(17 days)
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No
The document describes a calibration verification solution for a laboratory assay, not a device that processes data or makes decisions using AI/ML.
No
The device is described as a calibrator used to verify the calibration assignment for an assay, not for treating a condition.
No.
This device is described as a "calibration verification solution" used to verify the calibration of an assay, not to diagnose a patient condition directly.
No
The device description explicitly states it is manufactured using physical components (human serum albumin, vitamin B12, stabilizers, and preservatives) and is a physical solution used for calibration verification. It is not software.
Based on the provided information, the Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 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 Vitamin B12 assay." This is a function performed in vitro (outside the body) on a sample (presumably a control solution) to ensure the accuracy of a diagnostic test.
- Device Description: The description details the composition of the solution, which is a reagent used in a laboratory setting.
- Predicate Device: The mention of a predicate device (K963147; Elecsys® CalCheck™ TSH Calibration Verification Test) which is also a "Calibration Verification Test" strongly suggests that this type of product falls under the IVD category. Calibration verification solutions are essential components of many IVD workflows.
Therefore, the primary purpose of this device is to support the accurate performance of an in vitro diagnostic assay, making it an IVD itself.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Vitamin B12 assay.
Elecsys CalCheck Vitamin B12 calibration verification solutions comprise three levels - low, mid, and high - each with a defined Vitamin B12 concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Vitamin B12 is intended for use in periodic verification of the calibration of the Elecsys Vitamin B12 assay.
Product codes
JJX
Device Description
The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is manufactured using human serum albumin, vitamin B12, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys® CalCheck™ Vitamin B12 was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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510(k) Summary
:
DE 2007
| 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 |
| 4300 Hacienda Drive | |
| Pleasanton, CA 94588-2722 | |
| (510) 730-8215 | |
| Fax number: (510)-225-0654 | |
| Contact Person: Patricia M. Klimley | |
| Date Prepared: November 14, 1997 | |
| 2. | |
| Device Name | Proprietary name: Elecsys® CalCheck™ Vitamin B12 |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3. | |
| Predicate device | The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147). |
| 4. | |
| Device Description | The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is manufactured using human serum albumin, vitamin B12, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards. |
| Continued on next page |
1
510(k) Summary, Continued
| 5.
Intended use | The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is used to
verify the calibration assignment for the Boehringer Mannheim Elecsys
Vitamin B12 assay. | | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------|
| 6.
Comparison to
predicate
device | The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 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™ TSH Calibration Verification Test
(K963147). | | |
| | Both products are intended to be used for the verification of calibration for
analytes on automated immunoassay analyzers. | | |
| | The following table compares the Elecsys® CalCheck™ Vitamin B12 with
the predicate device, Elecsys® CalCheck™ TSH. Specific data on the
performance of the test have been incorporated into the draft labeling in
attachment 5. Labeling for the predicate devices are provided in attachment 6. | | |
| | Similatities: | | |
| | • Configuration: 3 CalCheck levels: low, mid, and high | | |
| | • Intended use: To verify calibration | | |
| | Differences: | | |
| | Feature
Matrix type
Analyte | CalCheck Vitamin B12
Human serum albumin
Vitamin B12 | CalCheck TSH
Horse serum
TSH |
| 7. Performance
Characteristics | The Elecsys® CalCheck™ Vitamin B12 was evaluated for value assignment
and stability. | | |
.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 8 1997
Patricia M. Klimley Regulatory Affairs Manager Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K974383 Elecsys® CalCheck™ Vitamin B12 Product Code: JJX Regulatory Class: I Dated: November 20, 1997 Received: November 21, 1997
Dear Ms. Klimley:
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, qood 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. ರ್ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
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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 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 one regulation entitled, "Misbranding by reference to
the regulation entification" (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
510(k) Number (if known): NA K 974383
Device Name: Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12
Indications For Use:
Elecsys CalCheck Vitamin B12 calibration verification solutions comprise three levels - low, mid, and high - each with a defined Vitamin B12 concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Vitamin B12 is intended for use in periodic verification of the calibration of the Elecsys Vitamin B12 assay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
510(k) Number: V974382