Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Device Description

The RapidBAR test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-barbiturate antibody between barbiturate-protein conjugate and free drug which may be present in the urine specimen being tested. When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.

AI/ML Overview

The provided document describes the 510(k) summary for the Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card. It states the intended use as qualitative determination of secobarbital in human urine specimens above a cutoff level of 300 ng/ml. The document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data in a comprehensive study report.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity thresholds). Instead, it lists various "Performance" studies conducted, implying that these studies were performed to demonstrate the device's acceptable performance and substantial equivalence.

Performance Study	Reported Device Performance
Rapid Barbiturate Test Strip Sensitivity	Implied as acceptable for substantial equivalence, but no specific values provided.
Rapid Barbiturate Test Strip Accuracy (comparison study of clinical urine specimens)	Implied as acceptable for substantial equivalence, but no specific values provided.
Stability - Specimen Stability	Study performed, but no specific results or acceptance criteria given.
Stability - Product	Study performed, but no specific results or acceptance criteria given.
Precision	Study performed, but no specific results or acceptance criteria given.
Reproducibility	Study performed, but no specific results or acceptance criteria given.
Specificity	Study performed, but no specific results or acceptance criteria given.
Interference	Study performed, but no specific results or acceptance criteria given.
Rapid Barbiturate Test Card Accuracy (comparison study of clinical urine specimens)	Implied as acceptable for substantial equivalence, but no specific values provided.
Precision	Study performed, but no specific results or acceptance criteria given.
Comparison between Rapid Barbiturate Test Strip and Test Card	Study performed, but no specific results or acceptance criteria given.

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

Sample Size: The document mentions that "Both urine control specimen and clinical urine specimen were tested," but it does not provide the specific sample size for either the control or clinical urine specimens used in the accuracy/comparison studies.
Data Provenance: The country of origin of the data is not explicitly stated. Given the manufacturer's address in Burlingame, CA, U.S.A., and the FDA 510(k) submission, it is implied that the studies were conducted to meet U.S. regulatory standards, but the physical location of the data collection is not specified. The studies involved "clinical urine specimens," indicating they were likely retrospective or prospective collections from a clinical setting, but this detail is not explicitly stated.

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

This information is not provided in the document. For in-vitro diagnostic devices like this, ground truth for drug testing typically involves confirmatory methods.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The Rapid Barbiturate Test is a rapid immunochromatography test designed for a qualitative, visual result, primarily relying on the presence or absence of a colored band. It does not involve human readers interpreting complex images or data in a way that an MRMC study would assess. The "comparison study of clinical urine specimens" mentioned is a comparison of the device's results against a reference method (ground truth), not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for both the Rapid Barbiturate Test Strip and Test Card. The document lists "Sensitivity Accuracy (comparison study of clinical urine specimens)," "Precision," "Reproducibility," "Specificity," and "Interference" as studies performed. These studies evaluate the device's intrinsic performance characteristics.

7. Type of Ground Truth Used

The most common type of ground truth for urine drug screens is a more specific and sensitive chemical method, such as Gas Chromatography-Mass Spectrometry (GC/MS). While the document states, "A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result," it doesn't explicitly state that GC/MS was used as the ground truth for the comparison studies mentioned. However, this is the standard practice for validating such devices, and it is highly probable that a similar confirmatory method was employed for ground truth establishment.

8. Sample Size for the Training Set

This information is not provided in the document. Immunochromatographic assays like this are typically developed based on laboratory experiments and antibody-antigen binding characteristics, rather than "training" an algorithm on a large dataset in the way a machine learning model would be. Therefore, the concept of a "training set" in the context of an algorithm may not directly apply.

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

As noted above, the concept of a "training set" for this type of device is not directly applicable in the same way it would be for AI/ML algorithms. The ground truth for the underlying immunochemistry would be established through known concentrations of barbiturates and cross-reactants, and the selection of antibodies would be based on their empirically determined binding characteristics. The document does not provide details on this developmental process.

Summary

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Ko3021L

JUN 1 3 2003

510 (k) SUMMARY (21 CFR PART 807.92)

Product

Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card

Name of Manufacturer

Rapid Diagnostics, Division of ICN BIOmedicals Inc. 1429 Rollins Road, Burlingame, CA 94010, U.S.A.

Principle

When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.

A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.

Intended Use

The RapidBarbiturate Tests are immunochromatography based one step in vitro test. It is designed for qualitative determination of secobarbital in human urine specimen above the cutoff level of 300 ng/ml.

Performance

The studies performed are listed below:

Rapid Barbiturate Test Strip Sensitivity Accuracy (comparison study of clinical urine specimens)

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Stability - Specimen Stability - Product Precision Reproducibility Specificity Interference

Rapid Barbiturate Test Card Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Barbiturate Test Strip and Test Card

Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card.

The results of performance characteristics demonstrate Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card to be substantially equivalent to the Applied Biotech SureStep ™ Drug Screen Test Barbiturate, which received 510 (k) approval.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 3 2003

Mr. Charles Yu Director of Technical Operation ICN Biomedicals, Inc. 1429 Rollins Road Burlingame, CA 94010

Re: K030211

Trade/Device Name: Rapid Barbiturate Test Strip Rapid Barbiturate Test Card Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate Test System Regulatory Class: Class II Product Code: DKX Dated: April 11, 2003 Received: April 16, 2003

Dear Mr. Yu:

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 (QS) 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). Other general information on your responsibilities under the Act may be obtained 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 Sutman

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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INDICATIONS FOR USE STATEMENT

510 (K) number (if known):__ K0 302 (1

Device Name: Rapid Barbiturate Test Strip

Indications for Use:

The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.

This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Jean Cooper

((Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030211
)

Prescription Use: (Per 21 CFR 801.109)

Over the Counter Use: ______

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INDICATIONS FOR USE STATEMENT

510 (K) number (if known): _ KO30 Al |______

Device Name: Rapid Barbiturate Test Card

Indications for Use:

The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.

This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Jean Cooper

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

Prescription Use: _ (Per 21 CFR 801.109)

Over the Counter Use:

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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).