(134 days)
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No
The document describes calibration and quality control materials for a diagnostic test panel and meter. There is no mention of AI or ML in the intended use, device description, or the specific sections searched for AI/ML terms.
No
The device is a laboratory control used to verify calibration and monitor test performance of a diagnostic panel, not to treat a condition.
No
This device is described as "Calibration Verification Controls" and "Controls" for monitoring test performance, not for diagnosing conditions in patients. It is used to verify the calibration of another device and to monitor its performance.
No
The device description explicitly mentions "Matrix: EDTA plasma", "Form: Liquid", and "Storage: -20 °C or colder", indicating it is a physical control material, not software. It is intended to be used with a meter and panel, which are also hardware components.
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 used "to verify the calibration" and "to assist the laboratory in monitoring test performance" of the Triage® Profiler S.O.B. Panel. This panel is used with the Triage® Meter Plus, which is a device that likely performs in vitro diagnostic tests on patient samples (EDTA plasma, as indicated in the Device Description).
- Device Description: The device is a "Calibration Verification Control" and "Control" for use with a diagnostic panel and meter. It contains specific analytes (CK-MB, Troponin I, Myoglobin, BNP, D-dimer) found in biological samples (EDTA plasma).
- Matrix: The matrix is "EDTA plasma," which is a biological sample type commonly used in in vitro diagnostic testing.
- Analytes: The listed analytes are biomarkers typically measured in clinical laboratories for diagnostic purposes.
- Intended User / Care Setting: The intended user is a "laboratory," which is the typical setting for performing in vitro diagnostic tests.
- Predicate Devices: The predicate devices listed (K030088 and K030089) are also described as "Calibration Verification Controls" and "Controls" for a "Cardio ProfilER," further supporting the nature of this device as an IVD control.
In summary, the device is a control material designed to be used with an in vitro diagnostic test system (the Triage® Profiler S.O.B. Panel and Triage® Meter Plus) to ensure the accuracy and reliability of the test results obtained from patient samples. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.
The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.
Product codes
JJY
Device Description
The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.
The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 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
JUL - 6 2004
510(k) Summary of Safety and Effectiveness
Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. 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: | 2/20/05 |
B. Device Names
-
- Trade Name
Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls
- Trade Name
-
- Common / Usual Name
Not Applicable
- Common / Usual Name
-
- Classification Name
Quality Control Material (Assayed and Unassaved) 21 CFR 862:1660 Class I Product Code: JJY
- Classification Name
C. Predicate Devices
Triage Cardio ProfilER Calibration Verification Controls (K030088) Triage Cardio ProfilER Controls (K030089)
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D. Device Description and Intended Use
The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.
The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus 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® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls and the predicate devices.
| Characteristic | Triage®
Profiler
S.O.B.
Controls /
Calibration
Verification
Controls | Triage®
Cardio
Profiler
Controls /
Calibration
Verification
Controls
(K030088,
K030089) |
|----------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use | Assayed
control for
monitoring
test
performance | Assayed
control for
monitoring
test
performance |
| Matrix | EDTA
plasma | EDTA
plasma |
| Form | Liquid | Liquid |
| Analytes | CK-MB,
Troponin I,
Myoglobin,
BNP, D-
dimer | CK-MB,
Troponin I,
Myoglobin,
BNP |
| Storage | -20 °C or
colder | -20 °C or
colder |
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F. Conclusion
The information provided in the premarket notification demonstrates that the Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls are safe and effective for their intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare.
Public Health Service
JUL - 6 2004
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Jeffrey R. Dahlen, Ph.D Principal Scientist, Clinical & Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121
K040459 Re:
Trade/Device Name: Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls Triage® Profiler S.O.B. (Shortness of Breath) Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assay and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 28, 2004 Received: June 29, 2004
Dear Dr. Dahlen:
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
4
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
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
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Indications for Use
510(k) Number (if known): K040459
Device Name: Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls
Triage® Profiler S.O.B. (Shortness of Breath) Controls
Indications For Use:
The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.
The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus 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)
Carol Benson
Division Sign-Off
Office of In Vitro Diagn Device Evaluation and So
510(k) K040459
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