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 OTC and prescription use.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the QuikScreen™ Multi (MDMA and OPI) Drug Cup Test:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion	Acceptance Criteria (Predicate Device K121166)	Reported Device Performance (QuikScreen™ Multi)
Intended Use	Detect MDMA, OPI in human urine	Detect MDMA (≥500 ng/ml) and OPI (≥300 ng/ml) in human urine
Analytes	MDMA, OPI	MDMA, OPI
Technology	Monoclonal/polyclonal antibody, colloidal gold conjugate, Drug-BSA conjugate	Monoclonal/polyclonal antibody, colloidal gold conjugate, Drug-BSA conjugate
Cutoff (MDMA)	500 ng/ml	500 ng/ml
Cutoff (OPI)	300 ng/ml	300 ng/ml
Assay Time	5 minutes	5 minutes
Preliminary Positive Reconfirmation	Yes (by GC/MS or LC/MS)	Yes (by GC/MS or LC/MS)
Matrix	Urine	Urine
Calibrator	None	None
Instrument	None, visual read	None, visual read
Calibration of Reagent	None	None
Storage	Below 28°C until expiration	Below 28°C until expiration
Sensitivity (MDMA)	≥500 ng/ml shows positive result	≥500 ng/ml shows positive result
Sensitivity (OPI)	≥300 ng/ml shows positive result	≥300 ng/ml shows positive result
Total Precision (within/inter-lot)	No appreciable variation across 3 lots with positive and negative spiked samples	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 days. (Similar to predicate)
Cutoff Determination (MDMA)	50% below cutoff negative, at cutoff and 25% above cutoff positive	50% below the cutoff level of MDMA are negative. The result set at cutoff and 25% above cutoff level of MDMA are positive. (Similar to predicate)
Cutoff Determination (OPI)	50% below cutoff negative, at cutoff and 25% above cutoff positive	50% below the cutoff level of OPI are negative. The result set at cutoff and 25% above cutoff level of OPI are positive. (Similar to predicate)
Accuracy	Good correlation with reference methods	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. (Similar to predicate). Cross-interference study indicated no cross-interference between MDMA/OPI and 11 other drugs in the multi-drug cup.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size:
- For Total Precision and Cutoff Determination, "positive and negative spiked samples across three (3) different lots of test device" were used. Specific numbers are not provided, but it implies a statistically significant sample to assess reproducibility.
- For Accuracy, "positive and negative specimens" were used. A specific number is not provided, but the statement "correlated very well" implies a sufficient sample for comparison.
- For Cross-interference study, "MDMA (500ng/ml cutoff), OPI (300ng/ml cutoff) Strip into the QuikScreen™ Multiple 11 drug cup device" was used. The number of samples tested for cross-interference is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of manufacturing in Tianjin, China (Submitter address), it's likely the studies were conducted there. The samples are human urine.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., interpreting results).
Instead, reference methods (GC/MS or LC/MS) are stated as the confirmatory methods for analytical results. Therefore, the "ground truth" is established by these laboratory-based chemical methods, not by human experts interpreting the device's output.

4. Adjudication Method for the Test Set:

No explicit adjudication method (e.g., 2+1, 3+1) is described. This is expected given that the device is a rapid diagnostic test, and ultimate confirmation is by instrumental chemical analysis (GC/MS or LC/MS) rather than expert consensus on its visual output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool. Human "reading" is limited to observing color bands, and the focus is on the device's analytical accuracy compared to reference methods. The document does not mention any AI component or human-in-the-loop performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is inherently a standalone performance study of the immunoassay device itself. The "algorithm" is the biochemical reaction and visual readout. The performance characteristics (sensitivity, precision, cutoff determination, accuracy against reference methods, cross-interference) are all evaluated for the device operating independently of any human interpretation beyond simply observing the presence or absence of a line.

7. The Type of Ground Truth Used:

The primary ground truth used is analytical confirmation by reference methods, specifically GC/MS or LC/MS. For the precision and cutoff determination studies, this would involve comparing the device's visual results to the known concentrations of spiked drug samples, which are analytically verified. For accuracy, it's a comparison against the results of GC/MS or LC/MS for actual specimens.

