The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use.

Analyte	Calibrator	Cutoff
Morphine/Opiates	Morphine	300 ng/mL
Oxycodone	Oxycodone	100 ng/mL
Oxycodone	Oxycodone	300 ng/mL

This assay provides only preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/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.

Device Description

A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to three (3) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a colored band during test regardless of the presence of the drug.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on the established performance characteristics of the predicate devices. The reported device performance is stated to be the same as the individual tests, which were previously 510(k) cleared. While specific numerical performance metrics are not given for the proposed device, the summary implies it meets the performance standards of its predicates.

Analyte	Cutoff (ng/ml)	Acceptance Criteria (Implied)	Reported Device Performance
Morphine	300	Same as predicate device performance (satisfactory accuracy, reproducibility, sensitivity, and specificity)	Same as individual test devices.
Oxycodone	100	Same as predicate device performance (satisfactory accuracy, reproducibility, sensitivity, and specificity)	Same as individual test devices.
Oxycodone	300	Same as predicate device performance (satisfactory accuracy, reproducibility, sensitivity, and specificity)	Same as individual test devices.

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

The document does not explicitly state the sample size used for the test set of the proposed device. Instead, it makes a general statement that the "Performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of the multi-drug of abuse test are the same as the individual tests, which have been 510(k) cleared for professional use previously."

The data provenance (country of origin, retrospective/prospective) for the test set is not specified.

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

This information is not provided in the document. The study relies on comparison to predicate devices, but details about how the performance was established for either the predicate or proposed device's test set ground truth are absent.

4. Adjudication Method for the Test Set

The adjudication method for the test set is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described for this device. This is an immunoassay, not an imaging device typically requiring such studies. The focus is on the device's analytical performance rather than human interpretation of complex images.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was implicitly done for the device. The 510(k) summary focuses entirely on the device's analytical performance, not on how humans interpret its results. It describes the device's technology and states that its performance characteristics (accuracy, reproducibility, sensitivity, and specificity) are the same as the individual tests. This implies direct measurement of the device's output against a known standard.

7. Type of Ground Truth Used

The document implies that the ground truth for establishing the performance of the individual tests (and by extension, the proposed multi-drug device) would involve chemical confirmation using methods like Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). The "Intended Use" section explicitly states: "A positive result from the device is considered to be a presumptive result and should never be interpreted as final without laboratory confirmation... Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method."

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It refers to the device using "the same technology and formulations for the detection of the drugs as individual test devices." This suggests that the "training" may have effectively been done on prior individual tests.

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

Similar to the test set, the ground truth for the training set (or the development of the underlying technology for the individual tests) would have been established through chemical confirmation methods, likely GC/MS or LC/MS, to accurately determine the presence and concentration of the target analytes. The document states the proposed device uses "the same technology and formulations" as previously cleared individual tests, implying the ground truth methods were consistent with those used for predicate devices.

Summary

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Alfa Scientific Designs, Inc.

510(k) Summary
Safety and effectiveness as required by 21 CFR 807.92
Manufacturerand Submitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, CA 92064
		Telephone: (858) 413-1266 (direct)Fax: (858) 513-8388
	Contact Person:	Naishu Wang, MD, Ph.D.Email: wnss@alfascientific.com
Device Name	Trade Name:
	INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) TestDrug of Abuse Urine (Cassette/Cup) Test
	Common Name:
	Immunoassay, Drug of Abuse Screen Urine Test

	Classification:
	Opiate Test System, Morphine Test System
	Product Code:
	DJG, NGI

Date ofSummaryPreparation	06/30/2010
PredicateDevices	INSTANT-VIEW® Multi-Drugs Urine Test (510(k) Number: K063545)INSTANT-VIEW® Oxycodone Urine Test (510(k) Number: K063545)INSTANT-VIEW® Morphine (300) Urine Test (510(k) Number: K060527Made by Alfa Scientific Designs, Inc.
DeviceDescription	A one-step lateral flow chromatographic immunoassay. The deviceconsists of any combination between one (1) to three (3) individual teststrip(s) for the drug(s) being tested. Each test strip in the device consistsof 1) a colored conjugate pad containing colloidal gold coupled with theanti-drug antibodies and 2) nitrocellulose membrane containing a testline (T line) coated with the conjugated drug antigen and a control line(C line). The C line serves as an internal quality control of the systemand appears as a colored band during test regardless of the presence ofthe drug.
Intended Use	The proposed drug of abuse device is intended for use in an OTC settingas an IVD screening test for any single one, or combination of, thefollowing three substances in urine:
	Analyte	Cutoff
	Morphine	300 ng/ml
	Oxycodone	100 ng/ml
	Oxycodone	300 ng/ml
	This test provides only a preliminary result. The results provided bythis device indicate whether the drug or drug metabolite may be present.A positive result from the device is considered to be a presumptiveresult and should never be interpreted as final without laboratoryconfirmation.
Similarity tothe PredicateDevices	• Both are one-step lateral-flow chromatographic immunoassays.• Both are intended to provide qualitative detection of drug abuse.• Both are in-vitro diagnostic devices.• Both have a built-in quality control feature, C line, to indicate that anadequate volume of specimen is applied and the liquid flow occurredproperly
PerformanceCharacteristics	The proposed drug of abuse device uses the same technology andformulations for the detection of the drugs as individual test devices.The performance characteristics, such as accuracy, reproducibility,sensitivity and specificity of the multi-drug of abuse test are the sameas the individual tests, which have been 510(k) cleared for professionaluse previously.
Stability	The shelf life stability of the test devices was done for each of the testdevices, three lots for each test in each format. The shelf life of theproposed tests is two years (24 months)
Formats of theDevice	The proposed multi- drug of abuse device has two formats, cassette andurine cup.
Conclusion	The proposed test is substantially equivalent to the predicate device.

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Multi-Drug of Abuse Urine Test

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the eagle.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Alfa Scientific Designs, Inc. C/O Naishu Wang 13200 Gregg St. Poway, CA 92064

JUL 0 0 0 2013

Re: K100051

Trade/Device Name: Instant-View Drug of Abuse Urine (Cassette/Cup) Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, NGI Dated: June 16, 2010 Received: June 17, 2010

Dear Ms. Wang:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requrements 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) number (if known): K100051

Device Name:

INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) Test

Drug of Abuse Urine (Cassette/Cup) Test

Indications for Use:

Abbreviation	Test	Calibrator	Cutoff
MOR/OPI300	Morphine/Opiates	Morphine	300 ng/mL
OXY100	Oxycodone	Oxycodone	100 ng/mL
OXY300	Oxycodone	Oxycodone	300 ng/mL

× Over-The-Counter Use AND/OR Prescription Use (Per 21 CFR 807 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Dus

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K.100051 510/k)

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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).