← Product Code [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG) · K182123

# ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K182123)

_Advin Biotech, Inc. · DJG · Mar 29, 2019 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K182123

## Device Facts

- **Applicant:** Advin Biotech, Inc.
- **Product Code:** [DJG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG.md)
- **Decision Date:** Mar 29, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3650
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## 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, Buprenorphine, EDDP, d/l-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: [Table of analytes/cutoffs]. 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.

## Device Story

Rapid lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle. Device consists of test strips with drug-protein conjugates on nitrocellulose membrane and anti-drug antibody-colloidal gold conjugates on a pad. Urine sample rehydrates gold conjugate; if target drug is below cutoff, gold conjugate binds to immobilized drug-protein conjugate, forming visible line (negative). If drug exceeds cutoff, antibody sites are saturated, preventing line formation (preliminary positive). Used in professional clinical settings; operated by healthcare professionals. Provides preliminary results requiring confirmation via GC/MS or LC/MS. Benefits include rapid, point-of-care screening for multiple drug analytes (up to 16) and optional specimen validity testing (SVT) to detect tampering.

## Clinical Evidence

Bench testing only. Precision/reproducibility evaluated at three sites using 180 replicates per format over 10 days. Analytical specificity and cross-reactivity tested against structurally similar compounds and endogenous substances. Method comparison performed against LC/MS quantitative methods using clinical urine specimens. No clinical studies performed.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Formats: Cup and Dip Card. Qualitative visual readout. Internal control line (C-line) for migration/volume verification. No external controls provided. Stable for 28 months. No electronic components or software algorithms.

## Regulatory 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.

## Special Controls

*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).

## Predicate Devices

- Advin Multi-Drug Screen Test Cup (k122809)
- Advin Multi-Drug Screen Test Dipcard (k122809)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k182123

B. Purpose for Submission:
Modification of a previously cleared device (k122809) to add Amphetamine (1000 ng/mL cutoff), Methamphetamine (1000 ng/mL cutoff), Cocaine (300 ng/mL cutoff), and 6-Acetylmorphine devices (10 ng/mL cutoff), and to change the formulation of the previously cleared Morphine device.

C. Measurands:
Amphetamine, Methamphetamine, Cocaine, Morphine, and 6-Acetylmorphine

D. Type of Test:
Qualitative, lateral flow immunoassay

E. Applicant:
Advin Biotech, Inc.

F. Proprietary and Established Names:
ATTEST Drug Screen Cup
ATTEST Drug Screen Dip Card

G. Regulatory Information:

|  Regulation names | Product Code | Class | Regulation | Panel  |
| --- | --- | --- | --- | --- |
|  Opiate Test System | DJG | II | 862.3650 | Toxicology (91)  |
|  Amphetamine Test system | DKZ | II | 862.3100 | Toxicology (91)  |
|  Cocaine and metabolites Test System | DIO | II | 862.3250 | Toxicology (91)  |
|  Methamphetamine Test System | DJC | II | 862.3610 | Toxicology (91)  |

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H. Intended Use:

1. Intended use(s):

Refer to Indications for Use

2. Indication(s) 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, Buprenorphine, EDDP, d/l-Methadone, d-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:

|  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

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adulteration/specimen validity tests (SVT) in the dip card format and 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.

3. Special conditions for use statement(s):

This assay is intended for prescription use

4. Special instrument requirements:

Not applicable.

I. Device Description:

The ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card devices are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepine, Cannabinoids, Cocaine, Methadone, Tricyclic antidepressants, Buprenorphine, EDDP, MDMA, Morphine, Oxycodone, Phencyclidine, Propoxyphene, and 6-Acetylmorphine. The ATTEST Drug Screen Cup device consists of a cup device and a package insert. The ATTEST Drug Screen Dip Card device consists of a Dip Card device, a package insert and a urine cup for sample collection.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Advin Multi-Drug Screen Test Cup, Advin Multi-Drug Screen Test Dipcard

2. Predicate 510(k) number(s):

k122809

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3. Comparison with predicate:

