(18 days)
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No
The document describes quality control samples for drug testing systems and does not mention any AI or ML components.
No
This device is described as a quality control sample for laboratory testing, not for treating a disease or condition in a patient.
No
The device is a quality control sample used with diagnostic systems, not a diagnostic device itself.
No
The device description clearly states that the device is a "quality control sample" prepared by adding substances to human urine, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are "quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC." These systems are used to test for the presence of these substances in human urine.
- Device Description: The description states that the controls are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This indicates that the controls are designed to mimic human biological samples and are used in a laboratory or testing setting.
- Predicate Devices: The listed predicate devices (K983387 OnTrak TesTcup/OnTrak TesTstik Controls, Synchron Systems DAT Low Urine Control II, Synchron Systems DAT High Urine Control II) are also IVD devices used for quality control in drug testing.
The combination of these factors strongly indicates that this device is intended for use in vitro (outside the body) to examine specimens derived from the human body (urine) for the purpose of providing information for diagnostic or monitoring purposes (in this case, the performance of drug tests).
N/A
Intended Use / Indications for Use
The Roche Diagnostics Corporation OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
The OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC. The OnTrak TesTcup M2K/OnTrak TesTstik Controls are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservatives and stabilizers are added to maintain product integrity.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.
0
2/26/99
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.
- Submitter name, address, contact
Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000
Contact Person: Jennifer Tribbett
Date Prepared: February 3, 1999
-
- Device name The device name, including both the trade/proprietary name and classification name is provided below.
| Product Name | Common Name | Regulation
Number | Classification
Name | Class | Product
Code |
|-------------------------------------------------------|-----------------------------------------|----------------------|----------------------------------|-------|-----------------|
| OnTrak TesTcup
M2K and OnTrak
TesTstik Controls | Clinical toxicology
control material | 862.3280 | Drug mixture
control material | I | DIF |
- Predicate We claim substantial equivalence to the currently marketed OnTrak device TesTcup/OnTrak TesTstik Controls as well as the Synchron Systems DAT Low Urine Control II and DAT High Urine Control II. The OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control 4) Device Description samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC.
Continued on next page
CONFIDENTIAL
1
510(k) Summary, Continued
| 5. Technology
Characteristics | The OnTrak TesTcup M2K/OnTrak TesTstik Controls are prepared by the
quantitative addition of drug or drug metabolite to drug-free human urine.
Preservatives and stabilizers are added to maintain product integrity. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. Substantial
Equivalence | The modified OnTrak TesTcup M2K/OnTrak TesTstik Controls are
substantially equivalent to the currently marketed OnTrak TesTcup/OnTrak
TesTstik Controls as well as the Synchron Systems DAT Low Urine Control
II and DAT High Urine Control II. |
| | The OnTrak TesTcup and TesTstik Control was previously cleared on
October 9, 1998 (K983387). |
| | This Premarket Notification [510(k)] is being submitted to the agency due to
the Department of Health and Human Services Substance Abuse and Mental
Health Services Administration's (SAMHSA) revision in the recommended
cutoff for morphine. The cutoff was previously 300 ng/mL, but SAMHSA is
currently recommending 2000 ng/mL. Therefore, the level of morphine in
the corresponding positive controls must also change to capture the higher
cutoff value. This notification addresses the change in the positive control
morphine level from 750 ng/mL to 5000 ng/mL. |
| | In addition, this notification also addresses the addition of oxazepam as a new
constituent. |
| | The current cutoff levels for the OnTrak TesTcup and TesTstik assays are: |
| | Amphetamines: 1000 ng/mL
Cannabinoids: 50 ng/mL
Cocaine: 300 ng/mL
Morphine: 2000 ng/mL
Phencyclidine: 25 ng/mL
Secobarbital: 200 ng/mL
Oxazepam: 200 ng/mL |
| | A summary of the similarities and differences between the OnTrak TesTcup
M2K/OnTrak TesTstik Controls and the predicate products is listed in Table
1 and Table 2. |
:
2
510(k) Summary, Continued
Table 1
| | Modified OnTrak TesTcup
M2K and TesTstik Controls | | Current OnTrak TesTcup
and TesTstik Controls | |
|---------------|------------------------------------------------------|-------------|-------------------------------------------------|-------------|
| | Negative | Positive | Negative | Positive |
| Matrix | Human urine | Human urine | Human urine | Human urine |
| Drugs: | ng/mL | ng/mL | ng/mL | ng/mL |
| Amphetamines | 0 | 2500 | 0 | 2500 |
| Cannabinoids | 0 | 125 | 0 | 125 |
| Cocaine | 0 | 750 | 0 | 750 |
| Morphine | 0 | 5000 | 0 | 750 |
| Phencyclidine | 0 | 62.5 | 0 | 62.5 |
| Secobarbital | 0 | 500 | 0 | 500 |
| Oxazepam | 0 | 500 | NA | NA |
3
510(k) Summary, Continued
- Substantial The predicate device for the oxazepam constituent is the Beckman Synchron Equivalence systems DAT Low and High Urine Controls II. The table below indicates (Continued) drug concentrations found in the Beckman Controls II.
| Beckman Synchron Systems DAT Low and High Urine Controls II | |||||
|---|---|---|---|---|---|
| Low Urine Control II | High Urine Control II | ||||
| Matrix | Human urine | Human urine | |||
| Drugs: | ng/mL | ng/mL | |||
| Secobarbital (Barbiturates) | 150 | 300 | |||
| Oxazepam (Benzodiazepine) | 150 | 300 | |||
| Methadone | 200 | 375 | |||
| Methaqualone | 200 | 375 | |||
| Propoxyphene | 200 | 375 |
CONFIDENTIAL
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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 stylized eagle or bird-like figure composed of three curved lines that resemble human profiles. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 26 1999
Jennifer L. Tribbett Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250-0457
K990377 Re:
Trade Name: OnTrack TesTcup M2K and OnTrack TesTstik Positive Control Regulatory Class: I Product Code: DIF Dated: February 3, 1999 Received: February 8, 1999
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 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 Onder 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) I mis letter will anow you to begin finding of substantial equivalence of your device to a promation hourselicate 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 and additionally 607.10 101 11 10 10 11 11 10 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
6
510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup M2K/OnTrak TesTstik Controls
Indications for Use:
-• -•
The Roche Diagnostics Corporation OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC. ﮯ
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_4990377
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)
CONFIDENTIAL