ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD

K131110 · Co-Innovation Biotech Co., Ltd. · DKZ · Jan 15, 2014 · Clinical Toxicology

Device Facts

• Record ID: K131110
• Device Name: ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
• Applicant: Co-Innovation Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jan 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations: Marijuana (THC) 50 ng/mL, Cocaine (COC) 300 ng/mL, Amphetamine (AMP) 1000 ng/mL, Methamphetamine (MET) 1000 ng/mL, Morphine 2000 (MOP) 2000 ng/mL. The tests contain two formats: 1) Test Cup, 2) Test Dipcard. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use. These tests provide only a preliminary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipcard Insert, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Lateral flow chromatographic immunoassay; detects drugs of abuse in human urine. Input: urine sample; capillary action draws sample across membrane pre-coated with drug-protein conjugates. Principle: competitive binding; drug in sample competes with drug-protein conjugate for limited antibody-dye conjugate binding sites. Output: visual colored bands in test (T) and control (C) regions. Negative result: colored band in T region (no drug or below cutoff); positive result: no band in T region (drug at or above cutoff). Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires GC/MS confirmation for clinical decision-making.

Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted at 3 hospitals (N=60 per lot) using spiked urine samples confirmed by GC/MS. Method comparison studies performed on 165-186 clinical samples per drug format compared against GC/MS reference method. Analytical specificity evaluated via cross-reactivity testing with structurally similar compounds and interference testing with endogenous/exogenous substances. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Test Dipcard. Storage: 4-30°C. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites (Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine) in human urine at specified cut-off levels. Intended for prescription use in clinical laboratories only. Not for point-of-care use.

Regulatory Classification

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

• UCP Home™ Drug Screening Test Cards (k091588)
• UCP Home™ Drug Screening Test Cup (k091588)

Submission Summary (Full Text)

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K131110

JAN 15 2014

### Section 5 - 510(k) Summary

Date of Summary Preparation: 12/30/2013

### 1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co., Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: [e-mail] Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

2. Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: [e-mail] Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

#### 3. Name of the Device

Recommended classification regulation;

| 21 CFR 862.3100 |
|-----------------|
| 21 CFR 862.3610 |
| 21 CFR 862.3250 |
| 21 CFR 862.3870 |
| 21 CFR 862.3640 |

Device class: Class II Panel: Toxicology (91) Product code: DKZ,DJC,DIO,LDJ,DK N Common Name:

> Amphetamine Test System Methamphetamine Test System Cocaine Test System Cannabinoid Test System Morphine Test System

· Proprietary names:

One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard

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### 4. The Predicate Devices

K091588

UCP Home™ Drug Screening Test Cards UCP Home™ Drug Screening Test Cup

#### 5. Device Description

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

### 6. Intended Use of Device

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

| Test | Calibrator | Cut-off level |
|-----------------------|-------------------|---------------|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 2000 (MOP) | Morphine | 2000 ng/mL |

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

#### 7. Comparison to Predicate Devices:

A summary comparison of features of the One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table:

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| Item | Device | Predicate (K091588) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Indication for use | Qualitative detection of<br>drugs-of-abuse in urine<br>(Cocaine, Morphine, Methamp<br>hetamine,Amphetamine,Marijua<br>na ) | Same (but the number of drugs<br>detected different) |
| Intended Users | Prescription Use | Over the Counter (OTC) Use<br>and Prescription Use |
| Specimen | Urine | Same |
| Cutoff | Cocaine:300 ng/mL<br>Methamphetamine:1000 ng/mL<br>Amphetamine:1000 ng/mL<br>Morphine:2000 ng/mL<br>Marijuana:50 ng/mL | Cocaine:300 ng/mL<br>Methamphetamine:1000 ng/mL<br>Amphetamine:1000 ng/mL<br>Morphine:300 ng/mL<br>Marijuana:50 ng/mL |
| Read time | 5 minutes | Same |
| Storage | 4 ~ 30 °C | 2 ~ 30 °C |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral<br>flow immunochromatographic<br>assay based on the principle of<br>antigen antibody<br>immunochemistry | Same |
| Configuration | Dipcard and Cup | Card and Cup |

### Remark:

- 1. The subject devices have all features of the predicate device except the number of drugs detected, the cutoff of Morphine and storage temperature condition different. These differences do not affect the performance characteristics of the subject devices.
### 8. Performance Data:

### Accuracy

Single drug Test:

165-186 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug<br>Test | Result | Co-Innovation Drug free by GC/MS<br>analysis | Less than half the<br>cutoff concentration<br>by GC/MS analysis | Near Cutoff Negative<br>(Between 50% below the<br>cutoff and the cutoff<br>concentration) | Near Cutoff Positive<br>(Between the cutoff<br>and 50% above the<br>cutoff concentration) | High Positive<br>(greater than 50%<br>above the cutoff<br>concentration) | Total | |
|--------------|--------------|------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|--|
| | 0<br>0<br>10 | | | ਨੇੜੇ | 176 | | | |
| AMP | | 117 | | 11 | | 0 | | |
| | + | 0 | 0 | | ರು | 31 | 186 | |
| COC | | 133 | 0 | 12 | O | 0 | | |
| | 12<br>0<br>0 | | 31 | 165 | | | | |
| THC | | 107 | এ | 0 | | O | | |

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| | הפרדים הרביעים המורדות היישוב המשפחת | | and and and the commend of the comments of the comments of the comments of the comments of the comments of the comments of | Angelo a manager a many a many a many a many and manager and manager and manager and the may be may be may be may be the may be the may be the may be the may be the may be th | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | and and the film the first of the first of the first of the first and | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----|--------------------------------------|----|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | | 00 | 165 |
| MET | | 25 | | 1<br>1 | | | |
| | | | | | 1) | | |
| MOP | | r | | 15 | | | 165 |

