(188 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Abbott Laboratories Cocaine assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Agreement with Predicate Device (Emit® II Cocaine assay on SYVA® 30R Analyzer) | Acceptable correlation (implied by "substantially equivalent" and "similar performance characteristics") | 100% agreement (concordance) |
| Agreement with GC/MS (Gold Standard for Confirmation) | Acceptable correlation (implied for substantial equivalence) | 87% agreement (concordance) |
| Within-run Total Precision for Verifier I | Not explicitly stated (implied for acceptable precision) | 0.48% CV |
| Within-run Total Precision for Cutoff Calibrator | Not explicitly stated (implied for acceptable precision) | 0.64% CV |
| Within-run Total Precision for Verifier II | Not explicitly stated (implied for acceptable precision) | 0.48% CV |
| Within-run Total Precision for -25% of Cutoff Calibrator | Not explicitly stated (implied for acceptable precision) | 0.42% CV |
| Within-run Total Precision for +25% of Cutoff Calibrator | Not explicitly stated (implied for acceptable precision) | 0.47% CV |
| Cutoff | 300 ng/mL | 300 ng/mL |
| Limit of Detection (Sensitivity) | Not explicitly stated (implied for acceptable sensitivity) | 35 ng/mL |
Note: The document explicitly states "acceptable correlation" as the general criteria for comparison studies. For precision, the low coefficient of variation (%CV) values implicitly define the acceptable range.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that the clinical specimens tested for the GC/MS comparison ranged from 56.8 to 70,040.0 ng/mL, implying a range of cocaine metabolite concentrations. However, the number of clinical specimens used as a test set for the comparison studies (both with the predicate and GC/MS) is not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical specimens tested" suggests real-world samples, but further details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable, as this device uses laboratory assays as its comparative standards, not human expert interpretation of images or clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The comparisons are based on analytical results from other laboratory assays (predicate device and GC/MS), which have predefined analytical criteria for results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic assay, meaning its performance is evaluated against other laboratory tests, not by human readers interpreting results.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes, the performance characteristics (precision, cutoff, limit of detection) of the Cocaine assay were evaluated in a standalone manner. The comparison studies (with the predicate device and GC/MS) also represent the standalone performance of the new device against established methods.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating the Cocaine assay's performance was established using two methods:
- Comparison to a legally marketed predicate device: The Emit® II Cocaine assay on the SYVA® 30R Analyzer (K902579).
- Comparison to a confirmatory chemical method: Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is explicitly stated as the "preferred confirmatory method" and serves as a higher-level analytical ground truth for drug testing.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated. The document describes performance and comparison studies but does not provide details about a specific "training set" in the context of machine learning, as this device is an immunoassay, not an AI/ML-based diagnostic. It's likely that internal development and validation samples were used during the assay's creation and optimization, but these are not specified as a "training set" in the provided text.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the context of machine learning. For an immunoassay, the "ground truth" for development would involve known concentrations of the analyte (cocaine metabolite) in control samples, and the assay is optimized to accurately detect these concentrations around the specified cutoff. This is established through standard laboratory practices for assay development and analytical validation using certified reference materials and known-concentration samples.
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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.
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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
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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 --
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
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)
§ 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).