Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.

Device Description

The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.

AI/ML Overview

The information discusses the Visualine®V Drugs of Abuse Dipstrip Panel for qualitative determination of several drugs and their metabolites in human urine.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a target value set before the study. Instead, it presents the results of a correlation study with a legally marketed predicate device (Hitachi 717) as evidence of performance. The performance metrics presented are Sensitivity, Specificity, and Efficiency.

Drug / Performance Metric	Reported Device Performance (Visualine®V Dipstrip Panel)
Cocaine:
Sensitivity	98 % (49 / 50)
Specificity	>99 % (247 / 247)
Efficiency	>99 % (296 / 297)
Cannabinoids:
Sensitivity	>99 % (50 / 50)
Specificity	>99 % (253 / 253)
Efficiency	>99 % (303 / 303)
Morphine:
Sensitivity	>99 % (50 / 50)
Specificity	>99 % (257 / 257)
Efficiency	>99 % (307 / 307)
Methamphetamine:
Sensitivity	>99 % (50 / 50)
Specificity	>99 % (255 / 255)
Efficiency	>99 % (305 / 305)
Phencyclidine:
Sensitivity	>99 % (50 / 50)
Specificity	>99 % (255 / 255)
Efficiency	>99 % (305 / 305)

Reproducibility (Precision) studies also reported:

Within run and run to run: > 99 %
Within day and day to day: > 99 %
Within lot and lot to lot: > 99 %

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

The test set consisted of:

Presumptive positive samples: 50 for each drug (Cocaine, Cannabinoids, Morphine, Methamphetamine, Phencyclidine). These were initially tested on the Hitachi 717.
Negative samples:
- Cocaine: 247
- Cannabinoids: 253
- Morphine: 257
- Methamphetamine: 255
- Phencyclidine: 255
  These negative samples came from UTAK Laboratories Drug Free Urine pool, Lot# 2647, and in-house negative urines (tested with Sun Biomedical's Visualine® II product).

Data Provenance: The correlation studies were conducted at Redwood Toxicology Laboratory, Santa Rosa, California, and Sun Biomedical Laboratories. The samples used were a mix of presumptive positive samples provided by Redwood (implying patient samples) and defined negative urine pools. This suggests a retrospective collection of samples for the positive cases and a controlled source for the negative cases. The country of origin is implicitly the USA (California).

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

The document does not mention the number or qualifications of experts used to establish a ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method with multiple readers. The "ground truth" for the correlation study relies on the results from the Hitachi 717 instrument using Diagnostic Reagents, Inc. material, which is treated as the reference method.

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

This is not applicable. The device is a "Dipstrip Panel" presenting a visual color comparison. It is an in-vitro diagnostic device, not an AI-powered image analysis tool or decision support system that would involve human readers making interpretations of complex data with or without AI assistance. The performance is based on the device's ability to detect substances, not on human interpretation of its results changing with AI.

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

Yes, this was a standalone performance evaluation. The Visualine®V Dipstrip Panel is described as a "visual color precipitin formation" detection method. The study involved "blinded studies" where the Visualine®V panel results were compared to the reference Hitachi 717 results. This implies the dipstrip panel was read and its results were correlated directly with the established results without human intervention or interpretation that would alter the device's inherent performance.

7. The Type of Ground Truth Used

The ground truth used for the correlation study was based on the results from the Hitachi 717 instrument using Diagnostic Reagents, Inc. EIA (Enzyme Immunoassay) individual assays. This legally marketed predicate device served as the reference standard. For negative samples, established drug-free urine pools were used.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is common for in-vitro diagnostic devices built on established chemical or immunological principles, where "training" in the machine learning sense is not applicable. The device's performance is determined by its design and chemical reactions, not by being "trained" on data.

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

As no training set is mentioned (see point 8), this question is not applicable. The device operates based on a competitive immunochromatographic technique.

Summary

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DEC 27 1999

K993485

SUN BIOMEDICAL LABORATORIES, INC.

604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 0801 TEL: (609) 401-1080 • FAX: (609) 401-1090 • E-mail: sunlabs@juscom.c

510(k) CONTENT SUMMARY

Name of Manufacturer:

Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

1. Trade Name Visualine®V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their metabolites in Human Urine Samples.
1. Common Name

An in-virro immunoassay test by visual color comparison for the detection of Cocaine. Carnabinoids, Morphine, Methamphetamine, and Phencvclidine in human urine samples,

4. Regulation # and Classification:

Reg. #862-3170, Class II Device

1. Test Description:
  The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.

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6. Comparison of Two Test Systems for Correlation Studies:

The Visualine@V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine assay is correlated to the individual Hitachi 717 instrument using Diagnostic Reagents, Inc. material. The following table illustrates the similarities and differences between the two assays.

