(17 days)
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.
Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).
This document is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." It is a quality control material intended for use in clinical laboratory quality assurance programs to assess the accuracy and precision of cardiac marker procedures. The document states that the device is "substantially equivalent" to a previously cleared predicate device, the "Liquichek Cardiac Markers Control" manufactured by Bio-Rad Laboratories (K961828).
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria (e.g., specific ranges for accuracy, precision, or recovery) or provide detailed performance data for the Dade® TRU-Liquid™ Cardiac Control device.
Instead, the core of the submission is a demonstration of substantial equivalence to a predicate device. This means the device is considered acceptable if it performs comparably to the predicate device for its intended use. The document affirms this substantial equivalence, but it does not present the direct experimental results that led to that conclusion for the new device.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Performance comparable to the predicate device (Liquichek Cardiac Markers Control, K961828) for controlling accuracy and precision of cardiac marker procedures. | Declared "substantially equivalent" in terms of intended use, safety, and effectiveness to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The document refers to the predicate device (K961828) which would have had its own testing, but details on the testing of the Dade® TRU-Liquid™ Cardiac Control itself are absent from this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The device is a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth. Its "truth" is based on the known concentrations of analytes within the control material, which are then used to assess other diagnostic assays.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used for diagnostic devices where human interpretation or consensus is required for complex cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting medical images or data. The Dade® TRU-Liquid™ Cardiac Control is a quality control material for laboratory instruments/assays.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (in the context of AI algorithms) was not done. This device is not an AI algorithm. Its performance is evaluated through its stability, homogeneity, and accuracy of assayed values when used to calibrate or check other diagnostic assays.
7. The Type of Ground Truth Used
For a quality control material like this, the "ground truth" would be the assigned or assayed values (known concentrations) of the cardiac markers within the control material itself. These values are typically established through rigorous analytical methods, often by the manufacturer using reference methods or certified reference materials. The purpose of the control is then to ensure that clinical laboratory instruments/assays accurately measure these known concentrations.
8. The Sample Size for the Training Set
This information is not applicable and not provided. A "training set" refers to data used to train machine learning models. This device is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
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17173974
NOV - 6 1997
510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Cardiac Control October 17, 1997
Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 Contact Person: Betty Hernandez-Labadie at (305)392-5618, or by facsimile at (305)392-5622.
| Trade or Proprietary Name: | Dade® TRU-Liquid™ Cardiac ControlLevels 1,2 and 3. | |
|---|---|---|
| Common or Usual Name: | Liquid Tri-Level Cardiac Control | |
| Classification Name: | Quality Control Material (Assayed and Unassayed) | |
| Registration Number: | ManufacturerDade International Inc.2173 N.W. 99th AvenueMiami, FL 33172(formerly at 9750 N.W. 25 Street, Miami, FL 33172)Dade International Inc.1851 Delaware ParkwayMiami, Florida 33125 | 10255061017272 |
The proposed Dade® TRU-Liquid™ Cardiac Control is substantially equivalent in terms of intended use and safety and effectiveness to the Liquichek Cardiac Markers Control manufactured by Bio-Rad Laboratories, previously cleared under Document Control No., K961828.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Betty Hernandez-Labadie . Senior Regulatory Specialist Dade International Inc. 2173 N.W. 99 Avenue Miami, Florida 33172
Re : K973974 Dade® TRU-Liquid™ Cardiac Control Levels 1,2, and 3 Requlatory Class: I Product Code: JJT October 17, 1997 Dated: Received: October 20, 1997
Dear Ms. Hernandez-Labadie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | --------- |
|---|---|
| --------------------------- | ----------- |
Dade TRU-Liquid Cardiac Control Device Name:
Indications For Use:
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricell. Bernkarót
(Division Sign-Off) (for Awm)
Division of Clinical Laboratory evices
510(k) Number K973974
::
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.