← Product Code [NGL](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NGL) · K193480

# BIOEASY Multi-Drug Test Cup (K193480)

_Shenzhen Bioeasy Biotechnology Co., Ltd. · NGL · Jan 31, 2020 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NGL/K193480

## Device Facts

- **Applicant:** Shenzhen Bioeasy Biotechnology Co., Ltd.
- **Product Code:** [NGL](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NGL.md)
- **Decision Date:** Jan 31, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3650
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

## Device Story

Single-use, lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine; cup format. Operates via competitive binding: target drugs in urine compete with immobilized drug-conjugate for binding sites on monoclonal mouse antibody-coated particles. Absence of colored line at test region indicates drug concentration above cutoff; presence of line indicates concentration below cutoff. Control line confirms proper test performance. Used in point-of-care or home settings by lay users. Provides preliminary results; requires confirmation by GC/MS or LC/MS. Aids in identifying potential drug presence for clinical consideration.

## Clinical Evidence

No clinical studies performed. Evidence consists of bench testing (precision, interference, specificity, stability, effect of pH/specific gravity) and a lay-user study. Lay-user study included 300 participants (ages 18 to >50) across three sites, demonstrating high accuracy (90-100%) across various drug concentrations relative to LC/MS-confirmed samples. Method comparison study performed in-house with 80 clinical samples per drug, showing high concordance with LC/MS results.

## Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use cup format. No energy source required. Stable at 4-30°C for 24 months. No specific materials or ASTM standards cited.

## 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

- [K182530](/device/K182530.md)

## 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

K193480

B Applicant

Shenzhen Bioeasy Biotechnology Co., Ltd.

C Proprietary and Established Names

BIOEASY Multi-Drug Test Cup

D Regulatory Information

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  NFT Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91)  |
|  NFW Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91)  |
|  NFY Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91)  |
|  NGG Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91)  |
|  NGI Morphine | II | 21 CFR § 862.3640, Morphine Test System | Toxicology (91)  |
|  NFV Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91)  |
|  NGL Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91)  |
|  PTH Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91)  |
|  NGL Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91)  |
|  NGG Methylenedioxy-methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91)  |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  NGM
Phencyclidine | unclassified | Enzyme Immunoassay
Phencyclidine | Toxicology (91)  |
|  PTG
Methadone | II | 21 CFR § 862.3620, Methadone
Test System | Toxicology (91)  |
|  QAW
Nortriptyline | II | 21 CFR, 862.3910 Tricyclic
Antidepressant Drugs Test System | Toxicology (91)  |
|  QBF
Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene
Test System | Toxicology (91)  |

## II Submission/Device Overview:

### A Purpose for Submission:

Modification of a previously cleared device (k182530) to add a Morphine (2000 ng/mL) test strip.

### B Measurand:

Morphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline, d-Propoxyphene.

### C Type of Test:

Qualitative, immunochromatographic assay

## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for Use:

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug Identifier Cut-off Level

Amphetamine 1000 ng/mL

Oxazepam 300 ng/mL

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Cocaine 300 ng/mL
Marijuana 50 ng/mL
Methamphetamine 1000 ng/mL
Morphine 300 ng/mL or 2000 ng/mL
Oxycodone 100 ng/mL
Secobarbital 300 ng/mL
Buprenorphine 10 ng/mL
Methylenedioxy-methamphetamine 500 ng/mL
Phencyclidine 25 ng/mL
Methadone 300 ng/mL
Nortriptyline 1000 ng/mL
d-Propoxyphene 300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

C Special Conditions for Use Statement(s):
OTC - Over The Counter
For in vitro diagnostic use only.

D Special Instrument Requirements:
None. This is an assay only device.

IV Device/System Characteristics:

A Device Description:

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The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

## B Principle of Operation:

The BIOEASY Multi-Drug Test Cup tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

## V Substantial Equivalence Information:

A Predicate Device Name(s):

BIOEASY Multi-Drug Test Cup

B Predicate 510(k) Number(s):

K182530

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K193480 | K182530  |
| --- | --- | --- |
|  Device Trade Name | BIOEASY Multi-Drug Test Cup | Same  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | For the qualitative determination of drugs of abuse in human urine. | Same  |
|  Calibrator and Cut-off Values | Amphetamine (AMP): 1000 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 300 ng/mL
Marijuana (THC): 50 ng/mL
Methamphetamine (MET): 1000 ng/mL
Morphine (MOR): 300 ng/mL | Same  |

