(109 days)
Not Found
No
The summary describes laboratory controls for drug screening tests and meters, with no mention of AI or ML.
No
The device is described as controls for monitoring test performance in a laboratory setting, not for treating any medical condition.
No
The device is described as controls for monitoring test performance of drug screen tests, not as a test itself that diagnoses a medical condition.
No
The device description explicitly states it is a "Drug Screen Controls" and is used with "Triage TOX Drug Screen tests and Triage Meters," indicating it is a physical control material used in conjunction with hardware (tests and meters). There is no mention of software as the primary or sole component.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used "with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance." This aligns with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While these controls aren't directly diagnosing, they are essential components for ensuring the accuracy and reliability of diagnostic tests.
- Device Description: The device description reiterates the intended use, further solidifying its role in supporting diagnostic testing.
- Intended User / Care Setting: The intended user is a "laboratory," which is a typical setting for IVD use.
- Predicate Device: The presence of a predicate device (K050037; Biosite Triage® TOX Drug Screen Controls) indicates that this type of device has been previously classified and regulated as an IVD by the FDA.
Therefore, the Triage TOX Drug Screen Controls, as described, function as a quality control component for in vitro diagnostic tests and are themselves considered IVDs.
N/A
Intended Use / Indications for Use
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.
Product codes
DIF
Device Description
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters 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
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
510(k) Summary of Safety and Effectiveness
(JUL 1 0 2006
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.
k 060788 510(k) Number: (To be determined)
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 9975 Summers Ridge Road |
| San Diego, CA 92121 | |
| Telephone: | (888) 246-7483 |
| Fax: | (858) 586-7543 |
| Contact Person: | Robin Weiner |
| Date Summary Prepared: | 03/21/06 |
B. Device Names
-
- Trade Name
Triage® TOX Drug Screen Controls
- Trade Name
-
- Common / Usual Name
TOX Drug Screen Controls
- Common / Usual Name
-
- Classification Name
Drug Mixture Control Materials 21 CFR 862.3280 Class I
- Classification Name
Product Code: DIF
C. Predicate Devices
Biosite Triage® TOX Drug Screen Controls (K050037)
D. Device Description and Intended Use
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.
1
E. Summary of Comparison Data
The table below provides a comparison of the technical principles between the Triage TOX Drug Screen Controls and the predicate device.
| Characteristic | Triage TOX Drug
Screen Controls
(proposed) | Triage TOX Drug
Screen Controls
(K050037) |
|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended Use | 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 |
| Form | Liquid | Liquid |
| Analytes | Commonly abused
drugs | Commonly abused
drugs |
| Storage | -20 °C or colder | -20 °C or colder |
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the eagle in the center.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 0 2006
Ms. Robin Weiner Vice President Regulatory and Government Affairs Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121
K060788 Re:
Trade/Device Name: Triage® TOX Drug Screen Controls Regulation Number: 21 CFR§862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: June 23, 2006 Received: June 26, 2006
Dear Ms. Weiner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Albert Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060788
Device Name: Triage® TOX Drug Screen Controls
Indications For Use:
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test performance.
Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carl Benson
Page 1 of 1
Livision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety