← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K052882

# FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE (K052882)

_Tianjin New Bay Bioresearch Co., Ltd. · DKZ · Feb 15, 2006 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K052882

## Device Facts

- **Applicant:** Tianjin New Bay Bioresearch Co., Ltd.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** Feb 15, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device is for the detection of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Cannabinoid, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant (TCA), Barbiturates and Propoxyphene and their metabolites in human urine at the following cutoff concentrations: | Amphetamine | D-Amphetamine | 1000 ng/mL | | --- | --- | --- | | Barbiturate | Secobarbital | 300 ng/mL | | Benzodiazepine | Oxazepam | 300 ng/mL | | Cannabinoid | THC-COOH | 50 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Methamphetamine | (+) Methamphetamine | 1000 ng/mL | | Methadone | (+/-) Methadone Hydrochloride | 300 ng/mL | | Opiates | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone Hydrochloride | 100 ng/mL | | Phencyclidine | Phencyclidine | 25 ng/mL | | Propoxyphene | (+) Propoxyphene | 300 ng/mL | | Tricyclic Antidepressant | Nortriptyline Hydrochloride | 1000 ng/mL | The assay provides only preliminary analytical test results. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. The testing and results are intended to be used by medical professional.

## Device Story

The Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup Device is a lateral flow chromatographic immunoassay for the qualitative detection of drugs of abuse in human urine. The device consists of absorbent strips containing immobilized drug conjugates and colloidal gold-labeled antibodies. As urine wicks through the membrane, drug metabolites in the sample compete with immobilized antigens for antibody binding sites. A negative result is indicated by the presence of two magenta bands (test and control zones), while a positive result is indicated by a single band in the control zone. The device is intended for use by medical professionals in clinical settings for rapid screening. Results are visual and qualitative; no instrumentation is required. The test provides preliminary results that must be confirmed by GC/MS. The device aids clinical decision-making by identifying potential substance use, allowing for subsequent confirmatory testing.

## Clinical Evidence

No clinical studies performed. Analytical performance established via bench testing. Precision/reproducibility evaluated using drug-spiked urine at 0, 50%, 75%, 100%, 125%, and 150% of cutoff. Method comparison conducted against GC/MS reference method using 83-110 samples per analyte; results showed high agreement with GC/MS values.

## Technological Characteristics

Lateral flow immunochromatographic assay; colloidal gold-labeled monoclonal antibodies; porous membrane support; goat anti-mouse antibody coating. Single-use test cup form factor. No external energy source required. Visual readout. Stable for 18 months at 15-28°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

- Monitect multiple Drug screen cassette test (k004034)
- Instant-View Propoxyphene Urine test (k022915)

## Submission Summary (Full Text)

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

A. 510(k) Number:
k052882

B. Purpose for Submission:
Pre-market clearance of a new device

C. Measurand:
Amphetamine, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine, Methamphetamine, Methadone, Opiates (2000), Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressant (TCA)

D. Type of Test:
Qualitative lateral flow immunochromatographic test

E. Applicant:
Tianjin New Bay Bioresearch

F. Proprietary and Established Names:
Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup device

G. Regulatory Information:

1. Regulation section:
862.3100, Amphetamine Test System
862.3150, Barbiturate Test System
862.3170, Benzodiazepine Test System
862.3870, Cannabinoids Test System
862.3250, Cocaine and Cocaine Metabolite Test System
862.3620, Methadone Test System
862.3610, Methamphetamine Test System
862.3650, Opiates (2000) and Oxycodone Test System
Unclassified, Enzyme Immunoassay, Phencyclidine
862.3700, Propoxyphene Test System
862.3910, Tricyclic Antidepressant Drugs Test System

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2. Classification:

Class II

3. Product code:

DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, DJG, LCM, JXN, LFH, respectively