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K193480 - Page 5 of 14

|   | Oxycodone (OXY): 100 ng/mL
Secobarbital (BAR): 300 ng/mL
Buprenorphine (BUP): 10 ng/mL
Methylenedioxy-methamphetamine (MDMA): 500 ng/mL
Phencyclidine (PCP): 25 ng/mL
Methadone (MTD): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Propoxyphene (PPX): 300 ng/mL |   |
| --- | --- | --- |
|  Test Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same  |
|  Test Type | Qualitative | Same  |
|  Specimen Type | Human Urine | Same  |
|  Intended Use | For over-the-counter use | Same  |
|  Configurations | Cup format | Same  |
|  General Device Characteristic Differences |  |   |
|  Calibrator and Cut-off Values | Morphine (MOR): 300 ng/mL or 2000 ng/mL | Morphine (MOR): 300 ng/mL  |

VI Standards/Guidance Documents Referenced:

None identified.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Combined precision and cutoff studies were carried out using samples at the analyte concentrations: -100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff of Morphine 2000 ng/mL. These samples were prepared by spiking morphine in negative urine samples to achieve final concentration of 4080 ng/mL, 3560 ng/mL, 3065 ng/mL, 2465 ng/mL, 2025 ng/mL, 1480 ng/mL, 970 ng/mL, 455 ng/mL and 0 ng/mL morphine as measured by LC/MS. All sample aliquots were blinded and labeled by the person who prepared the samples and did not participate in sample testing. Each sample was tested by three operators in two runs per day for 25 days per device lot in a randomized order using three lots of the candidate device. The results obtained are summarized in the following table for morphine 2000 ng/mL. The precision data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine (300), Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine,

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Phencyclidine, Methadone, Nortriptyline and Propoxyphene were previously reported in k182530.

Morphine 2000 ng/mL

|  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 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |

2. Linearity:

Not applicable, these devices are intended for qualitative use only.

3. Analytical Specificity/Interference:

Interference Studies:

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and urine with concentrations at 25% below (morphine 1500 ng/mL) and 25% above (morphine 2500 ng/mL) the cutoff level of 2000 ng/mL morphine. These urine samples were tested using three lots of the device by three operators. Compounds that showed no interference at a concentration of 100 µg/mL (albumin was tested at 100 mg/dL, ethanol at 1%, bilirubin at 500 µg/mL) are summarized in the following tables. The interferences data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine (300), Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were previously reported in k182530.

|  Acetaminophen | β-Estradiol | Oxalic acid  |
| --- | --- | --- |
|  Acetophenetidin | Erythromycin | Oxolinic acid  |
|  N-Acetylprocainamide | Ethanol | Oxymetazoline  |
|  Acetylsalicylic acid | Fenoprofen | Papaverine  |
|  Albumin (100 mg/dL) | Furosemide | Penicillin G  |
|  Aminopyrine | Gentisic acid | Perphenazine  |
|  Amoxicillin | Hemoglobin | Phenelzine  |
|  Ampicillin | Hydralazine | Prednisone  |
|  Apomorphine | Hydrochlorothiazide | (±)-Propranolol  |
|  Ascorbic acid | Hydrocortisone | Pseudoephedrine  |
|  Aspartame | O-Hydroxyhippuric acid | Quinine  |
|  Atropine | 3-Hydroxytyramine | Ranitidine  |
|  Benzilic acid | Ibuprofen | Salicylic acid  |
|  Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine)  |
|  Bilirubin | Isoxsuprine | Sulfamethazine  |
|  Chloral hydrate | Ketamine | Sulindac  |
|  Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide)  |
|  Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate  |

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K193480 - Page 7 of 14

|  Chlorpromazine | Loperamide | Tetrahydrozoline  |
| --- | --- | --- |
|  Cholesterol | Meperidine | Thiamine  |
|  Clonidine | Meprobamate | Thioridazine  |
|  Cortisone | Methoxyphenamine | Triamterene  |
|  (-)-Cotinine | Nalidixic acid | Trifluoperazine  |
|  Creatinine | Naloxone | Trimethoprim  |
|  Deoxycorticosterone | Naltrexone | DL-Tryptophan  |
|  Dextromethorphan | Naproxen | Tyramine  |
|  Diclofenac | Niacinamide | DL-Tyrosine  |
|  Diflunisal | Nifedipine | Uric acid  |
|  Digoxin | Norethindrone | Verapamil  |
|  Diphenhydramine | Noscapine | Zomepirac  |
|  Ecgonine methyl ester | (±)-Octopamine |   |

