(62 days)
Not Found
No
The device description details a simple lateral-flow immunoassay that is interpreted visually based on the presence or absence of colored lines. There is no mention of any computational analysis, image processing, or AI/ML algorithms.
No
The device is described as a diagnostic tool for detecting methamphetamine in urine and does not provide any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "qualitative detection of methamphetamine in human urine," which is a diagnostic purpose.
No
The device is a rapid chromatographic immunoassay test strip/device, which is a physical hardware component used for qualitative detection of methamphetamine in urine. It is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it's for the "qualitative detection of methamphetamine in human urine." This indicates it's used to test a sample taken from the human body (in vitro) to provide diagnostic information.
- Device Description: It describes a "rapid chromatographic immunoassay" that utilizes antibodies to detect a substance in a urine specimen. This is a common method for in vitro diagnostic tests.
- Performance Studies: The document details a clinical evaluation comparing the device's results to other tests and a reference method (GC/MS) using urine specimens. This type of performance evaluation is standard for IVDs to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" (K961249; LifeSign Status DS™ MET One-Step Methamphetamine Test) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used to demonstrate substantial equivalence to legally marketed IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1,000 ng/mL. It is intended for professional and point of care use.
Product codes
LAF
Device Description
The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device are competitive binding, lateral-flow immunochromatographic assays for the rapid qualitative detection of methamphetamine in human urine, utilizing antigen-antibody immunochemistry. It utilizes a mouse monoclonal antibody to selectively detect elevated levels of methamphetamine (positive results) at a cut-off concentration of 1,000 ng/mL. These tests can be performed and interpreted without the use of an instrument.
A drug-positive urine specimen will not generate a colored line in the test region, while a negative urine specimen will generate a colored line in the test region. To serve as procedural control, a colored line will always appear at the control region indicating that a proper volume of specimen has been applied and membrane wicking has occurred. When performing these ACON mAMP tests, one colored line indicates a positive result and two colored lines indicate a negative result; and the test includes a positive results when there is no colored line in the control region.
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
professional and point-of-care use.
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 300 urine specimens. This evaluation compared the study results obtained with ACON mAMP One Step Methamphetamine Test Strip, ACON mAMP One Step Methamphetamine Test Device, and LifeSign Status DS™ MET One-Step Methamphetamine Test to the customary Gas Chromatography/Mass Spectrometry analysis results.
ACON mAMP One Step Methamphetamine Test Strip compared to LifeSign Status DS™ MET One-Step Methamphetamine Test:
Positive Agreement: 145 / 148 = 98% (94% - 100%)
Negative Agreement: 152 / 152 = 100% (98% - 100%)
Overall Agreement: 297 / 300 = 99% (97% - 100%*)
- 95% confidence intervals
ACON mAMP One Step Methamphetamine Test Device compared to LifeSign Status DS™ MET One-Step Methamphetamine Test:
Positive Agreement: 147 / 148 = 99% (96% - 100%)
Negative Agreement: 152 / 152 = 100% (98% - 100%)
Overall Agreement: 299 / 300 = 100% (98% - 100%*)
- 95% confidence intervals
ACON mAMP One Step Methamphetamine Test Strip compared to GC/MS analysis data:
Positive agreement with GC/MS: 135 / 136 = 99% (96% - 100%)
Negative agreement with GC/MS: 154 / 164 = 94% (89% - 97%)
Total agreement with GC/MS: 289 / 300 = 96% (94% - 100%*)
- 95% confidence intervals
ACON mAMP One Step Methamphetamine Test Device compared to GC/MS analysis data:
Positive agreement with GC/MS: 135 / 136 = 99% (96% - 100%)
Negative agreement with GC/MS: 152 / 164 = 93% (86% - 96%)
Total agreement with GC/MS: 287 / 300 = 96% (93% - 98%*)
- 95% confidence intervals
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ACON mAMP One Step Methamphetamine Test Strip compared to GC/MS analysis data:
Positive Predictive Value (+): 135 / 145 = 93% (88% - 97%)
Negative Predictive Value (-): 153 / 154 = 99% (96% - 100%)
- 95% confidence intervals
ACON mAMP One Step Methamphetamine Test Device compared to GC/MS analysis data:
Positive Predictive Value (+): 135 / 147 = 92% (86% - 96%)
Negative Predictive Value (-): 152 / 153 = 99% (96% - 100%)
- 95% confidence intervals
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.3610 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
JUL 3 1 2001
SUMMARY OF 510 K SAFETY AND EFFECTIVENESS
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: K011672
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel .: 858-535-2030 X1072 Fax: 858-535-2038
Date:
July 12, 2001
Contact Person:
Edward Tung, Ph.D. Director of Regulatory Affairs
Product Names:
ACON mAMP One Step Methamphetamine Test Strip
ACON mAMP One Step Methamphetamine Test Device
Common Name:
Immunochromatographic test for the qualitative detection of methamphetamine in urine.
Device Classification:
ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device are similar to other FDA-cleared devices for the qualitative detection of methamphetamine in urine specimens. These tests are used for providing only a preliminary analytical result (21 CFR 862.3610). Methamphetamine test systems have been classified as Class II devices with moderate complexity. These methamphetamine tests bear Product Code LAF.
