ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

K243064 · Eterbio, Inc. · NGL · Nov 20, 2024 · Clinical Toxicology

Device Facts

• Record ID: K243064
• Device Name: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
• Applicant: Eterbio, Inc.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Nov 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: Drug (Identifier) Calibrator Cut-off Level Fentanyl (FYL) Fentanyl 1ng/mL Norfentanyl (NFYL) Norfentanyl 5ng/mL The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method. The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: Drug (Identifier) Calibrator Cut-off Level Fentanyl (FYL) Fentanyl 1ng/mL Norfentanyl (NFYL) Norfentanyl 5ng/mL The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.

Device Story

Lateral flow immunoassay for qualitative detection of fentanyl and norfentanyl in human urine; utilizes competitive binding principle. Urine sample migrates via capillary action; target drugs below cutoff do not saturate antibody-coated particles, allowing binding to immobilized drug conjugate and formation of visible colored test line. Drug levels exceeding cutoff saturate antibodies, preventing test line formation. Control line confirms proper wicking. Used in home or clinical settings; operated by lay users or professionals. Provides preliminary screening results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits patient by providing rapid, accessible preliminary screening for fentanyl exposure.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing: precision studies (10 days, 6 tests/day/lot), interference testing with various physiological/pathological substances, specificity/cross-reactivity analysis, and method comparison against LC/MS (80 clinical samples). Lay-user study (n=140) demonstrated 95-100% accuracy across various concentrations relative to cutoffs.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Colloidal gold-labeled antibodies. Form factor: Test panel. Storage: 2-30°C. No electronic components or software. Qualitative visual readout.

Indications for Use

Indicated for qualitative detection of Fentanyl and Norfentanyl in human urine. Intended for OTC home use or professional screening. Provides preliminary results; requires GC/MS or LC/MS confirmation.

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

• Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969)

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

K243064

B Applicant

Eterbio, Inc.

C Proprietary and Established Names

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

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/Norfentanyl

C Type of Test:

Qualitative

## III Intended Use/Indications for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K243064 - Page 2 of 12

# A Intended Use(s):

See Indications for Use below.

# B Indication(s) for Use:

The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:

| Drug (Identifier) | Calibrator | Cut-off Level |
| --- | --- | --- |
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |

The test is available as a single panel for FYL or NFYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.

The ETERBIO Fentanyl/Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:

| Drug (Identifier) | Calibrator | Cut-off Level |
| --- | --- | --- |
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |

The test is available as a single panel for FYL or NFYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.

# C Special Conditions for Use Statement(s):

OTC - Over the Counter

# D Special Instrument Requirements:

Not applicable.

# IV Device/System Characteristics:

# A Device Description:

The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay designed for the qualitative detection of Fentanyl (FTY) and Norfentanyl (NFTY) in human urine. The test is available as a single panel for FTY or NFTY, or as a dual panel that detects both analytes. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.

# B Principle of Operation:

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The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay based on the principle of competitive binding. During the testing process, the urine specimen migrates through the test strip via capillary action. If the concentration of the target drug in the specimen is below the specified cutoff level, the binding sites of the antibody-coated particles in the test device remain unsaturated. As a result, these antibody-coated particles are captured by the immobilized drug conjugate, leading to the appearance of a visible colored line in the test line region.

However, if the drug concentration exceeds the cutoff level, the drug will fully saturate the binding sites of the anti-drug antibodies, preventing the formation of a colored line in the test line region.

A procedural control is built into the test, indicated by the consistent appearance of a colored line in the control line region. This confirms that the appropriate volume of specimen has been added and that the membrane wicking process has occurred correctly.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

B Predicate 510(k) Number(s):

K241969

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K243064 | K241969 |
| --- | --- | --- |
| Device Trade Name | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the qualitative determination of fentanyl in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the | Same |

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VI Standards/Guidance Documents Referenced:

None Referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off for each target drug. These samples were prepared by spiking fentanyl or norfentanyl in negative urine samples. Each fentanyl or norfentanyl concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Three operators tested blinded urine samples over a 10-day period in randomized order with six tests per day per concentration per operator (2 replicates x 3 lots per day x 9 concentrations) for a total of 54 tests per day per operator.

Fentanyl

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 27+/33- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 26+/34- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/1+ | 26+/34- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |

Norfentanyl

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

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| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/2+ | 33+/27- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 34+/26- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 34+/26- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |

2. Linearity:

Not applicable. These devices are intended for qualitative use only.

