(67 days)
Not Found
FDA-cleared Oxycodone test, GC/MS
No
The device description and performance studies indicate a simple lateral flow immunoassay, which does not involve AI or ML. The analysis is based on a chemical reaction and visual interpretation of lines.
No.
The device is a rapid diagnostic test for the qualitative detection of Oxycodone levels in urine, used for preliminary analytical test results, not for therapeutic purposes.
Yes
The device is described as a "rapid chromatographic immunoassay for the qualitative detection of Oxycodone levels in urine," and its intended use section states it "provides only a preliminary analytical test result," which are characteristics of a diagnostic device used to detect specific substances in patient samples.
No
The device description clearly states it is a "rapid chromatographic immunoassay" and a "competitive binding, lateral flow immunochromatographic assay." These are physical test strips/devices that utilize chemical reactions and visual interpretation, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Oxycodone levels in urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes antibodies to detect a substance in a urine sample. This is a common method for in vitro diagnostic tests.
- Clinical Evaluation: The document describes a clinical evaluation using "clinical urine specimens" to compare the device's performance against other tests and a confirmatory method (GC/MS). This type of evaluation is standard for IVD devices to demonstrate their accuracy and reliability.
- Performance Studies: The document lists various performance studies conducted, such as analytical sensitivity, specificity, interference studies, and a POL (Point-of-Care) study. These studies are required to validate the performance of an IVD device.
- Target User: The intended users are "healthcare professionals including professionals at point-of-care sites," which aligns with the typical users of IVD devices.
The device is designed to provide diagnostic information about the presence of Oxycodone in a patient's urine sample, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone levels in urine at a designated cutoff concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at 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) are the preferred confirmatory methods.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
DJG
Device Description
The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Oxycodone 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 Oxycodone and its metabolite in urine at a cutoff concentration of 100 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 Oxycodone 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
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Oxycodone concentration fell between -- 25% cutoff to +25% cutoff range. This evaluation compared the test results between the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device with a FDA-cleared Oxycodone test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Evaluation
Sample Size: 300 clinical urine specimens
Key results:
ACON OXY II One Step Oxycodone Test Strip versus a FDA-cleared OXY Test:
Positive Agreement: 135 / 140 = 96% (92% - 99%)*
Negative Agreement: 159 / 160 = 99% (97% - 99%)*
Overall Agreement: 294 / 300 = 98% (96% - 99%)*
ACON OXY II One Step Oxycodone Test Device versus a FDA-cleared OXY Test:
Positive Agreement: 135 / 140 = 96% (92% - 99%)*
Negative Agreement: 159 / 160 = 99% (97% - 99%)*
Overall Agreement: 294 / 300 = 98% (96 % - 99%)*
ACON OXY II One Step Oxycodone Test Strip versus data obtained with GC/MS at the cutoff concentration of 100 ng/mL:
Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*
ACON OXY II One Step Oxycodone Test Device versus GC/MS.
Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*
POL Study Summary:
Test results obtained from three POL study sites indicated that personnel at different doctor's offices with various educational background and working experience could perform the ACON® OXY II One Step Oxycodone tests properly and interpret test results correctly in most cases (97%, 262/270). The POL study results are also comparable to those obtained from a trained lab technician (97%, 87/90).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement, Negative Agreement, Overall Agreement, and Total Agreement with GC/MS.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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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FEB 2 5 2005
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 K043507
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
December 17, 2004
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® OXY II One Step Oxycodone Test Strip ACON® OXY II One Step Oxycodone Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Oxycodone in urine.
Regulation Name:
Oxycodone test system.
Product Code:
DJG
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Classification Number:
21 CFR, 862.3650
Device Classification:
The Oxycodone test systems have been classified as Class II devices with moderate complexity. The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are similar to another FDA-cleared device for the qualitative detection of Oxycodone 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 OXY II One Step Oxycodone Test Strip and ACON OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone in urine at a cutoff concentration of 100 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 OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Oxycodone 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 Oxycodone and its metabolite in urine at a cutoff concentration of 100 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 Oxycodone 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.
