(7 days)
Not Found
No
The summary describes calibration verification controls, which are reagents used to check the accuracy of a diagnostic test. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The description focuses on the composition and intended use of the controls themselves.
No
The device is described as "Calibration Verification Controls" used to "verify the calibration" of another panel and meter. It is not intended to treat or diagnose a disease.
No
This device is described as "Calibration Verification Controls," which are used to verify the calibration of other diagnostic devices (the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter). It does not directly diagnose a patient condition.
No
The device description explicitly states it is a "combination of the two predicate devices" and describes physical components ("prepared in a matrix that contains EDTA"). This indicates it is a physical control material, 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 used "to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel". This panel is used for diagnostic purposes (measuring cardiac markers). Calibration verification is a crucial step in ensuring the accuracy and reliability of an IVD test.
- Device Description: The description confirms that these are "Calibration Verification Controls" used with a "Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter". This further reinforces their role in the diagnostic testing process.
- Predicate Devices: The predicate devices listed (K974827 and K000231) are also described as "Calibration Verification Controls" for cardiac markers, which are inherently IVD products.
Calibration verification controls are considered IVD accessories because they are used in conjunction with an IVD test to ensure its proper performance and accuracy. They are essential for maintaining the quality and reliability of diagnostic results.
N/A
Intended Use / Indications for Use
The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.
Product codes
JJY
Device Description
The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range. The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains EDTA.
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
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
No30053
JAN 1 7 2003
510(k) Summary of Safety and Effectiveness
Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification 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: | 1/7/03 |
B. Device Names
-
- Trade Name
Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls
- Trade Name
-
- Common / Usual Name
Not Applicable
- Common / Usual Name
-
- Classification Name
Quality Control Material (Assayed and Unassayed) 21 CFR 862:1660 Class I Product Code: JJY
- Classification Name
C. Predicate Devices
Triage® Cardiac Calibration Verification Controls (K974827) Triage® BNP Calibration Verification Controls (K000231)
D. Device Description and Intended Use
The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac
1
Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.
E. Summary of Comparison Data
The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are a combination of the two predicate devices. The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains heparin.
F. Conclusion
The information provided in the premarket notification demonstrates that the Triage® Cardio ProfilER / Triaqe® Cardiac Calibration Verification Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 7 2003
Jeffrev R. Dahlen, Ph.D. Principal Scientist Clinical and Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121
Re: K030088
Trade/Device Name: Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class II Product Code: JJY Dated: January 7, 2003 Received: January 10, 2003
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 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).
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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K030088
510(k) Number (if known): (to be determined)
Device Name: Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls
Indications For Use:
The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Looper
Clinical Laboratory Devices
K030088
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The Counter Use__
(Optional Format 1-2-96)