Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

K242428 · Guangzhou Decheng Biotechnology Co., Ltd. · NGL · Feb 6, 2025 · Clinical Toxicology

Device Facts

• Record ID: K242428
• Device Name: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
• Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Feb 6, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Lateral flow immunochromatographic assay; detects Fentanyl in human urine via competitive binding; urine sample migrates via capillary action; Fentanyl competes with antibody-dye conjugate for binding sites; presence of Fentanyl >1 ng/mL inhibits colored line in test region (T); control line (C) confirms proper function; intended for OTC use by lay users; provides preliminary results requiring professional confirmation; aids in identifying potential drug use.

Clinical Evidence

Bench testing only. Precision/reproducibility study conducted over 10 days with 3 lots; analytical specificity/interference testing against numerous compounds; cross-reactivity testing; effect of pH and specific gravity. Lay user study performed with 980 participants (ages 20-65) across three sites, demonstrating high agreement with LC/MS confirmed samples.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; qualitative detection; 1 ng/mL cutoff; storage 2-30°C; manual test strip/card/cup form factor; no electronic components or software.

Indications for Use

Indicated for qualitative detection of Fentanyl in human urine at 1 ng/mL cutoff. Intended for over-the-counter (OTC) use for preliminary screening. Requires confirmatory testing via GC/MS or LC/MS.

Regulatory Classification

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

• AllTest Fentanyl Rapid Test (Urine) (K231698)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K242428

B Applicant

Guangzhou Decheng Biotechnology Co., Ltd.

C Proprietary and Established Names

Fentanyl (FTY) Test System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NGL | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology |

## II Submission/Device Overview:

A Purpose for Submission:

New Device

B Measurand:

Fentanyl

C Type of Test:

lateral flow immunochromatographic assay

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K242428 - Page 2 of 13

# III Intended Use/Indications for Use:

## A Intended Use(s):

See Indications for Use below.

## B Indication(s) for Use:

Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more

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specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive..

## C Special Conditions for Use Statement(s):

OTC - Over The Counter

## D Special Instrument Requirements:

Not applicable

## IV Device/System Characteristics:

### A Device Description:

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.

Test Strip, Test card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.

### B Principle of Operation:

The Fentanyl (FTY) Test is an immunoassay based on the principle of competitive binding that is used to screen for the presence of Fentanyl in urine. It is a chromatographic absorbent device in which Fentanyl in a sample competitively combined to a limited number of antibody-dye conjugate binding sites.

During testing, the urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized FTY conjugate and a visible colored line will appear in the test region (T) to indicate a negative result. The colored line will not appear in the test region (T) if the Fentanyl level exceeds 1 ng/mL because it will saturate all the binding sites of anti-FTY antibodies and prevent the development of a distinct colored line, which indicating a positive result.

To serve as a procedure control, a colored line will always appear at the control region (C), if the test has been performed properly.

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V Substantial Equivalence Information:

A Predicate Device Name(s):
AllTest Fentanyl Rapid Test (Urine)

B Predicate 510(k) Number(s):
K231698

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K242428 | K231698 |
| --- | --- | --- |
| Device Trade Name | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | AllTest Fentanyl Rapid Test (Urine) |
| General Device Characteristic Similarities | | |
| Indications For Use | For the qualitative determination of fentanyl in human urine. | Same |
| Specimen | Urine | Same |
| Cutoff | 1 ng/mL | Same |
| Methodology | Competitive binding, lateral flow immunochromatographi c assay based on the principle of antigen antibody immunochemistry | Same |
| Storage | 2-30°C | Same |
| General Device Characteristic Differences | | |
| Intended Use | Over-The-Counter Use | Prescription Use |
| Configuration | Strip, card, and cup | Cassette |

K242428 - Page 4 of 13

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VI Standards/Guidance Documents Referenced:

Not applicable.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Precision study was performed using drug-free specimens spiked with Fentanyl at different concentrations: 0ng/mL, 0.25ng/mL, 0.5ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL. All concentrations were confirmed with LC-MS/MS. The study was performed 3 runs per day and lasted for 10 non-consecutive days by 6 laboratory professionals using three different lots of Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentanyl Urine Test Cup at the manufacturer site. 30 determinations were made for each concentration, and a total of 60 results were obtained per concentration per lot.

