(12 days)
Not Found
Not Found
No
The summary describes a calibration verification solution for a laboratory assay, not a device that processes data or makes decisions using AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a calibration verification solution for an assay, not a device used for treating a disease or condition.
No
The device is a calibration verification solution for an assay, not for diagnosing a condition in a patient. It is used to verify the calibration of an diagnostic device.
No
The device description explicitly states it is manufactured using physical components (bovine serum albumin, human Myoglobin, stabilizers, and preservatives), indicating it is a physical reagent, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "periodic verification of the calibration of the Elecsys Myoglobin assay." This assay is used to measure Myoglobin, which is a substance found in the body. Verifying the calibration of an assay that measures a substance in the body is a core function of an in vitro diagnostic device.
- Device Description: The description mentions it's manufactured using components like "bovine serum albumin, human Myoglobin, stabilizers, and preservatives" and that the analyte (Myoglobin) is "spiked into the CalCheck matrix." This describes a reagent or calibrator used in a laboratory test, which is typical of IVDs.
- Predicate Device: The mention of a "Predicate Device(s)" which is another "Elecsys® CalCheckTM" product further supports that this device falls under the category of IVDs, as predicate devices are used in the regulatory process for IVDs.
While the text doesn't explicitly use the term "In Vitro Diagnostic" in the intended use or description, the function and nature of the device as described clearly align with the definition of an IVD. It's a product used in vitro (outside the body) to assess the performance of a diagnostic test.
N/A
Intended Use / 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.
Product codes
JJY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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SEP 2 2 1998
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 information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.
Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, IN 46250
(317) 845 - 3723 |
| | Contact Person: Priscilla A. Hamill |
| | Date Prepared: September 08, 1998 |
| 2.
Device Name | Proprietary name: Elecsys CalCheck Myoglobin
Common name: Calibration Verification Material |
| | Classification name: Single (specified) analyte controls (assayed +
unassayed) |
| 3.
Predicate
device | The Boehringer Mannheim Elecsys CalCheck Myoglobin is substantially
equivalent to the currently marketed Elecsys CalCheck Troponin T. |
| 4.
Device
Description | 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. |
1
510(k) Summary, Continued
| 5.
Intended use | The Boehringer Mannheim Elecsys® CalCheckTM Myoglobin is used to
verify the calibration assignment for the Boehringer Mannheim Elecsys
Myoglobin assay. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.
Comparison to
predicate
device | The Boehringer Mannheim Elecsys® CalCheckTM Myoglobin is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably, it is substantially equivalent to the currently marketed
Elecsys® CalCheckTM Troponin T. |
| | Both products are intended to be used for the verification of calibration for
analytes on the Elecsys immunoassay analyzers. |
| 7. Performance
Characteristics | The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment
and 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
4
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