(271 days)
Not Found
No
The device description and performance studies indicate a simple lateral flow immunoassay that provides a qualitative result without the use of an instrument. There is no mention of AI, ML, image processing, or any computational analysis of the results.
No
This device is an in vitro diagnostic (IVD) test designed to detect the presence of drugs and drug metabolites in human urine. It is used for screening and provides preliminary analytical results, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The test is intended for in vitro diagnostics use." It is designed to qualitatively detect the presence of drugs and drug metabolites, which is a diagnostic function.
No
The device is a lateral flow chromatographic immunoassay, which is a physical test kit (hardware) for detecting substances in urine. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The test is intended for in vitro diagnostics use."
- Nature of the Test: The device is designed to detect the presence of drugs and drug metabolites in human urine, which is a biological sample. This type of testing performed outside of the body is the definition of in vitro diagnostics.
- Care Setting: The device is intended for "prescription use in clinical laboratories only," which is a typical setting for IVD testing.
N/A
Intended Use / Indications for Use
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:
Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DJC, DKN, LDJ, DIO
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.
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 in clinical laboratories only and not for point-of-care use.
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
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.
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.
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy studies were performed for both single drug tests and multi-drug tests, for both test cup and dipcard formats.
Single Drug Test (Cup): 165-186 clinical urine specimens per drug, analyzed by GC/MS and the subject device.
Single Drug Test (Dipcard): 165-186 clinical urine specimens per drug, analyzed by GC/MS and the subject device.
Multi-drug Test (Cup): 80 clinical urine specimens per drug, analyzed by GC/MS and the subject device.
Multi-drug Test (Dipcard): 80 clinical urine specimens per drug, analyzed by GC/MS and the subject device.
Samples were categorized into drug free, less than half the cutoff negative, near cutoff positive, and high positive. Discordant results were analyzed and listed with their drug concentration from GC/MS.
Other studies performed include: precision study, sensitivity study, specificity and cross reactivity study, interference study and stability 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 Found
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
§ 862.3100 Amphetamine test system.
(a)
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.(b)
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).
0
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: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285
- 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@l26.com 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
1
4. The Predicate Devices
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:
2
| Item | Device | Predicate (K091588) |
|---|---|---|
| Indication for use | Qualitative detection of | |
| drugs-of-abuse in urine | ||
| (Cocaine, Morphine, Methamp | ||
| hetamine,Amphetamine,Marijua | ||
| na ) | Same (but the number of drugs | |
| detected different) | ||
| Intended Users | Prescription Use | Over the Counter (OTC) Use |
| and Prescription Use | ||
| Specimen | Urine | Same |
| Cutoff | Cocaine:300 ng/mL | |
| Methamphetamine:1000 ng/mL | ||
| Amphetamine:1000 ng/mL | ||
| Morphine:2000 ng/mL | ||
| Marijuana:50 ng/mL | Cocaine:300 ng/mL | |
| Methamphetamine:1000 ng/mL | ||
| Amphetamine:1000 ng/mL | ||
| Morphine:300 ng/mL | ||
| Marijuana:50 ng/mL | ||
| Read time | 5 minutes | Same |
| Storage | 4 ~ 30 °C | 2 ~ 30 °C |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral | |
| flow immunochromatographic | ||
| assay based on the principle of | ||
| antigen antibody | ||
| immunochemistry | Same | |
| Configuration | Dipcard and Cup | Card and Cup |
Remark:
-
- 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
Test | Result | Co-Innovation 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 | |
|--------------|--------------|------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|--|
| | 0
0
10 | | | ਨੇੜੇ | 176 | | | |
| AMP | | 117 | | 11 | | 0 | | |
| | + | 0 | 0 | | ರು | 31 | 186 | |
| COC | | 133 | 0 | 12 | O | 0 | | |
| | 12
0
0 | | 31 | 165 | | | | |
| THC | | 107 | এ | 0 | | O | | |
3
| 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 | |||||
| 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
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 |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| 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 | |
| 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 |
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:
4
| 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 |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| 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
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 |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------|
| 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
.
5
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 ---
6
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.
7
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
8
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)