(49 days)
The MAS® Cardiolmmune® TL / DADE® Cardiac TL, Low Level, is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include MAS® Cardiolmmune® TL / DADE® Cardiac TL, Low Level, with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
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The provided text is a 510(k) clearance letter for a Class I medical device, MAS® CardioImmune® TL/Dade® Cardiac TL, Low Level, which is a quality control material.
Based on the typical regulatory requirements for Class I devices and the content of this specific letter, the document does not contain information on acceptance criteria, a study proving device performance against such criteria, or the detailed study design elements you've requested (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details).
Here’s why and what can be inferred:
- Class I Device: Quality control materials like this are classified as Class I devices. For Class I devices, the primary regulatory pathway is demonstrating substantial equivalence to a predicate device. This typically relies on showing that the new device has the same intended use, technological characteristics, and performance as a legally marketed predicate, without raising new questions of safety or effectiveness. Extensive clinical studies or performance studies with detailed acceptance criteria and statistical analysis as would be seen for higher-risk devices (e.g., diagnostic imaging AI) are generally not required for 510(k) clearance of Class I devices.
- 510(k) Clearance, Not a Study Report: This document is the FDA's clearance letter, not the submission itself or a study report. It acknowledges the review and determination of substantial equivalence. The actual data and studies (if any beyond basic verification/validation) would be in the 510(k) submission, which is not provided here.
- Nature of the Device: As a quality control material, its "performance" is primarily about its stability, homogeneity, and accurately assaying for known concentrations of cardiac markers. This involves internal verification and validation by the manufacturer rather than large-scale clinical trials against patient outcomes or expert consensus.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
However, I can make some educated inferences based on the device type and regulatory context:
Inferences/Assumptions about Acceptance Criteria (Typical for such a device):
Since this is a quality control material, acceptance criteria would likely relate to:
- Traceability: The assigned values for the cardiac markers in the control material should be traceable to recognized reference materials or methods.
- Stability: The control material should maintain its assigned values within specified tolerances over its shelf life and under recommended storage conditions.
- Homogeneity: Different aliquots of the control material should yield consistent results, indicating uniform distribution of analytes.
- Assigned Value Accuracy/Precision: When tested on specified assay systems, the control material should yield results within a defined range around its assigned values. This range is often set by the manufacturer based on method variability and clinical utility.
Placeholder Table (Based on typical expectations for this type of device, NOT from the provided text):
| Acceptance Criteria Category | Specific Criterion (Example) | Reported Device Performance (Example) |
|---|---|---|
| Assigned Value Accuracy | Mean recovery of cardiac markers within ±[X]% of the assigned value. | When tested across various systems, observed values were consistently within ±[Y]% of the assigned values, meeting manufacturer specifications. |
| Between-Vial Homogeneity | Coefficient of Variation (CV) ≤ [Z]% between vials. | Mean CV across multiple vials was [A]%, demonstrating adequate homogeneity for clinical use. |
| Analyte Stability (Shelf-Life) | Maintained assigned values within ±[X]% over 24 months. | All analytes demonstrated stability within acceptance limits for the claimed shelf-life of 24 months under recommended storage. |
| Analyte Stability (Open-Vial) | Maintained assigned values within ±[X]% for 7 days refrigerated. | After opening, analytes remained stable for 7 days when stored at 2-8°C, meeting user handling requirements. |
| Lot-to-Lot Consistency | New lot values within ±[X]% of previous lot values. | Demonstrated consistent performance across multiple manufacturing lots, with new lots falling within established tolerance limits of previous lots. |
Answers to Specific Questions (Based on available info and inferences):
- A table of acceptance criteria and the reported device performance: As stated above, this information is not present in the provided 510(k) clearance letter. A generic example table based on typical QC material validation is provided above.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document. For QC materials, "test sets" would relate to internal validation studies for stability, homogeneity, and value assignment, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/Not provided. Ground truth for QC materials refers to the assigned values of the analytes, which are established through certified reference methods, often in highly controlled laboratory settings, not by expert medical diagnosticians.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided. Adjudication is relevant for diagnostic interpretations, not for quantitative measurements in a quality control material.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a quality control material, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical reagent, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a quality control material, the "ground truth" for its assigned values would typically be traceability to internationally recognized reference materials and/or methods, often employing highly precise and accurate analytical techniques (e.g., isotope dilution mass spectrometry, or comparison to certified reference materials).
- The sample size for the training set: Not applicable/Not provided. There is no "training set" in the context of a quality control material.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval letter for a Class I device and does not contain the detailed study information typically associated with performance claims for more complex diagnostic devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
098 Gaither Road Rockville MD 20850
DFC 1 9 2002
Ms. Penny M. Layman Manager, Regulatory Affairs Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, CA 93012
Re: K023669 ·
Trade/Device Name: MAS® CardioImmune® TL/Dade® Cardiac TL, Low Level Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 30, 2002 Received: October 31, 2002
Dear Ms Layman:
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 (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).
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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 (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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INDICATIONS FOR USE FORM
510(k) Number (if known): k 023667
Device Name:
MAS® CardioImmune® TL Low Level Liquid Assayed Cardiac Marker Control
DADE® Cardiac TL Low Level Liquid Assayed Cardiac Marker Control
Indications for Use:
The MAS® Cardiolmmune® TL / DADE® Cardiac TL, Low Level, is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include MAS® Cardiolmmune® TL / DADE® Cardiac TL, Low Level, with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Juan Cropp
ivision Sign-Off Laboratory Devices o. Clinical 510(k) Number
(Optional Format 3-10-98)
x Prescription Use
§ 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.