Dochek® Fentanyl Urine Test Strip

| Sample concentration | % of cutoff | Lot 1 | | Lot 2 | | Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| 0ng/mL | Negative | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% | 8 | 52 | 4 | 56 | 4 | 56 |
| 1ng/mL | cutoff | 38 | 22 | 34 | 26 | 34 | 26 |
| 1.25ng/mL | +25% | 54 | 6 | 58 | 2 | 56 | 4 |
| 1.5ng/mL | +50% | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% | 60 | 0 | 60 | 0 | 60 | 0 |

Dochek® Fentanyl Urine Test Card

| Sample concentration | % of cutoff | Lot 1 | | Lot 2 | | Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| 0ng/mL | Negative | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% | 6 | 54 | 2 | 58 | 4 | 56 |

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| 1ng/mL | cutoff | 32 | 28 | 34 | 26 | 34 | 26 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.25ng/mL | +25% | 58 | 2 | 58 | 2 | 54 | 6 |
| 1.5ng/mL | +50% | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% | 60 | 0 | 60 | 0 | 60 | 0 |

Dochek® Fentanyl Urine Test Cup

| Sample concentration | % of cutoff | Lot 1 | | Lot 2 | | Lot 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| 0ng/mL | Negative | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% | 4 | 56 | 2 | 58 | 2 | 58 |
| 1ng/mL | cutoff | 34 | 26 | 34 | 26 | 36 | 24 |
| 1.25ng/mL | +25% | 56 | 4 | 58 | 2 | 56 | 4 |
| 1.5ng/mL | +50% | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% | 60 | 0 | 60 | 0 | 60 | 0 |

2. Linearity:

Not applicable. This device is intended for qualitative use only.

3. Analytical Specificity/Interference:

a. Interference

Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing Fentanyl with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100μg/mL or specified concentrations are summarized in the following tables. The urine specimens were tested with 3 lots of Dochek® Fentanyl Urine Test. None of the substances listed below were shown to interfere.

Opioids compounds

| 6-Acetyl morphine | Amphetamine | Buprenorphine | Buprenorphine glucuronide |
| --- | --- | --- | --- |
| Codeine | Dextromethorphan | Dihydrocodeine | EDDP |
| EMDP | Fluoxetine | Heroin | Hydrocodone |
| Hydromorphone | Ketamine, | Levorphanol | Meperidine |

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| Methadone | Morphine | Morphine-3-glucuronide | Naloxone |
| --- | --- | --- | --- |
| Naltrexone | Norbuprenorphine | Norcodeine | Norketamine |
| Normeperidine | Normorphine | Noroxycodone | Oxycodone |
| Oxymorphone | Pentazocine (Talwin) | Pipamperone | Risperidone |
| Tapentadol | Thioridazine | Tilidine | Tramadol |
| Tramadol-O-Desmethyl | Tramadol-N-Desmethyl | Trazodone | |

Commonly ingested medications or substances

| Acetaminophen | Doxepin (50 ug/mL) | Nortriptyline (25 ug/mL) |
| --- | --- | --- |
| Acetone (1000 mg/dL) | Ecgonine methyl ester | Noscapine |
| Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid |
| Acetylsalicylic acid | Erythromycin | Octopamine |
| Albumin (100 mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) |
| Albuterol | Fenoprofen | Oxazepam |
| Aminopyrine | Fluphenazine | Oxolinic acid |
| Amitriptyline (35 ug/mL) | Furosemide | Oxymetazoline |
| Amobarbital | Galactose (10 mg/dL) | Papaverine |
| Amoxicillin | Gamma Globulin (500mg/dL) | Penicillin G |
| Ampicillin | Gentisic acid | Perphenazine |
| Apomorphine | Glucose (3000 mg/dL) | Phencyclidine |
| Ascorbic acid | Hemoglobin | Phenelzine |
| Aspartame | DL-Tyrosine | Prednisone |
| Atropine | Hydralazine | Propoxyphene (50 ug/mL) |
| Benzilic acid | Hydrochlorothiazide | Propranolol |
| Benzoic acid | Hydrocortisone | Pseudoephedrine |
| Benzoylecgonine | Hydroxytyramine | Quinine |
| Bilirubin | Ibuprofen | Ranitidine |
| Boric Acid (1%) | Imipramine (30 ug/mL) | Riboflavin (7.5 mg/dL) |
| Bupropion (50 ug/mL) | Isoproterenol | Salicylic acid |
| Caffeine | Isoxsuprine | Secobarbital |
| Carbamazepine | Ketoprofen | Serotonin (5-Hydroxytyramine) |
| Chloral hydrate | Labetalol | Sulfamethazine |
| Chloramphenicol | Lidocaine (50 ug/mL) | Sulindac |
| Chlorothiazide | Loperamide | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorpromazine | Maprotiline (50 ug/mL) | Tetrahydrocortisone 3-acetate |
| Cholesterol | Meprobamate | Tetrahydrozoline |
| Clomipramine (50 ug/mL) | Methapyrilene (10 ug/mL) | Thiamine |
| Clonidine | Methaqualone (50 ug/mL) | Triamterene |
| Cortisone | Methoxyphenamine | Trifluoperazine |
| Cotinine | Metronidazole (300 ug/mL) | Trimethoprim |
| Creatinine | N-Acetylprocainamide | Tyramine |
| Cyclobenzaprine (10 ug/mL) | NaCl (4000 mg/dL) | Urea (2000 mg/dL) |
| Deoxycorticosterone | Nalidixic acid | Uric acid |
| Desipramine (50 ug/mL) | Naproxen | Valproic acid (250 ug/mL) |
| Diclofenac | Niacinamide | Venlafaxine |
| Diflunisal | Nicotine (10 ug/mL) | Verapamil |
| Digoxin | Nifedipine | Zomepirac |
| Diphenhydramine | Norethindrone | β-Estradiol |
| DL-Tryptophan | Phenobarbital | |

