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The Cardiac Troponin-I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.
This document is a 510(k) premarket notification for a medical device called the "Cardiac Troponin-I (TROP) Calibrator." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present "acceptance criteria" in the traditional sense of performance metrics for an AI/device, nor does it report "device performance" in terms of accuracy, sensitivity, or specificity. Instead, the focus is on demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" here are implicitly linked to the characteristics of the predicate device, the Stratus® Cardiac Troponin-I Calibrators, which the new device aims to match or be comparable to. The reported "device performance" is a comparison of features and intended use.
| Feature / Criterion | Dimension® RxL TROP Calibrator (New Device) | Stratus® Cardiac Troponin-I Calibrators (Predicate Device) | Statement of Equivalence |
|---|---|---|---|
| Intended Use | Calibrator | Calibrator | Substantially Equivalent |
| Analyte | cardiac troponin-l | cardiac troponin-l | Substantially Equivalent |
| Matrix | buffered bovine protein | buffered bovine protein | Substantially Equivalent |
| Form | frozen | frozen | Substantially Equivalent |
| Volume | 2.0 mL per vial | 2.0 mL per vial | Substantially Equivalent |
| Values | Assigned | Nominal | Substantially Equivalent (difference noted but deemed not to affect equivalence) |
| Levels | 5 levels | 6 levels | Substantially Equivalent (difference noted but deemed not to affect equivalence) |
2. Sample size used for the test set and the data provenance:
This type of information (sample size, data provenance from specific countries, retrospective/prospective studies) is not applicable to this document. This is a 510(k) submission for a calibrator, which is a reference material used to ensure the accuracy of a diagnostic test. It's not a diagnostic device itself that processes patient data or images. The "test set" in this context would refer to internal validation tests performed by the manufacturer, but details of such tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a calibrator, not a diagnostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" for a calibrator is its assigned value, which is determined through a rigorous manufacturing and quality control process using established analytical methods, not by expert medical consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in studies involving expert review of diagnostic interpretations, which is not relevant for a calibrator.
5. 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:
This information is not applicable. This document describes a calibrator, not an AI-powered diagnostic device. Therefore, no MRMC study or assessment of AI assistance to human readers would be performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This device is a biochemical calibrator, not an algorithm, so the concept of standalone algorithmic performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Cardiac Troponin-I (TROP) Calibrator is its assigned concentration value of cardiac troponin-I. This is established through the manufacturer's internal quality control processes, which would involve precise analytical measurements using reference methods and traceable standards. It is a chemical/analytical ground truth, not a medical or expert-based truth like pathology or outcomes data.
8. The sample size for the training set:
This information is not applicable. This device is a calibrator, not a machine learning model, so there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as #8.
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Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally.
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Chemistry Systems P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Rebecca S. AyashDade International Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101Phone: (302) 451-0276FAX: (302) 451-0299 |
|---|---|
| Date of Preparation: | 9/24/97 |
| Device Name: | Cardiac Troponin-I (TROP) Calibrator |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | Stratus® Cardiac Troponin-I Calibrators |
Device Description: The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.
Intended Use: The TROP Calibrator is intended to be used to calibrate the TROP Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Comparison to Predicate Device:
| Dimension® RxL TROP Calibrator | Stratus® Cardiac Troponin-I Calibrators | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | cardiac troponin-l | cardiac troponin-l |
| Matrix | buffered bovine protein | buffered bovine protein |
| Form | frozen | frozen |
| Volume | 2.0 mL per vial | 2.0 mL per vial |
| Values | Assigned | Nominal |
| Levels | 5 levels | 6 levels |
Comments on Substantial Equivalence: Both the TROP Calibrator for the Dimension® RxL system and the Stratus® Cardiac Troponin-I Calibrators are manufactured using the same matrix and contain cardiac troponin-1 as the analyte source. Both products are intended to be used as calibrators for cardiac troponin-l assays.
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Conclusion: The TROP Calibrator for the Dimension® RxL system is substantially equivalent to the Stratus ® Cardiac Troponin-I Calibrators based on the comparison summarized on the previous page.
Rebecca S. Aycock
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 9/24/97
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 20 1997
Rebecca S. Ayash . Regulatory Affairs and Compliance Manger Dade International, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
K973668 Re : Cardiac Troponin-I (TROP) Calibrator Requlatory Class: II Product Code: JIT September 24, 1997 Dated: Received: September 25, 1997
Dear Ms. Ayash:
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, qood 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 regulations 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 Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Reqister. 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 Gutman
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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Indications Statement
Device Name: Cardiac Troponin-I (TROP) Calibrator
Indications for Use: The Cardiac Troponin-I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Rebecca S. Ayersh
Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 9/24/97
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Concurrence of CDRH, Office of Device Evaluation (ODE)
K 973668
510(k) Number
Division Sign-Off
Office of Device Evaluation
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prescription use
(per 21 CFR 801.19) -
OVER-THE-COUNTER USE
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.