Cocaine II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Device Description

The ONLINE DAT II Cocaine II assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission.

AI/ML Overview

The provided text is a 510(k) Summary for the Roche Diagnostics ONLINE DAT II Cocaine II assay. This document describes an in vitro diagnostic test and establishes its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be presented to prove a device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text, nor can I provide details on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is missing from the 510(k) summary.

Here's what I can extract based on the available information, along with what is explicitly missing:

1. A table of acceptance criteria and the reported device performance:

Missing. The 510(k) summary does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or a performance table. It describes the device and its intended use, then compares it generally to a predicate device, but does not present the results of a validation study against predefined criteria.

2. Sample size used for the test set and the data provenance:

Missing. The document does not mention any specific test set, sample sizes, or data provenance (country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing. Since no specific test set or study results are detailed, there is no information on expert involvement for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Missing. Adjudication methods are not discussed as no test set details are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable / Missing. The device described is an in vitro diagnostic assay (a chemical test), not an AI-assisted diagnostic tool that would involve human "readers" or an MRMC study in the typical sense of imaging or clinical interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. This is a standalone in vitro diagnostic assay. Its performance would be evaluated as "algorithm only" (i.e., the assay's chemical reaction and detection system) without human intervention in the result generation itself (though human intervention is required for sample collection and operating the analyzer). However, the specific performance metrics and studies are not detailed here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Likely reference methodology or spiked samples, but not explicitly stated. For an immunoassay detecting a specific metabolite, ground truth would typically be established using:
- Confirmatory quantitative methods (e.g., GC/MS or LC/MS) on urine samples.
- Urine samples spiked with known concentrations of the analyte.
The document does not state how ground truth was established for any performance evaluation.

8. The sample size for the training set:

Not applicable / Missing. For an immunoassay, there isn't a "training set" in the machine learning sense. The assay's "training" refers to its development and optimization based on chemical principles, antibody-antigen binding, and reaction kinetics. However, data would be collected during development to optimize parameters and establish cutoff values. This specific sample size is not mentioned.

9. How the ground truth for the training set was established:

Not applicable / Missing. (See point 8).

Summary of what is available:

Device Name: ONLINE DAT II Cocaine II
Intended Use: Qualitative and semi-quantitative detection of benzoylecgonine (cocaine metabolite) in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Also permits assessment of assay performance as part of a quality control program.
Predicate Device: Abuscreen OnLine Cocaine Metabolite assay (K983697)
Principle of Procedure: Kinetic Interaction of Microparticles in a Solution (KIMS) – an immunoassay where drug-polymer conjugates bind to antibody-bound microparticles, causing aggregation. In the presence of sample drug, this aggregation is inhibited. Absorbance changes are measured.
Key Differences from Predicate:
- Use of a benzoylecgonine monoclonal antibody (mouse) attached to microparticles.
- A soluble drug-polymer conjugate.
- Addition of a 150 ng/ml cutoff concentration.
- Use of new calibrators and unassayed controls.

To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to refer to the full 510(k) submission or an associated scientific publication or device manual, which are not included in the provided text.

Summary

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K025281

DEC 0 6 2002

Section III: 510(k) Summary

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510(k) Summary

Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1) Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7637Contact Person: Kerwin KaufmanDate Prepared: September 30, 2002
2) Device name	Proprietary name: ONLINE DAT II Cocaine IICommon name: Cocaine and cocaine metabolite test systemClassification name: Enzyme immunoassay, cocaine and cocaine metabolites
3) Predicate device	We claim substantial equivalence to the currently marketed Abuscreen OnLine Cocaine Metabolite assay (K983697).

Continued on next page

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The ONLINE DAT II Cocaine II assay is an in vitro diagnostic test for the 4) Device Description qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Principal of procedure

The ONLINE DAT II Cocaine II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates.

When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited.

As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Negative Sample

drug-polymer conjugate + antibody-bound microparticle = particle aggregates (↑ absorbance)

Positive Sample

sample drug + antibody-bound microparticle = particle aggregation inhibited drug-polymer conjugate + antibody bound microparticle = particle aggregates

Continued on next page

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5.) Intended The ONLINE DAT II Cocaine II assay is an in vitro diagnostic test for the Use qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/m1. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The Roche ONLINE DAT II Cocaine II assay is substantially equivalent to 6.) Comparison to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Cocaine Metabolite (K983697).

The Roche ONLINE DAT II Cocaine II assay utilizes a modified KIMS technology relative to the currently marketed Abuscreen OnLine Cocaine Metabolite assay. Differences between this application and the cleared assay include:

use of a benzoylecgonine monoclonal antibody (mouse) attached to microparticles in solution,
a soluble drug-polymer conjugate,
addition of a cutoff concentration of 150 ng/ml, and .
use of new calibrators and unassayed controls. ●

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird's head and body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road, P.O. Box 50457 Indianapolis. IN 46250-0457

K023281 Re: Trade/Device Name: Roche Diagnostics ONLINE DAT II Cocaine II Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: September 30, 2002 Received: October 1, 2002

Dear Mr. Kaufman:

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 vour 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 vour 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Gutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

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510(k) Number (if known):	K023281
Device Name:	Roche Diagnostics ONLINE DAT II Cocaine II
Indications for Use:	Cocaine II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

(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)

(Division Sign-Off) . ' Division of Clinical Laboratory Devices
510(k) Number ________________________________________________________________________________________________________________________

.....

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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).