(59 days)
Not Found
Not Found
No
The device description details a simple lateral flow immunochromatographic assay based on antibody binding, which does not involve AI or ML. The performance studies are based on comparisons to existing tests and GC/MS, not on training or testing AI/ML models.
No.
The device is for diagnostic purposes, specifically for the qualitative detection of methamphetamine in urine, which aids in diagnosis and treatment monitoring, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose."
No
The device description clearly states it is a "rapid immunochromatographic assay" 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 "qualitative detection of methamphetamine... in urine" and that the measurements are "used in the diagnosis and treatment of methamphetamine use or overdose." This clearly indicates a diagnostic purpose performed on a sample taken from the human body.
- Device Description: The description details a "competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Methamphetamine in a urine sample." This describes a test performed in vitro (outside the body) on a biological specimen (urine).
- Performance Studies: The performance studies involve testing clinical urine specimens and comparing the results to a reference method (GC/MS) and another FDA-cleared test. This is typical for validating an IVD.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or other conditions. This device fits that description.
N/A
Intended Use / Indications for Use
The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine, a central nervous stimulating drug, in urine. Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose.
This assay provides only a preliminary result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.
Product codes
LAF
Device Description
The ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Methamphetamine 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 Methamphetamine and its metabolite in urine at a cutoff concentration of 500 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 Methamphetamine at the concentration i 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
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Methamphetamine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device with a FDA-cleared Methamphetamine test; as well as compared against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis.
ACON mAMP-500 One Step Methamphetamine Test Strip versus a FDA-cleared mAMP 500 Test:
Positive Agreement: 108 / 108 =>99% (97 % - 100 %)
Negative Agreement: 153 / 192 = 80% (73 % = 85%)
Overall Agreement: 261 / 300 = 87% (83 % - 91 %*) * 95% confidence intervals
ACON mAMP-500 One Step Methamphetamine Test Device versus a FDA-cleared mAMP 500 Test:
Positive Agreement: 108 / 108= 100% (97 % - 100 %)
Negative Agreement: 158 / 192= 82% (76 % - 87 %)
Overall Agreement: 266 / 300 = 89% (84 % - 92 %*) * 95% confidence intervals
ACON mAMP-500 One Step Methamphetamine Test Strip versus data obtained with GC/MS at the cutoff concentration of 500 ng/mL:
Total agreement with GC/MS : 293/300 = 98% (95%- 99%)* * Denotes 95% confidence intervals.
ACON mAMP-500 One Step Methamphetamine Test Device versus GC/MS:
Total agreement with GC/MS : 295/300 = 98% (96% - 99%)* * Denotes 95% confidence interval.
Performance Characteristics and Other information:
The performance characteristics 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 mAMP-500 One Step Methamphetamine Test Strip, ACON mAMP-500 One Step Methamphetamine Test Device and a FDA-cleared Methamphetamine test with the same Methamphetamine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Methamphetamine at a concentration of 500 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
Key Metrics
ACON mAMP-500 One Step Methamphetamine Test Strip versus a FDA-cleared mAMP 500 Test: Positive Agreement: 108 / 108 =>99%, Negative Agreement: 153 / 192 = 80%, Overall Agreement: 261 / 300 = 87%.
ACON mAMP-500 One Step Methamphetamine Test Device versus a FDA-cleared mAMP 500 Test: Positive Agreement: 108 / 108= 100%, Negative Agreement: 158 / 192= 82%, Overall Agreement: 266 / 300 = 89%.
ACON mAMP-500 One Step Methamphetamine Test Strip versus GC/MS: Total agreement: 293/300 = 98%.
ACON mAMP-500 One Step Methamphetamine Test Device versus GC/MS: Total agreement: 295/300 = 98%.
Predicate Device(s)
Not Found (The document references "a FDA-cleared Methamphetamine test" but does not provide its K/DEN number.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).
0
DEC 1. 2 2003
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 033299
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
October 7, 2003
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® mAMP-500 One Step Methamphetamine Test Strip ACON® mAMP-500 One Step Methamphetamine Test Device
Common Name:
Immunochromatographic test for the qualitative detection of Methamphetamine in urine.
Regulation Name:
Methamphetamine test system.
Product Code:
LAF
1
Classification Number:
21 CFR, 862.3610
Device Classification:
The Methamphetamine test systems have been classified as Class II devices with moderate complexity. The ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are similar to another FDA-cleared device for the qualitative detection of Methamphetamine 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 mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of Methamphetamine in urine at a cutoff concentration of 500 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 mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Methamphetamine 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 Methamphetamine and its metabolite in urine at a cutoff concentration of 500 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 Methamphetamine at the concentration i 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.
