(69 days)
- The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.
- The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.
The ONTRAK TESTSTIK Assays for Barbiturates and Benzodiazepines are in vitro diagnostic tests intended for professional use for the qualitative detection of drug in urine at or above a cutoff of 200 ng/mL. The ONTRAK TESTSTIK Assays are based on the principle of microparticle capture inhibition. These tests rely on the competition between the specific drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane test chamber. When an ONTRAK 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 conjugate and a blue band is formed at the result window ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated particles, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. Therefore, a positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are embedded in the reagent membrane, bind to the antigen on the blue microparticles.
Here's an analysis of the provided text regarding the ONTRAK TESTSTIK Assays, structured according to your requested information.
Please note that the provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full, highly detailed clinical study report. Therefore, some of your requested details might not be explicitly stated or fully elaborated in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in terms of numerical thresholds for a standalone device in this 510(k) summary. Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. The acceptance criteria for the new devices seem to be implied as achieving "greater than 95% confidence at 150% cutoff" for precision and demonstrating similar accuracy to the predicate devices when compared to GC/MS.
| Performance Characteristic | Acceptance Criteria (Implied) | ONTRAK TESTSTIK for Barbiturates Performance (Reported) | ONTRAK TESTSTIK for Benzodiazepines Performance (Reported) |
|---|---|---|---|
| Precision | > 95% confidence at 150% cutoff (matching predicate's precision)¹ | > 95% confidence at 150% cutoff | > 95% confidence at 150% cutoff |
| Accuracy (Positive Samples) | Demonstrably similar to predicate when compared to GC/MS | 50 positive samples identified correctly by TESTSTIK and ONTRAK vs. 50 by GC/MS | 50 positive samples identified correctly by TESTSTIK and ONTRAK vs. 50 by GC/MS |
¹Note: The predicate for Barbiturates claims "> 99% confidence at 200% of cutoff" and for Benzodiazepines "> 99% confidence at 200% of cutoff". The new device reports "> 95% confidence at 150% cutoff". While visually different, the document concludes "the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind," suggesting this difference was deemed acceptable for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Barbiturates: 50 positive samples were tested based on the comparison to GC/MS for both the new ONTRAK TESTSTIK and the predicate ONTRAK device. The number of negative samples is not explicitly mentioned in the tabulated accuracy data for positive samples.
- Benzodiazepines: 50 positive samples were tested based on the comparison to GC/MS for both the new ONTRAK TESTSTIK and the predicate ONTRAK device. The number of negative samples is not explicitly mentioned in the tabulated accuracy data for positive samples.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), not by human experts for interpretive tasks.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis method, not requiring human adjudication in the context described.
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. This device is an in vitro diagnostic test for qualitative drug detection in urine, not an AI-assisted diagnostic tool that requires human interpretation or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done for both devices. The output of the ONTRAK TESTSTIK Assays (formation of a blue band or lack thereof) is interpreted directly without human-in-the-loop assistance beyond visual inspection of the result window. The accuracy data presented (comparison to GC/MS) reflects this standalone performance.
7. The Type of Ground Truth Used
The ground truth used for performance comparison was Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "Accuracy: Positive Samples... GC/MS." This is a highly accurate analytical chemistry technique often considered the gold standard for drug detection and quantification in biological samples.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or its size. As a chemical assay, these devices are not based on machine learning or AI that typically requires separate training, validation, and test datasets in the same way. The development and optimization of such assays involve reagent selection, concentration optimization, and stability testing, but these are not referred to as "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the context of AI/machine learning is not described for these chemical assays. The underlying principles of the assay (antibody-antigen binding) are based on established biochemistry.
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Image /page/0/Picture/0 description: The image shows the Roche company logo. The logo consists of the word "Roche" written in a bold, sans-serif font. The word is enclosed in a hexagon shape.
510(k) Summary
ONTRAK TESTSTIK Assays for Barbiturates & Benzodiazepines
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
Identification of 510(k) Sponsor: I.
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated September 9, 1998
Contact: Maria Feijoo Manager, Regulatory Affairs Phone: (908) 253-7310 (908) 253-7547 Fax:
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II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Product Name | Classification Name | Regulatory Class | CFR Classification Number |
|---|---|---|---|
| ONTRAK TESTSTIK forBarbiturates | Barbiturates testsystem | Class II | 862.3150 |
| ONTRAK TESTSTIK forBenzodiazepines | Benzodiazepinestest system | Class II | 862.3170 |
Table 1
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Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| Product Name | Predicate ProductName | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|
| ONTRAK TESTSTIK forBarbiturates | Abuscreen OnTrak forBarbiturates | 7/28/88 | K881816/A |
| ONTRAK TESTSTIK forBenzodiazepines | Abuscreen OnTrak forBenzodiazepines | 4/05/91 | K910590 |
| 27ableশ | પ |
|---|---|
| --------------------- | --- |
IV. Description of the Device/Statement of Intended Use:
The ONTRAK TESTSTIK Assays for Barbiturates and Benzodiazepines are in vitro diagnostic tests intended for professional use for the qualitative detection of drug in urine at or above a cutoff of 200 ng/mL.
