(15 days)
Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
The Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
1. Acceptance Criteria and Reported Device Performance:
This document is a 510(k) summary for a calibrator device, not a diagnostic or screening device that would have performance metrics like sensitivity, specificity, or accuracy compared to a ground truth diagnosis. Therefore, there are no acceptance criteria in terms of clinical performance metrics like those typically seen for AI-enabled diagnostic tools.
Instead, the "acceptance criteria" for a calibrator device like the Calibrator for Automated Systems (C.f.a.s.) would revolve around its ability to function effectively as a calibrator for Roche clinical chemistry analyzers. This means demonstrating:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. This implies that the new device is as safe and effective as the predicate.
- Accuracy and Precision in Calibration: While not explicitly detailed as "acceptance criteria" within this summary, the underlying studies performed to support substantial equivalence would have involved assessing the calibrator's ability to produce accurate and precise calibration curves and subsequent accurate analyte measurements when used with the specified Roche methods and analyzers. This would typically involve comparing the results obtained using the new calibrator to those obtained using the predicate calibrator, or to established reference materials.
- Stability: Ensuring the calibrator maintains its established values over its shelf-life.
- Traceability: Ensuring the calibrator's values are traceable to higher-order reference materials, if applicable.
Reported Device Performance:
The document explicitly states: "We claim substantial equivalence to the currently marketed Calibrator for Predicate Device Automated Systems (C.f.a.s.) (K990460)." This is the primary reported "performance" from a regulatory standpoint. The FDA's letter (Page 2) confirms: "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...".
Therefore, a table of acceptance criteria and performance as typically requested for AI devices is not applicable here. The implicit "acceptance criterion" is successful demonstration of substantial equivalence, and the "performance" is that this was achieved.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the given 510(k) summary. For a calibrator, the "test set" would likely refer to the number of assays, instruments, and calibrator lots evaluated as part of the validation studies to demonstrate substantial equivalence. The document does not specify these details or the provenance of any data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This concept is not applicable to a calibrator device. Calibrators are used to establish a known relationship between an instrument's signal and an analyte concentration. "Ground truth" for a calibrator's values typically comes from:
- Reference Methods/Materials: Assaying the calibrator against highly accurate reference methods or certified reference materials with established values.
- Gravimetric/Volumetric Preparation: In some cases, values might be assigned based on the precise preparation of the calibrator components.
Experts are not involved in "establishing ground truth" in the way they would for medical image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set:
This concept is not applicable to a calibrator device. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing a clinical ground truth, particularly in diagnostic studies. For a calibrator, the "ground truth" for its values is determined by analytical methods, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the function of a calibrator.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable in the typical sense of AI algorithms. A calibrator is a physical reagent used in conjunction with an automated instrument. Its "performance" is inherent to its formulation and stability, and its effect is observed when the instrument uses it to generate a calibration curve. There isn't a standalone "algorithm" in the way AI devices have one. The "algorithm" here is the instrument's software interpreting the calibrator's signal to establish the calibration curve. The testing would focus on the accuracy of this curve when using the c.f.a.s.
7. The Type of Ground Truth Used:
For a calibrator, the "ground truth" for its assigned values would typically be:
- Reference Method Values: The concentrations of the analytes in the calibrator are determined using highly accurate and precise reference methods.
- Traceable Standards: The values are often traceable to international or national certified reference materials.
The given document does not explicitly state how the ground truth values for the C.f.a.s. calibrator were established, but these are the standard methods for such devices.
8. The Sample Size for the Training Set:
This concept is not applicable to a calibrator device. Calibrators are reagents, not machine learning models that require a "training set" in the computational sense. The "training" for a calibrator happens in its manufacturing and characterization to ensure its specified values are accurate and stable.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable for the same reasons as point 8.
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NOV 2 0 2003
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510(k) Summary - Calibrator for Automated Systems (C.f.a.s.)
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Sherri L. CoenenDate prepared: November 3, 2003 |
| Device Name | Proprietary name: Calibrator for Automated Systems (C.f.a.s.)Common name: Calibrator for Automated Systems (C.f.a.s.)Classification name: Calibrator, Multi-analyte mixture |
| Devicedescription | The Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serumcalibrator with chemical additives and materials of biological origin. Theconcentration of the calibrator components have been adjusted to ensureoptimal calibration of the appropriate Roche methods on clinical chemistryanalyzers. |
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510(k) Summary - Calibrator for Automated Systems
(C.f.a.S.), continued
Intended use Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. の 2006年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 We claim substantial equivalence to the currently marketed Calibrator for Predicate Device Automated Systems (C.f.a.s.)(K990460).
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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 stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 2003
Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K033501
Trade/Device Name: Calibrator for Automated Systems (C.f.a.s.) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 3, 2003 Received: November 5, 2003
Dear Ms. Coenen:
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). You may obtain other general information on your responsibilities under the Act 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 Butman
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 Statement
510(k) Number (if known): N/A
Device Name: Calibrator for Automated Systems (C.f.a.s.)
Indications For Use:
Calibrator for automated systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Alberto Cuté
Division Sign-Off for Team Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033501
§ 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.