(234 days)
No
The device description details a lateral flow immunochromatographic assay that relies on chemical reactions and visual interpretation of color bands. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The results are determined by the presence or absence of color lines, which is a purely physical and chemical process.
No
The device is a diagnostic tool used to detect the presence of specific drugs in urine samples, not to treat or alleviate a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device provides a "simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA... and OPI... in human urine." This indicates its purpose is to detect or identify a condition (presence of drugs), which aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical test cup with built-in strips and chemical reactions for detecting drugs in urine. There is no mention of any software component involved in the operation or interpretation of the results.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "analytical screening procedure to simultaneously detect the drugs of abuse MDMA... and OPI... in human urine." This is a diagnostic purpose, specifically for identifying the presence of substances in a biological sample.
- Sample Type: The device uses "human urine," which is a biological specimen.
- Method: The device employs "competitive binding, lateral flow immunochromatographic assays," which are common techniques used in IVD tests to detect specific analytes (in this case, drugs) in a sample.
- Device Description: The description details how the device works by binding to substances in the urine and producing a visual result (color bands) based on the presence or absence of the drugs. This is characteristic of an in vitro test.
- Performance Studies: The document includes sections on "Total Precision," "Cutoff determination," and "Accuracy," which are standard performance metrics evaluated for IVD devices to demonstrate their reliability and validity.
- Key Metrics: The document lists "Sensitivity," which is a key metric used to describe the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" (K121166; Guanzhou Wondfo Biotech Co Multi-Drug Urine Test Cup) and a "Reference Device" (K071489; QuikScreen™ Multiple 11 drug cup device) further indicates that this device is being compared to other devices in the IVD category.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuikScreenTM Multi (MDMA and OPI) Drug Cup Test consists of competitive bindine , lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for OTC and prescription use..
| Test | Calibrator | Cutoff |
|---|---|---|
| Opiate | Morphine | 300 ng/ml |
| MDMA | (+/-)-3,4 Methylene- | |
| dioxymethamphetamine | 500 ng/ml |
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be exercised with any drug of abuse test result, particularly when preliminary results are used.
The assay does not distinguish whether OPI or MDMA is being taken therapeutically or abused.
Product codes
LAF, DJG
Device Description
QuikScreen ™ Multi (MDMA and OPI) Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder, which is able to hold the Strip of MDMA and OPI within the container. The membrane of the MDMA test strip is coated with goat anti-mouse antibody and MDMA-Bovine serum albumin conjugate. The membrane of the OPI test strip is coated with goat anti-mouse antibody and OPI-Bovine serum albumin conjugate. The sample pad of the MDMA test strip contains a colloidal gold-labeled mouse monoclonal anti-MDMA antibody. The sample pad of the OPI test strip contains a colloidal gold-labeled mouse monoclonal anti-OPI antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of drug (500ng/ml of MDMA or 300ng/ml of OPI), Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A color line will always appear at the control region. A negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the test result shows 1 line (preliminary positive) you should send the sample for laboratory testing.
QuikScreen" Multi (MDMA and OPI) Drug Cup Test is for diagnostic and treatment purposes, consult with a healthcare or substance abuse professional.
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
The device is intended for OTC and prescription 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
Not Found
Summary of Performance Studies
Accuracy: A comparison study of positive and negative specimens or lay user study with reference methods were performed, the test results was correlated very well with reference methods.
Key Metrics
Sensitivity: ≥500 ng/ml of MDMA in urines show positive result
Sensitivity: ≥300 ng/ml of OPI in urines show positive result
Cutoff: The cutoff is 500 ng/ml of MDMA. 50% below the cutoff level of MDMA are negative. The result set at cutoff and 25 % above cutoff level of MDMA are positive
Cutoff: The cutoff is 300 ng/ml of OPI. 50% below the cutoff level of OPI are negative. The result set at cutoff and 25 % above cutoff level of OPI are positive
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K130275
Submitter:
Mr. Tony Shan Tianjin New Bay Bioresearch Co., Ltd. #1 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin. China Email: newbay@gmail.com Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Mr. Roger De Bock S.D.biotek, LLC. 4455 Murphy Canyon Road Suite 204 San Diego, CA 92123 email: rdebock@sdbiotek.com phone: (619) 453 0930 mobile: (619) 994 1417 Facsimile: (619) 453-0930
Preparation Date:
May 29, 2012
Device Information:
Trade or Proprietary Name: QuikScreen™ Multi (MDMA and OPI) Drug Cup Test Device Common/Usual Name: Lateral flow immunochromatographic assay for detection of MDMA and OPI in human urine
Device Classification Name: Immunoassay of MDMA
Immunoassay of OPI
Regulatory Name: MDMA Test System
OPI Test System
Regulation Section: 21 CFR § 862, 3650
21 CFR$ 862, 3610
Regulatory Class: Class II
Product Code: LAF, DJG,
SEP 2 6 2013
1
Panel: Toxicology (91)
Substantially Equivalent devices:
QuikScreen™ Multi (MDMA and OPI) Drug Cup Test Device is substantially equivalent to predicate device (Guanzhou Wondfo Biotech Co Multi-Drug Urine Test Cup) cleared by FDA (K121166) for its stated intended use.
