(23 days)
C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels.
The provided text is a 510(k) summary for a medical device called "C.f.a.s. (Calibrator for Automated Systems) HbA1c". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as often seen for diagnostic or therapeutic devices.
Therefore, many of the requested elements for a study proving device performance are not directly available in the provided text. The summary emphasizes the similarities and differences between the new calibrator and its predicate, asserting that these differences do not raise new questions of safety or effectiveness.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as it would be for a typical performance study. For a calibrator, "performance" is typically related to its stability, accuracy in providing a known concentration, and its ability to enable accurate measurements by the instrument it calibrates. The document asserts that the new device is substantially equivalent to a predicate calibrator.
| Characteristic | Predicate Calibrator (Performance/Reference) | C.f.a.s. HbA1c (Claimed Performance/Features) | Acceptance Criteria (Implied) |
|---|---|---|---|
| Intended Use | Calibration of quantitative Tina-Quant HbA1c method | Calibration of quantitative Roche methods on Roche clinical chemistry analyzers | To perform its intended calibration function effectively |
| Format | Lyophilized | Same | Maintain physical form and usability |
| Matrix & Composition | Hemolysate from human and sheep blood; 0.9% TTAB; stabilizers | Same | Maintain chemical stability and compatibility |
| Handling (Reconstitution) | 1.0 mL distilled or deionized water | 2.0 mL distilled or deionized water | Reconstitution leads to a stable and correct concentration |
| Levels | Four levels | Single level (diluted on-board to 6 levels) | Enable generation of accurate calibration curve when diluted |
| Stability (Unopened) | Up to expiration date | Same | Maintain integrity and performance until expiration |
| Stability (Reconstituted, 2-8°C) | 2 days | 2 days | Maintain integrity and performance for specified duration |
| Stability (Reconstituted, 20-25°C) | 8 hours | 8 hours (15-25°C) | Maintain integrity and performance for specified duration |
| Stability (Reconstituted, -20°C) | 3 months | 3 months (-15 to -25°C) | Maintain integrity and performance for specified duration |
The "acceptance criteria" for a calibrator like this would typically involve:
- Assigned value accuracy: The calibrator, once reconstituted, must have an accurate and stable assigned value for HbA1c.
- Stability: Meeting the stated stability claims (unopened, reconstituted at different temperatures and durations).
- Method compatibility: Successfully calibrating Roche clinical chemistry analyzers for Roche HbA1c methods, leading to accurate patient sample results.
The document implies these criteria are met by stating substantial equivalence to a predicate device with identical core characteristics. No quantitative performance metrics are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. As a 510(k) summary for a calibrator, it focuses on the device's characteristics and its equivalence to a predicate, not on a clinical trial with a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable/not provided. The device is a calibrator, not a diagnostic tool that interprets patient data. Therefore, there's no "ground truth" for a test set of patient cases established by experts in this context. The "ground truth" for a calibrator would be its accurately assigned HbA1c concentration.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. There is no "test set" of patient data that would require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable/not provided. This type of study is relevant for diagnostic imaging or interpretation devices where human performance is being evaluated, and is not relevant for a calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable/not provided. The device is a calibrator, not an algorithm.
7. The Type of Ground Truth Used
For a calibrator, the "ground truth" would be the assigned value of the analytes (HbA1c in this case) at each level of the calibrator. This value is established through highly accurate reference methods and/or traceability to international reference materials. The document implies this "ground truth" is reliably established, making the calibrator suitable for its intended purpose.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This concept applies to machine learning algorithms, not to a medical calibrator.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided.
In summary: The provided 510(k) summary for the C.f.a.s. HbA1c calibrator is a submission focused on demonstrating substantial equivalence to a predicate device. It highlights the physical, chemical, and functional similarities, and explains the differences (such as handling, levels, and stability conditions) without presenting specific, quantitative performance study data or details on "acceptance criteria" as they might apply to a diagnostic or therapeutic device. The "study" here is the comparison to the predicate device, asserting that the new device performs equivalently for its intended use as a calibrator.
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510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3723 |
| Contact person: Theresa M. Ambrose | |
| Date prepared: August 2, 2005 | |
| Device name | Proprietary name: C.f.a.s. (Calibrator for Automated Systems) HbA1c |
| Common name: calibrator for Hemoglobin measurements | |
| Classification name: Calibrator for hemoglobin or hematocrit measurement | |
| Device description | C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels. |
| Intended use | C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. |
| Predicate device | We claim substantial equivalence to the calibrator included in the Tina-Quant HbA1c reagent kit, originally cleared under K934070. |
| C.f.a.s. HbA1c is identical to this calibrator; however, it is now being provided at a single-level and sold as a separate product. |
Continued on next page
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510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c, Continued
The table below indicates the similarities between the modified C.f.a.s. Substantial (Calibrator for Automated Systems) HbA1c and its predicate device equivalency -(calibrator in Tina-Quant HbA1c test system, K934070). similiarities
| Characteristic | Predicate calibrator | C.f.a.s. HbA1c |
|---|---|---|
| Intended Use | Calibrator included in kitfor calibration of thequantitative Tina-QuantHbA1c method. | C.f.a.s. (Calibrator forautomated systems) HbA1c isfor use in the calibration ofquantitative Roche methodson Roche clinical chemistryanalyzers as specified in theenclosed value sheet. |
| Format | Lyophilized | Same |
| Matrix and composition | Hemolysate derived fromhuman and sheep blood;0.9% TTAB(tetradecyltrimethylammonium bromide);stabilizers | Same |
Continued on next page
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510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) HbA1c, Continued
The table below indicates the differences between the modified C.f.a.s. Substantial (Calibrator for Automated Systems) HbA1c and its predicate device equivalency -(calibrator in Tina-Quant HbA1c test system, K934070). differences
| Characteristic | Predicate calibrator | C.f.a.s. HbA1c |
|---|---|---|
| Handling | Reconstitute with 1.0 mL distilled or deionized water. | Reconstitute with 2.0 mL distilled or deionized water. |
| Levels | Four levels | Single level |
| Stability | Unopened: stable up to the expiration date | Unopened: same |
| Reconstituted:2 days @ 2-8 °C8 hours @ 20-25 °C3 months @ -20 °C | Reconstituted:2 days @ 2-8 °C8 hours @ 15-25 °C3 months @ (-15) to (-25) °C |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
AUG 26 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose. Ph.D., RAC Regulatory Principal Roche Diagnostics Centralized Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K052101
Trade/Device Name: C.f.a.s. (Calibrator for Automated Systems) HbA1c Regulation Number: 21 CFR 864.8165 Regulation Name: Calibrator for hemoglobin or hematocrit measurement Regulatory Class: Class II Product Code: KRZ Dated: August 2, 2005 Received: August 3, 2005
Dear Ms. Ambrose:
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. Iisting 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
KOS201
Device Name: C.f.a.s. (Calibrator for Automated Systems) HbA1c
Indications For Use:
C.f.a.s. (Calibrator for automated systems) HbA Ic is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
210(K)
Confidential
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a)
Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.(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 § 864.9.