## Cross-Reactivity Studies:

Cross-reactivity studies were performed to determine whether the drug metabolites of morphine or structurally related drugs cross-react with the candidate device. These compounds added at 100 µg/mL concentration in pooled negative human urine samples. Compounds that tested positive were serially diluted until a negative result was observed. The minimum concentration of each compound producing a positive result is shown in the table below. The cross-reactivity data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine (300), Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in k182530.

|  Opiate
(Morphine, Cut-off=2000 ng/mL) | Result | % Cross-Reactivity  |
| --- | --- | --- |
|  Morphine | Positive at 2000 ng/mL | 100%  |
|  Codeine | Positive at 200 ng/mL | 1000%  |
|  Ethylmorphine | Positive at 2500ng/mL | 80%  |
|  Hydrocodone | Negative at 100000 ng/mL | <2%  |
|  Hydromorphone | Positive at 4000 ng/mL | 50%  |
|  Levorphanol | Negative at 100000 ng/mL | <2%  |
|  6-Acetylmorphine | Positive at 3000 ng/mL | 67%  |
|  Morphine-3-β-D-glucuronide | Positive at 6000 ng/mL | 33%  |
|  Normorphine | Negative at 100000 ng/mL | <2%  |
|  Oxycodone | Negative at 100000 ng/mL | <2%  |
|  Oxymorphone | Negative at 100000 ng/mL | <2%  |
|  Procaine | Negative at 100000 ng/mL | <2%  |
|  Thebaine | Negative at 100000 ng/mL | <2%  |
|  Heroin | Positive at 3500 ng/mL | 57%  |

Effect of Urine Specific Gravity and Urine pH:

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To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with morphine at 25% below (morphine 1500 ng/mL) and 25% above (morphine 2500 ng/mL) the cutoff of 2000 ng/mL. These samples were tested by three operators using three lots of the candidate device. For all lots tested, results were all positive for samples at and above +25% cutoff and all negative for samples below -25% cutoff. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine (300), Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were previously reported in k182530.

4. Assay Reportable Range:

Not applicable.

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

The stability study protocols and acceptance criteria were reviewed and found to be acceptable. The candidate device is stable at 4 °C – 30 °C for 24 months based on the real time stability studies at both 4 °C and 30 °C. A transport simulation study was conducted to demonstrate that the candidate device is stable at the conditions of 40 °C and -20 °C for up to 35 days.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

See section VII.A.1.

B Comparison Studies:

1. Method Comparison with Predicate Device:

A method comparison study for the BOEASY Multi-Drug Test Cup Morphine (2000 ng/mL) test strip was conducted in-house by three laboratory personnel using one lot of the candidate device. Each of the three operators tested 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind-labeled and randomized by a laboratory personnel who does not participate in sample testing. The candidate device results were compared to results obtained by LC/MS. The study results are summarized in the below. The accuracy data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine (300), Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in k182530.

Morphine 2000 ng/mL

K193480 - Page 8 of 14

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|   |  | 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%)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Viewer A | Positive | 0 | 0 | 2 | 20 | 18  |
|   |  Negative | 7 | 15 | 16 | 2 | 0  |
|  Viewer B | Positive | 0 | 0 | 2 | 21 | 18  |
|   |  Negative | 7 | 15 | 16 | 1 | 0  |
|  Viewer C | Positive | 0 | 0 | 2 | 21 | 18  |
|   |  Negative | 7 | 15 | 16 | 1 | 0  |

Discordant Results for Morphine 2000 ng/mL

|  Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results  |
| --- | --- | --- | --- |
|  Viewer A | OPIC341 | 1920 | Positive  |
|  Viewer A | OPIC335 | 1870 | Positive  |
|  Viewer B | OPIC450 | 1860 | Positive  |
|  Viewer B | OPIC335 | 1870 | Positive  |
|  Viewer C | OPIC341 | 1920 | Positive  |
|  Viewer C | OPIC450 | 1860 | Positive  |
|  Viewer A | OPIC475 | 2150 | Negative  |
|  Viewer A | OPIC408 | 2100 | Negative  |
|  Viewer B | OPIC408 | 2100 | Negative  |
|  Viewer C | OPIC475 | 2150 | Negative  |