Product Description:
QuikScreen ™ Multi (MDMA and OPI) Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder, which is able to hold the Strip of MDMA and OPI within the container. The membrane of the MDMA test strip is coated with goat anti-mouse antibody and MDMA-Bovine serum albumin conjugate. The membrane of the OPI test strip is coated with goat anti-mouse antibody and OPI-Bovine serum albumin conjugate. The sample pad of the MDMA test strip contains a colloidal gold-labeled mouse monoclonal anti-MDMA antibody. The sample pad of the OPI test strip contains a colloidal gold-labeled mouse monoclonal anti-OPI antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of drug (500ng/ml of MDMA or 300ng/ml of OPI), Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A color line will always appear at the control region. A negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the test result shows 1 line (preliminary positive) you should send the sample for laboratory testing.
QuikScreen" Multi (MDMA and OPI) Drug Cup Test is for diagnostic and treatment purposes, consult with a healthcare or substance abuse professional.
Intended Use:
The QuikScreenTM Multi (MDMA and OPI) Drug Cup Test consists of competitive bindine , lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for OTC and prescription use..
| Test | Calibrator | Cutoff |
|---|---|---|
| Opiate | Morphine | 300 ng/ml |
| MDMA | (+/-)-3,4 Methylene- | |
| dioxymethamphetamine | 500 ng/ml |
2
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be exercised with any drug of abuse test result, particularly when preliminary results are used.
The assay does not distinguish whether OPI or MDMA is being taken therapeutically or abused.
Comparison to Predicate Device(s):
Tianjin New Bay QuikScreen™ OTC and CLIA WAIVED Multi (MDMA and OPI) Drug Cup Test is substantially equivalent to Guanzhou Wondfo Biotech Co Multi-Drug Urine Test Cup cleared by FDA (K121166).
| Device
Characteristics | Subject Device (s)
Tianjin New Bay
QuikScreen ™ Multi
(MDMA and OPI) Drug
Cup Test device. | Predicate Device(s)
Guanzhou Wondfo Biotech Co
Multi-Drug Urine Test Cup
cleared by FDA (K121166). | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use | QuikScreen™ Multi
(MDMA and OPI) Drug
Cup Test.
The assay provides a simple
and rapid analytical
screening procedure to
detect MDMA, and OPI, in
human urine | Multi-Drug Urine Test are
Immunochromatographic
Qualitative Strip test.
The assay provides a simple
and rapid analytical screening
procedure to detect MDMA
.OPI and other drug in human
urine | Same |
| Analytes | MDMA, OPI | MDMA, OPI | Same |
| Technology | Using monoclonal
/polyclonal antibody for the
colloidal gold conjugate,
Drug-BSA conjugate for
the test line of the
membrane | Using monoclonal /polyclonal
antibody for the colloidal gold
conjugate, Drug-BSA
conjugate for the test line of
the membrane | Same |
| Cutoff | MDMA: 500ng/ml.
OPI: 300ng/ml | MDMA: 500ng/ml,
OPI: 300ng/ml | Same |
| Assay time | 5 minutes | 5 minutes | Same |
| Preliminary Positive
Reconfirm by
GC/MS or LC/MS | Yes | Yes | Same |
| Matrix | Urine | Urine | Same |
| Calibrator | None | None | Same |
| Instrument | None, Visual read single
use | None, Visual Read single use | Same |
| Calibration of
Reagent | None | None | Same |
| Storage | Below 28°C until expiration | Below 28°C until expiration | Same |
| | MDMA | MDMA | Same |
| | Sensitivity: ≥500 ng/ml
of MDMA in urines show
positive result | Sensitivity: ≥500ng/ml of
MDMA in urines show
positive result | |
| | OPI | OPI | |
| | Sensitivity: ≥300 ng/ml
of OPI in urines show
positive result | Sensitivity: ≥300 ng/ml of
OPI in urines show positive
result | Same |
| Performance
Comparison | Total Precision: The
results demonstrate that
there is no appreciable
within and inter lot
variation when testing both
positive and negative
spiked samples across three
(3) different lots of test
device at different day.
