(7 days)
Not Found
No
The document 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
This device is a calibration verification solution for an assay, not a device used to provide therapy for a disease or condition.
No
This device is a calibration verification solution used to ensure the accuracy of another assay (Elecsys Troponin T assay). It does not directly diagnose a patient's condition.
No
The device description explicitly states it is manufactured using physical components (bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives), indicating it is a physical reagent, not software.
Based on the provided information, the Boehringer Mannheim Elecsys® CalCheck™ Troponin T is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is used to "verify the calibration assignment for the Boehringer Mannheim Elecsys Troponin T assay." This assay measures Troponin T, a biomarker in human samples, which is a diagnostic test. The CalCheck is a reagent used with this diagnostic test to ensure its accuracy.
- Device Description: It is a manufactured solution containing human recombinant Troponin T in a matrix, designed to be used in a laboratory setting with the Elecsys Troponin T assay.
- Purpose: Its purpose is to ensure the proper functioning and accuracy of a diagnostic assay that measures a substance in human samples.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While the CalCheck itself doesn't directly diagnose a patient, it is an essential component used with a diagnostic assay to ensure the reliability of the diagnostic results. This makes it an IVD accessory or reagent.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Troponin T assay.
Elecsys CalCheck Troponin T calibration verification solutions comprise three levels - low, mid. and high - each with a defined Troponin T 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 Troponin T is intended for use in periodic verification of the calibration of the Elecsys Troponin T assay.
Product codes
JJY
Device Description
The Boehringer Mannheim Elecsys CalCheck Troponin T is manufactured using bovine serum albumin, human recombinant Troponin T, 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® CalCheck™ Troponin T was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Boehringer Mannheim Elecsys CalCheck Troponin T is substantially equivalent to the currently marketed Elecsys CalCheck Troponin T.
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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DEC 1 4 1998
... . Radisplay or and
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. |
|---|---|
| Submitter | |
| name, address, | |
| contact | Boehringer Mannheim Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 845 - 3723 | |
| Contact Person: Priscilla A. Hamill | |
| Date Prepared: December 3, 1998 | |
| Device name | Proprietary name: Elecsys CalCheck Troponin T |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| Predicate | |
| device | The Boehringer Mannheim Elecsys CalCheck Troponin T is substantially equivalent to the currently marketed Elecsys CalCheck Troponin T. |
| Device | |
| description | The Boehringer Mannheim Elecsys CalCheck Troponin T is manufactured using bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels. |
| Continued on next page |
1
510(k) Summary, Continued
| Intended use | The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to
verify the calibration assignment for the Boehringer Mannheim Elecsys
Troponin T assay. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
predicate
device | The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably, it is substantially equivalent to the currently marketed
Elecsys® CalCheck™ Troponin T.
Both products are intended to be used for the verification of calibration for
analytes on the Elecsys immunoassay analyzers. |
| Performance
Characteristics | The Elecsys® CalCheck™ Troponin T was evaluated for value assignment
and stability. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEC 1 4 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road Indianapolis Indiana 46250-0457
Re: K984372 Elecsys CalCheck Troponin T Trade Name: Regulatory Class: I Product Code: JJY Dated: December 3, 1998 Received: December 7, 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listinq 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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.
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Paqe 2
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 requlation (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 qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
K984372 510(k) Number (if known): N/A
Device Name: Boehringer Mannheim Elecsys® CalCheck™ Troponin T
Indications For Use:
Elecsys CalCheck Troponin T calibration verification solutions comprise three levels - low, mid. and high - each with a defined Troponin T 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 Troponin T is intended for use in periodic verification of the calibration of the Elecsys Troponin T 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
510(k) Number K984372