	Hitachi 717(Diagnostic Reagents, Inc EIA)	Visualine®V Drugs of AbuseDipstrip Panel for QualitativeDetermination of Cocaine,Cannabinoids, Morphine,Methamphetamine, andPhencyclidine
Test Principle	Homogenous enzymeimmunoassay	Competitive bindingimmunoassay
Sample/Sample Size	200 uL urine	Approx. 200 ul urine
Antibody	Polyclonal and Monoclonal	Polyclonal and Monoclonal
Tracer	Drug-Glucose-6-PhosphateDehydrogenase	Ab Colloidal Complex
Detection Method	Change in absorbance (ΔΑ) valuedetected spectrophotometrically	Visual colorprecipitin formation
Test Run Time	10-20 minutes, dependent on test	5 minutes
Storage Requirement	2-8°C (36-46°F)	2-30°C (36-86°F)
Detection Level	Cocaine300 ng/mlCannabinoids50 ng/mlMorphine300 ng/mlMethamphetamine1000 ng/mlPhencyclidine25 ng/ml	300 ng/ml50 ng/ml300 ng/ml1000 ng/ml25 ng/ml
Ancillary Equipment	717 Hitachi Analyzer, EIACalibrators	none

7. Visualine®V Dipstrip Panel Performance Characteristics

A. Correlation studies between Diagnostic Reagents, Inc. EIA individual assays and Visualine® V dipstrip Panel for Cocaine and it's metabolites, Cannabinoids and it's metabolites, Morphine and it's metabolites, Methamphetamine, and Phencyclidine were conducted at Redwood Toxicology Laboratory, Santa Rosa California and Sun Biomedical Laboratories. Presumptive positive samples (tested on the Hitachi) for each drug were provided by Redwood and tested at Sun Biomedical Labs where blinded studies were conducted to determine the correlation between the two methodologies. Negative samples consisted of UTAK Laboratories Drug Free Urine

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pool, Lot# 2647, and in-house negative urines tested with Sun Biomedical's Visualine® II product. Correlation with Hitachi 717 yielded the following data:

Cocaine:	Sensitivity	49 / 50	98 %
	Specificity	247 / 247	>99 %
	Efficiency	296 / 297	>99 %
Cannabinoids:	Sensitivity	50 / 50	>99 %
	Specificity	253 / 253	>99 %
	Efficiency	303 / 303	>99 %
Morphine:	Sensitivity	50 / 50	>99 %
	Specificity	257 / 257	>99 %
	Efficiency	307 / 307	>99 %
Methamphetamine:	Sensitivity	50 / 50	>99 %
	Specificity	255 / 255	>99 %
	Efficiency	305 / 305	>99 %
Phencyclidine:	Sensitivity	50 / 50	>99 %
	Specificity	255 / 255	>99 %
	Efficiency	305 / 305	>99 %

B. Specificity and Substances Detected:

The individual tests are specific to the labeled drug of abuse or structurally related The test detects Cocaine and its metabolites at 300 ng/ml, compounds. Cannabinoids and its metabolites at 50 ng/ml, Morphine and its metabolites at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml.

C. Reproducibility studies for Cocaine, Cannabinoids, Morphine, Precision: Methamphetamine and PCP indicate:

Within run and run to run	> 99 %
Within day and day to day	> 99 %
Within lot and lot to lot	> 99 %

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8. Attachments:Correlation Studies	(Accuracy)	Section A
Specificity Studies	(Interference substances and cutoff levels ofEach individual Drug of Abuse)	Section B
Sensitivity Studies	(Analytical studies)	Section C
Reproducibility Studies	(Precision)	Section D
Visualine® V Dipstrip PanelPackage Insert		Section E
DRI Inserts for Hitachi 717		Section F
Label Copies		Section G
Stability Studies		Section H

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of an eagle with three human profiles incorporated into the design of the eagle's neck and head. The eagle is facing to the left.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 7 1999

Ming Sun, Ph.D. President Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, New Jersey 08012

Re: K993485

Trade Name: Visualine@ V Drugs of Abuse Dipstrip Panel Regulatory Class: II Product Code: DIO, LDJ, DJG, DKZ, LCM Dated: October 11. 1999 Received: October 14, 1999

Dear Dr. Sun:

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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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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"(21 CFR 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 Putman

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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Page__________________________________________________________________________________________________________________________________________________________________________

K 993485 S10(k) Number (if known): _

Visualine V Drugs of Abuse Dipstrip Panel crice Name:_

Indications For Use:

Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.

Den Cooper
(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993485

(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).