8. The Sample Size for the Training Set:

Not applicable / Not explicitly mentioned. This device is a lateral flow immunoassay, not a machine learning model that requires a "training set." Its operating principles are based on biochemistry and antibody-antigen reactions. The "development" of such a device involves optimizing reagents and manufacturing processes, but not training in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As explained above, there is no "training set" for this type of device.

Summary

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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

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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 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

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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).

DeviceCharacteristics	Subject Device (s)Tianjin New BayQuikScreen ™ Multi(MDMA and OPI) DrugCup Test device.	Predicate Device(s)Guanzhou Wondfo Biotech CoMulti-Drug Urine Test Cupcleared by FDA (K121166).
Intended Use	QuikScreen™ Multi(MDMA and OPI) DrugCup Test.The assay provides a simpleand rapid analyticalscreening procedure todetect MDMA, and OPI, inhuman urine	Multi-Drug Urine Test areImmunochromatographicQualitative Strip test.The assay provides a simpleand rapid analytical screeningprocedure to detect MDMA.OPI and other drug in humanurine	Same
Analytes	MDMA, OPI	MDMA, OPI	Same
Technology	Using monoclonal/polyclonal antibody for thecolloidal gold conjugate,Drug-BSA conjugate forthe test line of themembrane	Using monoclonal /polyclonalantibody for the colloidal goldconjugate, Drug-BSAconjugate for the test line ofthe membrane	Same
Cutoff	MDMA: 500ng/ml.OPI: 300ng/ml	MDMA: 500ng/ml,OPI: 300ng/ml	Same
Assay time	5 minutes	5 minutes	Same
Preliminary PositiveReconfirm byGC/MS or LC/MS	Yes	Yes	Same
Matrix	Urine	Urine	Same
Calibrator	None	None	Same
Instrument	None, Visual read singleuse	None, Visual Read single use	Same
Calibration ofReagent	None	None	Same
Storage	Below 28°C until expiration	Below 28°C until expiration	Same
	MDMA	MDMA	Same
	Sensitivity: ≥500 ng/mlof MDMA in urines showpositive result	Sensitivity: ≥500ng/ml ofMDMA in urines showpositive result
	OPI	OPI
	Sensitivity: ≥300 ng/mlof OPI in urines showpositive result	Sensitivity: ≥300 ng/ml ofOPI in urines show positiveresult	Same
PerformanceComparison	Total Precision: Theresults demonstrate thatthere is no appreciablewithin and inter lotvariation when testing bothpositive and negativespiked samples across three(3) different lots of testdevice at different day.The test result of bothwithin lot and inter lotreproducibility are similaras Predicate device.	Total Precision: The resultsdemonstrate that there isno appreciable within andinter lot variation whentesting both positive andnegative spiked samplesacross three (3) differentlots of test device atdifferent day	Same
	Cutoff determination:The cutoff is 500 ng/mlof MDMA. 50% belowthe cutoff level ofMDMA are negative. Theresult set at cutoff and 25% above cutoff level ofMDMA are positive andsimilar to the predicatedevice.The cutoff is 300 ng/mlof OPI. 50% below thecutoff level of OPI arenegative. The result set atcutoff and 25 % abovecutoff level of OPI arepositive and similar to thepredicate device.	Cutoff determination:The cutoff is 500 ng/ml ofMDMA. 50% below thecutoff level of MDMA arenegative. The result set atcutoff and 25 % abovecutoff level of MDMA arepositiveThe cutoff is 300 ng/ml ofOPI. 50% below the cutofflevel of OPI are negative.The result set at cutoff and25 % above cutoff level ofOPI are positive	Same
	Accuracy: A comparisonstudy of positive andnegative specimens or layuser study with referencemethods wereperformed, the test results	Accuracy: A comparisonstudy of positive andnegative specimens or layuser study with referencemethods were performed, thetest results was correlated	Similar
was correlated very wellwith reference methods.It is similar as thepredicate device	very well with referencemethods.

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•

・

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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 .

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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.

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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

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Indications for Use

510(k) Number (if known): K130275

Device Name: QuikScreen M Multi (MDMA and OPI) Drug Cup Test

Indications for Use:

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

Page I of

Regulation Number and Section

§ 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).