The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

Device Description

The Visualine® Methadone DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Methadone and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes 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. A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

AI/ML Overview

The Visualine® Methadone DipStripTest is an in-vitro immunoassay test by visual color comparison for the detection of Methadone and its metabolites in human urine samples, intended for professional use only.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Analytical Sensitivity:
- 0 ng/ml Methadone: Two distinct visible magenta lines (test and control)	Achieved (stated for stability: "A urine specimen containing 0 ng/ml of the analyte of interest will always render two distinct visible magenta lines, one test line and one control line.")
- 360 ng/ml Methadone: Positive results (>99% yielding only control line)	Achieved ("Samples containing 360 ng/ml of methadone show positive results >99% of the time, (yielding only the control line).")
Correlation with Hitachi EmitII® Methadone Assay (cutoff 300 ng/ml):
- Analytical Sensitivity: >= 99% Agreement	>99% Agreement (56/56)
- Analytical Specificity: >= 99% Agreement	>99% Agreement (76/76)
- Analytical Efficiency: >= 99% Agreement	>99% Agreement (132/132)
Precision:
- Within run and run to run: >99%	>99%
- Within day and day to day: >99%	>99%
- Within lot and lot to lot: >99%	>99%
Stability:
- Stable within marked expiration date and under specified storage conditions	Tested every three months and reviewed for acceptance by QC Manager for up to a period of over two years, meeting acceptance criteria.

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

Sample Size for Test Set:
- For Correlation Studies: 132 urine samples (56 positive, 76 negative based on Hitachi EmitII® Methadone Assay).
- For Analytical Sensitivity (360 ng/ml Methadone): The exact number of samples tested at 360 ng/ml isn't explicitly stated as a distinct sample size for that specific concentration, but the >99% performance suggests a sufficient number were used. It's likely a subset or part of a larger panel of samples tested to establish sensitivity.
Data Provenance: The samples were "provided by The Lab, Inc." and the correlation studies were "conducted at Sun Biomedical Laboratories". The origin of the samples (e.g., country, specific types of patients) is not specified. It is a retrospective analysis as it used existing samples.

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

The ground truth for the test set was not established by human experts in a traditional sense. Instead, the Hitachi EmitII® Methadone Assay with a cutoff at or above 300 ng/ml Methadone was used as the reference method (the "gold standard" or ground truth comparator). Therefore, no human experts with specific qualifications were involved in establishing the ground truth for these correlation studies.

4. Adjudication Method for the Test Set

Since the Hitachi EmitII® Methadone Assay served as the reference method, there was no human adjudication process involved for the test results of the Visualine® Methadone DipStrip Test. The results of the DipStrip Test were simply compared directly against the results of the Hitachi assay.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this submission. The study focuses purely on the standalone performance of the Visualine® Methadone DipStrip Test against a predicate device. This is a comparison of two analytical test systems, not a reader-based study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are standalone performance studies of the Visualine® Methadone DipStrip Test. The performance characteristics (sensitivity, specificity, efficiency, precision, stability) are intrinsic to the device itself when interpreted visually. While human interpretation of the visual color lines is part of the test's operation, the "standalone" context here refers to evaluating the device's accuracy compared to a reference method, rather than evaluating human readers using the device and comparing them to human readers without the device.

7. The Type of Ground Truth Used

The primary ground truth used was the results from the Hitachi EmitII® Methadone Assay, which is a homogenous enzyme immunoassay. This served as the reference method for determining the true positive or true negative status of the urine samples for methadone.

8. The Sample Size for the Training Set

The document does not explicitly mention a distinct "training set" or its sample size. Immunoassay devices typically do not undergo a training phase in the same way machine learning algorithms do. Development of such devices involves extensive R&D and optimization (which could be considered analogous to "training"), but specific sample sizes for this internal development are not usually disclosed in 510(k) summaries, nor is there a formal "training set" in the context of clinical validation as with AI models. The samples mentioned (132 for correlation) are for performance validation.

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

As no explicit training set is described in the provided document, the method for establishing its ground truth is also not applicable or not specified. The focus of the 510(k) summary is on demonstrating performance against predicate devices using a validation set.

