(45 days)
Not Found
No
The device description and intended use clearly state that the device is a quality control material for monitoring test performance, not a diagnostic device that would typically incorporate AI/ML for analysis. There are no mentions of AI, ML, or related technologies in the provided text.
No
The device is described as quality control materials to monitor test performance, not for direct patient care or treatment.
No
This device is described as a quality control material used to monitor product performance, containing CKMB, cardiac troponin I, and BNP at multiple concentrations. It is explicitly stated that "The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient." This indicates it is not used for diagnosing medical conditions in patients.
No
The device description clearly states that the device is a "quality control material" containing biological substances (CKMB, cardiac troponin I, and BNP). This indicates a physical, non-software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls and calibration verification materials are "to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance." These Triage® tests are themselves IVDs used to measure specific analytes in patient samples.
- Device Description: The description states they are "quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations." These are analytes measured in patient samples for diagnostic purposes.
- Purpose: The purpose is to "assist the laboratory in monitoring test performance throughout the measurable range." This is a fundamental aspect of quality control for IVD tests, ensuring the accuracy and reliability of patient results.
- Predicate Device: The predicate device listed (K072892: Triage® Total 5 Controls and Calibration Verification Set) is also a quality control material for IVD tests, further supporting the classification of this device as an IVD.
- Care Setting: The intended user is the "End user / Laboratory," which is the typical setting for performing IVD testing.
While the device itself doesn't directly diagnose a patient, it is an essential component used in vitro (outside the body) to ensure the proper functioning and accuracy of other IVD devices that do provide diagnostic information. This makes it an IVD accessory or reagent.
N/A
Intended Use / Indications for Use
The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
Product codes
JJY
Device Description
The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.
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
The Triage® Total 3 Controls and Cal Verification set were evaluated for value assignment and stability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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
Image /page/0/Picture/1 description: The image shows the word "BIOSITE" in all caps. The "O" in the word is replaced with a circular image of the earth. The word is written in a bold, sans-serif font and is black in color.
NEW DIMENSIONS !N DIAGNOSIS™
510(k) Summary
510(k) number:
NOV 1 3 2000
Date Prepared: 03 November 2009
| Submitter: | Biosite, Inc. | Contact: | Mara Caler |
|---|---|---|---|
| Address: | 9975 Summers Ridge Road | Regulatory Affairs | |
| San Diego, CA 92121 | Telephone: | 858 805 2083 | |
| Telephone: | 858 805 2083 | Fax: | 858 695 7100 |
| Fax: | 858 695 7100 | Email: | mcaler@biosite.com |
| Trade (proprietary) name: | Common Name (Device Type): |
|---|---|
| Triage® Total 3 Controls and Triage® | |
| Total 3 Calibration Verification Set | Assayed Quality Control materials |
| Class: | 1 |
|---|---|
| Regulation number: | 21 CFR 862.1660 |
| Product Code: | JJY |
| Panel: | Clinical Chemistry |
Predicate devices:
K072892: Triage® Total 5 Controls and Calibration Verification Set
The Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set is substantially equivalent to other products in commercial distribution intended for similar use, with substantial equivalency to the currently marketed Triage® Total 5 Controls and Triage® Total 5 Calibration Verification Set
Biosite, Inc.
Section 5
Triage® Total 3 Controls and Triage® Total 3 Calibration Verification
1
510(k) Summary
Device Description:
The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.
Intended Use / Indications for Use:
The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
Summary of Changes from Predicate Device:
The predicate device is the Triage® Total 5 controls and Triage® Total 5 Calibration Verification Set. The changes from the predicate device are:
- Lower levels of analyte .
- Removing the d-dimer analyte and the myoglobin analyte from the controls .
Substantial Equivalence to Predicate Device:
The predicate device is the Triage® Total 5 Controls and Triage® Total 5 Calibration Verification Set.
- The proposed Triage® Total 3 Controls and Triage® Total 3 Calibration . Verification Set are substantially equivalent to Triage® Total 5 Controls and Total 5 Calibration Verification Set in intended use, technology and performance.
- Bench performance testing was performed comparing the new device and the . predicate device, and was found to be substantially equivalent.
List of Similarities:
- Intended use is unchanged (except for the removal of the d-dimer analyte and the . myoglobin analyte from the control set)
- Indications for use is unchanged .
- The operating principle is unchanged .
- The technology is unchanged .
- The analytical performance is unchanged or improved .
Biosite, Inc.
Section 5
Triage® Total 3 Controls and Triage® Total 3 Calibration Verification
2
List of Differences:
- Control level 1 contains a lower level of troponin I than the predicate device .
- The individual assays contained within the control material has been reconfigured . (myoglobin and d-dimer have been removed from the control set).
Comparison Table:
| Characteristic | Predicate: K072892: Triage® Total 5 Controls and Calibration Verification Set | Triage® Total 3 Controls and Calibration Verification Set |
|---|---|---|
| Intended use | The Triage® Total 5 Controls are assayed controls to be used with the Triage® BNP Test, Triage® CardioProfilER Panel, Triage® Cardiac Panel and Triage® S.O.B Panel devices and the Triage® Meter to assist the end user in monitoring product performance. |
The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® BNP Test, Triage® CardioProfilER Panel, Triage® Cardiac Panel and Triage® S.O.B Panel devices and the Triage® Meter to assist the end user in monitoring product performance. | The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance. |
| Levels | 2 | 2 (same) |
| Format | Liquid/frozen | Liquid/frozen (same) |
| Handling | Thaw, no other user manipulation required | Thaw, no other user manipulation required (same) |
| Stability | 8 months | 4 weeks (real time stability on-going) |
| Matrix | Human EDTA plasma | Human EDTA plasma (same) |
Performance Characteristics:
The Triage® Total 3 Controls and Cal Verification set were evaluated for value assignment and stability.
Biosite, Inc.
Section 5
Triage® Total 3 Controls and Triage® Total 3 Calibration Verification
3
Conclusion :
Performance testing demonstrates that the Triage® Total 3 Control and Triage® Total 3 Calibration Verification Set are as safe, as effective and performs as well as the predicate device.
Biosite, Inc.
Section 5
Triage® Total 3 Controls and Triage® Total 3 Calibration Verification
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Biosite Incorporated c/o Mara Caler 9975 Summers Ridge Road San Diego, California 92121
NOV 1 3 2009
K093032 Re:
Trade Name: Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set Regulation Number: 21 CFR §862.1660 Regulation Name: Assayed Quality Control Materials Regulatory Class: Class I Product Codes: JJY Dated: September 25, 2009 Received: September 29, 2009
Dear Ms. Caler:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): 5093032
Device Name: Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set
Indications for Use:
The Triage® Total 3 Controls are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
The Triage® Total 3 Calibration Verification Set are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093032
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