4. Panel:

91, Toxicology

H. Intended Use:

1. Intended use(s):

See indications for use below

2. Indication(s) for use:

The Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device is for the detection of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Cannabinoid, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant (TCA), Barbiturates and Propoxyphene and their metabolites in human urine at the following cutoff concentrations:

|  Amphetamine | D-Amphetamine | 1000 ng/mL  |
| --- | --- | --- |
|  Barbiturate | Secobarbital | 300 ng/mL  |
|  Benzodiazepine | Oxazepam | 300 ng/mL  |
|  Cannabinoid | THC-COOH | 50 ng/mL  |
|  Cocaine | Benzoylecgonine | 300 ng/mL  |
|  Methamphetamine | (+) Methamphetamine | 1000 ng/mL  |
|  Methadone | (+/-) Methadone Hydrochloride | 300 ng/mL  |
|  Opiates | Morphine | 2000 ng/mL  |
|  Oxycodone | Oxycodone Hydrochloride | 100 ng/mL  |
|  Phencyclidine | Phencyclidine | 25 ng/mL  |
|  Propoxyphene | (+) Propoxyphene | 300 ng/mL  |
|  Tricyclic Antidepressant | Nortriptyline Hydrochloride | 1000 ng/mL  |

The assay provides only preliminary analytical test results. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. The testing and results are intended to be used by medical professional.

3. Special conditions for use statement(s):

For Prescription use only

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4. Special instrument requirements:

Not applicable, as the device is a visually-read single-use device.

I. Device Description:

The Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device and holder are designed to hold one or up to twelve individual chromatographic absorbent strips in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. The method employs unique monoclonal and polyclonal antibodies to selectively identify the drug or drug metabolite in the sample. The membrane on the strip is coated with goat anti-mouse antibody and a specific drug-protein conjugate. The sample pad contains a colloidal gold labeled mouse monoclonal anti specific drug antibody. The device is for single-use and visually read.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Branan Medical Corporation; Monitect multiple Drug screen cassette test

ALFA Scientific Designs INC.; Instant-View Propoxyphene Urine test

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

k004034 and k022915, respectively

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended use | Qualitative determination of drugs in human urine | Qualitative determination of drugs in human urine  |
|  Matrix | Human Urine | Human Urine  |
|  Test Principle | Immunochromatographic, lateral flow | Immunochromatographic, lateral flow  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Device | Test cup | Cassette  |

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

Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Program, Fed Register. 53(69): 11970-11979, 1988

Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA) research Monograph 73, 1986

L. Test Principle:

The Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device and holder are designed to hold one or up to twelve individual chromatographic absorbent strips in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the sample flows through the absorbent device by chromatography, the labeled antibody-Gold sol conjugate binds to the free drug in the sample forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the test zone. If the concentration of drug is above the cutoff concentration no magenta colored band will form, indicating a positive result. If the concentration of drug in the sample is below the cutoff, a magenta colored band will form, indicating a negative result. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta colored band, regardless of the presence or absence of drug or drug metabolite in the urine sample.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision studies were performed using in house drug standards. The standard was diluted in drug-free urine to give drug concentrations at the following levels: 0, 50%, 75%, 100%, 125% and 150% of the cutoff. A total of 15 determinations were made at each concentration for each analyte. Testing was performed on one day by one operator. All samples at 0 and -50% yielded negative results and all samples 150% yielded positive results. Within lot precision study data for 75%, 100% and 125% is summarized below:

75% of Cutoff

|   | AMP | BAR | BZD | COC | MET | MTD | OPI 2000 | OXY | PCP | PPX | TCA | THC  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15  |
|  Concentration (ng/mL) | 750 | 225 | 225 | 225 | 750 | 225 | 1500 | 75 | 18.75 | 225 | 750 | 37.5  |
|  #NEG/#POS | 14/1 | 15/0 | 13/2 | 14/1 | 13/2 | 13/2 | 14/1 | 12/3 | 13/2 | 10/5 | 11/4 | 14/1  |
|  Precision | 93% | 100% | 87% | 93% | 87% | 87% | 93% | 80% | 87% | 67% | 73% | 93%  |

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# 100% of Cutoff

|   | AMP | BAR | BZD | COC | MET | MTD | OPI 2000 | OXY | PCP | PPX | TCA | THC  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15  |
|  Concentration (ng/mL) | 1000 | 300 | 300 | 300 | 1000 | 300 | 2000 | 100 | 25 | 300 | 1000 | 50  |
|  #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15  |
|  Precision | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100%  |

