(27 days)
Not Found
No
The document describes quality control materials for a drug screen test and meter, with no mention of AI or ML technology.
No
The device is described as "assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance," indicating it is for quality control and not for treating patients.
No
The device is described as "assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance." This indicates it is a control material for validating the performance of a diagnostic test, rather than a diagnostic device itself that directly diagnoses a patient's condition.
No
The device description explicitly states it is "assayed materials" and is used with a "Triage® Meter," indicating it is a physical control material and a hardware meter, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are "to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance." This indicates the device is used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Device Description: The description reiterates the intended use, confirming its role in monitoring the performance of a diagnostic test.
- Intended User / Care Setting: The intended user is a "laboratory," which is a typical setting for IVD testing.
- Predicate Devices: The listed predicate devices are "Urine Toxicology Controls" and "Emit Calibrators/Controls." These are all examples of IVD devices used for quality control in diagnostic testing.
While the device itself isn't directly diagnosing a condition, it is an essential component used in vitro to ensure the accuracy and reliability of a diagnostic test (the Triage® TOX Drug Screen). This function falls squarely within the definition of an IVD.
N/A
Intended Use / Indications for Use
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
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
laboratory
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison data:
| Characteristic | Triage® TOX Drug
Screen 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 |
The information provided in the premarket notification demonstrates that the Triage® TOX Drug Screen Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Controls are safe and effective for their intended use.
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.
Not Found
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).
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
510(k) Summary of Safety and Effectiveness
Triage® TOX Drug Screen 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.
510(k) Number: (To be determined)
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 Controls
-
- Common / Usual Name
Not Applicable
3. Classification Name
Quality Control Material (Assayed and Unassayed) 21 CFR 862:3280 Class | Product Code: DIF
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 assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
1
E. Summary of Comparison Data
| Characteristic | Triage® TOX Drug
Screen 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 |
The table below provides a comparison of the technical principles between the Triage® TOX Drug Screen Controls and the predicate devices.
F. Conclusion
The information provided in the premarket notification demonstrates that the Triage® TOX Drug Screen Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Controls are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.
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: K012999
Trade/Device Name: Triage® TOX Drug Screen 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 nonification. The I 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 1 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, (Joase 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
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Page 1 of 1
510(k) Number (if known): {to-be-determined} Ko12999
Device Name: Triage® TOX Drug Screen Controls
Indications For Use:
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kuria Alexander Sr. Juan Lopez
Division Sign Off
(Division Sign-O)
Division of Clinical Laboratory Devices
510(k) Number K012999
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)