ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
Device Facts
| Record ID | K140748 |
|---|---|
| Device Name | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD |
| Applicant | Co-Innovation Biotech Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Aug 20, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| 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 the following cut-off concentrations: Buprenorphine (BUP) 10 ng/mL, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) 300 ng/mL, Morphine (MOP300) 300 ng/mL, Propoxyphene (PPX) 300 ng/mL, Tricyclic Antidepressants (TCA) 1000 ng/mL. There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use. The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, Propoxyphene, or Tricyclic Antidepressants are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine. or Tricyclic Antidepressants in urine. This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) or an equivalent analytical method 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.
Device Story
Lateral flow immunochromatographic competitive binding assay; detects drugs/metabolites in urine. Input: urine sample; capillary action moves sample across membrane. Principle: drug in sample competes with drug-protein conjugate for limited antibody binding sites. Output: visual colored lines; line in Test Region (T) indicates negative; absence of line indicates preliminary positive. Control line (C) confirms proper operation. Used at point-of-care or home; operated by clinicians or lay users. Provides preliminary analytical result; requires GC/MS or equivalent for confirmation. Assists clinical decision-making by identifying potential drug presence.
Clinical Evidence
Clinical performance evaluated using 80 urine specimens per drug. Results compared against GC/MS or HPLC. Study included drug-free, low-negative, near-cutoff negative, near-cutoff positive, and high-positive samples. Performance demonstrated satisfactory agreement with reference methods across all drug analytes.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Test Dipcard. Urine specimen. Visual readout. No instrumentation required. Identical chemical formulation and manufacturing procedures for all strips.
Indications for Use
Indicated for qualitative detection of Buprenorphine, EDDP, Morphine, Propoxyphene, and Tricyclic Antidepressants in human urine. Intended for prescription, point-of-care, and over-the-counter use. Not intended to distinguish between prescription use and abuse.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- Advin Multi-Drug Screen Test Dip Card (k122809)
- Advin Multi-Drug Screen Test Cup (k122809)
- Advin Multi-Drug Screen Test Cassette (k122809)
Related Devices
- K142800 — Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard · Co-Innovation Biotech Co., Ltd. · Dec 11, 2014
- K152908 — UCP COMPACT DRUG TESTS · Ucp Biosciences, Inc. · May 3, 2016
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
- K122419 — UCP HOME DRUG SCREENING TEST CUPS · Ucp Biosciences, Inc. · Nov 30, 2012
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2014 CO-INNOVATION BIOTECH CO., LTD. HONG FENG NO. 13, YANYUAN ROAD, TIANHE DISTRICT, GUANGZHOU, P.R. CHINA
Re: K140748
Trade/Device Name: One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DJR, DNK, JXN, LFG Dated: July 08, 2014 Received: July 09, 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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Katherine Serrano -S
For : 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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### Indications for Use
510(k) Number (if known) k140748
#### Device Name
One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard
#### Indications for Use (Describe)
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 drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cutoff Level (ng/mL) |
|---------------------------------------------------------------|--------------------------------------------------------|----------------------|
| Buprenorphine (BUP) | Buprenorphine | 10 |
| 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine | 300 |
| Morphine (MOP300) | Morphine | 300 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use.
The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, or Tricyclic Antidepressants are ingested, at prescribed to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine, or Tricyclic Antidepressants in urine.
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) or an equivalent analytical method 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
മ 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)
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### Section 5 - 510(k) Summary
Date of Summary Preparation: 8/14/2014
#### 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: fenghongfda@126.com 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: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285
#### 3. Name of the Device
Recommended classification regulation:
21 CFR 862.3650 Opiate test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3640 Morphine Test System 21 CFR 862.3700 Propoxyphene test system 21 CFR 862.3910 Tri-cyclic Antidepressants drug test system
Device class: Class II Panel: Toxicology (91) Product code: DJG,DJR,DNK,JXN,LFG Common Name: Buprenorphine(BUP) Test System 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP) Test System Morphine(MOP) Test System Propoxyphene(PPX) Test System Tri-cyclic Antidepressants (TCA)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
| K122809 | Advin Multi-Drug Screen Test Dip Card |
|---------|---------------------------------------|
| | Advin Multi-Drug Screen Test Cup |
| | Advin Multi-Drug Screen Test Cassette |
### 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 Buprenorphine, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Morphine, Propoxyphene, Tri-cyclic Antidepressants and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.