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Classification Name:
Methamphetamine test system
Intended Use:
The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One The ACON mAMP One Step Methanphenanine Fest provinci immunoassays for the Step Methamphetamine Fest Dorrecamine in human urine at a cut-off concentration qualifative detection of misunded for professional and point-of-care use.
Description:
The ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One The ACON MANI One Diep Mothanipers are competitive binding, lateral-flow Step Memailiphic assays for the qualitative detection of methamphetamine in a iffinunocificiliatographic assays for the quainless fantigen-antibody immunochemistry. It utilizes a mouse monoclonal antibody to selectively detect elevated levels of It unlizes a mouse monoconar unroover unroover tration of 1,000 ng/mL. These tests can be performed and interpreted without the use of an instrument.
A drug-positive urine specimen will not generate a colored line in the test region, A drug-positive urine specimen will generate a colored line in the test region. To while a negative unine speemien will generate always appear at the control region serve as procedural control, a colorecimen has been applied and membrane wicking indicating that a proper volume erforming these ACON mAMP tests, one colored line indicates a positive result and two colored lines indicate a negative result; and the test includes a positive results when there is no colored line in the control region.
Predicate Device:
LifeSign Status DS™ MET One-Step Methamphetamine Test
510(k) Number: K961249
Distributor: LifeSign, LLC 71 Veronica Avenue Somerset, New Jersey 08873
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Comparison to a Predicate Device:
A comparison of the features of ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device to LifeSign Status DS™ MET One-Step Methamphetamine Test is listed below.
- Both tests are assays intended for the qualitative detection of methamphetamine . and its derivatives 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 immunochemistry principles that rely on � antigen/antibody interactions to indicate a positive or negative result.
- � Both tests have a methamphetamine cut-off concentration of 1.000 ng/mL for the detection of methamphetamine in urine specimens.
Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 urine specimens. This evaluation compared the study results obtained with ACON mAMP One Step Methamphetamine Test Strip, ACON mAMP One Step Methamphetamine Test Device, and LifeSign Status DS MET One-Step Methamphetamine Test to the customary Gas Chromatography/Mass Spectrometry analysis results. The data from this study vielded the following results:
ACON mAMP One Step Methamphetamine Test Strip compared to LifeSign Status DS™ MET One-Step Methamphetamine Test:
Positive Agreement: 145 / 148 = 98% (94% - 100%) Negative Agreement: 152 / 152 = 100% (98% - 100%) Overall Agreement: 297 / 300 = 99% (97% - 100%*)
- 95% confidence intervals
3
ACON mAMP One Step Methamphetamine Test Device compared to LifeSign Status DS™ MET One-Step Methamphetamine Test:
Positive Agreement: 147 / 148 = 99% (96% - 100%) Negative Agreement: 152 / 152 = 100% (98% - 100%) Overall Agreement: 299 / 300 = 100% (98% - 100%*)
- 95% confidence intervals
ACON mAMP One Step Methamphetamine Test Strip compared to GC/MS analysis data
Positive agreement with GC/MS: 135 / 136 = 99% (96% - 100%) Negative agreement with GC/MS: 154 / 164 = 94% (89% - 97%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 100%*)
Positive Predictive Value (+): 135 / 145 = 93% (88% - 97%) Negative Predictive Value (-): 153 / 154 = 99% (96% - 100%)
- 95% confidence intervals
ACON mAMP One Step Methamphetamine Test Device compared to GC/MS analysis data:
Positive agreement with GC/MS: 135 / 136 = 99% (96% - 100%) Negative agreement with GC/MS: 152 / 164 = 93% (86% - 96%) Total agreement with GC/MS: 287 / 300 = 96% (93% - 98%*)
Positive Predictive Value (+): 135 / 147 = 92% (86% - 96%) Negative Predictive Value (-): 152 / 153 = 99% (96% - 100%)
- 95% confidence intervals
Conclusion:
These study results have demonstrated ACON mAMP One Step Methamphetamine Test Strip and Test Device are substantially equivalent to LifeSign Status DS™ MET One-Step Methamphetamine Test. It has also been demonstrated that these tests are safe and effective in detecting urine methamphetamine at a concentration of 1,000 ng/mL. They are suitable for professional and point-of-care use.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress.
JUL 3 1 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
Re: 510(k) Number: K011672 Trade/Device Name: ACON mAMP One Step Methamphetamine Test Strip and ACON mAMP One Step Methamphetamine Test Device Regulation Number: 862.3610 Regulatory Class: II Product Code: LAF Dated: May 18, 2001 Received: May 30 , 2001
Dear Dr. Tung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notheation. The I Dri imating of castion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and if you desire spoonly acrise to jiggnostic devices), please contact the Office of Compliance at additionally 607.10 for in the sur questions on the promotion and advertising of your device, (301) 594-4588. Rudinonally) for quest at (301) 594-4639. Also, please note the regulation prease conact the Orneo or Sompilation (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsiblemate and more (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10. INDICATIONS FOR USE
KO11672 510(k) Number: ACON mAMP One Step Methamphetamine Test Strip Device Name: ACON mAMP One Step Methamphetamine Test Device ACON mAMP One Step Methamphetamine Test Strip and ACON Indications for Use: mAMP One Step Methamphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1,000 ng/mL. It is intended for professional and point of care use.
Jean Copy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011672
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1/ (Per 21 CFR 801.109)
Or
Over-The-Counter Use