(13 days)
Not Found
No
The document describes laboratory controls for monitoring test performance and makes no mention of AI or ML.
No
The device is described as a control for monitoring test performance in a laboratory setting, not for treating or diagnosing patients directly.
No
The device is described as "controls" to "assist the laboratory in monitoring test performance," which indicates it's used for quality control, not for directly diagnosing patients.
No
The device description explicitly mentions "Triage® Meter," which is a hardware component used to perform the tests. The controls are used with this meter and the test panel, indicating a system that includes hardware.
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 assist the laboratory in monitoring test performance" with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter. This indicates that the controls are used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Device Description: The description reiterates the use of the controls with the Triage® system for monitoring test performance, further supporting its role in the diagnostic process.
- Intended User / Care Setting: The intended user is a "laboratory," which is a typical setting for performing in vitro diagnostic tests.
- Predicate Devices: The predicate devices listed (Triage® Cardiac Controls and Triage® BNP Controls) are also controls used in in vitro diagnostic testing.
The fact that it's a control material used to monitor the performance of a diagnostic test places it firmly within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to assist the laboratory in monitoring test performance.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter 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.
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
§ 862.1660 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 of Safety and Effectiveness
Triage® Cardio ProfilER / Triage® Cardiac 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: | 1/7/03 |
B. Device Names
-
- Trade Name
Triage® Cardio ProfilER / Triage® Cardiac 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
C. Predicate Devices
Triage® Cardiac Controls (K974461) Triage® BNP Controls (K000230)
D. Device Description and Intended Use
The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to assist the laboratory in monitoring test performance.
1
E. Summary of Comparison Data
The Triage® Cardio ProfilER / Triage® Cardiac Controls are a combination of the two predicate devices. The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Controls are prepared in a matrix that contains heparin.
F. Conclusion
The information provided in the premarket notification demonstrates that the Triage® Cardio ProfilER / Triage® Cardiac Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® Cardio ProfilER / Triage® Cardiac 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 often associated with healthcare. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JAN 2 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jeffrey R. Dahlen, Ph.D. Principal Scientist Clinical and Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121
Re: K030089
Trade/Device Name: Triage® Cardio ProfilER / Triage® Cardiac Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class I 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 vour 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).
3
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
K030089
510(k) Number (if known): (to be determined)
Device Name: Triage® Cardio ProfilER / Triage® Cardiac Controls
Indications For Use:
The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to assist the laboratory in monitoring test performance.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Coogey
Laporatory Devices
5 biky Number 2630089
Prescription Use✗
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
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