(12 days)
The Elecsys CalCheck Myoglobin is intended for use in periodic verification of the calibration of the Elecsys Myoglobin assay.
The Boehringer Mannheim Elecsys CalCheck Myoglobin is manufactured using bovine serum albumin, human Myoglobin, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
The provided document is a 510(k) summary for the Boehringer Mannheim Elecsys CalCheck Myoglobin, a calibration verification material. This type of submission focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes. It does not contain information about the clinical efficacy or performance of a diagnostic device in the way a study for a new AI-powered diagnostic might.
Therefore, many of the requested categories for describing acceptance criteria and a study to prove a device meets those criteria are not applicable to the information provided in this 510(k) summary. I can, however, extract relevant details about the device's "performance characteristics" as described in the approval.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
Based on the 510(k) summary, the device is a calibration verification material. Its "performance characteristics" revolve around its ability to accurately verify calibration and its stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Value assignment (accurate Myoglobin concentration) | "The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment" (Specific results not detailed in this summary) |
| Stability (maintaining concentration over time) | "The Elecsys® CalCheckTM Myoglobin was evaluated for... stability" (Specific results not detailed in this summary) |
| Intended Use | "Used to verify the calibration assignment for the Boehringer Mannheim Elecsys Myoglobin assay." |
| Concentration levels | Low (near lower detection limit), Mid (middle/clinically critical point), High (near upper limit). |
Regarding the study that proves the device meets the acceptance criteria:
The document states: "The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment and stability."
However, the 510(k) Summary does not provide the detailed results of this evaluation or the specific study design. It only mentions that an evaluation was performed. For a calibration verification material, typical studies would involve:
- Value Assignment: Multiple runs on the target analyzer using reference methods or highly accurate assays to determine the assigned concentration for each level (low, mid, high).
- Stability: Testing samples at various time points and storage conditions (e.g., refrigerated, frozen, room temperature) to ensure the assigned values remain within acceptable limits over the claimed shelf life and in-use stability period.
The following requested categories are NOT applicable or detailable from the provided 510(k) summary because it's for a calibration verification material, not a diagnostic AI device, and the summary itself is high-level:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The summary does not provide details on sample sizes for value assignment or stability testing, nor does it specify data provenance.
- 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/Not Provided. For a calibration verification material, "ground truth" for concentration would typically be established through highly accurate analytical methods, not expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. This relates to human expert review, which is not relevant for the performance evaluation of a calibration verification material.
- 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 is specific to AI-powered diagnostic devices involving human readers. This device is a calibration material.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Likely Analytical Reference Methods/Certified Standards (Not explicitly stated but implied by "value assignment"). For a calibration verification material, ground truth for analyte concentration is established through precise analytical techniques, often traceable to international reference materials.
- The sample size for the training set
- Not Applicable. This device is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established
- Not Applicable. This device is not an AI algorithm requiring a training set.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string is "K98316b".
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1.Submittername, address,contact | Boehringer Mannheim Corporation9115 Hague RoadIndianapolis, IN 46250(317) 845 - 3723 |
| Contact Person: Priscilla A. Hamill | |
| Date Prepared: September 08, 1998 | |
| 2.Device Name | Proprietary name: Elecsys CalCheck MyoglobinCommon name: Calibration Verification Material |
| Classification name: Single (specified) analyte controls (assayed +unassayed) | |
| 3.Predicatedevice | The Boehringer Mannheim Elecsys CalCheck Myoglobin is substantiallyequivalent to the currently marketed Elecsys CalCheck Troponin T. |
| 4.DeviceDescription | The Boehringer Mannheim Elecsys CalCheck Myoglobin is manufacturedusing bovine serum albumin, human Myoglobin, stabilizers, andpreservatives. The analyte is appropriately spiked into the CalCheck matrix tothe correct CalCheck concentration levels. |
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510(k) Summary, Continued
| 5.Intended use | The Boehringer Mannheim Elecsys® CalCheckTM Myoglobin is used toverify the calibration assignment for the Boehringer Mannheim ElecsysMyoglobin assay. |
|---|---|
| 6.Comparison topredicatedevice | The Boehringer Mannheim Elecsys® CalCheckTM Myoglobin is substantiallyequivalent to other products in commercial distribution intended for similaruse. Most notably, it is substantially equivalent to the currently marketedElecsys® CalCheckTM Troponin T. |
| Both products are intended to be used for the verification of calibration foranalytes on the Elecsys immunoassay analyzers. | |
| 7. PerformanceCharacteristics | The Elecsys® CalCheckTM Myoglobin was evaluated for value assignmentand stability. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICE . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Priscilla A. Hamill Requlatory Affairs Consultant Boehringer Mannheim Corporation 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re : K983166 Elecsys® CalCheck™ Myoglobin Regulatory Class: I Product Code: JJY Dated: September 8, 1998 Received: September 10, 1998
Dear Ms. Hamill:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
SEP 2 2 1998
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K983166
510(k) Number (if known): N/A
Device Name: Boehringer Mannheim-Elecsys® CalCheck™ Myoglobin
Indications For Use:
Elecsys CalCheck Myoglobin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Myoglobin concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Myoglobin is intended for use in periodic verification of the calibration of the Elecsys Myoglobin assay.
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
Division of Clinical Laboratory Devices
510(k) Number K983166
§ 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.