(96 days)
The Elecsys CEA 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 CEA CalCheck quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
The Elecsys CEA CalCheck 5 is a lyophilized product consisting of human CEA in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text is related to the 510(k) premarket notification for the Elecsys CEA CalCheck 5, an in vitro diagnostic device. It does not describe a study involving a medical device that analyzes patient data to provide diagnostic insights (e.g., an AI-powered diagnostic tool). Instead, it describes a quality control material used to verify the calibration and assay range of other in vitro diagnostic instruments.
Therefore, many of the typical acceptance criteria and study aspects you've asked for, such as sample size for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device and are not present in the provided document.
However, I can extract the relevant information regarding the performance characteristics that were evaluated for this quality control material.
Here's the information that can be extracted from the provided text, modified to reflect the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic quality control material, the "performance" relates to its stability and its ability to have its values assigned accurately. The document mentions these as the key performance characteristics evaluated.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Value Assignment | Evaluated | While the specific numerical acceptance criteria for value assignment are not detailed, the product is an "assayed control," meaning its anticipated values are assigned during its development. The evaluation confirms this process. |
| Stability (Unopened) | Store at 2-8°C until expiration date | The device maintained its intended characteristics when stored at 2-8°C until its expiration date. |
| Stability (Reconstituted) | 20-25°C: 4 hours | The device maintained its intended characteristics for 4 hours after reconstitution when stored at 20-25°C. |
Important Note: This document is a 510(k) summary, which provides a high-level overview. Detailed performance data, including specific acceptance ranges for value assignment or the full stability study protocols, would typically be found in the manufacturer's internal documentation and the complete 510(k) submission, not necessarily in this public summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the context of analyzing patient data. For a quality control material, "testing" involves evaluating its matrix, analyte concentration, and stability over time under various conditions. The document does not specify the number of lots or vials tested for stability or value assignment.
- The data provenance is from Roche Diagnostics, located in Indianapolis, IN, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. "Ground truth" in this context refers to the assigned values of the control material. These values are established through rigorous internal testing and calibration processes by the manufacturer, typically involving highly controlled laboratory instruments and reference methods, not clinical expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of images or clinical data, which is not relevant for a quality control material.
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
- Not Applicable. This type of study is for evaluating the impact of AI on human diagnostic performance, which is not relevant for a quality control material.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. The device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" (or more appropriately, the assigned values) for the control material are established through calibration against established reference materials and methods using highly precise laboratory analytical instruments. The analyte (CEA) is spiked into a human serum matrix at desired concentration levels during manufacturing.
8. The sample size for the training set
- Not Applicable. This device is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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| OCT - 5 2010 | |
|---|---|
| 510(k) Summary | |
| 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 46250-0416317-521-3501 |
| Contact Person: Jason FisherPhone: 317-521-3501Fax: 317-521-2324Email: jason.fisher@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: June 30, 2010 | |
| Device Name | Proprietary name: Elecsys CEA CalCheck 5Common name: CEA CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys CEA CalCheck 5 is substantially equivalent to other products incommercial distribution intended for similar use. We claim equivalency to thecurrently marketed Elecsys C-Peptide CalCheck 5 (K100810) and the ElecsysCEA CalCheck (K970452). |
| DeviceDescription | The Elecsys CEA CalCheck 5 is a lyophilized product consisting of humanCEA in human serum matrix. During manufacture, the analyte is spiked intothe matrix at the desired concentration levels. |
| Intended use | The Elecsys CEA CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys CEA CalCheck quantitative assay reagent on the indicatedElecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only. |
Continued on next page
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510(k) Summary, Continued
Comparison Table The table below compares Elecsys CEA CalCheck 5 with the predicate devices, Elecsys C-Peptide CalCheck 5 (K100810) and the CEA CalCheck (K970452).
Please note that the use of two predicates has been utilized for this submission based on previous FDA feedback to several of the most recently FDA-cleared CalCheck 5 products. The first predicate shows that the CEA CalCheck 5 is substantially equivalent to another CalCheck 5 product. The Elecsys CEA CalCheck 5 is also substantially equivalent to the second predicate, CEA CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and a predicate device.
. *
| Characteristic | Elecsys C-PeptideCalCheck 5 (K100810) | Elecsys CEA CalCheck 5(Candidate Device) | Elecsys CEA CalCheck(K970452) |
|---|---|---|---|
| Intended Use | The Elecsys C-Peptide CalCheck5 is an assayed control for use incalibration verification and foruse in the verification of theserum and plasma assay rangeestablished by the ElecsysC-Peptide reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys CEA Calcheck 5 isan assayed control for use incalibration verification and foruse in the verification of theassay range established by theElecsys CEA reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | For use in the verification of thecalibration established by theElecsys CEA reagent on theindicated Elecsys and cobas eimmunoassay analyzers. |
| Analyte | C-Peptide | CEA | CEA |
| Levels | Five | Five | Three |
| Format | Lyophilized | Same | Same |
| Handling | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0 mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion. | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0 mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion. | Reconstitute Check 1, Check 2,and Check 3 with exactly 1.0 mLdistilled or deionized water.Allow to stand closed for 15minutes, then mix gently byinversion. |
| Stability | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 15-25°C: 4 hours |
| Matrix | Equine serum matrix | Human serum matrix | Human serum matrix |
Performance Characteristics
The Elecsys CEA CalCheck 5 was evaluated for value assignment and stability.
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Public Health Service
Image /page/2/Picture/2 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 wing and body. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Roche Diagnostics Roche Diagnostics Operations, Inc. c/o Mr. Jason D. Fisher Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN, 46250-0457
OCT 05 2010
Re: K101856
Trade/Device Name: Elecsys CEA CalCheck 5 Regulation Number: 21 CFR§862.1660 Regulation Name: Quality Control Material, Assayed and Unassayed Regulatory Class: Class I (Reserved) Product Code: JJX Dated: September 7, 2010 Received: September 8, 2010
Dear Mr. Fisher:
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 class II (Special Controls), 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
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Page 2 - Mr. Jason D. Fisher
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 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,
Maria M. Chan, Ph.D.
Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
KIDI856 OCT - 5 2010
510(k) Number (if known): K (Ol 856
Device Name: Elecsys CEA CalCheck 5
Indication For Use:
The Elecsys CEA 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 CEA CalCheck quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
Prescription Usc __ X (21 CFR Part 801 Subpart D) And/Or
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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 101856
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.