(148 days)
The Elecsys proBNP II 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 proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalCheck 5 is a lyophilized product consisting of NT-proBNP (1-76) amide, human serum and a potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided submission discusses the Elecsys proBNP II CalCheck 5, a control product for immunoassay analyzers. As a control material and not a diagnostic device, the acceptance criteria and study detailed below focus on its performance as such.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | The CalCheck 5 levels must be accurately assigned. | Not explicitly detailed in the provided text, but implied by the "value assignment" evaluation. The device is expected to provide accurate control values for verification purposes. |
| Stability | The CalCheck 5 must maintain its specified range of values under various storage and handling conditions (unopened and reconstituted). | Unopened: Store at 2-8°C until expiration date. (Performance matches predicate) Reconstituted: 4 hours at 20-25°C. (Performance matches predicate) |
| Intended Use | The device must function as an assayed control for calibration verification and assay range verification for Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers. | The intended use is clearly stated and aligns with the device's function. The study implies successful verification of this claim. |
| Equivalency to Predicate | The Elecsys proBNP II CalCheck 5 must be substantially equivalent to the currently marketed Elecsys proBNP II CalCheck (K080147) in terms of characteristics and performance. | The submission directly states: "The Elecsys proBNP II CalCheck 5 was evaluated for value assignment and stability," and then states that the performance characteristics (format, handling, stability, matrix, buffer) are "Same" as the predicate, except for the number of levels (5 vs 3). This indicates equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a patient cohort. For a control material, the "test set" would primarily involve multiple batches or samples of the control material tested across various instruments and conditions. The sample size for these evaluations (value assignment and stability studies) is not explicitly stated in the provided text.
The data provenance is also not explicitly stated beyond being part of a regulatory submission from Roche Diagnostics, indicating it would be internally generated data from their manufacturing and testing facilities. It would be considered prospective for the purposes of the submission, as the studies would have been conducted specifically to support the 510(k) application for the new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a control material, the "ground truth" for its value is established through rigorous internal validation processes by the manufacturer, typically involving highly accurate reference methods and multiple expert analytical chemists or laboratory scientists. The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., the assigned values) for the Elecsys proBNP II CalCheck 5. This information is typically part of the internal quality control and manufacturing documentation, not necessarily detailed in a 510(k) summary for a Class I device.
4. Adjudication Method for the Test Set
Given the nature of a control material and the type of evaluation described ("value assignment and stability"), a formal "adjudication method" involving multiple human readers or reviewers of subjective data (like image interpretation) is not applicable. The "adjudication" in this context would be the internal quality control and statistical analysis methods used by Roche to determine the consensus assigned values and stability profiles, which are objective measurements.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often in conjunction with AI. The Elecsys proBNP II CalCheck 5 is a laboratory control material, not an AI-powered diagnostic device, and its use does not involve human readers interpreting complex medical cases or images.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The Elecsys proBNP II CalCheck 5 is a physical chemical control product, not a software algorithm or AI. Therefore, the concept of "algorithm only" performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys proBNP II CalCheck 5 refers to the assigned concentration values of NT-proBNP in each of the five levels. This ground truth is established through:
- Analytical measurement and calibration: Using highly accurate reference methods and calibrated instruments to determine the precise concentration of the analyte (NT-proBNP) spiked into the matrix during manufacturing.
- Manufacturer's internal validation: Rigorous testing and statistical analysis conducted by Roche Diagnostics to ensure the assigned values are accurate and reproducible.
It is not based on expert consensus of clinical images, pathology (histology), or patient outcomes data, as these are not relevant to the function of a laboratory control.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. The Elecsys proBNP II CalCheck 5 is a manufactured control material, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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DEC 162009
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510(k) Summary
DEC 16 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 Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3208 |
| Contact Person: Kelly French | |
| Date Prepared: July 15, 2009 | |
| Device Name | Proprietary name: Elecsys proBNP II CalCheck 5 |
| Common name: proBNP II CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and unassayed) | |
| Predicate device | The Elecsys proBNP II CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys proBNP II CalCheck (K080147). |
| Device Description | The Elecsys proBNP II CalCheck 5 is a lyophilized product consisting of NT-proBNP (1-76) amide, human serum and a potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys proBNP II 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 proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
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510(k) Summary, Continued
The table below compares Elecsys proBNP II CalCheck 5 with the predicate Comparison device, Elecsys proBNP II Calcheck (K080147). Table
| Characteristic | Elecsys proBNP II CalCheck(K080147) | Elecsys proBNP II CalCheck 5 |
|---|---|---|
| Intended Use | For use in the verification of thecalibration established by theElecsys proBNP II reagent on theElecsys and cobas e immunoassayanalyzers. | The Elecsys proBNP II CalCheck5 is an assayed control for use incalibration verification and for usein the verification of the assayrange established by the ElecsysproBNP II reagent on the indicatedElecsys and 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 mixing gently. | Same |
| Stability | Unopened:· Store at 2-8ºC until expirationdateReconstituted:· 20 - 25 °C : 4 hrs | Same |
| Matrix | Human serum | Same |
| Buffer | Potassium phosphate buffer | Same |
Performance Characteristics The Elecsys proBNP II CalCheck 5 was evaluated for value assignment and stability.
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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text and symbol are both in black and are set against a white background.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Roche Diagnostics Roche Professional Diagnostics c/o Ms. Kelly French Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 1 6 2009
K092169 Re:
Trade Name: Elecsys proBNP II CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: December 1, 2009 Received: December 2, 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.
CA
Courtney C. Harper, Ph.D. 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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Indications for Use
510(k) Number (if known): K092169
Device Name: Elecsys proBNP II CalCheck 5
Indications For Use:
The Elecsys proBNP II 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 proBNP II reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
:
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Koszlo 510(k)
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§ 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.