Comparison to a Predicate Device:
A comparison of the features of the ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device versus a FDA-cleared Methamphetamine test with 500 ng/mL Methamphetamine cutoff is shown below:
2
- Both tests are assays intended for the qualitative detection of Methamphetamine 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 . Methamphetamine 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 Methamphetamine concentration of 500 ng/mL. .
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including approximately 10% of the specimens containing Methamphetamine concentration fell between -25% cutoff to +25% cutoff range. This evaluation compared the test results between ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device with a FDA-cleared Methamphetamine 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 mAMP-500 One Step Methamphetamine Test Strip versus a FDA-cleared mAMP 500 Test:
Positive Agreement: 108 / 108 =>99% (97 % - 100 %) Negative Agreement: 153 / 192 = 80% (73 % = 85%) Overall Agreement: 261 / 300 = 87% (83 % - 91 %*) * 95% confidence intervals
ACON mAMP-500 One Step Methamphetamine Test Device versus a FDA-cleared mAMP 500 Test:
Positive Agreement: 108 / 108= 100% (97 % - 100 %) Negative Agreement: 158 / 192= 82% (76 % - 87 %) Overall Agreement: 266 / 300 = 89% (84 % - 92 %*) * 95% confidence intervals
3
ACON mAMP-500 One Step Methamphetamine Test Strip versus data obtained with GC/MS at the cutoff concentration of 500 ng/mL:
| | | Specimen Cutoff Range by GC/MS Data | | | | % Agreement with
GC/MS Data | |
|-----------------------------------|----------|-------------------------------------|------------------|-------------------|-------------------|--------------------------------|---------------------------------|
| | | Negative | +25%
Cutoff | |
| ACON
mAMP
500 Test
Strip | Positive | 0 | 0 | 7 | 8 | 132 | 100% (140/140)
(97% - 100%)* |
| | Negative | 150 | 0 | 3 | 0 | 0 | 97% (153/160)
(91% - 98%)* |
ACON mAMP-500 One Step Methamphetamine Test Strip versus GC/MS
Total agreement with GC/MS : 293/300 = 98% (95%- 99%)* * Denotes 95% confidence intervals.
ACON mAMP-500 One Step Methamphetamine Test Device versus GC/MS
| Specimen Cut off Range by GC/MS Data | % Agreement with GC/MS Data | ||||||
|---|---|---|---|---|---|---|---|
| Negative | +25% Cutoff | ||||||
| ACON | |||||||
| mAMP-500 | |||||||
| Test Device | Positive | 0 | 0 | 4 | 8 | 131 | 99% (139/140) |
| (96% - 99%)* | |||||||
| ACON | |||||||
| mAMP-500 | |||||||
| Test Device | Negative | 150 | 0 | 6 | 0 | 1 | 98% (156/160) |
| (94% - 99%)* |
Total agreement with GC/MS : 295/300 = 98% (96% - 99%)* * Denotes 95% confidence interval.
Performance Characteristics and Other information:
The performance characteristics of ACON mAMP-500 One Step Methamphetamine Test Strip, ACON mAMP-500 One Step Methamphetamine 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 mAMP-500 One Step Methamphetamine Test Strip, ACON mAMP-500 One Step Methamphetamine Test Device and a FDA-cleared Methamphetamine test with the same Methamphetamine cutoff concentration. It is also demonstrated that these tests are safe and effective in qualitatively detecting Methamphetamine at a concentration of 500 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care sites.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, represented by three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 2 2003
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley BLvd. San Diego, CA 92121
Re: K033299
Trade/Device Name: ACON mAMP-500 One Step Methamphetamine Test Strip ACON mAMP-500 One Step Methamphetamine Test Device Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF Dated: October 7, 2003 Received: October 14, 2003
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 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). 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 Putman
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
6
11. INDICATIONS FOR USE
510(k) Number: K033299
Device Name: ACON mAMP-500 One Step Methamphetamine Test Strip
ACON mAMP-500 One Step Methamphetamine Test Device
Indications for Use:
The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine, a central nervous stimulating drug, in urine. Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose.
This assay provides only a preliminary result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.
Albert Sarr
Joan
(opper
Division Sign-Off for
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033299
Prescription USE ✓
Over the Counter