OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale.

OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Description

The OnTrak TesTstik 2 Cocaine/THC assay described in this submission is an in vitro test intended for professional use in the qualitative detection of cocaine metabolite and cannabinoids in urine at or above a cutoff concentration of 300 ng/ml (cocaine) and 50 ng/ml (THC).

The TesTstik assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane.

When the TesTstik is immersed in the urine sample, some of the sample is absorbed into the TesTstik sample pad. The absorbed sample travels through a reagent strip contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugates and blue bands are formed at the result window ("negative" sign).

When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white.

An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the TEST VALID area are viable, and the results are ready to interpret.

AI/ML Overview

This K994164 submission describes a new device, OnTrak TesTstik™ 2 for Cocaine/THC, and claims substantial equivalence to two predicate devices, OnTrak TesTstik for Cocaine and OnTrak TesTstik for THC (both cleared under K973075).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria (New Device)	Reported Device Performance (New Device) - Cocaine	Reported Device Performance (New Device) - THC
Methodology	Competitive microparticle capture inhibition	Competitive microparticle capture inhibition	Competitive microparticle capture inhibition
Measurement	Qualitative	Qualitative	Qualitative
Sample Type	Urine	Urine	Urine
Endpoint read	Color	Color	Color
Cutoff	300 ng/ml (cocaine) 50 ng/ml (THC)	300 ng/ml (cocaine)	50 ng/ml (THC)
Reagent (active ingredients)	• Blue dyed microparticles coated with mouse monoclonal anti-benzoylecgonine antibody and anti-cannabinoid antibody. • Drug conjugates immobilized on a membrane. • Mouse monoclonal anti-BSA antibody immobilized on membrane.	• Blue dyed microparticles coated with mouse monoclonal anti-benzoylecgonine antibody and anti-cannabinoid antibody. • Drug conjugates immobilized on a membrane. • Mouse monoclonal anti-BSA antibody immobilized on membrane.	• Blue dyed microparticles coated with mouse monoclonal anti-benzoylecgonine antibody and anti-cannabinoid antibody. • Drug conjugates immobilized on a membrane. • Mouse monoclonal anti-BSA antibody immobilized on membrane.
Performance: Precision	>95% confidence at 150% cutoff	>95% confidence at 150% cutoff (Same as predicate)	>95% confidence at 150% cutoff (Same as predicate)
Performance: Accuracy (Cocaine)	Clinical correlation for all positive (including near cutoff samples) and negative specimens demonstrated as acceptable agreement to GC/MS and predicate.	94% agreement for all positive (including near cutoff samples) and negative specimens (Cocaine) compared to GC/MS and predicate (automated immunoassay & GC/MS for negatives).	N/A (This row is for Cocaine performance)
Performance: Accuracy (THC)	Clinical correlation for all positive (including near cutoff samples) and negative specimens demonstrated as acceptable agreement to GC/MS and predicate.	N/A (This row is for THC performance)	95% agreement for all positive (including near cutoff samples) and negative specimens (THC) compared to GC/MS and predicate (automated immunoassay & GC/MS for negatives).

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

Cocaine:
- Positive Specimens: 70 clinical specimens, including near cutoff specimens.
- Negative Specimens: 100 urine specimens from a clinical laboratory (screened negative by automated immunoassay), with 15% confirmed negative by GC/MS.
- Data Provenance: Clinical specimens obtained from a clinical laboratory; the country of origin is not specified but implicitly in the USA, where the submitter is located. The data is retrospective as it refers to "clinical specimens screened" and "obtained from a clinical laboratory."
THC:
- Positive Specimens: 70 clinical specimens, including near cutoff specimens.
- Negative Specimens: 100 urine specimens from a clinical laboratory (screened negative by automated immunoassay), with 15% confirmed negative by GC/MS.
- Data Provenance: Clinical specimens obtained from a clinical laboratory; the country of origin is not specified but implicitly in the USA. The data is retrospective.

