(74 days)
Not Found
No
The summary describes laboratory controls for drug screening tests and a meter, with no mention of AI or ML capabilities.
No
The device is described as a control for laboratory tests, used for monitoring test performance rather than directly treating or diagnosing patients.
No
Explanation: The device description states its purpose is to "assist the laboratory in monitoring test performance" when used with other drug screen tests and a meter. This indicates a role in quality control or assurance for existing tests, rather than directly diagnosing a patient's condition.
No
The device description explicitly states it is "Triage TOX Drug Screen Controls," which are physical control materials used in laboratory testing, not software.
Based on the provided information, 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 tests and Triage MeterPlus to assist the laboratory in monitoring test performance." This aligns perfectly 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. In this case, the controls are used to ensure the accuracy and reliability of a diagnostic test (the Triage TOX Drug Screen tests).
- Device Description: The description reiterates the intended use, confirming their role in monitoring test performance within a laboratory setting.
- Intended User / Care Setting: The intended user is a "laboratory," which is a typical setting for IVD use.
- Predicate Devices: The listing of predicate devices (K numbers and names) that are also controls for drug screening further supports the classification as an IVD. These predicate devices are themselves IVDs.
While the document doesn't contain information about image processing, AI/ML, or patient-specific details, the core function and intended use clearly place this device within the IVD category.
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 MeterPlus 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 to be used with the Triage TOX The Thage TOX Drug Triage MeterPlus 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K012999, K981590, K970666, K935230
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
K 050037
510(k) Summary of Safety and Effectiveness 11.
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.
(To be determined) 510(k) Number:
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: | 1/6/2005 |
B. Device Names
-
- Trade Name
Triage® TOX Drug Screen 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
Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)
D. Device Description and Intended Use
1
The Triage TOX Drug Screen Controls are to be used with the Triage TOX The Thage TOX Drug Triage MeterPlus to assist the laboratory in monitoring test performance.
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 devices.
| 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 |
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized stripes representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 2 2005
Jeffrey R. Dahlen, Ph.D Director, Clinical & Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121
K050037 Re:
Trade Name: Triage TOX Drug Screen Controls Regulatory Number: 21 CFR 862.3280 Regulatory Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: February 18, 2005 Received: February 22, 2005
Dear Dr. Dahlen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(th promaint is substantially equivalent (for the referenced above and have determined the to legally marketed predicate devices marketed in indications for use stated in the cholosary w regional date of the Medical Device interstate colliments, or to devices that have been reclassified in accordance with the provisions of Amendments, of to devices that have boon frequire approval of a premarket the Federal FOOd, Drug, and Cosment Pres (116) - Market the device, subject to the general approval application (1 Mr.). - 1 ove general controls provisions of the Act include controls provisions of the rec. "The gentiration 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 If your device is classinod (occ as a rey in a controls. Existing major regulations affecting (FMA), it may be subject to flact adally f Federal Regulations, Title 21, Parts 800 to 895. In your device can be found in the becan nouncements 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 mean that 117A has made a decemmaregulations administered by other Federal agencies. of the Act of ally I ederal states and virenents, including, but not limited to: registration r ou must compry with and 807); labeling (21 CFR Parts 801 and 809); and good alla listing (21 CF RT Part 001) Master 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) I his letter will anow you to ocgin marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your accruits premarket notification: "The PDT Intention 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, of fr If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion 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 I ou may obtain other general mormational 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,
Sean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. 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): K050037
Device Name: Triage TOX Drug Screen Controls
Indications For Use:
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage MeterPlus to assist the laboratory in monitoring test performance.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
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(Division Sign-C Division of Clinical Laboratory Devices 510(k) Number_KOS OO S OO S OO S 7