The test result of both
within lot and inter lot
reproducibility are similar
as Predicate device. | Total Precision: The results
demonstrate that there is
no appreciable within and
inter lot variation when
testing both positive and
negative spiked samples
across three (3) different
lots of test device at
different day | Same |
| | Cutoff determination:
The cutoff is 500 ng/ml
of MDMA. 50% below
the cutoff level of
MDMA are negative. The
result set at cutoff and 25
% above cutoff level of
MDMA are positive and
similar to the predicate
device.
The cutoff is 300 ng/ml
of OPI. 50% below the
cutoff level of OPI are
negative. The result set at
cutoff and 25 % above
cutoff level of OPI are
positive and similar to the
predicate device. | Cutoff determination:
The cutoff is 500 ng/ml of
MDMA. 50% below the
cutoff level of MDMA are
negative. The result set at
cutoff and 25 % above
cutoff level of MDMA are
positive
The cutoff is 300 ng/ml of
OPI. 50% below the cutoff
level of OPI are negative.
The result set at cutoff and
25 % above cutoff level of
OPI are positive | Same |
| | Accuracy: A comparison
study of positive and
negative specimens or lay
user study with reference
methods were
performed, the test results | Accuracy: A comparison
study of positive and
negative specimens or lay
user study with reference
methods were performed, the
test results was correlated | Similar |
| was correlated very well
with reference methods.
It is similar as the
predicate device | very well with reference
methods. | | |
3
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.
.
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:
.
·
・
・
:
·
4
Summary:
The information provided in this pre-market notification demonstrates that QuikScreen™ Multi (MDMA and OPI) Drug Cup Test is substantially equivalent to Guanzhou Wondfo Biotech Co Multi-Drug Urine Test Cup cleared by FDA (K121166) for its stated intended use and GC/MS or LC/MS.
Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the QuikScreen™ Multi (MDMA and OPI) Drug Cup Test Device is safe and effective for its stated intended use.
Cross interference study by incorporation MDMA (500ng/ml cutoff), OPI (300ng/ml cutoff) Strip into the QuikScreen™ Multiple 11 drug cup device that had previously received clearance from the agency with the assigned 510(K) number as K071489. It was cleared for OTC test and Prescription Test. The cross interference study have indicated that there is no cross-interference between the strips and no effect on either positive or negative result among 13 different drug strip by the addition of the MDMA (500ng/ml as cutoff), OPI (300ng/ml as cutoff ) test strip into the QuikScreen"M Multiple 11 drug Cup device .
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2013
Tianjin New Bay Bioresearch Co., Ltd. c/o Roger de Bock 4455 Murphy Canyon Rd. Suite 204 SAN DIEGO CA 92123
Re: K130275
Trade/Device Name: Quikscreen Multi (MDMA and OPI) Drug Cup Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Codc: DJG, LAF Dated: August 21, 2013 Received: August 26, 2013
Dear Mr. de Bock:
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 (sec above) into cither 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 couivalence 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.
6
Page 2—Mr. Bock
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.
Sincerely vours.
Courtney H. Lias, Ph.D.
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
7
Indications for Use
510(k) Number (if known): K130275
Device Name: QuikScreen M Multi (MDMA and OPI) Drug Cup Test
Indications for Use:
The QuikScreen™ Multi (MDMA and OPI) Drug Cup Test consists of competitive binding , lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for prescription use and Over-The-Counter settings.
| Test | Calibrator | Cutoff |
|---|---|---|
| Opiate | Morphine | 300 ng/ml |
| MDMA | (+/-)-3,4Methylene- | |
| dioxymethamphetamine | 500 ng/ml |
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical and professional judgment should be exercised with any drug of abuse test result, particularly when preliminary results are used. The assay does not distinguish whether OPI or MDMA is being taken therapeutically or abused.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.09.26 08:27:43 -04'00' Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130275
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