(32 days)
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance quarrer control accession the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.
Liquid Tri-Level Cardiac Control
The provided text is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic or therapeutic device.
Therefore, many of the requested categories (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable or detailed in this type of regulatory submission for a quality control material.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the format of a table with specific acceptance criteria (e.g., precision limits, accuracy targets) and corresponding reported performance for the TRU-Liquid Cardiac Control itself. The document's primary focus is on demonstrating substantial equivalence to a predicate device (Liquichek Cardiac Markers Control). This implies that the performance of the new device is expected to be comparable to this legally marketed predicate.
The document states: "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."
This "substantial equivalence" is the overarching acceptance criterion, evaluated by comparing the new device's characteristics and intended use to those of the predicate. The performance data that supports this would typically be found in the full 510(k) submission, not necessarily in this summary document.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document does not describe a clinical performance study with a test set of patient samples. The "test" for this device likely involved laboratory characterization and comparison to the predicate, but specific sample sizes for such internal testing are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable for the same reason as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC study is relevant for devices involving human interpretation of clinical data (e.g., imaging devices). This is a quality control material.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a quality control material, not an algorithm or an automated system.
7. The Type of Ground Truth Used:
Not applicable in the sense of patient outcomes, pathology, or expert consensus on clinical findings. For a quality control material, the "truth" is typically established through precise analytical methods and characterization of the material itself (e.g., target analyte concentrations determined by reference methods). The document implies that the "truth" for demonstrating equivalence relies on comparing the new device's characteristics to those of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of available information:
- Device Type: Quality Control Material (Liquid Tri-Level Cardiac Control) for Troponin I, CK-MB, and Myoglobin.
- Regulatory Basis: Substantial equivalence to a legally marketed predicate device (Liquichek Cardiac Markers Control, K961828).
- Intended Use: Assayed quality control material in clinical laboratory quality assurance for accuracy and precision of cardiac marker procedures.
- Study described: No specific clinical or performance study with defined acceptance criteria and performance results is detailed within this summary. The entire 510(k) process is based on demonstrating the device's equivalence to a predicate, which implies that appropriate testing was performed to support this claim, but the details are not in this public summary.
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JUN - 8 1998
510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Cardiac Control May 5, 1998
Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125 Contact Person: John Cramer at (305) 637-6882, or by facsimile at (305) 637-6888.
| 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: | Manufacturer |
| Dade Behring |
1851 Delaware Parkway Miami, Florida 33125
Registration Number 1017272
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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 8 1998
Richard D. Bliss, Jr. . Vice President Quality Assurance and Regulatory Affairs Dade Behring 1851 Delaware Parkway Miami, Florida 33125
K981622 Re : Dade® TRU-Liquid Cardiac™ Control Regulatory Class: I Product Code: JJX Dated: May 5, 1998 Received: May 7, 1998
Dear Mr . Bliss:
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 Requlations, Title 21, Parts 800 to 895. ਉ 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 requlations.
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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 regulation (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.qov/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 quarrer control accession the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.
(PLEASE DO NOT WITE BELQW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use U (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number. 498/622
013
§ 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.