(114 days)
For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Anti-CCP CalCheck is a lyophilized product consisting of human antibodies to cyclic citrullinated peptide (CCP) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Once reconstituted, this solution is used to verify the calibration established by the Elecsys Anti-CCP reagent on the Elecsys and cobas e immunoassay analyzers.
The provided text describes the Elecsys Anti-CCP CalCheck, a lyophilized product used to verify the calibration of the Elecsys Anti-CCP reagent on Elecsys and cobas e immunoassay analyzers. This device is a control material used in an in-vitro diagnostic (IVD) context, not a diagnostic algorithm or AI-powered system that would typically have the kinds of acceptance criteria and study designs specified in your request (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance).
Therefore, a direct answer to your request regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies for an AI/algorithm-based device cannot be fully provided based on the given information. The document focuses on showing substantial equivalence of a calibration control product to a predicate device.
However, I can extract information relevant to the performance characteristics of this specific type of device, which are its "acceptance criteria" in its own context:
1. Table of Acceptance Criteria and Reported Device Performance
For an IVD control material like the Elecsys Anti-CCP CalCheck, the "acceptance criteria" are related to its stability and its ability to accurately reflect the concentration it's designed to verify. The document mentions "value assignment and stability" as the performance characteristics evaluated. While specific numerical acceptance criteria (e.g., "stability must be within X% for Y days") are not explicitly stated in the provided text, the reported device performance is that it was evaluated and found suitable.
| Characteristic | Acceptance Criteria (Implied for control materials) | Reported Device Performance |
|---|---|---|
| Value Assignment | Must accurately assign target values or allow for verification within specified assay precision/accuracy. | Evaluated (Details not provided in summary, but assumed satisfactory for 510(k) clearance). |
| Stability (Unopened) | Maintain specified concentration within acceptable limits until expiration date when stored at 2-8°C. | Unopened: Store at 2-8°C until expiration date. (Assumed to meet stability requirements for this period). |
| Stability (Reconstituted) | Maintain specified concentration within acceptable limits for a defined period when stored at 20-25°C. | Reconstituted: 20-25°C : 4 hrs. (Assumed to meet stability requirements for this period). |
| Homogeneity/Lyophilization Quality | Consistent performance across different vials and effective reconstitution. | Lyophilized product, reconstitution instructions provided (implies homogeneity and reconstitution quality were assessed). |
2. Sample Sizes and Data Provenance
This information is typically not applicable to the validation of a reagent or control material. These devices are validated through laboratory testing to ensure their physical and chemical properties, stability, and compatibility with the target assay. The concept of "test set" in the context of disease detection algorithms doesn't apply here.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Ground truth for a control material involves analytical measurements of its concentration and stability, not expert interpretation of clinical data.
4. Adjudication Method
Not applicable.
5. MRMC Comparative Effectiveness Study
Not applicable, as this is not an AI/algorithm for clinical decision support or image interpretation.
6. Standalone Performance
The "standalone performance" of a control material is its ability to meet its specifications (e.g., target concentration, stability). The document states the Elecsys Anti-CCP CalCheck "was evaluated for value assignment and stability." This implies standalone performance testing was conducted, and the results were satisfactory for market clearance. Specific details of these evaluations (e.g., the number of lots tested, the analytical methods used, the number of replicates) are not provided in this summary.
7. Type of Ground Truth Used
For a control material, the "ground truth" for its value assignment and stability is established through analytical measurements using highly accurate and precise reference methods or master assays, typically traceable to international standards if applicable. It's about chemical concentration and stability over time.
8. Sample Size for the Training Set
Not applicable. This device is not an algorithm that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary:
The provided document describes an in-vitro diagnostic control material, not an AI or algorithm-based device. Therefore, many of the requested categories (e.g., test/training set size, expert ground truth, MRMC studies) are not applicable. The "acceptance criteria" and "study" for this device relate to its analytical performance, such as value assignment and stability, which were evaluated by the manufacturer to demonstrate its suitability for its intended use as a calibration verification control.
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K091/601
SEP % 5 2009
510(k) Summary
2.1 1
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
Roche Diagnostics Submitter name, address, contact
9115 Hague Road Indianapolis, IN 46250
Contact Person: Sarah Baumann Phone: 317-521-3952 Fax: 317-521-2324 Email: sarah.baumann@roche.com
Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com
Date Prepared: June 1, 2009
Proprietary name: Elecsys Anti-CCP CalCheck Device Name
Common name: Anti-CCP CalCheck
Classification name: Single (specified) analyte controls (assayed and unassayed)
the currently marketed Elecsys C-Peptide CalCheck (K040157).
Predicate device
Device Description
The Elecsys Anti-CCP CalCheck is a lyophilized product consisting of human antibodies to cyclic citrullinated peptide (CCP) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Once reconstituted, this solution is used to verify the calibration established by the Elecsys Anti-CCP reagent on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Anti-CCP CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to
Continued on next page
Confidential
1
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510(k) Summary, Continued
少 : ****
Intended use For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The table below compares Elecsys Anti-CCP CalCheck with the predicate Comparison Table device, Elecsys C-Peptide Calcheck (K040157).
| Characteristic | Elecsys C- Peptide CalCheck(K040157) | Elecsys Anti-CCP CalCheck |
|---|---|---|
| Intended Use | For use in the verification of thecalibration established by theElecsys C-Peptide reagent on theElecsys and cobas e immunoassayanalyzers. | For use in the verification of thecalibration established by the ElecsysAnti-CCP reagent on the indicatedElecsys and cobas e immunoassayanalyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mLdistilled or deionized water andallow to stand closed for 15minutes, then mix gently byinversion. | Same |
| Stability | Unopened:Store at 2-8℃ until expirationdateReconstituted:20—25°C : 4 hrs | Same |
| Matrix | Equine serum | Human serum |
The Elecsys Anti-CCP CalCheck was evaluated for value assignment and Performance Characteristics stability.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The overall design is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics Corporation c/o Sarah Baumann 9115 Hague Road Box 50140 Indianapolis, IN 46250-0457
SEP % 5 2009
K091601 Re:
Trade/Device Name: Elecsys Anti-CCP CalCheck Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: September 8, 2009 Received: September 14, 2009
Dear Sarah 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 (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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
G. C. H
Courtney C. Harper, Ph.D. 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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Indication for Use
510(k) Number (if known):
Device Name: Elecsys Anti-CCP CalCheck
Indication For Use:
For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Ör
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Cawl Benson
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K09/601
§ 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.