# 125% of Cutoff

|   | AMP | BAR | BZD | COC | MET | MTD | OPI 2000 | OXY | PCP | PPX | TCA | THC  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15  |
|  Concentration (ng/mL) | 1250 | 375 | 375 | 375 | 1250 | 375 | 2500 | 125 | 31.25 | 375 | 1250 | 62.5  |
|  #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15  |
|  Precision | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100%  |

# Inter Lot precision:

To test inter lot precision, drug-free urine was spiked with commercially available drug standard to the following levels: 0, 50%, 75%, 100%, 125% and 150% of cutoff. Testing was performed using three different lot numbers, 15 samples of each lot were run at each of the concentrations for each drug over 20 days. All samples tested at 0, -50% yielded negative results and all samples at 150% yielded positive results. Inter lot Precision Study data for 75%, 100% and 125% of cutoff is summarized below:

|  75% Cutoff | Total # determination |   |   | # Negative/# Positive |   |   | inter Lot Precision (%) |   |   | Average Lot  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Precision  |
|  AMP | 15 | 15 | 15 | 14/1 | 13/2 | 13/2 | 93% | 87% | 87% | 89%  |
|  BAR | 15 | 15 | 15 | 14/1 | 13/2 | 14/1 | 93% | 87% | 93% | 91%  |
|  BZD | 15 | 15 | 15 | 12/3 | 13/2 | 11/4 | 80% | 87% | 73% | 80%  |
|  COC | 15 | 15 | 15 | 13/2 | 14/1 | 14/1 | 87% | 93% | 93% | 91%  |
|  MET | 15 | 15 | 15 | 11/4 | 14/1 | 11/4 | 73% | 93% | 73% | 80%  |
|  MTD | 15 | 15 | 15 | 14/1 | 14/1 | 13/2 | 93% | 93% | 87% | 91%  |
|  OPI 2000 | 15 | 15 | 15 | 14/1 | 12/3 | 12/3 | 93% | 80% | 80% | 84%  |
|  OXY | 15 | 15 | 15 | 11/4 | 11/4 | 12/3 | 73% | 73% | 80% | 75%  |
|  PCP | 15 | 15 | 15 | 14/1 | 14/1 | 13/2 | 93% | 93% | 87% | 91%  |
|  PPX | 15 | 15 | 15 | 11/4 | 10/5 | 11/4 | 73% | 67% | 73% | 71%  |
|  TCA | 15 | 15 | 15 | 13/2 | 11/4 | 12/3 | 87% | 73% | 80% | 80%  |
|  THC | 15 | 15 | 15 | 13/2 | 14/1 | 14/1 | 87% | 93% | 93% | 91%  |

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|  100% Cutoff | Total # determination |   |   | # Negative/# Positive |   |   | inter Lot Precision (%) |   |   | Average Lot  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Precision  |
|  AMP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  BAR | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  BZD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  COC | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  MET | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  MTD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  OPI 2000 | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  OXY | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  PCP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  PPX | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  TCA | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  THC | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  125% Cutoff | Total # determination |   |   | # Negative/# Positive |   |   | inter Lot Precision (%) |   |   | Average Lot  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Precision  |
|  AMP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  BAR | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  BZD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  COC | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  MET | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  MTD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  OPI 2000 | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  OXY | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  PCP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  PPX | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  TCA | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |
|  THC | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100%  |

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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

Procedural controls are included in the test strip and device. A magenta line appearing in the control region (C) is considered as an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

External control materials are not supplied with these tests; however it is recommended that positive and negative controls be tested as a good

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laboratory practice to confirm the test procedure and to verify proper test performance. User should follow local, state and federal guidelines for testing QC material.

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 – 28 °C product is good until expiration date which is 18 months.

