← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K131069

# QUICKSCREEN AMPHETINE 500 TEST (K131069)

_Phamatech, Inc. · DKZ · May 14, 2014 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K131069

## Device Facts

- **Applicant:** Phamatech, Inc.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** May 14, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The QuickScreen Amphetamine 500 Test Model 9058 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. The QuickScreen Amphetamine 500 Test Model 9054 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

## Device Story

QuickScreen Drug Screening Test System uses lateral flow immunoassay technology to detect drugs of abuse in urine. Device formats include dip cards, cassettes, and integrated cups. Principle of operation relies on immunochemical sandwich assay; specific antibodies bind to target drug/metabolite; visual color change indicates presence or absence of analyte. Used in point-of-care settings by healthcare professionals. Provides preliminary qualitative results; requires confirmatory testing via GC/MS. Assists clinicians in identifying potential drug use; supports clinical decision-making when combined with professional judgment. Benefits patients by providing rapid, preliminary screening results.

## Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted at 3 point-of-care sites using 4 device formats over 20 days. Method comparison study performed on 106 clinical urine samples (64 negative, 42 positive) compared against GC/MS reference method. Cross-reactivity and interference testing (pH, specific gravity) performed. No clinical trials conducted.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Monoclonal/polyclonal antibodies. Visual readout. Single-use device. No energy source required. Stable for 20 months at 15–30°C.

## Regulatory Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An amphetamine 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

- QuikStrip™ OneStep Amphetamine 500 Test (k971218)

## 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:
k131069

B. Purpose for Submission:
Device Modification: Change in the amphetamine test strip cutoff concentration from 1000 ng/mL to 500 ng/mL for previously cleared devices. There were no modifications made to the following test strips; Cocaine, Methamphetamine, Opiates, Phencyclidine, Barbiturates, Benzodiazepines, Methadone, Oxycodone, and THC (Cannabinoids) which are contained within the QuickScreen Multi Drug Screening Test and QuickScreen Drug Cup, cleared under k103295.

C. Measurand:
Amphetamine

D. Type of Test:
Qualitative, lateral flow immunoassay

E. Applicant:
Phamatech Inc.

F. Proprietary and Established Names:
QuickScreen Amphetamine 500 Model 9058 (dip card)
QuickScreen Amphetamine 500 Test Model 9054 (cassette)
QuickScreen Multi Drug Screening Test Model 9346T (dip card)
QuickScreen Multi Drug Cup Model 9346Z

G. Regulatory Information:

1. Regulation section:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  DKZ | II | 21 CFR §862.3100, Amphetamine test system | Toxicology - 91  |

{1}

H. Intended Use:

1. Intended use(s):

See Indications for use below

2. Indication(s) for use:

QuickScreen™ Amphetamine 500 Test Model 9058 (dip card)

The QuickScreen Amphetamine 500 Test Model 9058 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only.

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

QuickScreen™ Amphetamine 500 Test Model 9054 (cassette)

The QuickScreen Amphetamine 500 Test Model 9054 is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only.

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

QuickScreen™ Multi Drug Screening Test Model 9346T (dip card)

The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only.

2

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Amphetamine (d amphetamine) 500 ng/ml
Cocaine (benzoylecgonine) 150 ng/ml
Methamphetamine (d methamphetamine) 500 ng/ml
Opiates (morphine) 300 ng/ml
PCP (phencyclidine) 25 ng/ml
Barbiturates (Secobarbital) 300 ng/ml
Benzodiazepines (Oxazepam) 200 ng/ml
Methadone (Methadone) 300 ng/ml
Oxycodone (Oxycodone) 100 ng/ml
THC (Cannabinoids) 50 ng/ml

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

## QuickScreen™ Drug Cup Model 9346Z

The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only.

Amphetamine (d amphetamine) 500 ng/ml
Cocaine (benzoylecgonine) 150 ng/ml
Methamphetamine (d methamphetamine) 500 ng/ml
Opiates (morphine) 300 ng/ml
PCP (phencyclidine) 25 ng/ml
Barbiturates (Secobarbital) 300 ng/ml
Benzodiazepines (Oxazepam) 200 ng/ml
Methadone (Methadone) 300 ng/ml
Oxycodone (Oxycodone) 100 ng/ml
THC (Cannabinoids) 50 ng/ml

This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

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3. Special conditions for use statement(s):

For prescription, point of care use only.