K242428 - Page 7 of 13

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# Cross-Reactivity

The following table lists the lowest concentration (ng/mL) of compounds that gave a positive result on the Dochek® Fentanyl Urine Test at the tested concentrations shown.

| Compound | Lowest Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Acetyl fentanyl | 1.0 | 100 |
| Acetyl norfentanyl | 10,000 | 0.01 |
| Acrylfentanyl | 1.5 | 66.7 |
| Butyryl fentanyl | 2.5 | 40 |
| Carfentanil | 50 | 2 |
| (±)-3-cis-methylfentanyl | 50 | 2 |
| 4-Fluoro-isobutyrylfentanyl | 5 | 20 |
| Furanyl fentanyl | 2.8 | 35.7 |
| ω-1-Hydroxyfentanyl | 20,000 | 0.005 |
| (±) β-hydroxythiofentanyl | 1.5 | 66.7 |
| Isobutyryl fentanyl | 1.0 | 100 |
| Ocfentanil | 1.8 | 55.6 |
| Para-fluorobutyrylfentanyl (p-FBF) | 4 | 25 |
| Para-fluoro fentanyl | 3 | 33.3 |
| Sufentanil | 20 | 5 |
| Valeryl fentanyl | 5 | 20 |
| Alfentanil | 5,000 | 0.02 |
| Despropionyl fentanyl (4-ANPP) | 20,000 | 0.005 |
| Remifentanil | 10,000 | 0.01 |
| Norcarfentanil | 10,000 | 0.01 |
| Norfentanyl | 10,000 | 0.01 |

# Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000, 1.005, 1.010, 1.0154, 1.02, 1.025, 1.030, and 1.035 specific gravity or urine samples with pH 4, 5, 6, 7, 8, and 9 were spiked with Fentanyl targets at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of device. Results were all positive for samples at and above +50% Cut-Offs and all negative for samples at and below -50% Cut-Offs.

4. Assay Reportable Range:

Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

K242428 - Page 8 of 13

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6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Not applicable.

## B Comparison Studies:

1. Method Comparison with Predicate Device:

80 clinical urine specimens were analyzed by LC/MS and by 3 lots of the corresponding Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentanyl Urine Test Cup. Samples were divided by concentration into five categories: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. The study was conducted by 3 laboratory professionals at the manufacturer site. Results were as follows.

Dochek® Fentanyl Urine Test Strip

| | | Negative | Low Negative by LC/MS (Less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (Greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |
| Viewer 2 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |
| Viewer 3 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |

Analysis of Discordant Results (Strip)

| Operator | Sample ID | Test Result | LC/MS Result (ng/mL) |
| --- | --- | --- | --- |
| Viewer 1 | F046-6 | Positive | 0.945 |
| | F062-5 | Negative | 1.012 |
| Viewer 2 | F045-3 | Positive | 0.894 |
| | F062-6 | Negative | 1.012 |
| | F060-3 | Positive | 0.920 |

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| Viewer 3 | F088-1 | Negative | 1.077 |
| --- | --- | --- | --- |

Dochek® Fentanyl Urine Test Card

| | | Negative | Low Negative by LC/MS (Less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (Greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |
| Viewer 2 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |
| Viewer 3 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |

Analysis of Discordant Results (Card)

| Operator | Sample ID | Test Result | LC/MS Result (ng/mL) |
| --- | --- | --- | --- |
| Viewer 1 | F043-6 | Positive | 0.885 |
| | F062-2 | Negative | 1.012 |
| Viewer 2 | F055-6 | Positive | 0.894 |
| | F083-4 | Negative | 1.020 |
| Viewer 3 | F046-2 | Positive | 0.945 |
| | F062-1 | Negative | 1.012 |

