(12 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 market procedure, specifically Troponin-I, CK-MB and Myoglobin.
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 the Dade® TRU-Liquid™ Cardiac Control, which is a quality control material. The document largely focuses on claiming substantial equivalence to a previously cleared device (K981622) rather than presenting a detailed study with specific acceptance criteria and performance data for the current device.
Therefore, the requested information, specifically regarding detailed acceptance criteria and a study proving the device meets those criteria, is not present in the provided text. The document states that the device "is substantially equivalent in terms of intended use and safety and effectiveness to the current Dade® TRU-Liquid™ Cardiac Control manufactured by Dade Behring, previously cleared under Document Control No., K981622." This implies that the current device is considered acceptable because a previous version was, and thus no new, detailed acceptance criteria or performance study for this specific 510(k) submission are provided.
However, based on the content and common practices for quality control materials, we can infer some general aspects and state what is missing:
Inferred Information and Missing Details:
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Table of Acceptance Criteria and Reported Device Performance: This specific table is not provided in the document. For a quality control material, acceptance criteria would typically involve:
- Analyte Concentration Stability: The control material must maintain stable target concentrations for specific cardiac markers (Troponin-I, CK-MB, Myoglobin) over its shelf-life and in-use period.
- Assigned Value Accuracy: The measured values of the control material on various diagnostic platforms should fall within a predefined range around the assigned target values.
- Within-lot and Lot-to-lot Reproducibility/Precision: The control material should produce consistent results within a single lot and across different manufacturing lots.
- Matrix Compatibility: The control material's matrix should behave similarly to patient samples across different assay methods.
The document does not report specific performance values against such criteria for this 510(k) submission. It relies on the substantial equivalence to a previous device.
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Sample Size Used for the Test Set and Data Provenance: This information is not provided. If a new study were conducted, it would typically involve:
- Test Set Size: Likely a series of runs or measurements of the control material over time and across multiple instruments/reagents.
- Data Provenance: Not specified, but generally, for such controls, data would be laboratory-generated, possibly from multiple sites.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: This is not applicable in the traditional sense for a quality control material. The "ground truth" for a quality control material is its assigned target value, which is established through rigorous characterization methods by the manufacturer, often using reference methods or certified reference materials, and then verified through collaborative studies or extensive in-house testing. It does not typically involve expert consensus on individual "cases."
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Adjudication Method for the Test Set: Not applicable for this type of device.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for diagnostic imaging or interpretation devices where human readers are interpreting cases. A quality control material like this does not involve human readers in that capacity.
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Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Not applicable. This device is a physical reagent used to verify the performance of diagnostic instruments, not an algorithm.
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Type of Ground Truth Used: For a quality control material, the "ground truth" (or assigned value) is established through reference methods, certified reference materials, and/or extensive independent laboratory testing and statistical analysis. The document does not explicitly state how the ground truth for this version of the control was established, but it would align with these general principles for quality control materials.
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Sample Size for the Training Set: Not applicable. This is a quality control material, not an AI/ML algorithm that requires a training set.
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How the Ground Truth for the Training Set Was Established: Not applicable. (See point 8).
In summary, the provided 510(k) document is a declaration of substantial equivalence for a quality control material. It does not contain the detailed performance study data, acceptance criteria, or specifics about ground truth establishment that would be expected for a novel diagnostic device or AI/ML product. The basis for its clearance is its similarity to a previously approved device (K981622).
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AUG - 5 1998
Image /page/0/Picture/1 description: The image shows a handwritten string of characters that appear to be alphanumeric. The characters are written in a cursive style, making it difficult to discern the exact letters and numbers. The string appears to be "K982591".
510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Cardiac Control July 25, 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 Behring1851 Delaware ParkwayMiami, Florida 33125 |
Registration Number 1017272
The Dade® TRU-Liquid™ Cardiac Control with expanded indications is substantially equivalent in terms of intended use and safety and effectiveness to the current Dade® TRU-Liquid™ Cardiac Control manufactured by Dade Behring, previously cleared under Document Control No., K981622.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, and is often used as a symbol of medicine and healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 5 1998
Richard D. Bliss Vice President Quality Assurance and Regulatory Affairs Dade Behring 1851 Delaware Parkway Miami, Florida 33125
K982591 Re : Dade TRU-Liquid Cardiac Control Regulatory Class: I Product Code: JJX Dated: July 24, 1998 Received: July 24, 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, Druq, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 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.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 market procedure, specifically Troponin-I, CK-MB and Myoglobin.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K98259
OR
Over-The-Counter Use
1 Prescription Use (Per 21 CFR 801.109)
(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.