### 6. Intended Use of Device
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 the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|--------------------------------------------------------------|--------------------------------------------------------|---------------|
| Buprenorphine(BUP) | Buprenorphine | 10ng/mL |
| 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine(EDDP) | 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine | 300 ng/mL |
| Morphine(MOP300) | Morphine | 300 ng/mL |
| Propoxyphene(PPX) | Propoxyphene | 300 ng/mL |
| Tri-cyclic Antidepressants (TCA) | Nortriptyline | 1000 ng/mL |
There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use.
The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, Propoxyphene, or Tricyclic Antidepressants are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine. or Tricyclic Antidepressants in urine.
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) or an equivalent analytical method 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.
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### 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:
| Item | Device | Predicate (K122809) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indication for use | Qualitative detection of drugs-of-abuse<br>in urine (Buprenorphine,<br>2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine, Morphine,<br>Propoxyphene, Tri-cyclic<br>Antidepressants) | Same (but the number of<br>drugs detected different) |
| Intended Users | Over the Counter (OTC) Use and<br>Prescription Use | Over the Counter (OTC)<br>Use and Prescription Use |
| Specimen | Urine | Same |
| Cutoff | Buprenorphine:10 ng/mL<br>EDDP:300 ng/mL<br>Morphine:300 ng/mL<br>Propoxyphene:300 ng/mL<br>Tri-cyclic Antidepressants:1000 ng/mL | Same |
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flow<br>immunochromatographic assay based<br>on the principle of antigen antibody<br>immunochemistry | Same |
| Configuration | Dipcard and Cup | Cassette Dip Card and Cup |
Remark:
- 1、The subject devices have all features of the predicate device except the number of drugs detected . This difference do not affect the performance characteristics of the subject devices.
### 8. Performance Data:
### Accuracy
Single drug Test:
80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC 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 | Co-Innov<br>ation<br>Result | Drug free by<br>GC/MS analysis | Less than half<br>the cutoff<br>concentration<br>by GC/MS<br>analysis | Near Cutoff<br>Negative (Between<br>50% below the<br>cutoff and the cutoff<br>concentration) | Near Cutoff<br>Positive (Between<br>the cutoff and<br>50% above the<br>cutoff<br>concentration) | High Positive<br>(greater than<br>50% above the<br>cutoff<br>concentration) | Total |
|--------------|-----------------------------|--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BUP | + | 0 | 0 | 1 | 5 | 35 | 80 |
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| - | 35 | 0 | 4 | 0 | 0 | | |
|------|----|----|---|---|---|----|----|
| EDDP | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 33 | 1 | 5 | 0 | 0 | |
| MOP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 31 | 2 | 6 | 0 | 0 | |
| PPX | + | 0 | 0 | 1 | 6 | 34 | 80 |
| | - | 33 | 1 | 5 | 0 | 0 | |
| TCA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 35 | 0 | 5 | 1 | 0 | |
Analysis of Discordant Results with One Step Single drug Test Cup
| One Step Single drug Test Cup | | | GC/MS Analysis | |
|-------------------------------|-------------------|----------------|----------------------------------|--------------------------------------------------------|
| Drug Test | Cutoff<br>(ng/mL) | Test<br>Result | Drug<br>Concentration<br>(ng/mL) | Drug in Urine |
| BUP** | 10 | Positive | 7.8 | Buprenorphine |
| EDDP | 300 | Positive | 285 | 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine |
| MOP | 300 | Positive | 275 | Morphine |
| PPX | 300 | Positive | 269 | Propoxyphene |
| TCA* | 1000 | Negative | 1138 | Nortriptyline |
(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)
80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC 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 negative, near cutoff positive, and high positive. Results were as follows:
| Drug<br>Test | Co-Innovation<br>Result | Drug free by<br>GC/MS<br>analysis | Less than half<br>the cutoff<br>concentration<br>by GC/MS<br>analysis | Near Cutoff<br>Negative (Between<br>50% below the<br>cutoff and the<br>cutoff<br>concentration) | Near Cutoff<br>Positive (Between<br>the cutoff and<br>50% above the<br>cutoff<br>concentration) | High Positive<br>(greater than<br>50% above the<br>cutoff<br>concentration) | Total |