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

The document does not specify the number or qualifications of experts directly establishing the ground truth. Instead, it relies on established laboratory methods:

For positive specimens: Initially screened by an automated immunoassay, and then confirmed positive by GC/MS. GC/MS (Gas Chromatography/Mass Spectrometry) is a highly accurate and widely accepted "gold standard" for drug confirmation in toxicology.
For negative specimens: Screened negative by automated immunoassays, and a portion (15%) confirmed negative by GC/MS.

Therefore, the ground truth is established by a combination of automated immunoassay screening and confirmatory GC/MS, rather than a human expert panel.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method involving human consensus for the test set results. The comparison is made directly against the "ground truth" established by laboratory methods (GC/MS for confirmation).

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

No MRMC study was performed or mentioned. This type of study (human readers with/without AI assistance) is not relevant for this in-vitro diagnostic device, which is an automated or semi-automated test reading designed for professional use. The performance evaluation focuses on the device's accuracy against laboratory standards.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The document details the "OnTrak TesTstik 2 for Cocaine/THC was evaluated using clinical specimens" and directly reports its agreement percentages (94% for Cocaine, 95% for THC) against the ground truth established by GC/MS and predicate comparison. This evaluation is of the device's intrinsic performance without human interpretation or assistance beyond loading the sample.

7. The Type of Ground Truth Used

The primary type of ground truth used is GC/MS (Gas Chromatography/Mass Spectrometry), which is considered a definitive confirmatory method in toxicology. This is supplemented by initial screening with an automated immunoassay.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its size. In a 510(k) submission for a diagnostic test like this, the focus is on the performance of the finalized device (the "test set" in your query context) rather than detailing developmental training data. This implies a traditional assay development workflow rather than a machine learning model that would require explicit training and validation sets.

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

As no training set is described, the method for establishing its ground truth is not applicable/mentioned.

Summary

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APR 1 3 2000

K994164

510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 Contact Person: Jennifer Tribbett Date Prepared: March 20, 2000 2) Device Name The device name, including both the trade/proprietary name and classification name is provided below.

Product Name	ClassificationName	ProductCode	CFRClassificationName	PredicateDeviceName	DatePredicateCleared	Predicate510(k)Number
OnTrakTesTstik™ 2 forCocaine/ THC	Cocaine TestSystem	91DIO	862.3250	OnTrakTesTstik forCocaine	10/9/97	K973075
OnTrakTesTstik™ 2 forCocaine/ THC	CannabinoidTest System	91LDJ	862.3870	OnTrakTesTstik forTHC	10/9/97	K973075

Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for Cocaine(K973075) and OnTrak TesTstik for THC (K973075).

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Device The OnTrak TesTstik 2 Cocaine/THC assay described in this submission is an Description in vitro test intended for professional use in the qualitative detection of cocaine metabolite and cannabinoids in urine at or above a cutoff concentration of 300 ng/ml (cocaine) and 50 ng/ml (THC).

The TesTstik assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane.

When the TesTstik is immersed in the urine sample, some of the sample is absorbed into the TesTstik sample pad. The absorbed sample travels through a reagent strip contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug In the absence of drug in the urine, the antibody-coated conjugate. microparticles bind to the drug conjugates and blue bands are formed at the result window ("negative" sign).

When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white.

An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the TEST VALID area are viable, and the results are ready to interpret.

5. Technology Tables 1, 2 & 3 on the following pages outline the technological Characteristics characteristics (methodologies) of the OnTrak TesTstik 2 for Cocaine/THC in comparison to the predicate devices.

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510K Summary -Continued-

Tables 1, 2 & 3 provide the significant characteristics relied upon for a 6. Substantial Equivalence determination of substantial equivalence. This information concludes that the performance of the TesTstik 2 for Cocaine/THC is substantially equivalent to the currently marketed OnTrak TesTstik Cocaine (K973075) and OnTrak TesTstik THC (K973075).

