(188 days)
No
The description details a standard enzyme immunoassay for drug detection, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an in vitro diagnostic assay used for qualitative analysis of a cocaine metabolite, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a "homogeneous enzyme immunoassay" based on competition for antibody binding sites and measuring enzyme activity. This indicates a physical chemical test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine" and that the measurements are used in the "diagnosis and treatment of cocaine use or overdose." This clearly indicates it's used to test a sample from the human body to provide information for medical purposes.
- Device Description: The description states it is an "in vitro diagnostic assay."
- Sample Type: It analyzes "human urine," which is a biological sample from the human body.
- Care Setting: It 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 Cocaine assay is used for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine with a cutoff of 300 ng/mL. For use in clinical laboratories.
The Cocaine assay is calibrated with Benzoylecgonine and will detect cocaine and the major metabolites.
The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocainc metabolite) in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
The Cocainc assay is calibrated with Benzoylcegonine and will detect cocaine and the major metabolites.
The Cocaine 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
DIO
Device Description
Cocaine is an in vitro diagnostic assay for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine. The assay is a homogencous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenasc (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 Cocaine assay method comparison yielded acceptable correlation with the Emit II Cocainc assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Cocaine assay method comparison vielded acceptable correlation with GC/MS. The concordance table shows 87% agreement with GC/MS. The clinical specimens tested ranged from 56.8 to 70,040.0 ng/mL. Precision studies were conducted using the Cocaine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verificr I is 0.48%, Cutoff Calibrator is 0.64%, Verificr II is 0.48%, - 25% of Cutoff Calibrator is 0.42%, and + 25% of Cutoff Calibrator is 0.47%. The Cocainc assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Cocaine assay is 35 ng/mL. These data demonstrate that the performance of the Cocaine assay is substantially equivalent to the performance of the Emit II Cocaine assay on the SYVA-30R Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of detection (sensitivity) of the Cocaine assay is 35 ng/mL. The total %CV for Verificr I is 0.48%, Cutoff Calibrator is 0.64%, Verificr II is 0.48%, - 25% of Cutoff Calibrator is 0.42%, and + 25% of Cutoff Calibrator is 0.47%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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 Cocaine
Cocaine
DIO/Class II
Classification Number/Class:
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: K013004.
Test Description:
Cocaine is an in vitro diagnostic assay for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine. The assay is a homogencous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenasc (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.
1
Substantial Equivalence:
The Cocaine assay is substantially equivalent to the Emit® II Cocainc assay (K902579) on the SYVA® 30R Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- ♥ Both assays are in vitro immunoassays.
- . Both assays can be used for the qualitative analysis of Cocaine.
- Both assays yield similar results. 방
- Both assays are based on the competition between drug in the specimen and drug labeled with the . enzyme glucosc-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
Differences:
- Cocaine is a qualitative assay. Emit II Cocaine assay is a qualitative and semiquantitative assay. .
Intended Use:
The Cocaine assay is used for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine with a cutoff of 300 ng/mL. For use in clinical laboratories.
The Cocaine assay is calibrated with Benzoylecgonine and will detect cocaine and the major metabolites.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Cocaine assay method comparison yielded acceptable correlation with the Emit II Cocainc assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Cocaine assay method comparison vielded acceptable correlation with GC/MS. The concordance table shows 87% agreement with GC/MS. The clinical specimens tested ranged from 56.8 to 70,040.0 ng/mL. Precision studies were conducted using the Cocaine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verificr I is 0.48%, Cutoff Calibrator is 0.64%, Verificr II is 0.48%, - 25% of Cutoff Calibrator is 0.42%, and + 25% of Cutoff Calibrator is 0.47%. The Cocainc
2
assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Cocaine assay is 35 ng/mL. These data demonstrate that the performance of the Cocaine assay is substantially equivalent to the performance of the Emit II Cocaine assay on the SYVA-30R Analyzer.
Conclusion:
The Cocaine assay is substantially equivalent to the Emit II Cocaine assay on the SYVA-30R Analyzcr as demonstrated by results obtained in the studies.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 2002
Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038
Re: K013004 Trade/Device Name: Cocaine Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine test system Regulatory Class: Class II Product Code: DIO 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.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and my 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 Butman
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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510(k) Number (if known): K013004
Device Name: ____ Cocaine
Indications For Use:
The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocainc metabolite) in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
The Cocainc assay is calibrated with Benzoylcegonine and will detect cocaine and the major metabolites.
The Cocaine 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.
Ke
Division Sign-Off) Division of Clinical Laboratory Levices 510(k) Number --
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)