|--------------|-------------------------|-----------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BUP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| BUP | - | 35 | 0 | 4 | 0 | 0 | |
| EDDP | + | 0 | 0 | 1 | 7 | 33 | 80 |
| EDDP | - | 33 | 1 | 5 | 0 | 0 | |
| MOP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MOP | - | 31 | 2 | 6 | 0 | 0 | |
| PPX | + | 0 | 0 | 1 | 6 | 34 | 80 |
| PPX | - | 33 | 1 | 5 | 0 | 0 | |
| TCA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| TCA | - | 35 | 0 | 5 | 1 | 0 | |
Analysis of Discordant Results with One Step Single drug Test Dipcard
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| 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 |
| BUP** | 10 | Positive | 7.8 | Buprenorphine |
| EDDP | 300 | Positive | 285 | 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine |
| MOP | 300 | Positive | 275 | Morphine |
| PPX | 300 | Positive | 269 | Propoxyphene |
| TCA* | 1000 | Negative | 1138 | Nortriptyline |
(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)
#### Multi-drug Test:
80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC 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:
| Drug<br>Test | Co-Innov<br>ation<br>Result | Drug free by<br>GC/MS<br>analysis | Less than half<br>the cutoff<br>concentration<br>by GC/MS<br>analysis | Near Cutoff<br>Negative (Between<br>50% below the<br>cutoff and the<br>cutoff<br>concentration) | Near Cutoff<br>Positive (Between<br>the cutoff and<br>50% above the<br>cutoff<br>concentration) | High Positive<br>(greater than<br>50% above the<br>cutoff<br>concentration) | Total |
|--------------|-----------------------------|-----------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BUP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| BUP | - | 35 | 0 | 4 | 0 | 0 | |
| EDDP | + | 0 | 0 | 1 | 7 | 33 | 80 |
| EDDP | - | 33 | 1 | 5 | 0 | 0 | |
| MOP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MOP | - | 31 | 2 | 6 | 0 | 0 | |
| PPX | + | 0 | 0 | 1 | 6 | 34 | 80 |
| PPX | - | 33 | 1 | 5 | 0 | 0 | |
| TCA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| TCA | - | 35 | 0 | 5 | 1 | 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 |
| BUP** | 10 | Positive | 7.8 | Buprenorphine |
| EDDP | 300 | Positive | 285 | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine |
| MOP | 300 | Positive | 275 | Morphine |
| PPX | 300 | Positive | 269 | Propoxyphene |
| TCA* | 1000 | Negative | 1138 | Nortriptyline |
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(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)
80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC 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, near cutoff negative, near cutoff positive, and high positive. Results were as follows:
| Drug<br>Test | Co-Innovation<br>Result | Drug free by<br>GC/MS<br>analysis | Less than half<br>the cutoff<br>concentration<br>by GC/MS<br>analysis | Near Cutoff<br>Negative (Between<br>50% below the<br>cutoff and the<br>cutoff<br>concentration) | Near Cutoff<br>Positive (Between<br>the cutoff and<br>50% above the<br>cutoff<br>concentration) | High Positive<br>(greater than<br>50% above the<br>cutoff<br>concentration) | Total |
|--------------|-------------------------|-----------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BUP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | |
| EDDP | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 33 | 1 | 5 | 0 | 0 | |
| MOP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 31 | 2 | 6 | 0 | 0 | |
| PPX | + | 0 | 0 | 1 | 6 | 34 | 80 |
| | - | 33 | 1 | 5 | 0 | 0 | |
| TCA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 35 | 0 | 5 | 1 | 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 |
| BUP** | 10 | Positive | 7.8 | Buprenorphine |
| EDDP | 300 | Positive | 285 | 2-ethylidene-1, 5-dimethyl-3,<br>3-diphenylpyrrolidine |
| MOP | 300 | Positive | 275 | Morphine |
| PPX | 300 | Positive | 269 | Propoxyphene |
| TCA* | 1000 | Negative | 1138 | Nortriptyline |
(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)
#### 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, stability study and home use consumer 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:
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One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are substantially equivalent to Advin Multi-Drug Screen Test Dip Card, Advin Multi-Drug Screen Test Cup and Advin Multi-Drug Screen Test Cassette.
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