Predicate Similarities and Differences Table for All Assays

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Candidate Device | Predicate Device (k122809)  |
|  Intended Use | Same | Qualitative detection of drugs of abuse and/or their metabolites in urine  |
|  Test Principle | Same | Lateral flow immunochromatographic assay based on competitive binding  |
|  Matrix | Same | Urine  |
|  Analyte cutoffs (ng/mL) | Same except for the following analytes: 6-AM - 10 Amphetamine - 1,000 Cocaine - 300 Methamphetamine - 1,000 Opiates - 300 | Amphetamine - 500 Barbiturates - 300 Benzodiazepine - 300 Buprenorphine - 10 Cocaine - 150 EDDP - 300 Ecstasy - 500 Methamphetamine - 500 Methadone - 300 Morphine - 300 Opiates - 2,000 Oxycodone - 100 Phencyclidine - 25 Propoxyphene - 300 Tricyclics - 1,000 Marijuana - 50  |
|  Differences  |   |   |
|  Formats | Cup and Dip Card only | Cup, Dip Card, Cassette  |

K. Standard/Guidance Document Referenced (if applicable):

None referenced

L. Test Principle:

Each device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of the antibody coated particles on the drug specific test strips. The goat-anti-rabbit IgG antibody-coated particles will then be captured by immobilized drug-specific conjugate. If the level of drug in the urine specimen is below the cutoff concentration, the T line appears as a visible burgundy line. If the level of drug in the urine specimen is above the cutoff, no T line develops.

The control line (C line) serves as an internal quality control. The control line should always

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appear as a burgundy-colored band regardless of the presence of the drug, if enough sample volume has been added to the test and if the sample has correctly migrated up the test strip. Testing is based on the principle of a competitive immunochemical reaction between a chemically labeled drug (drug-protein conjugate) and the drug or drug metabolites which may be present in the urine sample competing for the limited antibody binding sites.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

The precision study of the ATTEST Drug Screen Cup and Dip card were evaluated for Amphetamine (1000 ng/mL cutoff, AMP 1000), Methamphetamine (1000 ng/mL cutoff, MET 1000), Cocaine (300 ng/mL cutoff, COC 300), Opiates (300 ng/mL cutoff, OPI 300) and 6-Acetylmorphine devices (10 ng/mL cutoff, 6-AM 10) at three external testing sites. Samples tested were drug free urine spiked with certified reference standards to the target concentrations. The test solutions contain the following drug concentrations: negative, +/-75% cutoff, +/-50% cutoff, +/-25% cutoff, and +100% cutoff. All test solutions were confirmed by a chemically specific quantitative method to verify the drug concentrations.

Three operators performed the study using three lots of ATTEST Cup Drug Screen and three lots of ATTEST Card Drug Screen. Each sample was tested in 20 replicates for each device format at each of three sites. A total of 180 specimens for each device format were tested over 10 non-consecutive days. The results are shown in the tables below. Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.

Precision Study Result of ATTEST Cup:

|  Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  6-AM 10 | Neg | 60 | 60 | 60 | 58 | 32 | 0 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 2 | 28 | 60 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 97% | --- | 100% | 100% | 100% | 100%  |
|  AMP 1000 | Neg | 60 | 60 | 60 | 58 | 5 | 1 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 2 | 55 | 59 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 97% | --- | 98% | 100% | 100% | 100%  |

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|  COC 300 | Neg | 60 | 60 | 60 | 59 | 22 | 1 | 0 | 0 | 0  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Pos | 0 | 0 | 0 | 1 | 38 | 59 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 98% | --- | 98% | 100% | 100% | 100%  |
|  MET 1000 | Neg | 60 | 60 | 60 | 58 | 26 | 3 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 2 | 34 | 57 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 97% | --- | 95% | 100% | 100% | 100%  |
|  OPI 300 | Neg | 60 | 60 | 60 | 56 | 10 | 4 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 4 | 50 | 56 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 93% | --- | 93% | 100% | 100% | 100%  |

Precision Study Result of ATTEST Dip Card:

|  Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  6-AM 10 | Neg | 60 | 60 | 60 | 59 | 23 | 1 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 1 | 37 | 59 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 98% | --- | 98% | 100% | 100% | 100%  |
|  AMP 1000 | Neg | 60 | 60 | 60 | 60 | 18 | 2 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 0 | 42 | 58 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 100% | --- | 97% | 100% | 100% | 100%  |
|  COC 300 | Neg | 60 | 60 | 60 | 57 | 18 | 1 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 3 | 42 | 59 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 95% | --- | 98% | 100% | 100% | 100%  |
|  MET 1000 | Neg | 60 | 60 | 60 | 59 | 31 | 2 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 1 | 29 | 58 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 98% | --- | 97% | 100% | 100% | 100%  |
|  OPI 300 | Neg | 60 | 60 | 60 | 59 | 21 | 1 | 0 | 0 | 0  |
|   |  Pos | 0 | 0 | 0 | 1 | 39 | 59 | 60 | 60 | 60  |
|   |  Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60  |
|   | Agreement | 100% | 100% | 100% | 98% | --- | 98% | 100% | 100% | 100%  |

b. Linearity/assay reportable range:

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Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

This device has internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region. There are no external controls supplied with the device.

