The Visualine® Barbiturates DipStrip Test is used for qualitative testing for the presence of Secobarbital in 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® Barbiturates DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Barbiturates 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

Here's a breakdown of the acceptance criteria and study details for the Visualine® Barbiturates DipStrip Test, based on the provided document:

Acceptance Criteria and Device Performance

Criteria	Acceptance Level (Implied/Reported)	Reported Device Performance
Sensitivity	Not explicitly stated as a minimum acceptance level, but performance compared to a predicate device.	94% (95/101)
Specificity	Not explicitly stated as a minimum acceptance level, but performance compared to a predicate device.	95% (95/100)
Efficiency	Not explicitly stated as a minimum acceptance level, but performance compared to a predicate device.	95% (190/201)
Detection Level	300 ng/ml Barbiturates	Detects at 300 ng/ml
Sensitivity at 360 ng/ml	Not explicitly stated as a minimum for this specific concentration.	94%
Precision (Reproducibility)	Not explicitly stated (e.g., >X%).	Within run & run to run: >99%Within day & day to day: >99%Within lot & lot to lot: >99%
Stability	Stable until marked expiration date under specified storage conditions.	Tested every three months for up to two years and found stable.

Study Details

Sample Size used for the test set and data provenance:
- Sample Size: 201 urine samples (190 correctly identified + 11 misidentified = 201 total). Specifically, 101 samples were positive and 100 were negative according to the predicate device.
- Data Provenance: The samples were "provided by The Lab, Inc." The country of origin is not explicitly stated, but the manufacturer (Sun Biomedical Laboratories, Inc.) is located in Blackwood, NJ, USA, and FDA approval is being sought, suggesting a US context for the study. The study appears to be retrospective, using a collected set of samples.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This information is not provided in the document. The "ground truth" for correlation was established by comparison to results from the Hitachi Emit® Barbiturates Assay, which is a laboratory-based homogenous enzyme immunoassay. The document does not describe human expert involvement in establishing ground truth for the test set.
Adjudication method for the test set:
- None specified. The comparison is directly against the results of the Hitachi Emit® Barbiturates Assay.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in-vitro diagnostic dipstrip test for visual color comparison, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The reported performance (sensitivity, specificity, efficiency) is for the Visualine® Barbiturates DipStrip Test itself, in comparison to the Hitachi Emit® Barbiturates Assay. Although the dipstrip test is read visually, the reported performance metrics reflect the device's ability to produce its result (presence/absence of a line) accurately relative to a reference method, without specifying human variability in reading. The intent of the device is for professional use, implying trained personnel will interpret the visual results.
The type of ground truth used:
- Reference Method Comparison. The ground truth was established by the results obtained from the Hitachi Emit® Barbiturates Assay, which itself is a commercially available and presumably validated laboratory immunoassay.
The sample size for the training set:
- The document does not provide information about a separate "training set" for the Visualine® Barbiturates DipStrip Test. This type of immunoassay typically undergoes development and optimization, rather than a machine learning-style training process with a distinct training set. The correlation studies mentioned are evaluation studies.
How the ground truth for the training set was established:
- As there is no mention of a separate training set, this information is not applicable/not provided. The development of the immunochromatographic test would involve internal validation and optimization against known samples (spiked samples, characterized clinical samples), but these are not formally described as a "training set" with ground truth established in the same way a machine learning algorithm would.

Summary

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Image /page/0/Picture/0 description: The image shows a black circle with two horizontal lines cutting across the bottom portion of the circle. The lines are parallel to each other and are positioned close together. The overall impression is a simple, graphic representation of a sun or planet with a horizon line.

SUN BIOMEDICAL LABORATORIES. INC.

604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 08012 Tel. 856-401-1080 Fax. 856-401-1090

MAR 2 0 2002

KD20136

510(k) CONTENT SUMMARY

1. Name of Manufacturer:
  Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012

Visualine® Barbiturates DipStripTest 2. Trade Name:

1. Common Name:
  An in-vitro immunoassay test by visual color comparison for the detection of Barbiturates and it's metabolites in human urine samples. This test is intended for professional use only.
1. Regulation # and Classification:
  Reg. #862-3150, 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:

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

	Hitachi® Barbiturates Assay	Visualine® BarbituratesDipStrip Test
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 (AA) 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℃ (36-86°F)
Detection Level	300 ng/ml Barbiturates	300 ng/ml Barbiturates
Ancillary Equipment	Hitachi Emit Calibrators	none

7. Visualine® Barbiturates DipStrip Test Performance Characteristics

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

Sensitivity	95 / 101	= 94 %
Specificity	95 / 100	= 95 %
Efficiency	190 / 201	= 95 %

B. Specificity and Substances Detected: The test is specific to Barbiturates or structurally related compounds. The test detects Barbiturates at a concentration of 300 ng/ml.
C. Visualine® Barbiturates DipStrip Test Sensitivity: The sensitivity at 360 ng/ml Barbiturates read at 5 minutes is 94%.
Precision: Reproducibility studies indicate: D. 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® Barbiturates DipStrip Tests detect barbiturates at a cutoff of 300 ng/ml.

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F. Stability Statement:
Visualine® Barbiturates DipStrip Test stability has been studied. The drug urine tests are tested every three months for up to a period of two years. Visualine® Barbiturates DipStrip Test Kits are stable within their marked expiration date and under the storage conditions as described in the insert.

8. Attachments:Correlation Studies	(Accuracy)	Section A
Specificity Studies	(Interference substances and cutoff level ofBarbiturates detectable by Barbiturates test)	Section B
Sensitivity Studies	(Analytical studies)	Section C
Reproducibility Studies	(Precision)	Section D
Visualine® BarbituratesDipStripTest Package Insert		Section E
Label Copies		Section F
Hitachi Emit BarbituratesAssay Insert		Section G
Stability Study		Section H

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

MAR 2 0 2002

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K020136

Trade/Device Name: Visualine® Barbiturates DipStrip Test Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: January 11, 2002 Received: January 15, 2002

Dear Dr. Sun:

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 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 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 Part 801); 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 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his ication. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. THE I Dr 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 1 II you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 8011 o ditionally, for questions on the promotion and advertising of your device, (301) 591-1569. I radiations 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 mioritation on 5 var reserver 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 Sutman

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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SUN BIOMEDICAL LABORATORIES, INC.

604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 08012 Fax. 856-401-1090 Tel. 856-401-1080

Page 1 of 1

K020136 510 (k) Number:

DEVICE NAME: Visualine®Barbiturates DipStrip Test

INDICATIONS FOR USE: The Visualine® Barbiturates DipStrip Test is used for qualitative testing for the presence of Secobarbital in urine samples at or above300 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.

Kull

(Division Sign-Off) Division of Clinical Laboratory 510(k) Number K 11/2/12/12/12/2017

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

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

page 3 revised 3/15/2

Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).