Summary

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K023856

AUG 2 5 2003

510(k) CONTENT SUMMARY

1. Name of Manufacturer:

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

2. Trade Name: Visualine® Methadone DipStripTest

3. Common Name:

An in-vitro immunoassay test by visual color comparison for the detection of Methadone and it's metabolites in human urine samples. This test is intended for professional use only.

4. Regulation # and Classification:

Reg. #862-3620, Class II Device

5. Test Description:

A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.

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6. Comparison of Two Test Systems for Correlation Studies:

Emit The Visualine® Methadone DipStrip Test assay is correlated to the Hitachi The following table illustrates the similarities and differences Methadone Assay. between the two assays.

	Hitachi® Methadone Assay	Visualine® Methadone DipStripTest
Test Principle	Homogenous enzymeimmunoassay	Competitive bindingimmunoassay
Sample/Sample Size	200 uL urine	Approx. 150 uL (3 drops) urine
Antibody	Polyclonal	Polyclonal
Tracer	Drug-Glucose-6-PhosphateDehydrogenase	Ab Colloidal Complex
Detection Method	Change in absorbance (ΔΑ)value detectedspectrophotometrically	Visual colorprecipitin formation
Test Run Time	10-20 minutes, dependent on test	5 minutes
Storage Requirement	2-8℃ (36-46ºF)	2-30℃ (36-86°F)
Detection Level	300 ng/ml Methadone	300 ng/ml Methadone
Ancillary Equipment	Hitachi Emit Calibrators	none

1. Visualine® Methadone DipStrip Test Performance Characteristics
- A. Correlation studies between Hitachi Methadone Assay and

Visualine® Methadone DipStrip Test were conducted at Sun Biomedical Laboratories with samples provided by The Lab, Inc. Correlation with Hitachi EmitII® Methadone Assay with cutoff at or above 300 ng/ml Methadone yielded the following data:

Analytical Sensitivity	56 / 56	= >99% Agreement
Analytical Specificity	76 / 76	= >99% Agreement
Analytical Efficiency	132 / 132	= >99% Agreement

B. Analytical Specificity and Substances Detected: The test is specific to Methadone or structurally related compounds. The test detects Methadone at a concentration of 300 ng/ml.
C. Visualine® Methadone DipStrip Test Analytical Sensitivity: The analytical sensitivity at 360 ng/ml Methadone read at 5 minutes is >99%.
D. Precision: Reproducibility studies indicate:

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

E. Analytical Studies versus precision and accuracy studies: The Visualine® Methadone DipStrip Tests detect methadone at a cutoff of 300 ng/ml.
1131103

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F. Stability Statement:

Visualine® Methadone DipStrip Test stability has been studied. The drug urine tests are tested every three months and reviewed for acceptance by the Quality Control Manager for up to a period of over two years. The acceptance criteria are as follows: A urine specimen containing 0 ng/ml of the analyte of interest will always render two distinct visible magenta lines, one test line and one control line. Samples containing 360 ng/ml of methadone show positive results >99% of the time, (yielding only the control line). Visulaine® Methadone DipStrip Test Kits are stable within their marked expiration date and under the storage conditions as described in the package insert.

page 8 Amended 4/03

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the perimeter of the circle. The logo is black and white.

AUG 2 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Ann Bompadre Regulatory Manager Sun Biomedical Laboratories Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

Re: K023856

Trade/Device Name: Visualine® Methadone DipStrip Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: June 6, 2003 Received: July 22, 2003

Dear Ms. Bompadre:

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 either class II (Special Controls) or class III (PMA), 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 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2 -

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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo and address of Sun Biomedical Laboratories, Inc. The logo consists of a black circle with a white shape inside, followed by the company name in bold, uppercase letters. Below a horizontal line, the address is listed as 604 VPR Center, 1001 Lower Landing Rd, Blackwood, NJ, USA 08012.

www.sunbiomed.com

Tel: 856.401.1080

Fax: 856.401.1090

510 (k) Number: K 03385 6

DEVICE NAME: Visualine® Methadone DipStrip Test

INDICATIONS FOR USE: The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter-Use

(Optional Format 1-2-96)

A. Ueberlinz

Division Sian-Off Division of Clinical Laboratory D 510(k) Number

Regulation Number and Section

§ 862.3620 Methadone test system.

(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).