Device stability has been evaluated through accelerated and real-time studies. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that the devices are stable for 28 months.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Analytical specificity for both the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card 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 represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay. Identical results, provided in the table below, were obtained with the two devices. Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.

|  Assay/Cutoff | Compound | Concentration (ng/mL) | Relative cross-reactivity (%)  |
| --- | --- | --- | --- |
|  6-AM 10 | 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  |
|  AMP 1000 | d-Amphetamine | 1,000 | 100  |
|   |  l-Amphetamine | 100,000 | 1  |
|   |  MDA | 15,000 | 6.7  |
|   |  Phentermine | 100,000 | 1.0  |
|  COC 300 | Benzoylecgonine | 300 | 100  |
|   |  Cocaethylene | 100,000 | 0.3  |
|   |  Cocaine | 10,000 | 3  |

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The potential interference from compounds chemically dissimilar to target drugs, and known endogenous agents was also determined for both the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card. Testing of compounds and endogenous agents was performed by spiking the substances noted in the table below into pooled urine containing target drugs at near-cutoff concentrations. Identical results, provided in the table below, were obtained with the two devices. Unless otherwise indicated, substances were tested for potential interference at a concentration of 100 µg/mL. Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.

The following substances demonstrated no interference to the assays encompassed in this submission.

|  Acetaminophen | Acetone | Acetylsalicylic acid  |
| --- | --- | --- |
|  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  |

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|  Guaiacol glyceryl ether | Hemoglobin | Ibuprofen  |
| --- | --- | --- |
|  Isoproterenol | Ketamine | Lidocaine  |
|  Methylephedrine | Naproxen | Niacinamide  |
|  Nicotine | Norephedrine | Oxalic acid  |
|  Pantoprazole | Penicillin-G | Pheniramine  |
|  Phenothiazine | 1-Phenylephrine | B-Phenylethylamine  |
|  Pregablin | Procaine | Quinidine  |
|  Ranitidine | Riboflavin | Sertraline  |
|  Sodium chloride | Sulindac | Theophylline  |
|  Tyramine |  |   |

Interference from pH and specific gravity variation was also evaluated for both the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card using pooled urine specimens containing target drugs at near-cutoff concentrations. 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 for either of the devices. Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.

f. Assay cut-off:

For characterization of how the device performs analytically around the claimed cutoff concentration, please refer to section M.1.a., above.

2. Comparison studies:

a. Method comparison with predicate device:

A method comparison study was conducted for the ATTEST Drug Screen Cup and ATTEST Drug Screen Dip card, using clinical urine specimens quantitated for the target drugs of abuse by chemically specific quantitative methods (e.g. LC-MS). Identical results, provided in the table below, were obtained with the two devices. Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.

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|  Device | Device Result | Concentration determined by chemically specific quantitative method (e.g. LC/MS)  |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  ≤50% cutoff concentration | Near Cutoff Negative (-50% to the cutoff concentration) | Near Cutoff Positive (cutoff to 150% of the cutoff) | High Positive (≥150% of the cutoff)  |
|  6-AM/10 | Negative | 40 | 5 | 0 | 0  |
|   |  Positive | 0 | 0 | 5 | 35  |
|  AMP/1000 | Negative | 40 | 6 | 0 | 0  |
|   |  Positive | 0 | 0 | 6 | 40  |
|  COC/300 | Negative | 40 | 5 | 0 | 0  |
|   |  Positive | 0 | 0 | 5 | 35  |
|  MET/1000 | Negative | 40 | 6 | 0 | 0  |
|   |  Positive | 0 | 0 | 5 | 40  |
|  OPI/300 | Negative | 40 | 3 | 0 | 0  |
|   |  Positive | 0 | 1 | 4 | 46  |

Summary of Discordant Results:

|  Drug / Cutoff (ng/ml) | ATTEST Cup Result | GC/MS result  |   |
| --- | --- | --- | --- |
|   |   |  Drug Concentration (ng/ml) | Analyte  |
|  OPI/300 | Positive | 289 | Morphine  |

b. Matrix comparison:
Not applicable.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

{10}

Not applicable.

5. Expected values/Reference range:

Not applicable.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K182123](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJG/K182123)

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**Cite:** Innolitics at https://innolitics.com