(36 days)
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
This document describes the Elecsys proBNP II CalCheck, a quality control material intended for use in verifying the calibration of the Elecsys proBNP II reagent on specific immunoassay analyzers. As this is a quality control material and not a diagnostic device for patient diagnosis, the typical acceptance criteria and study designs for diagnostic accuracy (like sensitivity, specificity, accuracy against a gold standard in patient datasets) are not applicable in the same way.
Instead, the "performance" of such a device is evaluated by its ability to provide stable and accurate assigned values over time and under various conditions, ensuring it can properly verify the calibration of the main diagnostic assay.
Here's an analysis based on the provided text, addressing the requested information where applicable for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical "acceptance criteria" for the Elecsys proBNP II CalCheck in the format typically seen for diagnostic devices (e.g., sensitivity >X%, specificity >Y%). Instead, the performance is demonstrated through its intended function as a calibration verification material and its stability characteristics, compared to a predicate device.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Must effectively verify calibration for Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers, similar to predicate. | "For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers." (Identical functional intent to predicate, but for the 'proBNP II' reagent). |
| Levels | Must provide three calibration verification levels, similar to predicate. | "Three" (same as predicate). |
| Format | Must be a lyophilized product, similar to predicate. | "Lyophilized" (same as predicate). |
| Handling | Must have similar reconstitution and handling instructions as predicate. | "Reconstitute with exactly 1.0 mL distilled or deionized water and allow standing closed for 15 minutes, then mixing gently." (same as predicate). |
| Stability (Unopened) | Must demonstrate stability comparable to or better than predicate (2-8℃ until expiration date). | "Unopened: · Store at 2-8℃ until expiration date" (same as predicate). |
| Stability (Reconstituted) | Must demonstrate stability comparable to or better than predicate (20-25℃: 4 hrs). | "Reconstituted: ● 20-25℃:4 hrs" (same as predicate). |
| Matrix Composition | Must have a matrix suitable for its intended use, comparable to predicate. | "Level 1: NT-proBNP free human serum matrix; Levels 2/3: synthetic NT-proBNP in human serum / buffer matrix" (same as predicate). |
| Overall Performance | Must demonstrate satisfactory "value assignment" and "stability" for its intended purpose. | "The Elecsys proBNP II CalCheck was evaluated for value assignment and Performance Characteristics stability." (Specific data not provided in the summary, but implied to be acceptable for 510(k) clearance). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide specific details on the sample size (number of replicate measurements, number of lots, etc.) or data provenance (e.g., country of origin, retrospective/prospective) for the "value assignment and stability" evaluation of the Elecsys proBNP II CalCheck. Such details would typically be found in the full 510(k) submission and not in the summary. For a quality control material, the "test set" would generally refer to batches of the control material tested for analyte concentration, consistency, and stability over time and varying conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a quality control material used to verify calibration of an assay measuring a specific analyte (NT-proBNP), the "ground truth" is established through analytical methods and metrology, not by expert consensus or clinical interpretation. The assigned values for the control material are determined by precise laboratory measurements using reference methods or by comparison to primary standards.
4. Adjudication Method for the Test Set
Not applicable for a quality control material. Adjudication methods (like 2+1, 3+1) are used in studies where human readers are making subjective interpretations, typically with imaging or pathology. For analytical controls, the "truth" is determined by quantitative measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. MRMC studies are designed to assess the performance of diagnostic devices (especially those involving human interpretation, like imaging AI) by comparing the accuracy of multiple readers across multiple cases, often with and without AI assistance. The Elecsys proBNP II CalCheck is an analytical control material, not a diagnostic device that involves human interpretation or diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a biochemical control material, not an algorithm or AI system.
7. The Type of Ground Truth Used
For a quality control material like Elecsys proBNP II CalCheck, the "ground truth" for the assigned values is established through analytical laboratory measurements and metrological traceability. This means the concentration of NT-proBNP in each level of the control material is precisely quantified using validated analytical methods, often traceable to internationally recognized standards or highly characterized reference materials for NT-proBNP. It is a value assigned through rigorous scientific measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is an analytical control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted in point 8, there is no training set for this type of device.
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510(k) Summary
FEB 27 2009 -
| 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 Diagnostics 9115 Hague Road Indianapolis, IN 46250 317-521-2458 |
| Contact Person: Kay A. Taylor | |
| Date Prepared: January 18, 2008 | |
| Device Name | Proprietary name: Elecsys proBNP II CalCheck |
| Common name: proBNP II CalCheck | |
| Classification name: Single (specified) analyte controls (assayed and unassayed) | |
| Predicate device | The Elecsys proBNP II CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys ProBNP CalCheck (K020883). |
| Device Description | The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers. |
| Continued on next page |
.
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510(k) Summary, Continued
The table below compares Elecsys proBNP II CalCheck with the predicate Comparison Table device, Elecsys ProBNP CalCheck (K020883).
. . . . .
| Characteristic | Elecsys proBNP CalCheck(Predicate) | Elecsys proBNP II CalCheck |
|---|---|---|
| Intended Use | For use in the verification of thecalibration established by theElecsys proBNP reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | For use in the verification of thecalibration established by the ElecsysproBNP II reagent on the Elecsys andcobas e immunoassay analyzers. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly 1.0 mLdistilled or deionized water and allowstanding closed for 15 minutes, thenmixing gently. | Reconstitute with exactly 1.0 mLdistilled or deionized water and allowstanding closed for 15 minutes, thenmixing gently. |
| Stability | Unopened:· Store at 2-8℃ until expiration dateReconstituted:● 20-25℃:4 hrs | same |
| Matrix | Level 1: NT-proBNP free humanserum matrixLevels 2/3: synthetic NT-proBNP inhuman serum / buffer matrix | same |
The Elecsys proBNP II CalCheck was evaluated for value assignment and Performance Characteristics stability.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 7 2008
Roche Diagnostics c/o Ms. Kay Taylor, (ASCP) Regulatory Affairs Principal 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416
K080147 Re:
Trade Name: Elecsys proBNP II CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJX Dated: January 18, 2008 Received: January 22, 2008
Dear Ms. Taylor:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. 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 - Elecsys proBNP II CalCheck
510(k) Number (if known):
2080147
Device Name: Elecsys proBNP II CalCheck
Indication For Use:
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (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)
Signature
Divisign Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080147
§ 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.