3. Analytical Specificity/Interference:

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drug fentanyl /norfentanyl urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100μg/mL or specified concentrations are summarized in the following tables.

| Acetaminophen | Ecgonine methyl ester | Oxolinic acid |
| --- | --- | --- |
| Acetone (1000 mg/dL) | Ephedrine | Oxymetazoline |
| Acetophenetidin | Erythromycin | Papaverine |
| Acetylsalicylic acid | Estradiol | Penicillin G |
| Albumin (100 mg/dL) | Estrone | Perphenazine |
| Albuterol | Ethanol (1%) | Phencyclidine |
| 7-Aminonitrazepam | Fenfluramine | Phenelzine |
| Amitriptyline | Fenofibrate | Phenobarbital |
| Amlodipine besylate | Fenoprofen | Phentermine |
| Amobarbital | Fluphenazine | Phenylethylamine |
| Amoxicillin | Fotemustine | Prednisone |
| Ampicillin | Furosemide | Promazine |
| Apomorphine | Galactose | Promethazine |
| Ascorbic acid | γ-Globulin (500 mg/dL) | Propoxyphene |
| Aspartame | Gemfibrozil | Propranolol |
| Aspirin | Gentisic acid | Pseudoephedrine |
| Atropine | Glucose (3000 mg/dL) | Pyridoxine |
| Baclofen | Guaiacolglyceryl ether | Pyrilamine |
| Benzilic acid | Hemoglobin | Pyrogallol |
| Benzocaine | Hexobarbital | Quinidine |
| Benzoic acid | Hydralazine | Quinine |
| Benzoylecgonine | Hydrochlorothiazide | Quinolinic Acid |
| Benzylpiperazine | Hydrocortisone | Ranitidine |
| Bilirubin | Hydroxybutyric Acid | Riboflavin |
| Boric Acid (1%) | Ibuprofen | Salicylic acid |
| Bromo-2,5,Dimethoxyphenethylamine | Imipramine | Secobarbital |
| Bupropion | Isoproterenol | Serotonin |
| Caffeine | Isoxsuprine (10 μg/mL) | Sodium Azide |
| Carbamazepine | Ketoprofen | Sulfamethazine |
| Carisoprodol | Labetalol | Sulindac |

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| Cetirizine | Lamotrigine | Tetracycline |
| --- | --- | --- |
| Chloral hydrate | Lidocaine | Tetrahydrocortisone3-(β-glucuronide) |
| Chloramphenicol | Lisinopril | Tetrahydrocortisone 3-acetate |
| Chlordiazepoxide | Loperamide | Tetrahydrozoline |
| Chlorothiazide | Loratidine | Thiamine |
| Chlorpheniramine | Maprotiline | Triamterene |
| Chlorpromazine | Meperidine | Trifluoperazine |
| Cholesterol | Meprobamate | Trifluoromethylphenyl-piperazine |
| Clofibrate | Methapyrilene | Trimethoprim |
| Clomipramine | Methaqualone | Tryptamine |
| Clonidine | Methoxyphenamine | Tyramine |
| Cortisone | Methylphenidate | Urea (2000 mg/dL) |
| Cotinine | Metoprolol | Uric acid |
| Creatine Hydrate | Metronidazole | Valproic acid (250 μg/mL) |
| Creatinine | N-Acetylprocainamide | Venlafaxine |
| Cyclobenzaprine | N-desmethyl Tapentadol | Verapamil |
| γ-Cyclodextrin | Nacl (4000 mg/dL) | Zolpidem |
| Cyproheptadine | Nalidixic acid | Zomepirac |
| Demoxepam | Naproxen | 7-Aminoflunitrazepam |
| Deoxycorticosterone | Niacinamide | Metformin |
| Desipramine | Nicotine | Norpseudoephedrine |
| Diclofenac | Nicotinic Acid | Oxazepam Glucuronide |
| Diflunisal | Nifedipine | Lorazepam Glucuronide |
| Digoxin | Norethindrone | LSD |
| Dimethyl-aminoantipyrine | Norpropoxyphene | THC |
| Diphenhydramine | Nortriptyline | L-thyroxine |
| Diphenylhydantoin | Noscapine | Dextromethorphan |
| DL-Tryptophan | O-Hydroxyhippuric acid | Ketamine |
| DL-Tyrosine | Octopamine | Thioridazine |
| Dopamine (Hydroxytyramine) | Oxalic acid (100mg/dL) | Naloxone |
| Doxepin | Oxazepam | Naltrexone |
| Aminopyrine | | |

## Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested in analyte free urine samples using three batches of the device. The lowest concentration that caused a positive result for each compound are listed below. If no cross reactivity was observed the highest concentration tested is shown.

| Fentanyl (Cutoff=1ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |

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| (±) β-hydroxythiofentanyl | 2.8 | 35.7% |
| --- | --- | --- |
| (±)-3-cis-methyl fentanyl | 5 | 20% |
| 4-Fluoro-isobutyryl fentanyl | 3 | 33.3% |
| 9-Hydroxy Risperidone | 10000 | 0.01% |
| Acetyl fentanyl | 1.2 | 83.3% |
| Acetyl norfentanyl | 10000 | 0.01% |
| Acrylfentanyl | 1.2 | 83.3% |
| Alfentanil | 100000 | 0.001% |
| Butyryl fentanyl | 1.6 | 62.5% |
| Carfentanil | 500 | 0.20% |
| Despropionyl fentanyl (4-ANPP) | 50000 | 0.002% |
| Fentanyl | 1 | 100% |
| Furanyl fentanyl | 1.75 | 57.1% |
| Isobutyryl fentanyl | 1.5 | 66.7% |
| Labetalol Hydrochloride | 100000 | 0.001% |
| MT-45 | 10000 | 0.01% |
| Norcarfentanil | 10000 | 0.01% |
| Norfentanyl | 5000 | 0.02% |
| Ocfentanil | 1.5 | 66.7% |
| Para-fluoro fentanyl | 3 | 33.3% |
| Para-fluorobutyryl fentanyl | 3 | 33.3% |
| Remifentanil | 10000 | 0.01% |
| Risperidone | 1000 | 0.1% |
| Sufentanil | 625 | 0.16% |
| Thienyl Fentanyl | 1000 | 0.1% |
| Trans-d, I 3-Methylfentanyl | 1000 | 0.1% |
| Trazodone | 1000 | 0.1% |
| U-47700 | 100000 | 0.001% |
| Valeryl fentanyl | 2.5 | 40 % |
| ω- 1-Hydroxyfentanyl | 20000 | 0.005% |
| Norfentanyl (Cutoff=5ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| (±) β-hydroxythiofentanyl | 7 | 71.4% |
| (±)-3-cis-methyl fentanyl | 10 | 50% |
| 4-Fluoro-isobutyryl fentanyl | 25 | 20% |
| 9-Hydroxy Risperidone | 10000 | 0.05% |
| Acetyl fentanyl | 10 | 50% |

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The following opioids compounds were tested at a concentration of 100ug/mL. Negative results were obtained for all these compounds. There is no cross-reactivity for these compounds using the ETERBIO Device.

| 6-Acetyl morphine | Naloxone |
| --- | --- |
| Amphetamine | Naltrexone |
| Buprenorphine | Norbuprenorphine |
| Buprenorphineglucuronide | Norcodeine |
| Codeine | Norketamine |
| Dextromethorphan | Normeperidine |
| Dihydrocodeine | Normorphine |
| EDDP | Noroxycodone |
| EMDP | Oxycodone |
| Fluoxetine | Oxymorphone |
| Heroin | Pentazocine (Talwin) |
| Hydrocodone | Pipamperone |
| Hydromorphone | Tapentadol |
| Ketamine | Thioridazine |
| Lipid | Lipid |
| Methadone | Methadone |
| Norepinephrine | Norepinephrine |
| Pentazocine | Pentazocine |
| Phenpropoxime | Phenpropoxime |
| Phenpropoxime | Phenpropoxime |
| Phenpropoxime | Phenpropoxime |
| Phenpropoxime | Phenpropoxime |
| Phenpropoxime | Phenpropoxime |
| Phenpropoxime | Phenpropoxime |

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| Levorphanol | Tilidine |
| --- | --- |
| Meperidine | Tramadol |
| Methadone | Tramadol-O-Desmethyl |
| Morphine | Tramadol-N-Desmethyl |
| Morphine-3-glucuronide | |

## Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000, 1.003, 1.008, 1.014, 1.018, 1.02, 1.022, 1.025, 1.028, 1.030, 1.032, and 1.035 specific gravity or urine samples with pH 4, 5, 6, 7, 8, and 9 were spiked with targets fentanyl and norfentanyl 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.

