(256 days)
The Elecsys® proBNP CalCheck is intended for use in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys® proBNP CalCheck is a lyophilized product manufactured using proBNP in human serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels.
The provided 510(k) summary for the Elecsys® proBNP CalCheck does not contain information about specific acceptance criteria or a detailed study proving the device meets them in the format requested.
This document describes a "Calibration Verification Material" and its intended use is to verify the calibration of an immunoassay system. The 510(k) process for such a device typically focuses on demonstrating substantial equivalence to a predicate device and validating certain performance characteristics like value assignment and stability, rather than setting specific clinical performance acceptance criteria like sensitivity or specificity.
Here's a breakdown of the information that could be extracted and what is explicitly missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (Implicit for this type of device): The primary implicit acceptance criteria for a calibration verification material would be its ability to consistently produce expected values within a defined range when tested on the intended immunoassay analyzers, and its stability over its shelf life. However, no specific numerical acceptance criteria (e.g., ±X% deviation from target value, or stability within Y%) are stated in the provided text.
- Reported Device Performance:
- "The Elecsys® proBNP CalCheck was evaluated for value assignment and stability."
- This statement confirms these evaluations were performed, but no quantitative results (e.g., actual assigned values, observed stability data, or precision data) are reported.
Summary Table (Based on available information in the document):
| Acceptance Criteria (Implicit for K020883) | Reported Device Performance (K020883) |
|---|---|
| Consistent Value Assignment | Evaluated for value assignment |
| Stability over Shelf-life | Evaluated for stability |
| Accuracy relative to target proBNP concentrations (low, mid, high) | Not explicitly stated with numerical results |
| Precision/Reproducibility when used with the Elecsys® immunoassay systems | Not explicitly stated with numerical results |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The "ground truth" for a calibration verification material would typically be its manufacturing-assigned concentration, determined through highly controlled analytical methods, not through expert consensus on cases.
4. Adjudication method for the test set
- This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or complex diagnostic outcomes.
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
- This information is not applicable and not provided. The Elecsys® proBNP CalCheck is a calibration verification material, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. The device is a physical calibration material, not an algorithm.
7. The type of ground truth used
- For this type of device, the "ground truth" for the proBNP concentrations in the CalCheck solutions would be their assigned analytical values, established during manufacturing using reference methods and materials, which ensures accuracy and traceability. The document states: "The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels." and "Elecsys® proBNP CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined proBNP concentration."
8. The sample size for the training set
- This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable and not provided.
In summary: The provided 510(k) summary is for a calibration verification material, not a diagnostic or AI-powered device that would typically involve the comprehensive clinical study details requested. The focus for this type of device is on demonstrating manufacturing quality, analytical performance (value assignment, stability), and equivalence to a predicate. Most of the requested comparative effectiveness and expert-driven ground truth details are not relevant to this specific product.
{0}------------------------------------------------
510(k) Summary
NOV 2 9 2002
| 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 Corporation 9115 Hague Road Indianapolis, IN 46250 521 - 3831 |
| Contact Person: Sherri L Coenen | |
| Date Prepared: March 15, 2002 | |
| Device Name | Proprietary name: Elecsys® proBNP CalCheck |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| Predicate device | The Elecsys® proBNP CalCheck is substantially equivalent to the currently marketed Elecsys® Thyroglobulin CalCheck (K001015). |
| Device Description | The Elecsys® proBNP CalCheck is a lyophilized product manufactured using proBNP in human serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels. |
{1}------------------------------------------------
510(k) Summary, Continued
:
| Intended use | The Elecsys® proBNP CalCheck is used in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. |
|---|---|
| Comparison to predicate device | The Elecsys® proBNP CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® Thyroglobulin CalCheck (K001015). |
| Performance Characteristics | The Elecsys® proBNP CalCheck was evaluated for value assignment and stability. |
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kay A. Taylor Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
NOV 2 9 2002
Re: K020883 Trade/Device Name: Elecsys® proBNP CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 20. 2002 Received: November 22, 2002
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 vour 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).
{3}------------------------------------------------
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 (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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
.
510(k) Number (if known): N/A
Device Name: Elecsys® proBNP CalCheck
Indications For Use:
.
Elecsys® proBNP CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined proBNP concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® proBNP CalCheck is intended for use in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ (
§ 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.