### Analysis of Discordant Results with One Step Single drug Test Cup .

| One Step Single drug Test Cup | | | GC/MS Analysis | |
|-------------------------------|---------------|-------------|----------------------------|----------------------|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| · MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-A9-THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-A9-THC-9-COOH |

165-186 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug<br>Test | Co-Innovation<br>Result | Drug free by GC/MS<br>analysis | Less than half the<br>cutoff concentration<br>by GC/MS analysis | Near Cutoff Negative<br>(Between 50% below the<br>cutoff and the cutoff<br>concentration) | Near Cutoff Positive<br>(Between the cutoff<br>and 50% above the<br>cutoff concentration) | High Positive<br>(greater than 50%<br>above the cutoff<br>concentration) | Total |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 1 | 10 | 29 | 176 |
| AMP | - | 117 | 7 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 186 |
| COC | - | 133 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 31 | 165 |
| THC | - | 107 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 17 | 44 | 165 |
| MET | - | 85 | 4 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 19 | 57 | 165 |
| MOP | - | 67 | 5 | 15 | 0 | 0 | |

| One Step Single drug Test Dipcard | | | GC/MS Analysis | |
|-----------------------------------|---------------|-------------|----------------------------------|----------------------|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug<br>Concentration<br>(ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9-THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9-THC-9-COOH |

Analysis of Discordant Results with One Step Single drug Test Dipcard

Multi-drug Test:

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

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| Drug<br>Test | Co-Innovation<br>Result | Drug free by GC/MS<br>analysis | Less than half the<br>cutoff concentration<br>by GC/MS analysis | Near Cutoff Negative<br>(Between 50% below the<br>cutoff and the cutoff<br>concentration) | Near Cutoff Positive<br>(Between the cutoff<br>and 50% above the<br>cutoff concentration) | High Positive<br>(greater than 50%<br>above the cutoff<br>concentration) | Total |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 1 | 10 | 29 | 80 |
| | - | 25 | 3 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 80 |
| | - | 27 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 26 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 24 | 2 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 11 | 29 | 80 |
| | - | 21 | 2 | 15 | 0 | 0 | |

Analysis of Discordant Results with One Step Multi-drug Test Cup

| | One Step Multi-drug Test Cup | | | GC/MS Analysis | |
|-----------|------------------------------|-------------|----------------------------|----------------------|--|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine | |
| AMP | 1000 | Positive | 867 | Amphetamine | |
| AMP | 1000 | Negative | 1175 | Amphetamine | |
| COC | 300 | Positive | 172 | Benzoylecgonine | |
| MET | 1000 | Positive | 904 | Methamphetamine | |
| MET | 1000 | Negative | 1248 | Methamphetamine | |
| MOP | 2000 | Positive | 1608 | Morphine | |
| MOP | 2000 | Positive | 1875 | Morphine | |
| THC | 50 | Positive | 40 | 11-nor-Δ9-THC-9-COOH | |
| THC | 50 | Negative | 59 | 11-nor-Δ9-THC-9-COOH | |

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug<br>Test | Co-Innovation<br>Result | Drug free by GC/MS<br>analysis | Less than half the<br>cutoff concentration<br>by GC/MS analysis | Near Cutoff Negative<br>(Between 50% below the<br>cutoff and the cutoff<br>concentration) | Near Cutoff Positive<br>(Between the cutoff<br>and 50% above the<br>cutoff concentration) | High Positive<br>(greater than 50%<br>above the cutoff<br>concentration) | Total |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| AMP | + | 0 | 0 | 1 | 10 | 29 | 80 |
| | - | 25 | 3 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 80 |
| | - | 27 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 26 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 24 | 2 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 11 | 29 | 80 |
| | - | 21 | 2 | 15 | 0 | 0 | |

| Analysis of Discordant Results with One Step Multi-drug Test Dipcard | | |
|----------------------------------------------------------------------|--|--|
|----------------------------------------------------------------------|--|--|

| One Step Multi-drug Test Dipcard | | | GC/MS Analysis | |
|----------------------------------|---------------|-------------|----------------------------|----------------------|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9-THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9-THC-9-COOH |

05-5

.

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### Other Information About Performance Characteristics:

The performance characteristics of One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard were evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard perform satisfactorily when used according to the package inserts.

### 10. Conclusion:

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are substantially equivalent to UCP Home™ Drug Screening Test Cards and UCP Home™ Drug Screening Test Cup. .

--- End of this section ---

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2014

CO-INNOVATION BIOTECH CO., LTD. HONG FENG, PRODUCT MANAGER NO. 13 YANYUAN ROAD. TIANHE DISTRICT GUANGZHOU, GUANGDONG 510507 CH

Re: K131110

Trade/Device Name: One Step Single/Multi-drug Test Cup; One Step Single Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJC, DKN, LDJ, DIO Dated: January 2, 2014 Received: January 2, 2014

Dear Hong Feng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fcc.gov/mediabureau/radio/licensing/sourcesector1/radioindustry.html

Sincercly yours.

# Courtney H. Lias -S

Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) k131110

#### Device Name

One-Step Single/Multi-drug Test Cup; One-Step single/multi-drug Test Card

#### Indications for Use (Describe)

One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:

ી જિડા Marijuana (THC) Cocaine (COC) Amphetamine (AMP) Methamphetamine (MET) Morphine 2000 (MOP)

Calibrato r · Delta-9-THC-COOH Benzoylecgonine D-Amphetamine D-Methamphetamine Morphine

Cut-off level 50 ng/ml. 300 ng/ml. 1000 ng/ml. 1000 ng/mL 2000 ne/ml.

The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.

These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)