(160 days)
Not Found
No
The summary describes a standard enzyme immunoassay for detecting opiates in urine. There is no mention of AI, ML, or any computational analysis beyond basic signal processing for enzyme activity measurement.
No
This device is an in vitro diagnostic assay used for qualitative analysis, which aids in diagnosis and treatment but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of opiates use or overdose."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a "homogeneous enzyme immunoassay" based on chemical reactions and enzyme activity. This indicates a physical reagent-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the qualitative analysis of opiates in human urine "for use in clinical laboratories." It also mentions that the measurements are used "in the diagnosis and treatment of opiates use or overdose." These are clear indicators of an in vitro diagnostic purpose.
- Device Description: The "Device Description" section directly states, "Opiates is an in vitro diagnostic assay for the qualitative analysis of opiates in human urine."
- Clinical Laboratories: The "Intended User / Care Setting" is specified as "clinical laboratories," which is a typical setting for IVD use.
- Performance Studies: The document describes performance studies comparing the device to a predicate device (Emit II Opiates assay) and a confirmatory method (GC/MS), which are standard practices for evaluating IVDs.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K971596) further confirms that this device is being compared to a previously cleared IVD.
All of these points strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Opiates assay is used for the qualitative analysis of opiates in human urine with a cutoff of 300 ng/mL or 2,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of opiates use or overdose.
The Opiates assay is calibrated with morphine and will detect a variety of opiates and their metabolites.
The Opiates 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 (GCMS) 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
DJG
Device Description
Opiates is an in vitro diagnostic assay for the qualitative analysis of opiates in human urine. The assay is a homogeneous 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 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
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET® System. The Opiates assay method comparison yielded acceptable concordance with the Emit II Opiates assay on the SYVA-30R Analyzer. The concordance table for the Opiates assay using the 300 ng/mL cutoff shows 100% agreement. The concordance table for the Opiates assay using the 2,000 ng/m/L cutoff shows 98.3% agreement. Two samples were positive using the Emit II Opiates assay on the SYVA-30R Analyzer and negative using the Opiates assay on the AEROSET System. These 2 samples were shown to contain morphine at a concentration of 1,826 and 1,404 ng/mL as determined by GC/MS. The Opiates assay method comparison yielded acceptable concordance with GC/MS. The concordance table for the Opiates assay using the 300 ng/mL cutoff shows 99% agreement with GC/MS. The clinical specimens tested ranged from 189.0 to 3,063.0 ng/mL. The concordance table for the Opiates assay using the 2,000 ng/mL cutoff shows 83% agreement with GC/MS. The clinical specimens tested ranged from 575.0 to 34,980.0 ng/mL. Precision studies were conducted using the Opiates assay. A within-run and total precision study was performed using five levels of control material. For the 300 ng/mL cutoff the total %CV for Verifier 1 is 0.63%. The total %CV for the Cutoff Calibrator is 1.44%. The total %CV for Verifier II is 0.62%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples are 1.00% and 1.41%, respectively. For the 2,000 ng/mL cutoff the total %CV for Verifict I is 0.50%. The total %CV for the Cutoff Calibrator is 0.63%. The total %CV for Verificr II is 0.65%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples ure 0.95% and 0.62%, respectively. The Opiates assay cutoff is 300 ng/mL or 2,000 ng/mL. The limit of detection (sensitivity) of the Opiates assay is 20 ng/mL for the 300 ng/mL cutoff, and 140 ng/mL for the 2,000 ng/mL cutoff.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of detection (sensitivity) of the Opiates assay is 20 ng/mL for the 300 ng/mL cutoff, and 140 ng/mL for the 2,000 ng/mL cutoff.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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MAR 1 3 2002
510(k) Summary
KO13314
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Tcxas 75038
Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-7864 Fax (972) 518-6533
Date of Preparation of this Summary: November 21, 2001 Opiates Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Opiates DJG/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: K013314.
Test Description:
Opiates is an in vitro diagnostic assay for the qualitative analysis of opiates in human urine. The assay is a homogeneous 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 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.
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Substantial Equivalence:
The Opiates assay is substantially equivalent to the Emit II Opiates assay (K971596) 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 opiates, .
- Both assays yield similar results. .
- Both assays are based on the competition between drug in the specimen and drug labeled with the u enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
- . Both assays have the same assay ranges (cutoff).
Differences:
- The Opiates assay is qualitative. The Emit II Opiates assay is qualitative and semiquantitative. .
Intended Use:
The Opiates assay is used for the qualitative analysis of opiates in human urine with a cutoff of 300 ng/mL or 2,000 ng/mL. For use in clinical laboratories.
The Opiates assay is calibrated with morphine and will detect a variety of opiates and their metabolites.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Opiates assay method comparison yielded acceptable concordance with the Emit II Opiates assay on the SYVA-30R Analyzer. The concordance table for the Opiates assay using the 300 ng/mL cutoff shows 100% agreement. The concordance table for the Opiates assay using the 2,000 ng/m/L cutoff shows 98.3% agreement. Two samples were positive using the Emit II Opiates assay on the SYVA-30R Analyzer and negative using the Opiates assay on the AEROSET System. These 2 samples were shown to contain morphine at a concentration of 1,826 and 1,404 ng/mL as determined by GC/MS. The Opiates assay
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method comparison yielded acceptable concordance with GC/MS. The concordance table for the Opiates assay using the 300 ng/mL cutoff shows 99% agreement with GC/MS. The clinical specimens tested ranged from 189.0 to 3,063.0 ng/mL. The concordance table for the Opiates assay using the 2,000 ng/mL cutoff shows 83% agreement with GC/MS. The clinical specimens tested ranged from 575.0 to 34,980.0 ng/mL. Precision studies were conducted using the Opiates assay. A within-run and total precision study was performed using five levels of control material. For the 300 ng/mL cutoff the total %CV for Verifier 1 is 0.63%. The total %CV for the Cutoff Calibrator is 1.44%. The total %CV for Verifier II is 0.62%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples are 1.00% and 1.41%, respectively. For the 2,000 ng/mL cutoff the total %CV for Verifict I is 0.50%. The total %CV for the Cutoff Calibrator is 0.63%. The total %CV for Verificr II is 0.65%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples ure 0.95% and 0.62%, respectively. The Opiates assay cutoff is 300 ng/mL or 2,000 ng/mL. The limit of detection (sensitivity) of the Opiates assay is 20 ng/mL for the 300 ng/mL cutoff, and 140 ng/mL for the 2,000 ng/mL cutoff. These data demonstrate that the performance of the Opiates assay is substantially equivalent to the performance of the Emit II Opiates assay on the SYVA-30R Analyzer.
Conclusion:
The Opiates assay is substantially equivalent to the Emit II Opiates assay on the SYVA-30R Analyzer 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 U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
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: K013314 Trade/Device Name: Opiates Regulation Name: 21 CFR 862.3650 Regulatory Class: Class II Product Code: DJG 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 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594 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 Part 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 Sutman
Steven I. Gutman, M.D., M.B 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): K013314
Opiates Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Opiates assay is used for the qualitative analysis of opiates in human urine with a cutoff of 300 ng/mL or 2,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of opiates use or overdose.
The Opiates assay is calibrated with morphine and will detect a variety of opiates and their metabolites.
The Opiates 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 (GCMS) 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
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Clinical Laboratory Devices
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_V Over-The-Counter Use_ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)