(27 days)
No
The document describes calibration verification controls for a drug screen and meter, which are standard laboratory quality control materials and equipment. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is a calibration verification control used to check the performance of a drug screen test, not to diagnose, treat, or prevent a disease or condition in a patient.
No
The device is described as "Calibration Verification Controls" used to "verify the calibration" of a drug screen, not to diagnose a condition in a patient. It is a quality control product for a diagnostic device.
No
The device description clearly states the product is in liquid form and requires storage at -20°C or colder, indicating it is a physical substance (controls) and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used "to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range." This indicates the device is used in a laboratory setting to ensure the accuracy of a diagnostic test (the Triage® TOX Drug Screen).
- Device Description: The description confirms it's a "Control" used with a "Drug Screen" and "Meter." Controls are a fundamental component of in vitro diagnostic testing to ensure the reliability of the results.
- Matrix: The matrix is "Human Urine," which is a biological specimen commonly used in in vitro diagnostic testing.
- Analytes: The analytes are "Commonly abused drugs," which are substances detected in diagnostic tests.
- Predicate Devices: The listed predicate devices are also "Urine Toxicology Controls" and "Calibrators/Controls," which are clearly IVD products.
All these factors point to the device being used outside of the body to provide information about a patient's health status (in this case, the presence of drugs), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triage® TOX Drug Screen Calibration Verification Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.
Product codes
DIF
Device Description
The Triage® TOX Drug Screen Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.
Comparison data:
- Intended Use: Assayed control for monitoring urine-based drugs of abuse assays
- Matrix: Human Urine
- Form: Liquid
- Analytes: Commonly abused drugs
- Storage: -20 °C or colder
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
OCT - 3 2001
510(k) Summary of Safety and Effectiveness
Triage TOX Drug Screen Calibration Verification Controls
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
(To be determined) 510(k) Number:
K0/3002
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 11030 Roselle Street |
| San Diego, CA 92121 | |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 9/4/01 |
B. Device Names
-
- Trade Name
Triage® TOX Drug Screen Calibration Verification Controls
- Trade Name
-
- Common / Usual Name
Not Applicable
- Common / Usual Name
-
- Classification Name
Quality Control Material (Assayed and Unassayed) 21 CFR 862:3280 Class I Product Code: DIF
- Classification Name
C. Predicate Devices
BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)
D. Device Description and Intended Use
The Triage® TOX Drug Screen Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.
1
E. Summary of Comparison Data
The table below provides a comparison of the technica! principles between the Triage® TOX Drug Screen Calibration Verification Controls and the predicate devices.
| Characteristic | Triage® TOX Drug
Screen
Calibration
Verification
Controls | Bio-Rad
Liquicheck | Dade Behring
Emit |
|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended Use | Assayed control for
monitoring urine-
based drugs of
abuse assays | Assayed control for
monitoring urine-
based drugs of
abuse assays | Assayed control for
monitoring urine-
based drugs of
abuse assays |
| Matrix | Human Urine | Human Urine | Human Urine |
| Form | Liquid | Liquid | Liquid |
| Analytes | Commonly abused
drugs | Commonly abused
drugs | Commonly abused
drugs |
| Storage | -20 °C or colder | 2-8 °C | 2-8 °C |
F. Conclusion
The information provided in the premarket notification demonstrates that the Triage® TOX Drug Screen Calibration Verification Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Calibration Verification Controls are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head.
OCT - 3 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Jeffrey R. Dahlen Principal Scientist Biosite Diagnostics, Inc. 11030 Roselle Street San Diego, CA 92121
Re: K013002
Trade/Device Name: Triage® TOX Calibration Verification Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I, reserved Product Code: DIF Dated: September 5, 2001 Received: September 6, 2001
Dear Dr. Dahlen:
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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
3
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 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 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
4
Page 1 of 1
510(k) Number (if known): (to be determined) K013002
Device Name: Triage® TOX Drug Screen Calibration Verification Controls
Indications For Use:
The Triage® TOX Drug Screen Calibration Verification Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kinia Alexander/Ian Lopez
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013002
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)