(81 days)
Not Found
No
The description details a standard enzyme immunoassay for drug detection, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic test for the qualitative detection of cocaine metabolites in urine, used for screening purposes, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "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. ... For in vitro diagnostic use." This clearly indicates its purpose is for diagnosis.
No
The device is an in vitro diagnostic (IVD) assay, which is a chemical test kit used in a laboratory setting. It involves reagents and a chemical reaction, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Nature of the Test: The device is an "enzyme immunoassay for the determination of cocaine metabolites in urine specimens." This is a laboratory test performed on a biological sample (urine) outside of the body to provide information about a person's health status (in this case, the presence of cocaine metabolites). This is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is for the "qualitative detection of benzoylecgonine... in human urine on automated clinical chemistry analyzers." This is a diagnostic purpose.
- Laboratory Use Only: The test is intended for "laboratory use only," which is typical for IVDs.
N/A
Intended Use / 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.
Product codes
DIO
Device Description
Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the determination of cocaine metabolites in urine specimens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory use only
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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).
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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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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) | |
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| Division Sign-Off | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | Page 1 of _______ |
| 510(k) | K062929 |