Instant-View Cocaine (Benzoylecgonine) Urine Dip Strip Test is a qualitative one step lateral flow,competitive binding immunoassay device intended to be used to detect Benzoylecgonine, a metabolite of cocaine in human urine at a cutoff level of 300 ag/ml. It is intended for health care professional use only.

This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

Device Description

This test is a one-step lateral flow chromatographic immunoassay.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test:

Based on the provided 510(k) Summary and the FDA clearance letter, the device is a qualitative immunoassay for detecting benzoylecgonine in human urine. The information presented describes performance characteristics and comparisons rather than explicitly stated "acceptance criteria" presented as pass/fail thresholds. However, we can infer the performance metrics considered acceptable based on the reported results.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Inferred Acceptance Criteria	Reported Device Performance
Correlation with Predicate Device	(Implied: High correlation, demonstrating substantial equivalence) The statement "higher than 94.6 %" suggests that a correlation in this range was considered acceptable for demonstrating equivalence to a legally marketed device.	94.6%
Agreement across POL sites	(Implied: High agreement across different user environments) The 94.2% agreement suggests that maintaining consistency in results when used by diverse personnel in various settings (Physician's Office Laboratories, POL) was an important consideration.	94.2% agreement across three POL sites
Accuracy (vs. expected results/ground truth)	(Implied: High accuracy against established reference or expected results). The 97.8% agreement figure suggests that a high level of accuracy when compared to a reference method or expected outcome was necessary to demonstrate the device's reliability. The phrasing "agreed 97.8% with the results expected" implies a comparison to a gold standard or a highly reliable method.	97.8% agreement with expected results in Clinical Laboratory and three Physician's Offices

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

The document does not explicitly state the specific numerical sample size for the test set used in the performance studies. It mentions:

"The correlation of results from the Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test, and the legally marketed test device compared, is higher than 94.6 %." (This implies a comparison study with an unspecified number of samples.)
"The results from the three POL sites agreed 94.2%." (This indicates data collected from three Physician's Office Laboratories, but not the number of samples.)
"The Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 97.8 % with the results expected." (This indicates data from a clinical lab and three POLs, but no sample count.)

Data Provenance: The studies were conducted in a "Clinical Laboratory" and "three Physician's Offices (POL sites)." This suggests the data was collected likely within the United States, given the context of a 510(k) submission to the FDA. The studies appear to be prospective in nature, as they involve testing the device and comparing its performance to predicate devices or expected results.

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

This information is not provided in the document. The text refers to "results expected" and comparison with a "legally marketed test device," implying a reference method was used, but details on the experts or their qualifications for establishing ground truth are absent. Given it's a diagnostic test for a substance, the "expected results" would likely be derived from a more definitive analytical method, such as GC/MS if used as a reference.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. It describes agreement percentages between the device and a predicate, or expected results, and agreement across POL sites, but not a process for resolving discrepancies.

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

An MRMC study, specifically for comparing human readers with and without AI assistance, is not relevant or described for this device. This is a qualitative immunoassay for substance detection, not an image-based AI diagnostic tool requiring human interpretation comparison. The "diverse educational backgrounds and working experience" of personnel in the POLs suggests a multi-user evaluation, but not an MRMC study in the context of AI-assisted human reading.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the algorithm (device) was done. The entire document describes the performance of the "Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test" itself. The reported correlations and accuracy percentages (94.6%, 94.2%, 97.8%) are measures of the device's performance in detecting benzoylecgonine.

7. Type of Ground Truth Used

The ground truth or reference standard appears to be based on:

Comparison with a predicate device: "legally marketed test device compared" (QuikStrip One Step Cocaine Test, K971926).
"Results expected": This strongly implies a comparison against a more definitive method or a known concentration of benzoylecgonine in urine samples. The "Indications For Use" also explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method." This suggests that GC/MS or a similar high-precision analytical method would be the ultimate ground truth for establishing the "expected results."

8. Sample Size for the Training Set

The document does not mention a training set. This type of immunoassay device typically does not involve machine learning algorithms that require a "training set" in the conventional sense. Its performance is based on the inherent biochemical properties of the antibodies and reagents used.

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

As there is no mention of a training set, the establishment of ground truth for such a set is not applicable and not described.

Summary

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Alfa Scientific Designs, Inc.

11494 Sorrento Valley Road, Suite M San Diego, CA 92121

510(K) Summary

In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92.

Submitter	Name:	Alfa Scientific Designs, Inc.
	Address:	11494 Sorrento Valley Road, Suite MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net
Device Name	Trade Name: Instant-View™ Cocaine (Benzoylecgonine)Urine Dip Strip Test
	Common Name: Cocaine Test
	Classification Name: 21 CFR 862.3250, Class II
Predicate Device	The Instant-View™ Cocaine (Benzoylecgonine) Urine DipStrip Test is substantially equivalent to other legallymarketed devices for the similar intended use. The deviceused for comparison study is QuikStrip One Step CocaineTest, manufactured by Syntron Bioresearch, Inc. with510(K) #: K971926, Date of Approval: 07/14/97.
Device Description	This test is a one-step lateral flow chromatographicimmunoassay.
Intended Use	The Instant-View™ Cocaine (Benzoylecgonine) Urine DipStrip Test is a qualitative immunoassay device intended todetect benzoylecgonine in human urine at a cutoff level of300 ng/ml. It is for health care professional use only.
Summary of theSimilarities to thePredicate Device	• Intended Use:Both devices are intended to detect benzoylecgonine inhuman urine at a cutoff level of 300 ng/ml.• Interpretation of results:The appearance of only one line - C line indicates apositive result, and that the benzoylecgonine level is at acutoff level of 300 ng/ml or higher. And, the appearance
	of two lines - both C line and T line indicates a negativeresult, and the benzoylecgonine level is below 300 ng/ml.Technological Characteristics:Both devices are one step, qualitative, competitivebinding immunoassay test, utilizing the basicimmunochemical sandwich assay principle ofrecognition and formation of the specificBenzoylecgonine/Antibody/Benzoylecgonine complexes.
Discussion andConclusion	The correlation of results from the Instant-View™Cocaine (Benzoylecgonine) Urine Dip Strip Test, and thelegally marketed test device compared, is higher than94.6 %. The results from the three POL sites agreed94.2%.
	· The Accuracy Evaluation results from the ClinicalLaboratory and the three Physician's Offices conductedby persons with diverse educational backgrounds andworking experience agreed 97.8 % with the resultsexpected.
	· Based on the results of the Performance Characteristicsand Comparison Studies, it may be concluded that theInstant-View™ Cocaine (Benzoylecgonine) Urine DipStrip Test is suitable for use by health care professionalswith diverse educational backgrounds and workexperiences, and it is substantially equivalent to theexisting legally marketed device.

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Short Bearing

San Diego, CA 92121

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: 上一篇:

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures in profile, facing to the right, with their bodies merging into a single form.

AUG 1 4 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Niashu Wang Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite M San Diego, California 92121

Re: K994403

Trade Name: Instant-View™ Cocaine (Benzoylecgonine) Urine Dip Strip Test Regulatory Class: II Product Code: DIO Dated: July 7, 2000 Received: July 10, 2000

Dear Mr. Wang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K994403 510(k) Number (if known):

1155-1166

Instant-View Cocaine (Benzoylecgonine) Urine Dip Strip Test Device Name:

Indications For Use:

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number R994905

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).