Dochek® Fentanyl Urine Test Cup

| | | Negative | Low Negative by LC/MS (Less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (Greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |
| Viewer 2 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |
| Viewer 3 | Positive | 0 | 0 | 1 | 26 | 13 |
| | Negative | 10 | 14 | 15 | 1 | 0 |

Analysis of Discordant Results (Cup)

| Operator | Sample ID | Test Result | LC/MS Result (ng/mL) |
| --- | --- | --- | --- |

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K242428 - Page 11 of 13

| Viewer 1 | F055-8 | Positive | 0.894 |
| --- | --- | --- | --- |
| | F049-8 | Negative | 1.044 |
| Viewer 2 | F046-4 | Positive | 0.945 |
| | F049-9 | Negative | 1.044 |
| Viewer 3 | F060-9 | Positive | 0.920 |
| | F062-4 | Negative | 1.012 |

2. **Matrix Comparison:**

Not applicable.

C **Clinical Studies:**

1. **Clinical Sensitivity:**

Not applicable.

2. **Clinical Specificity:**

Not applicable.

3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**

**Lay User Study**

A lay user study was performed at three intended user sites with 980 lay persons. They had diverse educational and professional backgrounds and ranged in age from 20 to 65 years. Urine samples were prepared at the following concentrations: 0ng/mL, 0.25 ng/mL 0.5ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL cutoff by spiking target drug fentanyl into drug free urine specimens. The concentrations of samples were confirmed by LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the English package insert, 1 blind labeled sample, and a device. Results were as follows:

Lay user study date of Dochek® Fentanyl Urine Test Strip:

| Sample concentration | % of cutoff | Number of samples | Layer user Results | | Agreement (%) |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| 0ng/mL | Negative | 40 | 0 | 40 | 100% |
| 0.25ng/mL | -75%cutoff | 40 | 0 | 40 | 100% |
| 0.5ng/mL | -50%cutoff | 40 | 0 | 40 | 100% |
| 0.75ng/mL | -25%cutoff | 40 | 2 | 38 | 95% |

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Lay user study date of Dochek® Fentanyl Urine Test Card (Cassette method):

| Sample concentration | % of cutoff | Number of samples | Layer user Results | | Agreement (%) |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| 0ng/mL | Negative | 30 | 0 | 30 | 100% |
| 0.25ng/mL | -75%cutoff | 30 | 0 | 30 | 100% |
| 0.5ng/mL | -50%cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/mL | -25%cutoff | 30 | 1 | 29 | 96.7% |
| 1.25ng/mL | +25%cutoff | 30 | 28 | 2 | 93.3% |
| 1.5ng/mL | +50%cutoff | 30 | 30 | 0 | 100% |
| 1.75ng/mL | +75%cutoff | 30 | 30 | 0 | 100% |

Lay user study date of Dochek® Fentanyl Urine Test Card (Dip card method):

| Sample concentration | % of cutoff | Number of samples | Layer user Results | | Agreement (%) |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| 0ng/mL | Negative | 30 | 0 | 30 | 100% |
| 0.25ng/mL | -75%cutoff | 30 | 0 | 30 | 100% |
| 0.5ng/mL | -50%cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/mL | -25%cutoff | 30 | 2 | 28 | 93.3% |
| 1.25ng/mL | +25%cutoff | 30 | 29 | 1 | 96.7% |
| 1.5ng/mL | +50%cutoff | 30 | 30 | 0 | 100% |
| 1.75ng/mL | +75%cutoff | 30 | 30 | 0 | 100% |

Lay user study date of Dochek® Fentanyl Urine Test Cup:

| Sample concentration | % of cutoff | Number of samples | Layer user Results | | Agreement (%) |
| --- | --- | --- | --- | --- | --- |
| | | | Positive | Negative | |
| 0ng/mL | Negative | 40 | 0 | 40 | 100% |
| 0.25ng/mL | -75%cutoff | 40 | 0 | 40 | 100% |

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| 0.5ng/mL | -50%cutoff | 40 | 0 | 40 | 100% |
| --- | --- | --- | --- | --- | --- |
| 0.75ng/mL | -25%cutoff | 40 | 3 | 37 | 92.5% |
| 1.25ng/mL | +25%cutoff | 40 | 37 | 3 | 92.5% |
| 1.5ng/mL | +50%cutoff | 40 | 40 | 0 | 100% |
| 1.75ng/mL | +75%cutoff | 40 | 40 | 0 | 100% |

D Clinical Cut-Off:
Not applicable

E Expected Values/Reference Range
Not applicable

VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

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

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