(148 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay without any mention of computational analysis or learning algorithms.
No.
The device is an in vitro diagnostic immunoassay designed to detect drug metabolites in human urine, providing preliminary analytical test results for screening purposes rather than delivering therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The assays are intended for in vitro diagnostic use."
No
The device is described as a lateral flow chromatographic immunoassay in two physical formats (Test Cup and Test Dipcard), which are hardware components. The description explicitly states the tests can be performed without the use of an instrument, further indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The assays are intended for in vitro diagnostic use."
N/A
Intended Use / Indications for 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 drug metabolites in human urine at the following cut-off concentrations:
Test: Buprenorphine (BUP), Calibrator: Buprenorphine, Cutoff Level (ng/mL): 10
Test: 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), Calibrator: 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Cutoff Level (ng/mL): 300
Test: Morphine (MOP300), Calibrator: Morphine, Cutoff Level (ng/mL): 300
Test: Propoxyphene (PPX), Calibrator: Propoxyphene, Cutoff Level (ng/mL): 300
Test: Tricyclic Antidepressants (TCA), Calibrator: Nortriptyline, Cutoff Level (ng/mL): 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.
Product codes
DJG, DJR, DNK, JXN, LFG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) and Over-The-Counter Use (21 CFR 801 Subpart C). Intended for prescription use including point of care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
For Single drug Test and Multi-drug Test (both Test Cup and Test Dipcard):
Sample size: 80 clinical urine specimens for each drug.
Data source: Clinical urine specimens. Analyzed by GC/MS or HPLC.
Annotation protocol: Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Study:
- Study Type: Clinical accuracy study comparing device results to GC/MS or HPLC.
- Sample Size: 80 clinical urine specimens for each drug (Buprenorphine, EDDP, Morphine, Propoxyphene, Tricyclic Antidepressants) for both single drug and multi-drug formats, and for both Test Cup and Test Dipcard.
- Standalone Performance: The tables show the number of positive and negative results from the Co-Innovation device compared to reference methods (GC/MS or HPLC) for various concentration categories (drug free, less than half cutoff, near cutoff negative, near cutoff positive, high positive).
- Key Results for Single drug Test Cup (example for BUP):
- BUP positive results: 1 (Near Cutoff Negative), 5 (Near Cutoff Positive), 35 (High Positive)
- BUP negative results: 35 (Drug free), 0 (Less than half the cutoff concentration), 4 (Near Cutoff Negative), 0 (Near Cutoff Positive), 0 (High Positive)
- Key Results for Single drug Test Dipcard (example for BUP):
- BUP positive results: 1 (Near Cutoff Negative), 5 (Near Cutoff Positive), 35 (High Positive)
- BUP negative results: 35 (Drug free), 0 (Less than half the cutoff concentration), 4 (Near Cutoff Negative), 0 (Near Cutoff Positive), 0 (High Positive)
- Key Results for Multi-drug Test Cup (example for BUP):
- BUP positive results: 1 (Near Cutoff Negative), 5 (Near Cutoff Positive), 35 (High Positive)
- BUP negative results: 35 (Drug free), 0 (Less than half the cutoff concentration), 4 (Near Cutoff Negative), 0 (Near Cutoff Positive), 0 (High Positive)
- Key Results for Multi-drug Test Dipcard (example for BUP):
- BUP positive results: 1 (Near Cutoff Negative), 5 (Near Cutoff Positive), 35 (High Positive)
- BUP negative results: 35 (Drug free), 0 (Less than half the cutoff concentration), 4 (Near Cutoff Negative), 0 (Near Cutoff Positive), 0 (High Positive)
- Discordant Results: Specific details are provided for cases where the device result differed from the GC/MS or HPLC result, including the drug, cutoff, test result, drug concentration, and drug in urine. For example, for BUP on the Single drug Test Cup, a positive result was obtained for a sample at 7.8 ng/mL (cutoff 10 ng/mL). For TCA on the Single drug Test Cup, a negative result was obtained for a sample at 1138 ng/mL (cutoff 1000 ng/mL). Similar discordant results are reported for EDDP, MOP, and PPX across all device configurations.
Other Performance Characteristics:
- Evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study, stability study and home use consumer study.
- Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly provided as summary metrics. Raw data is presented in tables from which these metrics could be calculated.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
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.(b)
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).
0
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.
1
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
2
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, | ||
| 3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1, 5-dimethyl-3, | |
| 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)
3
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4
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
5
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, | ||
| 3-diphenylpyrrolidine(EDDP) | 2-ethylidene-1, 5-dimethyl-3, | |
| 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.
6
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 | |
| in urine (Buprenorphine, | ||
| 2-ethylidene-1, 5-dimethyl-3, | ||
| 3-diphenylpyrrolidine, Morphine, | ||
| Propoxyphene, Tri-cyclic | ||
| Antidepressants) | Same (but the number of | |
| drugs detected different) | ||
| Intended Users | Over the Counter (OTC) Use and | |
| Prescription Use | Over the Counter (OTC) | |
| Use and Prescription Use | ||
| Specimen | Urine | Same |
| Cutoff | Buprenorphine:10 ng/mL | |
| EDDP:300 ng/mL | ||
| Morphine:300 ng/mL | ||
| Propoxyphene:300 ng/mL | ||
| Tri-cyclic Antidepressants:1000 ng/mL | Same | |
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flow | |
| immunochromatographic assay based | ||
| on the principle of antigen antibody | ||
| 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
Test | Co-Innov
ation
Result | Drug free by
GC/MS analysis | 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) | Total |
|--------------|-----------------------------|--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BUP | + | 0 | 0 | 1 | 5 | 35 | 80 |
7
| - | 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 | |||
| (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 |
(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
Test | Co-Innovation
Result | Drug free by
GC/MS
analysis | 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) | 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
8
| One Step Single 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, |
| 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
Test | Co-Innov
ation
Result | Drug free by
GC/MS
analysis | 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) | 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 |
9
(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
Test | Co-Innovation
Result | Drug free by
GC/MS
analysis | 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) | 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, |
| 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:
10
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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