(89 days)
JXN
Not Found
No
The device description and performance studies indicate a simple lateral flow immunoassay, which does not involve AI or ML.
No
The device is a diagnostic test kit used to detect propoxyphene in urine. It does not provide any therapeutic intervention.
Yes
Explanation: The device is described as "a lateral flow chromatographic immunoassay test for the qualitative detection of Dpropoxyphene in human urine." It is explicitly stated that this "assay provides only a preliminary analytical test result," and that a "more specific alternate chemical method must be used in order to obtain a confirmed analytical result." This clearly indicates its role in identifying the presence of a substance for further investigation, which is a diagnostic function.
No
The device description explicitly states it is a "lateral flow chromatographic immunoassay test" and a "competitive binding, lateral flow immunochromatographic assay," which are physical test strips/devices, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "qualitative detection of D-propoxyphene in human urine". This is a test performed on a biological sample (urine) outside of the body to provide information about a person's health status (in this case, the presence of a drug).
- Device Description: The description details a "lateral flow chromatographic immunoassay test" that utilizes "antibody immunochemistry" to detect a substance in a urine sample. This is a common method used in IVD tests.
- Sample Type: The test is performed on "human urine".
- Purpose: The purpose is to provide a "preliminary analytical test result" for the presence of propoxyphene, which is used for diagnostic or screening purposes.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. This device fits that description.
N/A
Intended Use / Indications for Use
The ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device are rapid chromatographic immunoassays for the qualitative detection of Propoxyphene in urine at a cutoff concentration of 300 ng/mL. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for healthcare professionals including professionals at point-of-care sites.
ACON PPX One Step Propoxyphene Test Strip or ACON PPX One Step Propoxyphenc Test Device is a lateral flow chromatographic immunoassay test for the qualitative detection of D-propoxyphene in human urine at a cut-off concentration of 300 ng/mL. It is a prescription assay intended for use by healthcare professionals including those at the point of care sites.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
JXN
Device Description
The ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Propoxyphene in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Propoxyphene and its metabolite in urine at a cutoff concentration of 300 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Propoxyphene at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals including professionals at point-of-care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical evaluation was conducted using 314 clinical urine specimens including approximately 10% of the specimens containing Propoxyphene concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device with a FDA-cleared Propoxyphene test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ACON PPX One Step Propoxyphene Test Strip versus a FDA-cleared Propoxyphene Urine Test:
Positive Agreement: 157 / 157 >99% (98 % - 99 %)
Negative Agreement: 157 / 157 >99% (98 % - 99 %)
Overall Agreement: 314 / 314 >99% (99 % - 99 % **) ** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.
ACON PPX One Step Propoxyphene Test Device versus a FDA-cleared Propoxyphene Urine Test:
Positive Agreement: 157 / 157 >99% (98 % - 99 % **)
Negative Agreement: 157 / 157 >99% (98 % - 99 % **)
Overall Agreement: 314 / 314 >99% (99 % - 99 % **) ** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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8. 510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is __K 040445 | S 00 /
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tcl.: 858-535-2030 Fax: 858-535-2038
Date:
February 16, 2004
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® PPX One Step Propoxyphene Test Strip ACON® PPX One Step Propoxyphene Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Propoxyphene in urine.
Regulation Name:
Propoxyphene test system.
Product Code:
JXN
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Classification Number:
21 CFR. 862.3700
Device Classification:
The Propoxyphene test systems have been classified as Class II devices with moderate complexity. The ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device are similar to another FDA-cleared device for the qualitative detection of Propoxyphene in urine specimens. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis.
Intended Use:
The ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device are rapid chromatographic immunoassays for the qualitative detection of Propoxyphene in urine at a cutoff concentration of 300 ng/mL. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for healthcare professionals including professionals at point-of-care sites.
Description:
The ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Propoxyphene in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Propoxyphene and its metabolite in urine at a cutoff concentration of 300 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Propoxyphene at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Comparison to a Predicate Device:
A comparison of the features of the ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device versus a FDA-cleared Propoxyphene test with 300 ng/mL Propoxyphene cutoff is shown below:
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- Both tests are assays intended for the qualitative detection of Propoxyphene in urine samples. .
- Both tests are intended as a screening method that provides a preliminary analytical test result. .
- Both tests are immunochromatographic, lateral flow assays for the rapid detection of . Propoxyphene with a visual, qualitative end result.
- Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody . interactions to indicate a positive or negative result.
- Both tests have a cutoff Propoxyphene concentration of 300 ng/mL. .
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 314 clinical urine specimens including approximately 10% of the specimens containing Propoxyphene concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON PPX One Step Propoxyphene Test Strip and ACON PPX One Step Propoxyphene Test Device with a FDA-cleared Propoxyphene test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. These comparisons of data vielded the following results:
ACON PPX One Step Propoxyphene Test Strip versus a FDA-cleared Propoxyphene Urine Test:
Positive Agreement: 157 / 157 >99% (98 % - 99 %) Negative Agreement: 157 / 157 >99% (98 % - 99 %) Overall Agreement: 314 / 314 >99% (99 % - 99 % **) ** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.
ACON PPX One Step Propoxyphene Test Device versus a FDA-cleared Propoxyphene Urine Test:
Positive Agreement: 157 / 157 >99% (98 % - 99 % **) Negative Agreement: 157 / 157 >99% (98 % - 99 % **) Overall Agreement: 314 / 314 >99% (99 % - 99 % **) ** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.
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Performance Characteristics and Other information:
The performance characteristics of ACON PPX One Step Propoxyphene Test Strip, ACON PPX One Step Propoxyphene Test Device were verified by analytical sensitivity study, specificity and cross reactivity study, interference studies, precision study, read time flex study, temperature flex study, specimen storage and stability study. Study results indicate that these test devices are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in their package inserts.
Conclusion:
These clinical studies demonstrated substantial equivalency on performance between the ACON PPX One Step Propoxyphene Test Strip, ACON PPX One Step Propoxyphene Test Device and a FDA-cleared Propoxyphene test with the same Propoxyphene cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Propoxyphene at a concentration of 300 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of several curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 9 2004
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories 4108 Sorrento Valley Blvd. San Diego, CA 92121
Rc: K040445
Trade/Device Name: ACON PPX One Step Propoxyphene Test Strip, and ACON PPX One Step Propoxyphene Test Device Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: April 16, 2004 Received: April 20, 2004
Dear Dr. Tung:
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 cnclosure) 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 mcan 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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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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Names:
ACON PPX One Step Propoxyphene Test Strip, and ACON PPX One Step Propoxyphene Test Device
Indications for Use:
ACON PPX One Step Propoxyphene Test Strip or ACON PPX One Step Propoxyphenc Test Device is a lateral flow chromatographic immunoassay test for the qualitative detection of Dpropoxyphene in human urine at a cut-off concentration of 300 ng/mL. It is a prescription assay intended for use by healthcare professionals including those at the point of care sites.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Dev Evaluation and Safety
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)