(16 days)
Elecsys® CalCheckTM TSH
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No
The document describes a calibration verification solution for an immunoassay, focusing on chemical composition and performance evaluation for value assignment and stability. There is no mention of AI or ML technologies.
No
The device is a calibration verification solution used to check the accuracy of an assay, not to treat a medical condition.
No
The device is described as a calibration verification solution for an assay, not a device that directly diagnoses a disease or condition in a patient. Its purpose is to ensure the accuracy of another diagnostic assay.
No
The device description explicitly states it is manufactured using physical components (human serum albumin, Ferritin, stabilizers, and preservatives) and is a calibration verification solution, not software.
Based on the provided information, the Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin 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 Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay." This assay measures Ferritin, which is a substance in the body. Verifying the calibration of an assay that measures a substance in the body is a key function of an IVD device.
- Device Description: The device is manufactured using human serum albumin and Ferritin, and is used in conjunction with the Elecsys Ferritin assay. This further supports its role in an in vitro diagnostic process.
- Predicate Device: The mention of a predicate device (K981281 Elecsys® CalCheckTM TSH) which is also a "CalCheck" product for another assay (TSH) strongly suggests that this type of product is classified as an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use and context clearly align with the definition and function of an IVD. It is a reagent or material used to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys Ferritin assay).
N/A
Intended Use / Indications for Use
The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay. Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid 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 Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.
Product codes
JJX
Device Description
The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is manufactured using human serum albumin, Ferritin, 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 ID-GC/MS.
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™ Ferritin was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Elecsys® CalCheckTM TSH
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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APR 2 4 1998
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| 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 | Roche Diagnostics/Boehringer Mannheim Corporation |
| 4300 Hacienda Drive | |
| Pleasanton, CA 94566-0900 | |
| (925) 730 - 8215 | |
| Fax number: (925) 225 - 0654 | |
| Contact Person: Patricia M. Klimley | |
| Date Prepared: April 6, 1998 | |
| 2. | |
| Device Name | Proprietary name: Elecsys® CalCheckTM Ferritin |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3. | |
| Predicate | |
| device | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is substantially equivalent to the currently marketed Elecsys® CalCheckTM TSH. |
| 4. | |
| Device | |
| Description | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is manufactured using human serum albumin, Ferritin, 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 ID-GC/MS. |
Continued on next page
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510(k) Summary, Continued
| 5. Intended use | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay. |
|---|---|
| 6. Comparison to predicate device | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ Ferritin is substantially euivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH. |
| Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. |
The Elecsys® CalCheck™ Ferritin was evaluated for value assignment and 7. Performance Characteristics stability.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three wavy lines representing the body. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 1998
Patricia M. Klimley Manager, Elecsys Regulatory Affairs Roche Diagnostics/Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
K981281 Re : Elecsys® CalCheck™ Ferritin Requlatory Class: I Product Code: JJX Dated: April 7, 1998 Received: April 8, 1998
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device; subject to the general controls provisions The general controls provisions of the Act 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. ਦੇ substantially equivalent determination assumes compliance withthe Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 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 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 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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510(k) Number (if known):
Device Name: Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin
Indications For Use:
Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid 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 Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981281
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺮﺍﺟﻊ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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