4. Special instrument requirements:

Not applicable; this is a visually read single use device

I. Device Description:

The QuickScreen™ test devices employ lateral flow immunochromatographic technology and are based on the principle of competitive binding. The devices are available in either the cassette, dipcard, or cup formats as indicated by the device names. The devices are for use with human urine and results are visually read as positive or negative for the detection/presence of drug(s) in urine.

J. Substantial Equivalence Information:

1. Predicate device name(s):

QuikStrip™ OneStep Amphetamine 500 Test

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

k971218

3. Comparison with predicate:

|  Similarities/Differences  |   |   |
| --- | --- | --- |
|  Item | Candidate Device | Predicate Device  |
|  Intended Use | Detection of drugs of abuse | Same  |
|  Format | Integrated Cup/Dip/Card/Cassette | Dip card  |
|  Specimen | Urine | Same  |
|  Methodology | Lateral flow Immunoassay | Same  |
|  Qualitative | Yes | Same  |
|  Antibodies | Monoclonal/Polycolonal | Same  |
|  Amphetamine Cutoff | 500 ng/mL | Same  |
|  Sample Incubation Time | 10 minutes | 5 minutes  |
|  End User | Prescription Point-of-Care | Same  |

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

None referenced.

L. Test Principle:

The QuickScreen test devices are chromatographic absorbent devices in which drug or drug metabolite(s) in an urine sample compete with a drug-antigen conjugate, immobilized on a porous support membrane. When an urine sample is applied to the test device, if drug is present in the sample at a concentration less than the stated cut-off, it will not block the binding sites of the immobilized drug-antigen conjugate in the test region and the antibody-dye conjugate will migrate to the test region with the urine. As a result, a visible rose pink band will form in the test region, indicating a negative result. Conversely, where drug concentrations are equal to or greater than the stated cut-off, the antibody - dye conjugate binds to the free drug, forming a complex which competes with immobilized drug-antigen conjugate in the test region. This prevents the development of a rose pink band, indicating a positive sample.

To serve as a procedural control, a colored band will always appear in the control region regardless of the presence of drug(s) in the test sample. This verifies the device is functioning correctly.

M. Performance Characteristics (if/when applicable):

Performance testing was conducted on the amphetamine test strip only due to the change in cutoff for this drug analyte. The other drug analyte test strips in the QuickScreen Multi Drug Screening Test and QuickScreen Drug Cup have not been modified and were previously cleared (k103295).

1. Analytical performance:

a. Precision/Reproducibility:

Precision studies were performed using drug-free urine spiked to the following concentrations: cutoff, +/-25%, +/-50%, +/-75% and 100% of the cutoff. Also, negative urine was tested. For each device, sixty urine samples were assayed for each test concentration. The samples were aliquotted, randomized, and blinded prior to testing. Testing was performed at 3 point-of-care sites by 2 operators/site with each testing the 4 device formats (dipcard multi 9346T, cup 9346Z, cassette 9054, dipcard single 9058). Testing was performed once a day for 20 days. Results are shown in the tables below:

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Dipcard multi 9346T

|  Conc. | Site 1 |   | Site 2 |   | Site 3 |   | Combined  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  |   |   |   |   |   |   |   |   |
|   | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos  |
|  Negative | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -75% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -50% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -25% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  Cutoff | 5 | 15 | 0 | 20 | 5 | 15 | 10 | 50  |
|  125% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  150% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  175% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  200% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |

Cassette 9054

|  Conc. | Site 1 |   | Site 2 |   | Site 3 |   | Combined  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  |   |   |   |   |   |   |   |   |
|   | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos  |
|  Negative | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -75% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -50% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -25% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  Cutoff | 19 | 1 | 0 | 20 | 19 | 1 | 38 | 22  |
|  125% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  150% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  175% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  200% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |

Cup 9346Z

|  Conc. | Site 1 |   | Site 2 |   | Site 3 |   | Combined  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  |   |   |   |   |   |   |   |   |
|   | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos  |
|  Negative | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -75% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -50% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -25% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  Cutoff | 19 | 1 | 0 | 20 | 19 | 1 | 38 | 22  |
|  125% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  150% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  175% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  200% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |

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Dipcard single 9058

|  Conc. | Site 1 |   | Site 2 |   | Site 3 |   | Combined  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  |   |   |   |   |   |   |   |   |
|   | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos  |
|  Negative | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -75% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -50% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  -25% | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0  |
|  Cutoff | 19 | 1 | 0 | 20 | 19 | 1 | 38 | 22  |
|  125% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  150% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  175% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |
|  200% | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60  |

b. Linearity/assay reportable range:

Not applicable, the device is intended for qualitative use.

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

Control standards are not supplied with this device; however the labeling states that it is good laboratory practice to confirm the test procedure and to verify proper test performance. Users should follow all applicable guidelines for testing QC materials.

Stability:

Real time and accelerated studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date:

"When stored at 15–30°C, the product is stable until the expiration date which is 20 months."

d. Detection limit:

Not applicable, the device is intended for qualitative use

e. Analytical specificity:

Cross-reactivity was established by spiking structurally related compounds into drug-free urine. Results are expressed as a minimum concentration of compound required to produce a response approximately equivalent to the cutoff concentration of the assay. Testing was performed on three devices (dipcard- multi 9346T, cup 9346Z, cassette 9054). All devices produced similar results. The percent cross-reactivity of those compounds are presented below:

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Structurally related:

|  Substances | Concentration (ng/mL) | % Cross-reactivity  |
| --- | --- | --- |
|  d-amphetamine | 500 | 100%  |
|  l-amphetamine | 10,000 | 5.0%  |
|  Methylenedioxyamphetamine (MDA) | 1000 | 50%  |
|  Methylenedioxymethamphetamine(MDMA) | 100,000 | 0  |
|  Norephedrin | >10,000 | >5.0%  |
|  Tyramine | 5000 | 10%  |

Structurally un-related:

This study was performed by spiking structurally unrelated compounds and endogenous substances at a concentration of  $100\mu \mathrm{g / mL}$  into urine samples containing drug at  $+ / - 50\%$  respective drug cutoff concentrations. Testing was performed on three devices (dipcard- multi 9346T, cup 9346Z, cassette 9054). The following compounds showed no interference when tested at the  $+ / - 50\%$  drug concentration:

|  Acetaminophen | 5,5-Diphenylhydantoin | Oxalic Acid  |
| --- | --- | --- |
|  Acetylsalicylic Acid | Dopamine | Papaverine  |
|  6-Acetylmorphine | (-)-ephedrine | Perphenazine  |
|  Amoxicillin | 1-Erythromycin | Phenelzine  |
|  R-(-)-Apomorphine | Estradiol | L-Phenylephrine  |
|  L-Ascorbic Acid | Estrone | Phenylethylamine  |
|  Atropine | Ethanol | Phenylproanolamine  |
|  Baclofen | Fenofibrate | Prednisone  |
|  Benzocaine | Fentanyl | Promazine  |
|  Benzoic Acid | Fotemustine | Promethazine  |
|  Bilirubin | Furosemide | D-Propoxphene  |
|  Buprenorphine | Gemfibrozil | d,l Propranolol  |
|  Cannabidiol | Gentisic acid | d-Pseudophedrine  |
|  Carisoprodol | Glucose | Pyridoxal-5-phosphate  |
|  Cholesterol | Guaiacol glyceryl ether | Pyridoxine  |
|  Chloral hydrate | Hemoglobin | Pyrilamine  |
|  Chloramphenicol | Hydralazine | Pyrogallol  |
|  Chlordiazepoxide | Hydrocortisone | Quinidine  |
|  (+)-Chlorpheniramine | 3-Hydroxytyramine | Quinine  |
|  Chlorpromazine | (+/-)-Isoproterenol | Quinolinic Acid  |
|  Chlorprothixene | Ketamine | Riboflavin  |
|  Clofibrate | Meprobamate | Salicylic Acid  |
|  Clonidine | Methapyrilene | Sodium Chloride  |
|  Cortisone | Methylphenidate | Sulfamethazine  |
|  (-)-Cotinine | Nalidixic Acid | Sulindac  |

