(81 days)
The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 ng/ml and 150 ng/ml of benzoylecgonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use.
The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoylecgonine in urine. The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine.
Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the determination of cocaine metabolites in urine specimens.
The provided 510(k) summary describes the Quest Diagnostics Urine Cocaine Metabolite EIA, a competitive homogenous enzyme immunoassay for the qualitative detection of benzoylecgonine in urine specimens.
Here's an analysis of the provided information, focusing on acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for specific performance metrics in a tabular format as one might see for digital health devices. Instead, it demonstrates substantial equivalence to a predicate device by comparing various performance characteristics. The implied acceptance criterion for this type of submission is usually that the new device performs as well as or substantially equivalent to the predicate device, especially when using a reference method like GC/MS.
| Performance Characteristic | Quest Diagnostics Urine Cocaine Metabolite EIA Performance | Predicate Device (DAT II Cocaine II) Performance |
|---|---|---|
| Precision | Shown to be substantially equivalent | (Not explicitly detailed, but implied as a benchmark) |
| Analytical Sensitivity | Shown to be substantially equivalent | (Not explicitly detailed, but implied as a benchmark) |
| Interference | Shown to be substantially equivalent | (Not explicitly detailed, but implied as a benchmark) |
| Antibody Cross-Reactivity | Shown to be substantially equivalent | (Not explicitly detailed, but implied as a benchmark) |
| Qualitative Results (Compared to GC/MS Reference) | Substantially equivalent | Substantially equivalent (implied, as the standard for comparison) |
Notes on Cutoffs: The indications for use specify cutoffs of 300 ng/ml and 150 ng/ml for benzoylecgonine. The performance data would have been evaluated against these cutoffs.
2. Sample Size Used for the Test Set and Data Provenance:
The summary states: "Results screened from patient specimens with both the Quest Diagnostics Urine Cocaine Metabolite EIA and the DAT II Cocaine II assay also showed that the qualitative results from this two test systems are substantially equivalent when using GC/MS results as reference."
- Sample Size: The exact number of "patient specimens" used for the test set is not specified in the provided document.
- Data Provenance: The document refers to "patient specimens," implying real-world human samples. However, the country of origin is not specified, nor is it explicitly stated whether the data was retrospective or prospective. Given the context of a 510(k) submission for an in vitro diagnostic, it would typically involve prospective or retrospectively collected de-identified clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The ground truth for the test set was established using Gas Chromatography/Mass Spectroscopy (GC/MS).
- GC/MS is an analytical chemical method, not reliant on human expert interpretation in the same way as imaging or clinical diagnosis relies on physicians. Therefore, the concept of "number of experts" or "qualifications of experts" as typically applied to clinical or imaging studies is not directly applicable here. The "experts" would be the technicians or chemists operating the GC/MS equipment, ensuring its proper calibration and interpretation of analytical results, and laboratories performing GC/MS are subject to stringent quality control and accreditation.
4. Adjudication Method for the Test Set:
- Not Applicable. Since GC/MS is an objective analytical method providing a definitive chemical concentration, there is no need for an adjudication method among multiple human readers for establishing ground truth. The GC/MS result itself serves as the unadjudicated "ground truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is an in vitro diagnostic device for chemical analysis, not a device requiring human interpretation of medical images or clinical data. Therefore, an MRMC comparative effectiveness study, which typically evaluates improvements in human reader performance with AI assistance, is not relevant or applicable to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence. The entire study described focuses on the standalone performance of the Quest Diagnostics Urine Cocaine Metabolite EIA (the "algorithm" or device) against a reference standard (GC/MS) and a predicate device. The output of the EIA is a qualitative result (positive/negative based on cutoffs), and its performance is evaluated directly without human intervention needed to interpret the EIA's direct output for the purpose of the study. The "human-in-the-loop" component comes later in clinical practice when a physician interprets the preliminary result in the context of the patient's overall clinical picture, but the device performance itself is standalone.
7. Type of Ground Truth Used:
- The type of ground truth used is analytical chemical confirmation via Gas Chromatography/Mass Spectroscopy (GC/MS). The summary explicitly states: "when using GC/MS results as reference."
8. Sample Size for the Training Set:
- The document does not provide information regarding a separate "training set" or its sample size. This is typical for a traditional immunoassay device. While method development and optimization would have involved extensive testing, the concept of a distinct, labeled "training set" (as in machine learning) is not usually described in 510(k) summaries for these types of IVDs. The "performance characteristic studies" and testing with patient specimens serve as the validation and verification of the final assay.
9. How the Ground Truth for the Training Set Was Established:
- Since a distinct "training set" with established ground truth, in the context of machine learning, is not described, this question is not applicable as phrased for this device. The development of the assay would have been based on established chemical and immunological principles, and calibration (using calibrators mentioned in the Indications for Use) would be performed using materials with known concentrations, verified by methods like GC/MS.
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510(k) Summary----------------------------------------------------------------------------------------------------------------------------------------------------------------
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 1002929
Date of Summary: Sep. 15, 2006
Correspondent:
Name: Address:
Phone Number: Fax Number:
Liuming Yu 10101 Renner Boulevard Lenexa, Kansas 66210-9752 913-895-2308 913-577-1429 liuming.yu@labone.com
DEC 1 8 2006
Product Name:
Common Name: Quest Diagnostics Urine Cocaine Metabolite EIA Trade Name: Quest Diagnostics Urine Cocaine Metabolite EIA Classification Number: 862.3250
Substantially Equivalent Device:
Product: DAT II Cocaine II Manufactured by: Roche Diagnostics Cooperation 510(k) Number: K023281
Product Description:
Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the determination of cocaine metabolites in urine specimens.
Intended Use:
Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the qualitative detection of benzoylecgonine, the primary cocaine metabolite, in urine human specimens on automated clinical chemistry analyzers.
Comparison:
Quest Diagnostics Urine Cocaine Metabolite EIA, when used to qualitatively determine benzoylecgonine in urine specimens, is substantially equivalent to the DAT II Cocaine II assay manufactured by Roche Diagnostics Cooperation.
Comparison Performance Data:
Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the Quest Diagnostics Urine Cocaine Metabolite EIA is substantially equivalent to the DAT II Cocaine II assay.
Results screened from patient specimens with both the Quest Diagnostics Urine Cocaine Metabolite EIA and the DAT II Cocaine II assay also showed that the qualitative results from this two test systems are substantially equivalent when using GC/MS results as reference.
Conclusion:
Quest Diagnostics Urine Cocaine Metabolite EIA can be used to qualitatively screen benzoylecgonine, the primary cocaine metabolite, in human urine specimens.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Liuming Yu Quest Diagnostics 10101 Renner Boulevard Lenexa, KS 66219
DEC 1 8 2006
Re: K062929 Trade/Device Name: Quest Diagnostics Urine Cocaine Metabolite EIA Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: September 28, 2006 Received: September 28, 2006
Dear Mr. Yu:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062929
Device Name: Quest Diagnostics Urine Cocaine Metabolite EIA
Indications For Use:
The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 ng/ml and 150 ng/ml of benzoylecgonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use.
The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoylecgonine in urine. The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | Page 1 of _______ |
| 510(k) | K062929 |
§ 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).