## Read Time Study:

Fentanyl and Norfentanyl Standards with concentrations of -50% cutoff, +50% cutoff, and drug free urine were tested using three lots of the device and read at 10 time points (i.e. 3rd, 4th, 5th, 10th, 15th, 20th, 25th, 30th, 35th, 40th minutes) by three different operators according to procedures in the product insert. All the results were consistent with the required reading time at 5 minutes and not more than 10 minutes.

## 4. Assay Reportable Range:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section VII.A.1 above.

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

All drug calibrators of the device are traceable to available commercial reference materials.

## 6. Detection Limit:

Characterization of how the device performs at low concentrations appears in the precision section, VII.A.1, above.

## 7. Assay Cut-Off:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, VII.A.1, above.

## B Comparison Studies:

### 1. Method Comparison with Predicate Device:

Method comparison studies for the ETERBIO Fentanyl/Norfentanyl Urine Rapid Test Panel were performed by three different operators. Operators ran 80 (40 negative and 40 positive)

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unaltered clinical samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below.

Fentanyl

| | | 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 the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 8 | 16 | 14 | 1 | 0 |
| Operator 2 | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 8 | 16 | 15 | 2 | 0 |
| Operator 3 | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 8 | 16 | 14 | 0 | 0 |

Discordant Results

| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
| --- | --- | --- | --- |
| Operator 1 | MF046 | 0.986 | + |
| Operator 1& Operator 3 | MF079 | 0.937 | + |
| Operator 2 | MF062 | 0.925 | + |
| Operator 3 | MF058 | 0.914 | + |
| Operator 2 | MF016 | 1.02 | - |
| Operator 1 | MF060 | 1.01 | - |
| Operator 2 | MF063 | 1.09 | - |

Norfentanyl

| | | 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 the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 8 | 17 | 14 | 1 | 0 |
| Operator 2 | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 8 | 17 | 14 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 20 | 20 |

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| Operator 3 | Negative | 8 | 17 | 14 | 0 | 0 |
| --- | --- | --- | --- | --- | --- | --- |

Discordant Results

| Operator | Sample ID | LC/MS Result (ng/mL) | Rapid Test Result |
| --- | --- | --- | --- |
| Operator 1 | MC083 | 5.2 | - |
| Operator 2 | MC019 | 5.25 | - |
| Operator 1 & Operator 2 | MC048 | 4.85 | + |
| Operator 3 | MC009 | 4.68 | + |

2. Matrix Comparison:

Not applicable. These devices are for use with urine samples only.

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):

A lay user study was performed at three testing sites representative of intended use sites with 140 lay users. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Three lots of the device were used in the study. Urine samples were prepared at the following concentrations: -100%, +/-75%, +/-50%, +/-25% of the cut-offs by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:

| % of Cutoff | Number | Fentanyl Concentration | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | of samples | by LC/MS (ng/mL) | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100.0% |
| -75% Cutoff | 20 | 0.25 | 0 | 20 | 100.0% |
| -50% Cutoff | 20 | 0.52 | 0 | 20 | 100.0% |
| -25% Cutoff | 20 | 0.75 | 1 | 19 | 95.0% |
| +25% Cutoff | 20 | 1.30 | 20 | 0 | 100.0% |

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| +50% Cutoff | 20 | 1.55 | 20 | 0 | 100.0% |
| --- | --- | --- | --- | --- | --- |
| +75% Cutoff | 20 | 1.65 | 20 | 0 | 100.0% |
| % of Cutoff | Number of samples | Norfentanyl Concentration by LC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100.0% |
| -75% Cutoff | 20 | 1.27 | 0 | 20 | 100.0% |
| -50% Cutoff | 20 | 2.54 | 0 | 20 | 100.0% |
| -25% Cutoff | 20 | 3.78 | 0 | 20 | 100.0% |
| +25% Cutoff | 20 | 6.55 | 20 | 0 | 100.0% |
| +50% Cutoff | 20 | 7.85 | 20 | 0 | 100.0% |
| +75% Cutoff | 20 | 8.95 | 20 | 0 | 100.0% |

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on the package insert and the score revealed a reading grade level of less than 7.

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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