(32 days)
The Elecsys Ferritin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys® Ferritin CalCheck 5 is a liquid product consisting of ferritin from human liver in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's an analysis of the provided text regarding the Elecsys Ferritin CalCheck 5, focusing on acceptance criteria and supporting studies:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria and proving the device meets them with a standalone study. The primary intent is to show that the new device (Elecsys Ferritin CalCheck 5) is as safe and effective as the previously cleared device (Elecsys Ferritin CalCheck).
Therefore, some of the requested information, such as detailed acceptance criteria for specific performance metrics (e.g., accuracy, precision), sample sizes for test sets, expert qualifications for ground truth, MRMC studies, or training set details, are not explicitly stated or are not applicable in the context of this 510(k) submission style.
However, I can extract the information that is present and explain why other details are missing based on the document's content.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for a quality control material and not a new diagnostic assay, the "acceptance criteria" are implied by the comparison to the predicate device, particularly regarding its intended use, composition, and general performance (value assignment and stability). Specific quantitative acceptance criteria for performance are not explicitly listed in the submission document as they would be for a diagnostic test.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to K981281) | Reported Device Performance (Elecsys Ferritin CalCheck 5) |
|---|---|---|
| Analyte | Ferritin (human liver) | Ferritin (human liver) |
| Format | Liquid | Liquid |
| Handling | Mix gently by inversion to ensure homogeneity. | Mix gently by inversion to ensure homogeneity. |
| Matrix | Human serum matrix | Human serum matrix |
| Intended Use | For use in verification related to Elecsys Ferritin reagent on specified immunoassay analyzers. | Broader indicated use: calibration verification and assay range verification on indicated Elecsys and cobas e immunoassay analyzers. (This is a difference, but deemed substantially equivalent). |
| Levels | Equivalent to previous levels of control. | Five levels (vs. three for predicate). (This is a difference, but deemed substantially equivalent). |
| Stability (Unopened) | Store at 2-8°C until expiration date. | Store at 2-8°C until expiration date. |
| Stability (Opened) | Stable for a specified duration at 20-25°C. | 20-25°C: 4 hours (vs. 5 hours for predicate). (This is a difference, but deemed substantially equivalent). |
| Overall Performance | Performance (value assignment and stability) should be comparable to predicate. | "The Elecsys Ferritin CalCheck 5 was evaluated for value assignment and stability." "The data demonstrate that the performance of the Elecsys Ferritin CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys Ferritin CalCheck (K981281)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions the Elecsys Ferritin CalCheck 5 "was evaluated for value assignment and stability," but does not provide details on the number of samples, replicates, or lots tested.
- Data Provenance: Not specified. Standard practice for a control material would typically involve laboratory testing. The country of origin of the data is not mentioned, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For a quality control material, "ground truth" often refers to the assigned concentration of the analyte (ferritin) within the control. This is typically established through a value assignment process using calibrated reference methods and internal standards, not by human expert consensus or a "test set" in the diagnostic study sense.
4. Adjudication Method for the Test Set
- Not Applicable. As explained above, there's no "test set" in the diagnostic study sense requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for imaging or interpretative diagnostic devices where human readers evaluate cases. This document describes a quality control material for an immunoassay, so an MRMC study is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively. The performance evaluation of a quality control material is inherently "standalone" in the sense that the material's characteristics (value assignment, stability) are assayed independently. There is no "human-in-the-loop" component in the direct performance assessment of the control material itself; it's an analytical performance evaluation.
7. The Type of Ground Truth Used
- Assigned Value/Reference Method. For quality control materials, the "ground truth" is typically the assigned value of the analyte (ferritin in this case) within the control material, established through a rigorous value assignment process using reference methods and calibrated instruments. The document only states the material "was evaluated for value assignment," implying this process was performed.
8. The Sample Size for the Training Set
- Not Applicable. This is a quality control material, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of Study Demonstrating Substantial Equivalence:
The study demonstrating that the Elecsys Ferritin CalCheck 5 meets "acceptance criteria" (defined by substantial equivalence to the predicate) is an internal performance evaluation focusing on value assignment and stability.
- The device was compared to the predicate device, Elecsys Ferritin CalCheck (K981281).
- The primary method of demonstrating equivalence was through a comparison of characteristics (analyte, format, handling, matrix, intended use, levels, stability) and a general statement that its performance (value assignment and stability) was "substantially equivalent."
