(67 days)
The Elecsys Rubella IgG 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 Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
The Elecsys Rubella IgG CalCheck 5 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 text regarding the acceptance criteria and study for the Elecsys Rubella IgG CalCheck 5, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary only states that the device was "evaluated for value assignment and stability." It does not provide specific numerical acceptance criteria or the reported device performance against those criteria. This type of information is typically detailed in the full testing report, which is usually not included in the public-facing 510(k) summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Only stated that the device was "evaluated for value assignment and stability." No specific results or adherence to criteria are given. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an IVD control, ground truth is typically established by the manufacturer through rigorous characterization of the control material against a reference method or known value. The document states the analyte is "spiked into the matrix at the desired concentration levels," implying the manufacturer establishes the target values.
4. Adjudication Method for the Test Set
This information is not applicable and thus not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or complex data where there might be inter-reader variability. For an IVD control, the "ground truth" (i.e., the target value of the control) is established by the manufacturer and is not subject to expert adjudication in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and often seeks to quantify the improvement in human performance with AI assistance. The Elecsys Rubella IgG CalCheck 5 is an in-vitro diagnostic control material, not a diagnostic device involving human interpretation, so such a study would not be applicable.
6. Standalone Performance Study
Yes, a standalone performance evaluation was done. The document states, "The Elecsys Rubella IgG CalCheck 5 was evaluated for value assignment and stability." This indicates that the performance of the control material itself was assessed. This is inherently a standalone evaluation as it assesses the control's properties directly, independent of a human-in-the-loop.
7. Type of Ground Truth Used
The ground truth used for this device would be the assigned target values and expected performance characteristics (e.g., stability over time) established by the manufacturer. The description states the device "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." This "spiking" process allows the manufacturer to determine the nominal (ground truth) concentration of the analyte within the control.
8. Sample Size for the Training Set
This information is not applicable to this device. The Elecsys Rubella IgG CalCheck 5 is a control material, not an algorithm or AI model that requires a training set. Its development involves chemical and biological formulation, purification, and characterization.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device, as there is no "training set." The ground truth for the control material itself (i.e., the intended concentration of Rubella IgG antibodies) is established by the manufacturer through the controlled spiking process and subsequent analytical validation using reference methods and assays.
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OCT 3 0 2009
510(k) Summary
| 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 RoadIndianapolis, IN 46250317-521-3952 |
| Contact Person: Kelly FrenchPhone: 317-521-3208Fax: 317-521-2324Email: kelly.french@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: August 21, 2009 | |
| Device Name | Proprietary name: Elecsys Rubella IgG CalCheck 5Common name: Rubella IgG CalCheck 5Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | The Elecsys Rubella IgG CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys Rubella IgG CalCheck (K090311). |
| Device Description | The Elecsys Rubella IgG CalCheck 5 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. |
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Intended use The Elecsys Rubella IgG 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 Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
510(k) Summary, Continued
The table below compares Elecsys Rubella IgG CalCheck 5 with the Comparison Table predicate device, Elecsys Rubella IgG Calcheck (K090311).
| Characteristic | Elecsys Rubella IgG CalCheck(K090311) | Elecsys Rubella IgGCalCheck 5 |
|---|---|---|
| Intended Use | The Elecsys Rubella IgG CalCheckis an assayed calibrator controlintended for use in the verificationof the calibration established by theElecsys Rubella IgG reagent on theElecsys 2010, MODULARANALYTICS E170 and cobas eimmunoassay analyzers. | The Elecsys Rubella IgG CalCheck5 is an assayed control for use incalibration verification and for usein the verification of the assay rangeestablished by the Elecsys RubellaIgG reagent on the Elecsys 2010,MODULAR ANALYTICS E170and cobas e immunoassayanalyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mLdistilled or deionized water andallow standing closed for 15minutes, then mix gently byinversion. | Same |
| Stability | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20 – 25°C : 4 hrs | Same |
| Matrix | Human serum matrix | Same |
Performance Characteristics The Elecsys Rubella IgG CalCheck 5 was evaluated for value assignment and stability.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping lines, resembling a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Kelly French Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN, 46250-3831
OCT 3 0 2009
K 092585 Re:
| Trade/Device Name: | Elecsys Rubella IgG CalCheck 5 |
|---|---|
| Regulation Number: | 21CFR §862.1660 |
| 21CFR §866.3510 | |
| Regulation Name: | Quality Control Material (assayed and unassayed) |
| Rubella Virus Serological Reagents | |
| Regulatory Class: | Class I (Quality Control) |
| Class II (Rubella IgG) | |
| Product Code: | JJX, LFX |
| Dated: | August 21, 2009 |
| Received: | August 24, 2009 |
Dear Ms. French:
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.
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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).
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Vaisattaygus
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
10.92585 510(k) Number (if known):
Device Name: Elecsys Rubella IgG CalCheck 5
Indication For Use:
The Elecsys Rubella IgG 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 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)
Uve Schuf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092585
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.