'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.

'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)

'Rapid One'-Propoxyphene Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

Device Description

The assay employed in the 'Rapid One'-Propoxyphene Test is based on the same principle of highly specific reactions between antigens and antibodies.

This assay is a one-step, competitive, immunoassay for the detection of propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.

When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device Name: 'Rapid One'-Propoxyphene Test

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of specific performance targets (e.g., sensitivity, specificity, accuracy percentages) that the device must meet. Instead, it describes the expected performance and successful reproducibility.

Acceptance Criterion (Implicit)	Reported Device Performance
Detection of propoxyphene or norpropoxyphene at 300 ng/ml.	"‘Rapid One’-Propoxyphene Test will detect propoxyphene or norpropoxyphene at 300 ng/ml."
Reproducibility of results (above/below cut-off, negative).	"The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance."
Consistent control band presence for all reactions.	"The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions."
Visual distinction between positive (one band) and negative (two bands) samples.	"A negative urine will produce two colored bands, and a positive sample will produce only one band."

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

Sample Size for Test Set: The document states: "Each sample was tested four times, twice daily, for five days." It also mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls." However, the total number of distinct samples (e.g., individual patient urine samples) used for the reproducibility study is not specified.
Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the testing was performed in a controlled laboratory setting. The data is prospective as it involves the preparation and testing of control urines for the study.

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

Number of Experts: Not applicable, as the ground truth was established by analytical methods, not expert interpretation.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth (drug concentration) was objectively verified by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold-standard analytical method for drug confirmation. There was no mention of human adjudication.

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

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted or described. This type of study is typical for imaging devices where human interpretation is a primary component. The 'Rapid One'-Propoxyphene Test is an in vitro diagnostic immunoassay with a direct visual output, not requiring human interpretation of complex images or data in the same way.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the described performance relates to the device itself performing the test and producing results. The statement "The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance" explicitly refers to the device's ability to provide consistent outputs. This is a standalone performance assessment in that it's the test kit's output without human influence on the result generation, though human observation is needed to visually read the bands.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the test samples (drug concentrations) was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and confirmatory analytical method for drug detection and quantification. The document states: "All concentrations were verified by GC/MS."

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is an immunoassay kit, not a machine learning or AI-based algorithm that requires a separate "training set." The performance is inherent to the chemical and biological components of the test.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of medical device.

Summary

{0}------------------------------------------------

MAY 22 2003

K030835

510 (k) Summary

Submitter's Name/Address:

American Bio Medica Corportion 122 Smith Road Kinderhook, NY 12106

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Contact Person:

Henry Wells VP Product Development Phone: 410 992-4734 Fax: 410 992-0328

March 12, 2003

'Rapid One'-Propoxyphene Test

Propoxyphene Test System

Classification Number/Class:

Classification Name:

Device Common/Usual Name or

{no classification regulation]/Class II

This 510(k) Summary is being submitted in accordance with the requirement of 21 CFR 807.92.

The assigned 510(k) number is: K030835

Predicate Device: MedTox Diagnostics, Inc. 2-Panel Propoxyphene/MAMP-MDMA Test. (510 (k) No. K002141).

Test Description:

The assay employed in the 'Rapid One'-Propoxyphene Test is based on the same principle of highly specific reactions between antigens and antibodies.

{1}------------------------------------------------

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Intended use:

'Rapid One'-Propoxyphene Test is used for the qualitative detection of propoxyphene and norpropoxyphene in human urine. This immunoassay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing. i.e. gas chromatography/mass spectrometry (GC/MS.)

Performance Characteristics:

'Rapid One'-Propoxyphene Test will detect propoxyphene or norpropoxyphene at 300 ng/ml.

Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days. The results confirmed the reproducibility of the 'Rapid One'-Propoxyphene Test performance.

Conclusion:

'Rapid One'-Propoxyphene Test is substantially equivalent to the previously cleared propoxyphene section of MedTox 2 Panel PPX/MAMP-MDMA Test (510(k) No. K002141).

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Henry Wells Vice President Product Development American Bio Medica Corporation 9110 Red Branch Road Suite B Columbia, Maryland 21045

MAY 22 2003

Re: K030835

Trade/Device Name: Rapid One - Propoxyphene Test Regulation Number: 21 CFR § 862.3700 Regulation Name: Propoxyphene Test System Regulatory Class: II Product Code: JXN Dated: March 14, 2003 Received: March 17, 2003

Dear Dr. Wells:

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). 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.

{3}------------------------------------------------

Page 2 -

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 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

{4}------------------------------------------------

Page of

K030835

510(k) Number (if known):__

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

'Rapid One'-Propoxyphene Test

'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.

'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for i over-the-counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Prescription Use
(Per 21 CFR 801.109)	510(k)

	K030835
	OR

	Over-The-Counter Use
--	----------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3700 Propoxyphene test system.

(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).