Storage of sample:

To determine if there was any effect on the specimen from prolonged exposure to the device the following study was performed. An in-house positive urine control containing drug for each analyte in the test device was tested on the Chromatograph Mass Spectrometry GC/MS to obtain an initial value. The sample was then aliquot into the test device and moderately shaken for 10 minutes, then stored at room temperature (15-30 °C) for total of 60 hours. Samples for GC/MS analysis were taken at times 0, 12, 36 and 60 hours. The results demonstrate that the test device did not affect the expected or accuracy of the results.

d. Detection limit:

A drug-free urine pool was spiked with specific drug at the following concentrations: 25% and 50% below the cutoff, cutoff and 25% above the cutoff. The results are presented in the table below:

|   | AMP | BAR | BZD | COC | MET | MTD | OPI 2000 | OXY | PCP | PPX | TCA | THC  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15  |
|  -50% of cutoff/concentration ng/mL | 500 | 150 | 150 | 150 | 500 | 150 | 1000 | 50 | 12.5 | 150 | 500 | 25  |
|  #NEG/#POS | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |
|  -25% of cutoff/concentration ng/mL | 750 | 225 | 225 | 225 | 750 | 225 | 1500 | 75 | 18.75 | 225 | 750 | 37.5  |
|  #NEG/#POS | 11/4 | 12/3 | 11/4 | 11/4 | 11/4 | 9/6 | 12/3 | 11/4 | 10/5 | 10/5 | 13/2 | 10/5  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Cutoff/concentration ng/mL | 1000 | 300 | 300 | 300 | 1000 | 300 | 2000 | 100 | 25 | 300 | 1000 | 50  |

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|  #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  |   |   |   |   |   |   |   |   |   |   |   |
|  +25% of cutoff/concentration ng/mL | 1250 | 375 | 375 | 375 | 1250 | 375 | 2500 | 125 | 31.25 | 375 | 1250  |
|  #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15  |

e. Analytical specificity:

Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into normal human urine. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the tables below:

Amphetamine

|  Drug Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  d-amphetamine | 1000  |
|  d,l-amphetamine | 10,000  |
|  l-amphetamine | 25,000  |
|  B-Phenylethylamine | 180,000  |
|  d-Methamphetamine | 400,000  |
|  l-Methamphetamine | 400,000  |
|  (±)3,4-Methylenedioxy-methylamphetamine-HCL-(±) 3,4 MDMA-HCL | 400,000  |
|  3,4-Methylenedioxyamphetamine (MDA) | 1200  |
|  Tyramin | 100,000  |

Methamphetamine

|  Drug Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  (+)methamphetamine | 1000  |
|  d,l-Amphetamine Sulfate | 200,000  |
|  l-Amphetamine Sulfate | 200,000  |
|  (±) 3,4 - Methylenedioxy-amphetamine-HCL (±) 3,4 MDA-HCL | 200,000  |
|  d-Amphetamine Sulfate | 200,000  |
|  3,4-Methylenedioxymethamphetamine (MDMA) | 1000  |

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Opiates 2000

|  Drug compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Opiate | 2000  |
|  Codeine | 2,000  |
|  Heroin | 2000  |
|  Levorphanol | 4000  |
|  Ranitidine | 100,000  |
|  Morphine-3-β-D glucuronide | 2,000  |
|  6-Acetylmorphine | 50  |

Cocaine

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Benzoylecgonine | 300  |
|  Cocaine | 300  |

Cannabinoids (THC)

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Cannabinol | 10,000  |
|  11-Nor-Δ⁸-Tetrahydrocannabinol carboxylic acid | 50  |
|  11-Nor-Δ⁹-Tetrahydrocannabinol carboxylic acid | 50  |
|  Δ⁸-Tetrahydrocannabinol | 7500  |
|  Δ⁹-Tetrahydrocannabinol | 10,000  |
|  11-hydroxy-Δ⁹-Tetrahydrocannabinol | 2500  |

Phencyclidine

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Tenocyclidine | 2000  |
|  Phencyclidine | 25  |

Barbiturates

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Secobarbital | 300  |
|  Allobarbital | 600  |
|  Amobarbital | 600  |
|  Barbital | 300  |
|  Butabarbital | 300  |
|  Butalbital | 300  |
|  Pentobarbital | 300  |
|  Phenobarbital | 300  |

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Benzodiazepines

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Alprazolam | 600  |
|  Chlordiazepoxide | 300  |
|  Diazepam | 300  |
|  Oxazepam | 300  |
|  Clonazepam | 300  |
|  Flunitrazepam | 300  |
|  Nitrazepam | 250  |
|  Bromazepam | 100  |
|  Clobazam | 300  |
|  Estazolam | 300  |
|  Flurazepam | 150  |
|  Lorazepam | 500  |
|  Lormetazepam | 500  |
|  Clorazepate | 200  |
|  Nordiazepam | 150  |
|  Prazepam | 1500  |
|  Temazepam | 150  |
|  Delorazepam | 3000  |
|  Triazolam | 200  |

