(188 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay, a traditional biochemical method, with no mention of AI or ML.
No
A therapeutic device is used for treating or preventing diseases. This device is an in vitro diagnostic assay used for qualitative analysis in human urine to diagnose amphetamine/methamphetamine use or overdose, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose." Additionally, the "Device Description" states it is an "in vitro diagnostic assay".
No
The device description clearly indicates it is an in vitro diagnostic assay based on a homogeneous enzyme immunoassay, which involves chemical reagents and reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is "used for the qualitative analysis of amphetamine/methamphetamine in human urine" and that "Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose." This clearly indicates the device is intended for use on specimens derived from the human body for the purpose of providing information for diagnosis or treatment.
- Device Description: The description states "Amphetamine/Methamphetamine is an in vitro diagnostic assay".
- Anatomical Site: The assay is performed on "human urine," which is a specimen from the human body.
- Intended User/Care Setting: The device is intended for use in "clinical laboratories," which are settings where diagnostic testing is performed.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose.
The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.
The Amphetamine/Methamphetamine 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
DKZ
Device Description
Amphetamine/Methamphetamine is an in vitro diagnostic assay for the qualitative analysis of amphetamine/methamphetamine in human urine. The assay is a homogeneous enzyme immunoassay with a 1,000 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
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)
Comparative performance studies were conducted using the AEROSET® System. The Amphetamine/Methamphetamine assay method comparison yielded acceptable correlation with the Emit II Monoclonal Amphetamine assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Amphetamine assay method comparison yielded acceptable correlation with GC/MS. The concordance table shows 81% agreement with GC/MS. The clinical specimens tested ranged from 826 to 1,994 ng/mL. Precision studies were conducted using the Amphetamine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.42%, Cutoff Calibrator is 0.40%, Verifier II is 0.39%, - 25% Control of Cutoff Calibrator is 0.44%, and + 25% Control of Cutoff Calibrator is 0.41%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The Amphetamine assay cutoff is 1,000 ng/mL. The limit of detection (sensitivity) of the Amphetamine/Methamphetamine assay is 500 ng/mL.
Predicate Device(s)
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
MAR 1 3 2002
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Texas 75038
Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-7864 Fax (972) 518-6533
Date of Preparation of this Summary:
Device Trade or Proprietary Name:
Device Common/Usual Name or Classification Name:
November 21, 2001 Amphetamine/Methamphetamine
Amphetamine/Methamphetamine
Classification Number/Class:
LAF/Class II
This summary of 510(k) 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: K012998.
Test Description:
Amphetamine/Methamphetamine is an in vitro diagnostic assay for the qualitative analysis of amphetamine/methamphetamine in human urine. The assay is a homogeneous enzyme immunoassay with a 1,000 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyne activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.
Substantial Equivalence:
The Amphetamine/Mothamphetamine assay is substantially equivalent to the Eimit® II Monoclonal Amphetarnine/Methamphetamine assay (K920507) on the SYVA®-30R Analyzer.
1
Both assays vield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro immunoassays.
- Both assays can be used for the qualitative analysis of amphetamine/methamine. .
- . Both assays yield similar results.
- Both assays are based on the competition between drug in the specimen and drug labeled with the enzyme ♥ glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
Differences:
- Amphetamine/Methamphetamine is a qualitative assay. Emit II is a qualitative and semiquantitative assay. .
Intended Use:
The Amphetamine/Mcthamphetamine assay is used for the qualitative analysis of amphetamine in human urine with a cutoff of 1,000 ng/mL. For use in clinical laboratories.
The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will delect a variety of amphetamines and their metabolites.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The
Amphetamine/Methamphetamine assay method comparison yielded acceptable correlation with the Emir II Monoclonal Amphetamine assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Amphetamine assay method comparison yielded acceptable correlation with GC/MS. The concordiance table shows 81% agreement with GC/MS. The clinical specimens tested ranged from 826 to 1,994 ng/trL. Precision studies were conducted using the Amphetamine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.42%, Cutoff Calibrator is 0.40%. Verifier II is 0.39%. - 25% Connol of Cutoff Calibrator is 0.44%, and + 25% Control of Cuty/T Calibrator is 0.41%. The Amphetamine assay cutoff is 1,000 ng/mL. The limit of detection (sensitivity) of the Amphetamine/Methamphetamine assay is 500 ng/mL.
These data demonstrate that the performance of the Amphetamine assay is substantially equivalent to the performance of the Emit II Monoclonal Amphetamine assay on the SYVA-30R Analyzer.
2
Conclusion:
: 上一篇: 上一篇:
.
:
:
,
The Amphetamine/Methamphetamine assay is substantially equivalent to the Emit II Monoclonal Amphetamine/Methamphetamine assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The overall design is simple and monochromatic.
MAR 1 3 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive 8-21 Irving, TX 75038
K012998 ... Re:
Trade/Device Name: Amphetamine/Methamphetamine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: November 26, 2001 Received: November 28, 2001
Dear Ms. Simpson:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 predicate device results in a classification 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 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K012998
Device Name: Amphetamine/Methamphetamine
Indications For Use:
The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose.
The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.
The Amphetamine/Methamphetamine 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use_ (Per 21 CFR 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number, 1012958