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Comparison to a Predicate Device:
A comparison of the features of the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device versus a FDA-cleared Oxycodone test with 100 ng/mL Oxycodone cutoff is shown below:
- . Both tests are assays intended for the qualitative detection of Oxycodone 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 Oxycodone 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 Oxycodone concentration of 100 ng/mL.
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Oxycodone concentration fell between -- 25% cutoff to +25% cutoff range. This evaluation compared the test results between the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device with a FDA-cleared Oxycodone test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. These comparisons of data yielded the following results:
ACON OXY II One Step Oxycodone Test Strip versus a FDA-cleared OXY Test:
Positive Agreement: 135 / 140 = 96% (92% - 99%)* Negative Agreement: 159 / 160 = 99% (97% - 99%)* Overall Agreement: 294 / 300 = 98% (96% - 99%)* * 95% confidence intervals
ACON OXY II One Step Oxycodone Test Device versus a FDA-cleared OXY Test:
Positive Agreement: 135 / 140 = 96% (92% - 99%)* Negative Agreement: 159 / 160 = 99% (97% - 99%)* Overall Agreement: 294 / 300 = 98% (96 % - 99%)* 95% confidence intervals *
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ACON OXY II One Step Oxycodone Test Strip versus data obtained with GC/MS at the cutoff concentration of 100 ng/mL:
| ACON OXY II One Step Oxycodone Test Strip versus GC/MS. | ||
|---|---|---|
| --------------------------------------------------------- | -- | -- |
| | Test
Result | Specimen Cutoff Range by GC/MS Data | | | | | |
|---------------------------------|----------------|-------------------------------------|------------------|-------------------|-------------------|------------------|-------------------------------|
| | | Negative† | +25%
Cutoff | % Agreement |
| ACON
OXY II
Test
Strip | Positive | 0 | 0 | 1 | 2 | 133 | 99% (135/136)
(96% - 99%)* |
| | Negative | 147 | 6 | 8 | 0 | 3 | 98% (161/164)
(95% - 99%)* |
Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*
-
Denotes 95% confidence interval.
-
Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of 5.
ACON OXY II One Step Oxycodone Test Device versus GC/MS.
| | Test
Result | Specimen Cutoff Range by GC/MS Data | | | | | |
|----------------------------------|----------------|-------------------------------------|------------------|-------------------|-------------------|------------------|-------------------------------|
| | | Negative+ | +25%
Cutoff | % Agreement |
| ACON
OXY II
Test
Device | Positive | 0 | 0 | 1 | 2 | 133 | 99% (135/136)
(96% - 99%)* |
| | Negative | 147 | 6 | 8 | 0 | 3 | 98% (161/164)
(95% - 99%)* |
Total agreement with GC/MS: 296/300 = 98.67% (97%- 99%)*
-
Denotes 95% confidence interval.
-
Negative specimens were confirmed using GC/MS analysis by pooling these samples in groups of vi
Performance Characteristics and Other information:
The performance characteristics of the ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone 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.
POL Study Summary:
:
Test results obtained from three POL study sites indicated that personnel at different doctor's offices with various educational background and working experience could perform the ACON® OXY II One Step Oxycodone tests properly and interpret test results correctly in most cases (97%, 262/270). The POL study results are also comparable to those obtained from a trained lab technician (97%, 87/90).
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Conclusion:
These clinical studies demonstrated substantial equivalency on performance among the ACON OXY II One Step Oxycodone Test Strip, the ACON OXY II One Step Oxycodone Test Device and a FDA-cleared Oxycodone test with the same Oxycodone cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Oxycodone at a concentration of 100 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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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 5 2005
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd San Diego, CA 92121
Re: K043507 Trade/Device Name: ACON OXY II One Step Oxycodone Test Strip ACON OXY II One Step Oxycodone Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: December 17, 2004 Received: December 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 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 dcvices 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).
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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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Jean M. Coogen, MS, DUM
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
7
INDICATIONS FOR USE 11.
510(k) Number (if known): K043507
ACON OXY II One Step Oxycodone Test Strip Device Name:
ACON OXY II One Step Oxycodone Test Device
Indications for Use:
The ACON OXY II One Step Oxycodone Test Strip and the ACON OXY II One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone levels in urine at a designated cutoff concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at 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) are the preferred confirmatory methods.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-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)
Division Sign-Off
acting
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043507
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