(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
This device is a calibration verification solution used to verify the calibration of an assay, not for treating any medical condition.
No
The device is described as a "calibration verification solution" used to verify the calibration of an assay, not to diagnose a patient's condition directly.
No
The device is a calibration verification solution, which is a physical reagent, not software.
Based on the provided text, the Boehringer Mannheim Elecsys® CalCheck™ Folate 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 Folate assay." This assay measures Folate, a substance in the body, and the CalCheck is used to ensure the accuracy of that measurement. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description mentions it is manufactured using human serum albumin and Folate, and is used in conjunction with the Elecsys Folate assay. This further supports its role in the in vitro diagnostic process.
- Predicate Device: The mention of a predicate device (K963147; Elecsys® CalCheck™ TSH Calibration Verification Test) which is also a calibration verification test for an Elecsys assay, strongly suggests that this type of product is classified as an IVD.
While the text doesn't explicitly use the term "In Vitro Diagnostic" in the intended use, the function and context clearly place it within the scope of IVD devices. It's a reagent used to ensure the accuracy of a diagnostic test performed on a sample from the human body.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys® CalCheck™ Folate is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Folate assay.
Elecsys CalCheck Folate calibration verification solutions comprise three levels - low, mid, and high - each with a defined Folate 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 Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Boehringer Mannheim Elecsys® CalCheck™ Folate is manufactured using human serum albumin, Folate, 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™ Folate was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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DEC - 8 1997
| 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™ Folate |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3. | |
| Predicate device | The Boehringer Mannheim Elecsys® CalCheck™ Folate is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147). |
| 4. | |
| Device Description | The Boehringer Mannheim Elecsys® CalCheck™ Folate is manufactured using human serum albumin, Folate, 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 |
510(k) Summary
・
:
1
510(k) Summary, Continued
| 5.
Intended use | The Boehringer Mannheim Elecsys® CalCheck™ Folate is used to verify the
calibration assignment for the Boehringer Mannheim Elecsys Folate assay. | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 6.
Comparison to
predicate
device | The Boehringer Mannheim Elecsys® CalCheck™ Folate 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™ Folate 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 is provided in attachment 6. | |
| | Similarities: | |
| | • Configuration: Three CalCheck levels: low, mid, and high | |
| | • Intended use: To verify calibration | |
Differences:
:
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- Performance
Characteristics
The Elecsys® CalCheck™ Folate was evaluated for value assignment and stability.
2
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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 8 K
Patricia M. Klimley .Requlatory Affairs Manager Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
K974384 Re : Elecsys® CalCheck™ Folate Product Code: JJY Requlatory 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, 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 requlations 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 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 In addition, FDA may publish further announcements action. 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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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 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
510(k) Number (if known): N/A
Device Name: Boehringer Mannheim Elecsys® CalCheck™ Folate
Indications For Use:
Elecsys CalCheck Folate calibration verification solutions comprise three levels - low, mid, and high - each with a defined Folate 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 Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
ivision Sign-Off)
Division of Clinical Laboratory
10(k) Number K974384