(88 days)
The Elecsys Rubella IgG CalCheck is an assayed calibrator control intended for use in the verification of the calibration established by the Elecsys Rubella IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.
The Elecsys Rubella IgG CalCheck is a lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's an analysis of the provided 510(k) summary for the Elecsys Rubella IgG CalCheck, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a calibrator control, not a diagnostic device. As such, the typical "performance criteria" for diagnostic devices (sensitivity, specificity, accuracy) and associated studies (MRMC, standalone) are not applicable or detailed in the same way. This summary focuses on verifying calibration and stability, which are the relevant performance characteristics for a calibrator.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys Rubella IgG CalCheck revolve around its ability to perform as an assayed calibrator control for the Elecsys Rubella IgG reagent. The key performance characteristics evaluated are value assignment and stability. While specific numerical acceptance criteria (e.g., ±X% deviation from target value) are not explicitly stated in this summary, they would have been defined internally by Roche Diagnostics and submitted as part of the full 510(k) application.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Value Assignment | The Elecsys Rubella IgG CalCheck was evaluated for value assignment. (Specific values and their deviation from target are not provided in this summary but would have been part of the full submission). |
| Stability | The Elecsys Rubella IgG CalCheck was evaluated for stability. (Specific stability data and duration are not provided in this summary but would have been part of the full submission). |
Study That Proves the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is implied by the statement: "The Elecsys Rubella IgG CalCheck was evaluated for value assignment and stability." This indicates internal testing performed by Roche Diagnostics.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in this summary. For a calibrator, the sample size typically refers to the number of lots or batches tested and the number of replicates for each test.
- Data Provenance: Not specified in this summary. Given it's a calibrator manufactured by Roche Diagnostics, the testing would likely be performed in their R&D and manufacturing facilities, presumably in the US or Europe. The study would be prospective, as it involves testing newly manufactured calibrators.
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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 in the context of a calibrator control. "Ground truth" for a calibrator is established by precise manufacturing, characterization, and assignment of target values based on established reference methods and robust statistical analysis within a quality control framework, not by expert consensus on clinical findings.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used for interpreting clinical data, often in cases of diagnostic disagreement. For a calibrator, the 'truth' is defined by the manufacturing process and metrological traceability.
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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 device is a calibrator control, not an AI-powered diagnostic device, nor does it involve human readers interpreting images or data for diagnostic purposes.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "performance" of a calibrator is its ability to consistently provide expected values when measured on the intended immunoassay analyzers.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a calibrator, the "ground truth" for value assignment is the assigned target concentration/value of the analyte (Rubella IgG antibodies) within the calibrator material. This is established through a rigorous process of:
- Traceability: Often traceability to international reference standards or highly characterized internal reference materials.
- Multi-site/Multi-instrument testing: Measuring the calibrator on multiple instruments and sites using the Elecsys Rubella IgG reagent to ensure consistency and assign robust mean values.
- Statistical analysis: Using statistical methods to determine the mean and acceptable ranges for the assigned values.
- For a calibrator, the "ground truth" for value assignment is the assigned target concentration/value of the analyte (Rubella IgG antibodies) within the calibrator material. This is established through a rigorous process of:
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The sample size for the training set:
- Not applicable. This device is a calibrator, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a calibrator control.
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510(k) Summary
MAY - 5 2009
| Introduction | According to the requirements of 21 CFR 807.92, the followinginformation provides details to understand the basis for adetermination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3208Contact Person: Kelly FrenchDate Prepared: February 2, 2009 |
| Device Name | Proprietary name: Elecsys Rubella IgG CalCheckCommon name: Rubella IgG CalCheckClassification name: Single (specified) analyte controls (assayed andunassayed) |
| Device Description | The Elecsys Rubella IgG CalCheck is a lyophilized productconsisting of human anti-Rubella IgG antibodies in human serummatrix. During manufacture, the analyte is spiked into the matrix atthe desired concentration levels. |
| Intended use | The Elecsys Rubella IgG CalCheck is an assayed calibrator controlintended for use in the verification of the calibration established bythe Elecsys Rubella IgG reagent on the Elecsys 2010, theMODULAR ANALYTICS E170, and cobas e immunoassayanalyzers. |
| Comparison Table | The table below compares Elecsys Rubella IgG CalCheck with thepredicate device, Elecsys C-Peptide Calcheck (K040157). |
| Characteristic | Elecsys C-Peptide CalCheck(K040157) | Elecsys Rubella IgGCalCheck |
|---|---|---|
| Intended Use | For use in the verification of the | For use in the verification ofthe calibration established |
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| Characteristic | Elecsys C-Peptide CalCheck(K040157) | Elecsys Rubella IgGCalCheck |
|---|---|---|
| calibration established by the ElecsysC-Peptide reagent on the Elecsys andcobas e immunoassay analyzers. | by the Elecsys Rubella IgGreagent on the Elecsys2010, the MODULARANALYTICS E170, andcobas e immunoassayanalyzers. | |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mLdistilled or deionized water and allowstanding closed for 15 minutes, thenmix gently. | Same |
| Stability | Unopened:Store at 2-8°C until expiration dateReconstituted:20 - 25°C: 4 hrs | Same |
| Matrix | Equine serum matrix | Human Serum |
Performance Characteristics
.
:
The Elecsys Rubella IgG CalCheck was evaluated for value assignment and stability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming three distinct, curved shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kelly French Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Haguc Road PO Box 50416 Indianapolis, IN, 46250-3831
| : | K090311 |
|---|---|
| Trade/Device Name: | Elecsys Rubella IgG CalCheck |
| Regulation Number: | 21CFR §866.166021CFR §866.3510 |
| Regulation Name: | Quality control material (assayed and unassayed)Rubella virus serological reagents |
| Regulatory Class: | Class I reserved (quality control)Class II (Rubella IgG) |
| Product Code: | JJXLFX |
| Dated: | February 5, 2009 |
| Received: | February 6, 2009 |
MAY - 5 2009
Dear Ms. French:
Re:
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
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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 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 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attgins
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices 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): K090311
Device Name:
Elecsys Rubella İgG CalCheck
Indication For Use:
The Elecsys Rubella IgG CalCheck is an assayed calibrator control intended for use in the verification of the calibration established by the Elecsys Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
Prescription Use _ 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)
Uwe Schef
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
2090311 510(k)
§ 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.