The ONTRAK TESTSTIK Assays are based on the principle of microparticle capture inhibition. These tests rely on the competition between the specific drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane test chamber.
When an ONTRAK 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 conjugate and a blue band is formed at the result window ("negative" sign).
When drug is present in the specimen, it binds to the antibody-coated particles, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. Therefore, a positive sample causes the membrane to remain white ("positive" sign).
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An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are embedded in the reagent membrane, bind to the antigen on the blue microparticles.
V. Summary of the technological characteristics of the new device in comparison to those of the predicate.
Tables 3-4 outline the technological characteristics (methodologies) of the ONTRAK TESTSTIK Assays in comparison to those of legally marketed predicate products.
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 3-4 demonstrate the results of clinical and nonclinical studies performed using the ONTRAK TESTSTIK Assays. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind.
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،
| ONTRAK TESTSTIKfor Barbiturates | Abuscreen ONTRAK forBarbiturates | ||||
|---|---|---|---|---|---|
| Methodology | Competitive microparticle captureinhibition | Competitive latex agglutinationinhibition | |||
| Measurement | Qualitative | Qualitative | |||
| Sample type | urine | urine | |||
| Endpoint read | color | agglutination pattern | |||
| Cutoff(s) | 200 ng/mL | 200 ng/mL | |||
| Reagent (activeingredients) | 1. Blue dyed microparticles coatedwith mouse monoclonal anti-barbiturates2. Drug conjugates immobilized on amembrane3. Mouse monoclonal anti-BSAantibody immobilized on amembrane | 1. Rabbit anti-barbiturateantibody in a bufferedsolution2. Reaction buffer3. Latex-barbiturate conjugatein a buffered solution | |||
| Precision | > 95% confidence at 150% cutoff | > 99% confidence at 200% ofcutoff | |||
| Accuracy:Positive Samples | TesTstik | ONTRAK | GC/MS | GC/MS | |
| + | 50 | 50 | 50 | 48 | |
| - | 0 | 0 | 0 | 0 |
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| ONTRAK TESTSTIKfor Benzodiazepines | Abuscreen ONTRAK forBenzodiazepines | ||||
|---|---|---|---|---|---|
| Methodology | Competitive microparticle captureinhibition | Competitive latex agglutinationinhibition | |||
| Measurement | Qualitative | Qualitative | |||
| Sample type | urine | urine | |||
| Endpoint read | color | agglutination pattern | |||
| Cutoff(s) | 200 ng/mL | 200 ng/mL | |||
| Reagent (activeingredients) | 1. Blue dyed microparticles coatedwith sheep polyclonal anti-benzodiazepine analogue2. Drug conjugates immobilized on amembrane3. Mouse monoclonal anti-BSAantibody immobilized on amembrane | 1. Mouse monoclonal anti-benzodiazepine antibody in abuffered solution2. Reaction buffer3. Latex- benzodiazepineconjugate in a bufferedsolution | |||
| Performance Characteristics: | |||||
| Precision | > 95% confidence at 150% cutoff | > 99% confidence at 200% ofcutoff | |||
| Accuracy:Positive Samples | TESTSTIK | ONTRAK | GC/MS | GC/MS | |
| + | 50 | 50 | 50 | 66 | |
| - | 0 | 0 | 0 | 1 |
Table 4 - ONTRAK TESTSTIK for Benzodiazepines
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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The logo is black and white.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Maria Feijoo Manager, Regulatory Affairs Roche Diagnostic System, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771
Re: K983174 Trade Name: OnTrak TesTstik for Barbiturates and OnTrak TesTstik for Benzodiazepines Regulatory Class: II, II Product Code: DIS, JXM Dated: September 9, 1998 Received: September 10, 1998
Dear Ms. Feijoo:
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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page 1 of 1
K 983174 510(k) Number (if known)
Device Name: ONTRAK TESTSTIK FOR BARBITURATES ONTRAK TESTSTIK FOR BENZODIAZEPINES
Indications for Use:
-
- The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL.
Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.
- The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL.
-
- The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL.
Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.
- The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL.
(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: K983174
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).