(91 days)
No
The document describes calibration and quality control materials for a diagnostic test, not a device that processes data or makes decisions using AI/ML.
No
The device is described as controls used to verify calibration and monitor performance of
another test (Triage D-Dimer Test), not directly for treating patients. Therefore, it is not a therapeutic device.
No
The device is described as "Calibration Verification Controls" and "assayed materials to be used... to verify the calibration" or "assist the laboratory in monitoring test performance." This indicates it is for quality control and verification of another test, not for diagnosing patients itself.
No
The device description explicitly states the device is "assayed materials" and "controls," which are physical substances used for calibration and monitoring, not software. It is used with a meter (Triage MeterPlus) and a test (Triage D-Dimer Test), implying a hardware and reagent component, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls are "to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test" and "to assist the laboratory in monitoring test performance." This indicates that the controls are used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The device description reiterates the intended use, confirming that the controls are used with the Triage D-Dimer Test and Triage MeterPlus for calibration verification and performance monitoring.
- Predicate Device: The mention of a predicate device (K032017 Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3) which is also a control material for a D-dimer test, further supports its classification as an IVD. Control materials for diagnostic tests are a common type of IVD.
The purpose of these controls is to ensure the accuracy and reliability of the Triage D-Dimer Test, which is itself a diagnostic test performed on biological samples in vitro. Therefore, the controls are essential components of the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.
The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.
Product codes
GGN
Device Description
The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.
The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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JUN 2 9 2005
510(k) Summary of Safety and Effectiveness
Triage D-Dimer Calibration Verification Controls / Triage D-Dimer 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.
K050799 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) 535-8344 |
| Contact Person: | Rachael S. Williamson |
| Date Summary Prepared: | 6/22/05 |
B. Device Names
-
- Trade Name
Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls
- Trade Name
-
- Common / Usual Name
Not Applicable
- Common / Usual Name
.
3. Classification Name
Plasma, Coagulation Control 21 CFR 864.5425 Class II Product Code: GGN
C. Predicate Devices
Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3 (K032017)
D. Device Description and Intended Use
The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.
The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.
E. Conclusion
The information provided in the premarket notification demonstrates that the Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls are substantially equivalent to previously approved predicate devices. The information provided assures
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that the Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls are safe and effective for their intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird.
JUN 2 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rachael S. Williamson Regulatory Affairs Specialist Biosite Incorporated 11030 Roselle Street San Diego, California 92121
K050799 Re:
Trade/Device Name: Triage D-Dimer Calibration Verification Controls and Triage D-Dimer Controls Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma coagulation control Regulatory Class: II Product Code: GGN Dated: May 17, 2005 Received: May 18, 2005
Dear Ms. Williamson:
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). 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.
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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,
lobatz Beckerich
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050799
Device Name: Triage® D-Dimer Test
Indications For Use:
The Triage D-Dimer Calibration Verification Controls are to be used with the The Thage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimor Test throughout the measurable range.
The Triage D-Dimer Controls are assayed materials to be used with the The Thage D-Dimer Test 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)
Josephine Bautista
(Division Sign-Øff)
510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division of Clinical Laboratory Devices
510(k) Number K050799
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