(89 days)
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.
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.
Acceptance Criteria and Study for ACON PPX One Step Propoxyphene Test Strip/Device
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it demonstrates "substantial equivalency" to an FDA-cleared predicate device. The performance is reported in terms of agreement with both the predicate device and Gas Chromatography/Mass Spectrometry (GC/MS).
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (ACON PPX One Step Propoxyphene Test Strip) | Reported Device Performance (ACON PPX One Step Propoxyphene Test Device) |
|---|---|---|---|
| Positive Agreement vs. Predicate Device | High agreement, approaching 100% | >99% (98% - 99% CI) | >99% (98% - 99% CI) |
| Negative Agreement vs. Predicate Device | High agreement, approaching 100% | >99% (98% - 99% CI) | >99% (98% - 99% CI) |
| Overall Agreement vs. Predicate Device | High agreement, approaching 100% | >99% (99% - 99% CI) | >99% (99% - 99% CI) |
| Agreement with GC/MS for Positive Results | Not explicitly stated, but expected to be high for confirmation | Implicitly demonstrated by overall high agreement with a device that is compared to GC/MS | Implicitly demonstrated by overall high agreement with a device that is compared to GC/MS |
| Agreement with GC/MS for Negative Results | Not explicitly stated, but expected to be high for confirmation | Implicitly demonstrated by overall high agreement with a device that is compared to GC/MS | Implicitly demonstrated by overall high agreement with a device that is compared to GC/MS |
Note: The confidence intervals provided (e.g., 98% - 99%) are described as "97.5% confidence interval" in the document, which might be a typo for a standard 95% CI. However, without further clarification, it's presented as stated. The ">99%" indicates that the observed agreement was 100%.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 314 clinical urine specimens.
- Approximately 10% of these specimens contained Propoxyphene concentrations between -25% and +25% of the 300 ng/mL cutoff.
- The agreement calculations (positive, negative, overall) were based on 157 positive and 157 negative results, summing to 314.
- Data Provenance: The document states "clinical urine specimens," implying human-derived samples. However, the country of origin and whether the data was retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of diagnostic device (immunochromatographic assay for drug detection) typically does not rely on human "experts" in the traditional sense (e.g., radiologists interpreting images) for establishing ground truth in clinical validation. Instead, the ground truth for chemical analytes is established by a reference method.
- The ground truth in this study was primarily established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "gold standard" for confirmatory drug testing.
- The study also compared the device performance against "a FDA-cleared Propoxyphene test," which can be considered a strong predicate for comparison.
- Therefore, there were no human experts involved in establishing the ground truth, but rather analytical instruments and methodologies.
4. Adjudication Method for the Test Set
Since the ground truth was established by an objective analytical method (GC/MS), an adjudication method (like 2+1, 3+1 consensus among human readers) is not applicable in this context. The GC/MS results are considered definitive.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study, which typically evaluates the performance of human readers with and without AI assistance, was not performed. This is a standalone diagnostic device that does not involve human interpretation in the same way imaging AI models do.
6. Standalone Performance Study
Yes. The described accuracy study conducted against GC/MS analysis serves as a standalone performance evaluation of the ACON PPX One Step Propoxyphene Test Strip and Device. The results indicate the device's ability to qualitatively detect Propoxyphene in urine.
7. Type of Ground Truth Used
The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. The study also utilized comparison to an "FDA-cleared Propoxyphene test" as part of its validation.
8. Sample Size for the Training Set
The document is a 510(k) summary for a rapid immunochromatographic assay. This type of device does not typically involve a "training set" in the context of machine learning or AI models. The device's mechanism is based on established immunochemistry principles and monoclonal antibodies. Therefore, a training set sample size is not applicable or reported for this device.
9. How Ground Truth for the Training Set Was Established
As mentioned above, this device does not utilize a training set in the AI/machine learning sense. Therefore, the method for establishing ground truth for a training set is not applicable. The underlying principles (antibody sensitivity/specificity) are developed and optimized during the research and development phase of the assay, not through a "training set" of clinical data.
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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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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,
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)
§ 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).