Methadone

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Methadone | 300  |
|  Doxylamine | 50,000  |
|  (±)-2-Ethyl-1,5-dimethyl-3,3-diphenylpyrrolinium | 100,000  |
|  Methadol | 25,000  |
|  Perphenazine | 75,000  |
|  Protriptyline | 2000  |
|  Trimipramine | 10,000  |

Propoxyphene

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Propoxyphene | 300  |
|  Norpropoxphene | 1000  |
|  Methadone | 1,350,000  |
|  2-ethyl-1,5-dimethyl 3,3-diphenylpyrroline | 200,000  |

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11

Oxycodone

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Oxycodone-HCL | 100  |
|  Morphine-Sulfate | 7000  |
|  Codeine | 700  |
|  Morphine 3-β-D glucuronide | 40,000  |
|  Hydromorphone | 1500  |
|  Norcodeine | 40,000  |
|  Oxymorphone | 300  |
|  Hydrocodone | 500  |

Tricyclic Antidepressant (TCA)

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Amitriptyline | 1000  |
|  Cyclobenzaprine | 1500  |
|  Clomipramine | 5000  |
|  Desipramine | 600  |
|  Doxepin | 1000  |
|  Imipramine | 600  |
|  Nortriptyline | 1000  |
|  Nordoxepin | 1000  |

The following list of substances showed no interference at a concentration of 100 ug/mL in urine:

Common Substances:

|  Acetaminophen | Diphenhydramine | (+/-) Naproxen  |
| --- | --- | --- |
|  Acetone | 5,5-Diphenylhydantoin | Nicotine  |
|  Acetylsalicylic Acid | Dopamine | Nor-Bupreorphine  |
|  Amikacin | EDDP | Noscapine Hydrochloride  |
|  Amitriptyline | + Ephedrine | Oxalic Acid  |
|  Ampicillin | - Ephedrine | Omega-3-fatty acid  |
|  l-Ascorbic Acid | +/- Epinephrine | Penicillin-G  |
|  Aspartame | Erythromycin | Phenalzine  |
|  Aspirin | Ethanol | l-Phenylephrine  |
|  Atropine | Fentanyl | (+/-) Phenylpropanolamine  |
|  Benzocaine | Fluoxetine | Promathazine  |
|  Benzoic Acid | Furosemide | Pseudoephedrine  |
|  Buprenophine-3-β-D-glucuronide | Glucosamine | Quinine  |
|  (+)-Brompheniramine | Guaiacol Glyceryl Ether | Quinidine  |

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|  Buprenorphine | Hydrochlorothiazide | Salicylic Acid  |
| --- | --- | --- |
|  Caffeine | Hydrocodone | Sustiva  |
|  (+)-Chlorpheniramine | Ibuprofen | Sulindac  |
|  (+/-)- Chlorpheniramine | Ketamine | Theophyline  |
|  Chlorpromazine | Lidocaine | Thioridazine  |
|  Cortisone | Maprotiline | Tramandol  |
|  (-)-Cotinin | Meperidine | d(+)-Trehalose  |
|  Creatinine | Methanol | Trifluoperazine  |
|  Dextromethorphan | Methylphenidate |   |
|  4-Dimethylaminoantipyrine | Naltrexone |   |

The following list of substances showed no interference at the following concentrations in either drug-free or drug positive urines:

|  Bilirubin | 0.2 -1.0 mg/dL  |
| --- | --- |
|  Creatinine | 500 mg/dL  |
|  Glucose | 1500 mg/dL  |
|  Hemoglobin | 300 mg/dL  |
|  Potassium | 10-110 mEq/dL  |
|  Human Serum Albumin | 500 mg/dL  |
|  Globulin | 1500 mg/dL  |
|  Sodium chloride | 0-6000 mg/dL  |
|  Uric Acid | 23 mg/dL  |
|  Cholesterol | 500 mg/dL  |

Specific Gravity:

Two drug free urines, one with a specific gravity of 1.030 and the other 1.003. The sample was divided into two and one was spiked with drug concentration at 25% above the cutoff for all the analytes. Each sample was run in duplicate. The results demonstrate that a specific gravity range of 1.003 - 1.030 did not affect the expected or accuracy of the results.

pH:

The pH of an aliquot negative urine pool was adjusted to a pH range of 4 to 9 in 1 pH increments for a total of six samples. Each of the samples was split into two samples to form a pair for each pH level. One of the paired samples from each set was spiked with drug concentration at 25% above the cutoff for all the analytes. Each sample was run on the device and the results demonstrate that varying ranges of pH dose not interfere with the performance of the test.