**Lay user study:**

A lay user study was conducted at three intended user sites by 300 lay users using three lots of the candidate device. The lay users had diverse educational and professional backgrounds. Urine samples were prepared by spiking amphetamine, oxazepam, cocaine, marijuana, methamphetamine, morphine, oxycodone, secobarbital, buprenorphine, methylenedioxy-methamphetamine, phencyclidine, methadone, nortriptyline and propoxyphene at various concentrations (negative, +/-75%, +/-50%, +/-25% of the cutoff) into 23 drug-free urine sample pools. The concentration of the drugs in these samples were confirmed by LC/MS/MS. Each sample was aliquoted into individual containers and blind-labeled by a lab personnel who did not participate in sample testing. Each lay user participant was provided with the package insert, one blind labeled sample and a candidate device, with no training to test the sample. The results are summarized in the below table.

K193480 - Page 9 of 14

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The summary result for Amphetamine

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 261 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 507 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 771 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 1290 | 20 | 0 | 100  |
|  +50% Cutoff | 40 | 1560 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 1870 | 20 | 0 | 100  |

The summary result for Secobarbital

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 75.9 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 150 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 220 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 360 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 429 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 501 | 20 | 0 | 100  |

The summary result for Cocaine

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 81.5 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 151 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 225 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 395 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 455 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 520 | 20 | 0 | 100  |

The results summary for Buprenorphine

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |

K193480 - Page 10 of 14

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The results summary for Methamphetamine

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 268 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 526 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 769 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 1270 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 1560 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 1780 | 20 | 0 | 100  |

The results summary for Methadone

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 76.8 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 147 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 226 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 375 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 441 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 504 | 20 | 0 | 100  |

The results summary for Morphine (2000 ng/mL)

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 535 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 1010 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 1580 | 0 | 20 | 100  |
|  +25% Cutoff | 20 | 2600 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 3050 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 3240 | 20 | 0 | 100  |

K193480 - Page 11 of 14

{11}

The results summary for Oxycodone

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 24.5 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 49.3 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 71.1 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 118 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 147 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 169 | 20 | 0 | 100  |

The results summary for Phencyclidine

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 6.27 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 12.5 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 17.9 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 30.8 | 20 | 0 | 100  |
|  +50% Cutoff | 40 | 36.4 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 42.8 | 20 | 0 | 100  |

The results summary for Marijuana

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 13 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 25.3 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 41 | 2 | 18 | 90  |
|  +25% Cutoff | 20 | 65 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 79 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 93 | 20 | 0 | 100  |

The results summary for Oxazepam

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |

K193480 - Page 12 of 14

{12}

The results summary for Methylenedioxy-methamphetamine

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 137 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 250 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 351 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 600 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 745 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 925 | 20 | 0 | 100  |

The results summary for Nortriptyline

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 273 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 509 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 809 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 1190 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 1510 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 1680 | 20 | 0 | 100  |

The results summary for d-Propoxyphene

|  % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS (ng/mL) | Lay person Results |   | The percentage of correct results (%)  |
| --- | --- | --- | --- | --- | --- |
|   |   |   |  No. of Positive | No. of Negative  |   |
|  -100% Cutoff | 20 | 0 | 0 | 20 | 100  |
|  -75% Cutoff | 20 | 77.4 | 0 | 20 | 100  |
|  -50% Cutoff | 160 | 150 | 0 | 160 | 100  |
|  -25% Cutoff | 20 | 227 | 1 | 19 | 95  |
|  +25% Cutoff | 20 | 351 | 19 | 1 | 95  |
|  +50% Cutoff | 40 | 420 | 40 | 0 | 100  |
|  +75% Cutoff | 20 | 492 | 20 | 0 | 100  |

K193480 - Page 13 of 14

{13}

Lay users completed surveys on the ease of understanding the package insert instructions, and the results were found to be acceptable. A Flesch-Kincaid reading analysis on the package insert revealed a reading grade level of less than 7.

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):**
Not applicable.

**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.

K193480 - Page 14 of 14

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NGL/K193480](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NGL/K193480)

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