Item	OnTrak TesTstik 2 forCocaine/THCNew Device	OnTrak TesTstik forCocainePredicate	OnTrak TesTstik forTHCPredicate
Methodology	Competitive microparticlecapture inhibition	Same	Same
Measurement	Qualitative	Same	Same
Sample Type	Urine	Same	Same
Endpoint read	Color	Same	Same
Cutoff	300 ng/ml (cocaine)50 ng/ml (THC)	Same300 ng/ml (cocaine)	Same50 ng/ml (THC)
Reagent(activeingredients)	• Blue dyed microparticlescoated with mousemonoclonal anti-benzoylecgonine anti-bodyand anti-cannabinoidantibody.	• Blue dyed microparticlescoated with mousemonoclonal anti-benzoylecgonine antibody.	• Blue dyedmicroparticles coatedwith mouse monoclonalanti-cannabinoidantibody.
	• Drug conjugates immobilizedon a membrane	• Drug conjugatesimmobilized on amembrane	• Drug conjugatesimmobilized on amembrane
	• Mouse monoclonal anti-BSAantibody immobilized onmembrane	• Mouse monoclonal anti-BSA antibody immobilizedon a membrane	• Mouse monoclonal anti-BSA antibodyimmobilized on amembrane
Performance:Precision	>95% confidence at 150%cutoff	Same	Same

TABLE 1

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510K Summary -Continued-

Item	OnTrak TesTstik 2 forCocaine/THC	OnTrak TesTstik for CocainePredicate
CocainePerformance:Accuracy	OnTrak TesTstik 2 forCocaine/THC was evaluatedusing clinical specimens screenedby an automated immunoassayand confirmed positive byGC/MS. Seventy (70)specimens, including near cutoffspecimens, positive for cocainewere evaluated on OnTrakTesTstik 2.	OnTrak TesTstik for Cocainewas evaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at a 150ng/mL cutoff. Fifty (50) samplespositive for cocaine were positiveby OnTrak TesTstik (100%).
	One hundred urine specimenswere obtained from a clinicallaboratory and screened negativeby automated immunoassaysrelative to a 300 ng/ml cutoff forcocaine. A portion (15%) of thenegative specimens were alsoconfirmed negative for cocaineby GC/MS. Clinical correlationfor all positive (including nearcutoff samples) and negativespecimens was demonstrated as94% agreement.	One hundred six (106) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 300 ng/mL cutoff forcocaine were evaluated andfound negative using OnTrakTesTstik.All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnTrakfor Cocaine. All samplesdemonstrated 100% agreementbetween the two assays.

Table 2

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510K Summary --Continued-

Item	OnTrak TesTstik 2 forCocaine/THC	OnTrak TesTstik for THCPredicate
THCPerformance:Accuracy	OnTrak TesTstik 2 forCocaine/THC was evaluatedusing clinical specimens screenedby an automated immunoassayand confirmed positive byGC/MS. Seventy (70)specimens, including near cutoffspecimens, positive for THCwere evaluated on OnTrakTesTstik 2.	OnTrak TesTstik for THC wasevaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at a 15 ng/mLcutoff. Forty five (45) samplespositive for THC were positive byOnTrak TesTstik (100%).
	One hundred urine specimenswere obtained from a clinicallaboratory and screened negativeby automated immunoassaysrelative to a 50 ng/ml cutoff forTHC. A portion (15%) of thenegative specimens were alsoconfirmed negative for THC byGC/MS. Clinical correlation forall positive (including near cutoffsamples) and negative specimenswas demonstrated as 95%agreement.	One hundred six (105) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 50 ng/mL cutoff forTHC were evaluated and foundnegative using OnTrak TesTstik.All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnTrakfor THC. All samplesdemonstrated 100% agreementbetween the two assays.

Table 3

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2000

Ms. Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis. Indiana 46250-0457

Re: K994164 Trade Name: OnTrak TesTstik™ 2 for Cocaine/THC Regulatory Class: II Product Code: LDJ, DIO Dated: March 7, 2000 Received: March 8, 2000

Dear Ms. Tribbett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTstik™ 2 for Cocaine/THC

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lan sos
(Division Sign-Off)

Division of Clinical Laboratory De 510(k) Number JA

Prescription Use \ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).