{8}

|  Creatine Hydrate | Naloxone | Tetracycline  |
| --- | --- | --- |
|  Creatinine | Naltrexone | Tetrahydrozoline  |
|  Cyclobenzaprine | (+)-Naproxen | Thiamine  |
|  Cyclodextrin-r | Niacinamide | Thioridazine  |
|  Cyproheptadine | Nicotinic Acid | Tramadol  |
|  Deoxycorticosterone | Nifedipine | Trifluoperazine  |
|  Dextromethorphan | 19-Norethindrone | Tryptamine  |
|  Diclofenac | Norpropoxphene | Tyamine  |
|  Diflunisal | Nortriptyline | Uric Acid  |
|  4-Dimethyl-aminoantipyrine | Noscapine | Zomepirac sodium salt  |
|  Diphenhydramine | Octopamine |   |

Evaluation of Specific Gravity and pH on test results:

To evaluate the effect of pH value on the test results, urine controls at +/-25% and +/-50% of the cutoff value were used. Testing was conducted on 3 devices (dipcard-multi 9346T, cup 9346Z, cassette 9054). The pH levels tested were 4.5, 5.5, 6.5, 7.5, and 8.5. Each test sample was tested in triplicate.

To evaluate the effect of specific gravity, urine controls at +/-25% and +/-50% of the cut-off values had specific gravities of 1.002, 1.010, 1.015, 1.020, 1.025, and 1.030, 1.040. Testing was performed with 3 devices (dipcard-multi 9346T, cup 9346Z, and cassette 9054). Each test sample was tested in triplicate.

The testing results demonstrate that varying pH's and specific gravities do not affect urine testing results around each analyte cut-off.

f. Assay cut-off:

The cut-off characterization study results can be found in the precision section of this summary. See section M.1.a.

2. Comparison studies:

a. Method comparison with predicate device:

Testing was performed at 3 point-of-care site. All four device formats (dipcard-multi 9346T, cup 9346Z, cassette 9054, dipcard-single 9058) were individually tested over a period of several days by 3 operators. Operators tested 106 (64 negative and 42 positive) unaltered clinical samples. The samples were blind labeled and randomized to each individual device prior to testing, such that operators tested both the samples and devices in a randomized fashion. The results were compared to GC/MS and are presented in the table below:

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|   |  | Negative | Negative (<50% cutoff concentration by GC/MS) | Near cutoff negative (-50% to the cutoff concentration) | Near cutoff positive (cutoff to 50%) | High Positive (>50% cutoff)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Dipcard-multi 9346T | Positive | 0 | 0 | 4 | 22 | 20  |
|   |  Negative | 23 | 19 | 18 | 0 | 0  |
|  Cassette 9054 | Positive | 0 | 0 | 4 | 22 | 20  |
|   |  Negative | 23 | 19 | 18 | 0 | 0  |
|  Cup 9346Z | Positive | 0 | 0 | 4 | 22 | 20  |
|   |  Negative | 23 | 19 | 18 | 0 | 0  |
|  Dipcard-single 9058 | Positive | 0 | 0 | 4 | 22 | 20  |
|   |  Negative | 23 | 19 | 18 | 0 | 0  |

Discordant results were the same for all 4 devices. The summary of discordant results are listed in the table below:

|  Assay | Cutoff Value (ng/mL) | Device Pos/Neg | Major metabolite present by GC/MS value (ng/mL)  |
| --- | --- | --- | --- |
|  Amphetamine | 500 | Positive | 421.6 amphetamine  |
|   |   |  Positive | 440.2 amphetamine  |
|   |   |  Positive | 450.1 amphetamine  |
|   |   |  Positive | 454.6 amphetamine  |

b. Matrix comparison:

Not applicable. The assay is intended for only one sample matrix.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

{10}

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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/DKZ/K131069](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K131069)

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