(36 days)
Not Found
No
The description details a standard enzyme immunoassay (EIA) for detecting cocaine metabolites. There is no mention of AI, ML, or any computational analysis beyond standard laboratory procedures for interpreting assay results.
No
The device is an in vitro diagnostic test for the qualitative detection of cocaine and its metabolite for laboratory use, not for treating a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." The device detects cocaine metabolites in oral fluid, providing a preliminary result that requires professional judgment for evaluation, aligning with the definition of a diagnostic device.
No
The device description clearly indicates it is a "solid phase competitive enzyme immunoassay," which is a laboratory test involving physical reagents and a micro-plate, 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."
- Purpose: The device is intended for the qualitative detection of cocaine and its metabolite in oral fluid, which is a biological specimen. This is a classic application of an in vitro diagnostic test.
- Laboratory Use: The test is intended for "laboratory use only," which is a common setting for IVD tests.
- Calibrators and Controls: The description of the calibrators and controls further reinforces its use in a laboratory setting for diagnostic purposes, as these are essential components for ensuring the accuracy and reliability of IVD tests.
N/A
Intended Use / Indications for Use
The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic use.
The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (ELA) 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/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method.
The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva.
The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite.
Product codes
DIO
Device Description
LabOne Cocaine Metabolite Micro-Plate ELA is a solid phase competitive enzyme immunoassay for the determination of cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid / saliva
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
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)
Performance characteristic studies on precision, analytical sensitivity, interference and antibody I cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA.
Results from patient specimens and diluted samples with both the LabOne Cocaine Metabolite Micro-Plate also showed that the MS with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 - 5 2004
510(k) Summary------LabOne Cocaine Metabolite Micro-Plate ElA
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 15040198
Date of Summary:
Dec. 17, 2003
Correspondent:
| Name: | Liuming Yu |
|---|---|
| Address: | 10101 Renner Boulevard |
| Lenexa, Kansas 66210-9752 | |
| Phone Number: | 913-895-2308 |
| Fax Number: | 913-888-4186 |
Product Name:
Common Name: Cocaine Metabolite Micro-Plate EIA Trade Name: LabOne Cocaine Metabolite Micro-Plate EIA Classification Number: 862.3250
Substantially Equivalent Device:
Product: STC Cocaine Metabolite Micro-Plate EIA Manufactured by: OraSure® Technologies, Inc. 510(k) Number: K973651
Product Description:
LabOne Cocaine Metabolite Micro-Plate ELA is a solid phase competitive enzyme immunoassay for the determination of cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device.
Intended Use:
LabOne Cocaine Metabolite Micro-Plate EIA is a competitive micro-immunoassay for the qualitative detection of cocaine and its metabolites in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device.
Comparison:
LabOne Cocaine Metabolite Micro-Plate EIA, when used to determine cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device, is substantially equivalent to the STC Cocaine Metabolite Micro-Plate ELA.
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Comparison Performance Data:
Performance characteristic studies on precision, analytical sensitivity, interference and antibody I cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA.
equivalent to the BTC Octains recimens and diluted samples with both the LabOne Cocaine Kesults Screence from patent speciale Metabolite Micro-Plate also showed that the MS with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference.
Conclusion:
LabOne Cocaine Metabolite Micro-Plate EIA can be used to screen cocaine and cocaine Labone Cocains Metaoone Interes inthe OraSure® Oral Fluid Specimen Collection Device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 5 2004
LabOne, Inc. c/o:Ms. Laura L. Danielson TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112
Re: K040198
Trade/Device Name: LabOne Cocaine Metabolite Micro-Plate EIA Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: February 19, 2004 Received: February 20, 2004
Dear Ms. Danielson:
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 docs 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 practicc 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) I his letter with and h your hinding of substantial equivalence of your device to a legally premits to licated 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, If you destre specific and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Tou indy obtain 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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
510(k) Number (if known) K O40 | 98
Device Name: LabOne Cocaine Metabolite Micro-Plate EIA
Indication For Use:
The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic use.
The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (ELA) 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/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method.
The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva.
The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040198