(82 days)
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No
The document describes quality control materials for laboratory tests and does not mention any AI or ML components in its description, intended use, or performance studies.
No
This device is a quality control material used to assess the accuracy and precision of laboratory test methods for measuring cardiac markers, not for direct therapeutic use on patients.
No
This device is described as a "quality control material" and "calibration control set" used to assess the accuracy and precision of laboratory test methods, and to verify the calibration of various test methods. It is not used to directly diagnose a patient's condition.
No
The device is a physical quality control material (frozen liquid) used in laboratory testing, not a software application.
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 assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control" and "to validate the measurement of these analytes in patient samples." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description mentions the controls are prepared in a "human EDTA plasma matrix" and are used to measure "cardiac markers" (antigens and enzymes). These are components and analytes typically measured in a clinical laboratory setting for diagnostic purposes.
- Intended User/Care Setting: The intended user is "laboratory test methods," indicating use in a clinical laboratory environment.
- Performance Studies: The document describes stability testing and assay value establishment, which are typical performance evaluations for IVD devices.
- Predicate Devices: The mention of predicate devices like "Triage® Profiler S.O.B.™ Control" and "Bayer Healthcare LLC Liquid Cardiac Markers Plus Control" further supports its classification as an IVD, as these are known IVD control materials.
While the document doesn't explicitly use the term "IVD," the intended use, device description, and context of its use in a laboratory setting for validating patient sample measurements clearly indicate that it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Compass Bioscience Cardiac Markers Controls are intended for use as quality control materials to assess the accuracy and precision of assay procedures for the analytes included in the control. The Compass Bioscience Cardiac Marker Calibration Set is used to verify the calibration of various test methods over the measurable range of the test.
The Compass Bioscience Cardiac Markers Controls are to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control. It is intended to validate the measurement of these analytes in patient samples.
Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.
The Compass Bioscience Cardiac Marker Calibration Control Set is used to verify the calibration of various test methods over the measurable range of the test.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Compass Bioscience Cardiac Markers Controls are supplied in three levels, 2 x 1 mL each level per box and as a four Level Calibration Verification set, 2 x 1 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human EDTA plasma matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the levels. Sodium Azide 10% of analyte recovery compared to the initial test value ± the highest allowable instrument/reagent imprecision was used as the analyte failure criterion for determining shelf-life. Real time stability testing is ongoing on multiple lots of product.
The closed and opened vial stability claim for this product when stored at 2-8° C is 30 days for CK-MB and Myoglobin and 14 days for Troponin I and BNP. Real time testing was used to determine the closed and open vial refrigerated shelf life. The Cardiac Markers Control at 2 - 8° C and the recovery (vs. day 0) was measured in intervals of 7 days. The product passed stability if its recovery was within ±(10% + % CVmethod) after 44 days of storage at 2- 8°C.
Multiple lots of product were tested with no significant difference in performance.
Assay values for the package inserts were established from assays performed in the Compass Bioscience laboratory using three Triage® MeterPlus readers with the Triage® Profiler S.O.B.™ Panel tests, the Triage® CardioProfiler Panel, and the Triage® Cardiac Panel, and from interlaboratory data using instrument manufacturers' reagents. Mean values for the listed lots of controls were calculated from multiple instruments and reagent lots available at the time of assay. Ranges were determined based on 2 SD - 3SD of the overall mean values from stability and interlaboratory data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Prepared: 8/29/2006 Submitted by: Establishment Address:
Evy K. Johnson Compass Bioscience 1850 Evergreen Street Duarte CA 91010 Phone: 626.359.96.45 FAX: 626.359.9645
NOV 2 2 2006
Establishment Registration Number: 2032652
Contact Person: Dr. Carter Grandjean, Director R&D
Proprietary Name: Cardiac Markers Control and Calibration Verification Set Common Name: Cardiac Markers Control and Calibration Verifier Controls Classification Name: Multi Analyte Controls, All Kinds (assayed and unassayed) 75 JJY Substantial Equivalence:
The Compass Bioscience Cardiac Markers Control and Calibration Set are supplied liguid in three or 4 levels and consist of a human plasma matrix containing preservatives to which reagent grade chemicals and human source antigens and enzymes have been added at different concentrations to achieve the levels. Assayed values are determined from in house and interlaboratory data.
The Compass Bioscience controls and calibration verifiers are substantially equivalent to other such controls and verifiers in general use, such as the Triage® Profiler S.O.B.™ (Shortness of Breath) Control and the Triage® Profiler S.O.B.™ (Shortness of Breath) Calibration Verification Controls which are supplied liquid in a two level control set and five level calibration set as a human EDTA plasma matrix with human source constituents and pure chemicals added by the manufacturer.
Description:
Compass Bioscience Cardiac Markers Controls are supplied in three levels, 2 x 1 mL each level per box and as a four Level Calibration Verification set, 2 x 1 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human EDTA plasma matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the levels. Sodium Azide 10% of analyte recovery compared to the initial test value ± the highest allowable instrument/reagent imprecision was used as the analyte failure criterion for determining shelf-life. Real time stability testing is ongoing on multiple lots of product.
The closed and opened vial stability claim for this product when stored at 2-8° C is 30 days for CK-MB and Myoglobin and 14 days for Troponin I and BNP. Real time testing was used to determine the closed and open vial refrigerated shelf life. The Cardiac Markers Control at 2 - 8° C and the recovery (vs. day 0) was measured in intervals of 7 days. The product passed stability if its recovery was within ±(10% + % CVmethod) after 44 days of storage at 2- 8°C.
Multiple lots of product were tested with no significant difference in performance.
The equivalent predicate device, Triage® Profiler S.O.B.™ Control claims a 2 year shelf life for storage at -20°C and a single use. The Bayer Healthcare LLC Liquid Cardiac Markers Plus Control claims a 20 day opened/closed vial stability at refrigerated (2-8°C) storage.
Assayed Values
Assay values for the package inserts were established from assays performed in the Compass Bioscience laboratory using three Triage® MeterPlus readers with the Triage® Profiler S.O.B.™ Panel tests, the Triage® CardioProfiler Panel, and the Triage® Cardiac Panel, and from interlaboratory data using instrument manufacturers' reagents. Mean values for the listed lots of controls were calculated from multiple instruments and reagent lots available at the time of assay. Ranges were determined based on 2 SD - 3SD of the overall mean values from stability and interlaboratory data.
2 L. Kennon, Stability Prediction Model, Journal of Pharmaceutical Sciences 53:7, 815-818, 1964.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned inside a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 2 2006
Ms. Evy K. Johnson Compass Bioscience 1850 Evergreen Street Duarte, CA 91010
Re: K062593 Trade/Device Name: Cardiac Markers Control Cardiac Markers Calibration Verification Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 30, 2006 Received: September 6, 2006
Dear Ms. Johnson:
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 (sec 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 not 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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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 (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,
Albert Gutt
Alberto Gutierrez, Ph.D. 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): K
Device Name: Cardiac Markers Control
Cardiac Markers Calibration Verification Control Set
Indications For Use:
The Compass Bioscience Cardiac Markers Controls are to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control. It is intended to validate the measurement of these analytes in patient samples.
Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.
The Compass Bioscience Cardiac Marker Calibration Control Set is used to verify the calibration of various test methods over the measurable range of the test.
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)
Carole Benam
Division Sign Off
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Office of In Vitro Diagnostic Device Evaluation and Safety