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.

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.

AI/ML Overview

The provided text describes the LabOne Cocaine Metabolite Micro-Plate EIA and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a table format with performance metrics as requested, nor does it detail a study proving the device meets specific acceptance criteria in the comprehensive manner implied by the prompt.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (STC Cocaine Metabolite Micro-Plate EIA) through performance characteristic studies.

Here's an attempt to extract and infer the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance. Instead, it states that various performance characteristic studies showed the LabOne device to be substantially equivalent to the predicate device. The key comparison involved using GC/MS/MS as a reference.

Characteristic	Acceptance Criteria (Inferred from "Substantially Equivalent")	Reported Device Performance
Precision	Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA.	"Performance characteristic studies on precision... showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA."
Analytical Sensitivity	Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA.	"Performance characteristic studies on ... analytical sensitivity... showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA."
Interference	Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA.	"Performance characteristic studies on ... interference... showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA."
Antibody/Cross-reactivity	Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA.	"Performance characteristic studies on ... antibody/cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA."
Overall Agreement with GC/MS/MS	Results from both the LabOne and STC systems should be substantially equivalent to GC/MS/MS results.	"Results... also showed that the [agreement] with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "patent speciale" (likely a typo for patient samples) and "diluted samples," but no numbers or details on their origin are provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method

The document does not describe any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This device is an in vitro diagnostic (EIA), not typically subject to MRMC studies like imaging devices that involve human interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was done in the sense that the LabOne device's "performance characteristic studies" were conducted. The comparison was primarily against a predicate device and then against GC/MS/MS as a reference. The document states:

"Performance characteristic studies on precision, analytical sensitivity, interference and antibody / 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 samples and diluted samples] also showed that the [agreement] with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference."

This implies a direct evaluation of the device's characteristics, with GC/MS/MS serving as the "gold standard" ground truth for assessing accuracy in a subset of the tests.

7. Type of Ground Truth Used

The primary ground truth used for assessing accuracy was Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS). The document explicitly states: "GC/MS/MS results as reference." It also mentions "patent speciale" (patient samples) and "diluted samples" being tested with both systems.

8. Sample Size for the Training Set

The document does not provide any information about a training set since this is a diagnostic assay, and the "study" described is for validation, not AI/machine learning model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for an AI/ML model is described.

Summary

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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:

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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II

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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.

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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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Page 2

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

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Indication for Use Statement

510(k) Number (if known) K O40 | 98

Device Name: LabOne Cocaine Metabolite Micro-Plate EIA

Indication For Use:

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

Regulation Number and Section

§ 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).