Cannabinoids II (THC II) is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 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 Cannabinoids II (THC II) assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The ONLINE DAT II Cannabinoids 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.

AI/ML Overview

This is an in vitro diagnostic device (IVD) for detecting cannabinoids in human urine. The provided text is a 510(k) summary, which outlines the device's information, intended use, and comparison to a predicate device. The information needed to fully respond to the request, particularly detailed acceptance criteria and a comprehensive study for proving device performance, is not available in the provided text. IVD submissions typically focus on analytical performance data (e.g., sensitivity, specificity, accuracy, precision, linearity, interference studies) rather than the study design elements usually associated with imaging or AI-driven diagnostic devices.

However, based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the provided 510(k) summary. For IVDs like this, acceptance criteria would typically involve demonstrating:

Accuracy: The ability to correctly identify positive and negative samples at specified cutoffs.
Precision: The reproducibility of results.
Specificity: The absence of interference from other substances.
Sensitivity: The lowest concentration detectable.

The "reported device performance" is broadly stated as the device being "substantially equivalent" to the predicate device, Abuscreen OnLine Cannabinoids assay (K983701). Substantial equivalence implies that the new device performs at least as well as the predicate device for its intended use. Without the specific performance data from the K030213 submission or the predicate, a detailed table cannot be created.

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

The provided text does not include information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the "Performance Data" or "Analytical Performance Characteristics" sections, which are not present in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or not provided in the context of this IVD device. For a chemical assay, "ground truth" for a urine sample is typically established by definitive analytical methods (e.g., Gas Chromatography/Mass Spectrometry - GC/MS) or by spiking known concentrations of the analyte into urine, rather than by human expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical scenarios, not for chemical assays where the output is a quantitative or qualitative chemical measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the purpose of this chemical assay.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone "algorithm only" study as typically understood for AI/imaging devices was not done. This device is a chemical assay, and its performance is inherently standalone in the sense that the assay itself generates the result without human interpretation of a complex signal that would then be compared to human performance. The assay's performance would be evaluated analytically.

7. The Type of Ground Truth Used

While not explicitly stated, for in vitro diagnostic tests like this, the ground truth for performance studies is typically established by:

Reference Method Analysis: Using highly accurate and precise analytical methods (e.g., GC/MS for cannabinoids) to determine the true concentration of the analyte in samples.
Spiked Samples: Using urine samples that have known, precisely measured quantities of the target analyte added to them.

8. The Sample Size for the Training Set

The provided text does not include information on the sample size for any training set. For an IVD like this, there isn't a "training set" in the machine learning sense. Instead, product development involves optimizing reagents and reaction conditions, which might involve iterative testing, but not a formally defined "training set" with ground truth in the way AI models are trained.

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

As there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for optimizing the assay's performance during development would involve knowing the true concentration of cannabinoids in the samples used for optimization, likely established through spiking or reference methods as described in point 7.

Summary

{0}------------------------------------------------

K030213

510(k) Summary	APR 11 2003
----------------	-------------

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: January 17, 2003
2) Device name	Proprietary name: ONLINE DAT II Cannabinoids IICommon name: Cannabinoids test systemClassification name: Enzyme immunoassay, cannabinoids
3) Predicate device	We claim substantial equivalence to the currently marketed Abuscreen OnLine Cannabinoids assay (K983701).

Continued on next page

{1}------------------------------------------------

510(k) Summary. Continued

Device The ONLINE DAT II Cannabinoids II (THC II) assay is an in vitro diagnostic Description test for the qualitative and semi-quantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 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

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

{2}------------------------------------------------

510(k) Summary, Continued

The ONLINE DAT II Cannabinoids II (THC II) assay is an in vitro 5.) Intended Use diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. 6.) Comparison The Roche ONLINE DAT II Cannabinoids II assay is substantially equivalent to the Predicate to other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Cannabinoids assay (K983701). The Roche ONLINE DAT II Cannabinoids II assay utilizes a modified KIMS technology relative to the currently marketed Abuscreen OnLine Cannabinoids assay. Differences between this application and the cleared assay include: use of a new cannabinoids monoclonal antibody (mouse) attached . to microparticles in solution, . a soluble drug-polymer conjugate, and . use of new calibrators and unassayed controls.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with the first profile being the most defined and the subsequent profiles becoming more abstract. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 1 2003

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

Re: K030213

Trade/Device Name: Roche Diagnostics ONLINE DAT II Cannabinoids II Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: January 17, 2003 Received: January 21, 2003

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 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).

{4}------------------------------------------------

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). 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

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

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):	K030213
Device Name:	Roche Diagnostics ONLINE DAT II Cannabinoids II
Indications for Use:	Cannabinoids II (THC II) is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/ml, 50 ng/ml and 100 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 K030213

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).