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f. Assay cut-off:

The identified cutoff concentrations for amphetamine, cocaine, methamphetamine, opiates 2000, Phencyclidine and THC are those recommended by the Substance Abuse and Mental Health Services Administration (SAMHSA). The SAMHSA has not recommended a cutoff concentration for Barbiturate, Benzodiazepine, Oxycodone, Propoxyphene and Tricyclic Antidepressant (TCA).

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision and detection limit sections, above.

2. Comparison studies:

a. Method comparison with predicate device:

83-110 urine samples, depending on the drug type were evaluated. Specimens obtained from a reference laboratory were tested using the Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device and the Gas Chromatography/Mass Spectrometry (GC/MS). For each tested, approximately 10% of samples had drug concentration between 50% below the cutoff and the cutoff concentration, another 10% of samples had drug concentration between the cutoff and 50% above the cutoff concentration.

13

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Candidate Device Results vs. stratified GC/MS Values

|   | Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | % Agreement (among positives and negatives)  |
| --- | --- | --- | --- | --- | --- | --- |
|  AMP | Positive | 0 | 4 | 5 | 42 | 100%  |
|   |  Negative | 58 | 1 | 0 | 0 | 94%  |
|  BAR | Positive | 0 | 2 | 19 | 20 | 100%  |
|   |  Negative | 49 | 3 | 0 | 0 | 96%  |
|  BZD | Positive | 0 | 4 | 14 | 28 | 100%  |
|   |  Negative | 49 | 2 | 0 | 0 | 93%  |
|  COC | Positive | 0 | 2 | 14 | 28 | 100%  |
|   |  Negative | 49 | 3 | 0 | 0 | 93%  |
|  MET | Positive | 0 | 0 | 10 | 31 | 100%  |
|   |  Negative | 50 | 5 | 0 | 0 | 100%  |
|  MTD | Positive | 0 | 4 | 8 | 33 | 100%  |
|   |  Negative | 62 | 1 | 0 | 0 | 94%  |
|  OPI 2000 | Positive | 0 | 0 | 17 | 24 | 100%  |
|   |  Negative | 50 | 5 | 0 | 0 | 100%  |
|  OXY | Positive | 0 | 1 | 5 | 50 | 100%  |
|   |  Negative | 40 | 3 | 0 | 0 | 98%  |
|  PCP | Positive | 0 | 4 | 16 | 25 | 100%  |
|   |  Negative | 50 | 3 | 0 | 0 | 93%  |
|  PPX | Positive | 0 | 3 | 19 | 24 | 100%  |
|   |  Negative | 50 | 2 | 0 | 0 | 95%  |
|  TCA | Positive | 0 | 1 | 18 | 13 | 100%  |
|   |  Negative | 38 | 4 | 0 | 0 | 98%  |
|  THC | Positive | 0 | 1 | 6 | 36 | 100%  |
|   |  Negative | 50 | 3 | 0 | 0 | 98%  |

During the accuracy for Amphetamine and Methamphetamine testing one discordant result was observed. A sample was run for both analytes, during the Amphetamine testing the PCP was recorded as positive and in the Methamphetamine the PCP was recorded as negative. The results were not confirmed by a reference method.

During the accuracy of the other analytes there were positive results recorded for analytes other than the one being tested. None of the other results were confirmed by a reference method.

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b. Matrix comparison:

Not applicable. This device is only for use with urine sample.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable. Clinical studies are not typically submitted for this device type.

b. Clinical specificity:

Not applicable. Clinical studies are not typically submitted for this device type.

c. Other clinical supportive data (when a. and b. are 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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K052882](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K052882)

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