Pos0037133100%
PCP/25Neg400300097.7%
Pos0013833100%
PPX/300Neg400100095.3%
Pos0025233100%
TCA/1000Neg400200095.5%
Pos0025728100%
THC/50Neg401200097.7%
Pos001000100%

The ATTEST Drug Screen Dip Card format

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| Drug Test/

Cutoff (ng/ml)ATTEST Dip Card ResultDrug Concentration (ng/ml)Analyte
AMP/500Positive477Amphetamine
BAR/300Positive265Barbital
BAR/300Positive286Barbital
BUP/10Positive8Buprenorphine
BUP/10Positive9Buprenorphine
BZO/300Positive244Oxazepam
BZO/300Positive252Oxazepam
BZO/300Positive295Oxazepam
COC/150Positive146Benzoylecgonine
EDDP/300Positive250EDDP
EDDP/300Positive263EDDP
EDDP/300Positive275EDDP
MDMA/500Positive368MDMA
MDMA/500Positive381MDMA
MDMA/500Positive394Methamphetamine
MET/500Positive461Methamphetamine
MET/500Positive478Methamphetamine
MTD/300Positive266Methadone
MTD/300Positive273Methadone
OPI/300Positive289Morphine
OPI/2000Positive1,898Morphine
OPI/2000Positive1,990Morphine
OXY/100Positive88Oxycodone
OXY/100Positive98Oxycodone
OXY/100Positive99Oxycodone
PCP/25Positive22.9Phencyclidine
PPX/300Positive242Norpropoxyphene
PPX/300Positive285Norpropoxyphene
TCA/1000Positive786Nortriptyline
TCA/1000Positive859Nortriptyline
THC/50Positive4911-nor-Δ9-THC-9-COOH

Summary of Discordant Results, ATTEST Dip Card format

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, the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card and 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.

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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.