- The document implies that laboratory studies were conducted to confirm the value assignment and stability of the new CalCheck 5, and the results of these studies were favorably compared to the expected performance of the predicate device, despite some minor differences (e.g., number of levels, opened stability duration, expanded analyzer use).
In essence, the "study" is a collection of internal analytical verification and validation activities designed to demonstrate that the new control performs comparably to the legally marketed predicate device, thereby supporting the claim of substantial equivalence. Specific quantitative data from these studies are not disclosed in this summary document.
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Roche Diagnostics
K102267 Elecsys® Ferritin CalCheck 5
510(k) Summary
SEP 1_0 2010
| 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 Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3501Contact Person: Sarah BaumannPhone: 317-521-3952Fax: 317-521-2324Email: sarah.baumann@roche.comSecondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.comDate Prepared: August 6, 2010 |
| Device name | Proprietary name: Elecsys® Ferritin CalCheck 5Common name: Ferritin CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys Ferritin CalCheck 5 is substantially equivalent to other productsin commercial distribution intended for similar use. We claim equivalency tothe currently marketed Elecsys Ferritin CalCheck (K981281). |
| Devicedescription | The Elecsys Ferritin CalCheck 5 is a liquid product consisting of ferritin fromhuman liver in a human serum matrix. During manufacture, the analyte isspiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Ferritin CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys Ferritin reagent on the indicated Elecsys and cobas eimmunoassay analyzers. |
| Continued on next page |
.
Confidential
Page 1 of 3
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510(k) Summary, Continued
Table 1 below presents the similarities between Elecsys Ferritin CalCheck 5 Device and the predicate device, Elecsys Ferritin CalCheck (K981281). comparisonsimilarities
| Table 1. Device Comparison-Similarities between Candidate and Predicate Devices | |||
|---|---|---|---|
| Characteristic | Elecsys Ferritin CalCheck 5(Candidate Device) | Elecsys Ferritin CalCheck(K981281) |
|---|---|---|
| Analyte | Ferritin (human liver) | Same |
| Format | Liquid | Same |
| Handling | Mix gently by inversion to ensurehomogeneity. | Same |
| Matrix | Human serum matrix | Same |
| Device | Table 2 below presents the differences between Elecsys Ferritin CalCheck 5 |
|---|---|
| comparison-differences | and the predicate device, Elecsys Ferritin CalCheck (K981281). |
| Table 2. Device Comparison-Differences between Candidate and Predicate Devices | ||
|---|---|---|
| -------------------------------------------------------------------------------- | -- | -- |
| Characteristic | Elecsys Ferritin CalCheck 5(Candidate Device) | Elecsys Ferritin CalCheck(K981281) |
|---|---|---|
| Intended Use | The Elecsys Ferritin Calcheck 5is an assayed control for use incalibration verification and foruse in the verification of theassay range established by theElecsys Ferritin reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | For use in the verification of thecalibration established by theElecsys Ferritin reagent onElecsys 1010 or 2010immunoassay analyzers. |
| Levels | Five | Three |
| Stability | Unopened:• Store at 2-8°C until expirationdate | Unopened:• Store at 2-8°C until expirationdate |
| Opened:• 20-25°C: 4 hours | Opened:• 20-25°C: 5 hours |
Continued on next page
Confidential
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:
・
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510(k) Summary, Continued
| Performancecharacteristics | The Elecsys Ferritin CalCheck 5 was evaluated for value assignment andstability. |
|---|---|
| Conclusion | The data demonstrate that the performance of the Elecsys Ferritin CalCheck 5is substantially equivalent to that of the predicate device, Elecsys FerritinCalCheck (K981281). |
Confidential
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Roche Diagnostics c/o Sarah Baumann 9115 Hague Road Indianapolis, IN 46250
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
SEP 1 0 2010
Re: K102267
Trade Name: Elecsys Ferritin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX Dated: August 6, 2010 Received: August 9, 2010
Dear Ms. Baumann:
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 (sec above) into cither 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. 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 Form
510(k) Number (if known): _ K / 022267
SEP 1 0 2010
Device Name: Elecsys Ferritin CalCheck 5
Indications for Use: The Elecsys Ferritin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102267
Page 1 of 1
§ 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.