(16 days)
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.
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.
The provided text describes the Elecsys® CalCheck™ Ferritin, a calibration verification material. However, it does not contain a detailed study with acceptance criteria and reported device performance in the manner requested (e.g., accuracy, sensitivity, specificity, or a comparative effectiveness study with human readers).
The document is a 510(k) summary for a calibration verification material. The "Performance Characteristics" section [1] states that the device was evaluated for "value assignment and stability," but no specific metrics, acceptance criteria, or study results are provided in the available text.
Therefore, many of the requested details about acceptance criteria and study design cannot be extracted from this document.
Here's an attempt to answer based on the available information, with specific notes where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states, "The Elecsys® CalCheck™ Ferritin was evaluated for value assignment and stability," but no specific criteria or results are given. | Not provided in the document. No specific quantitative performance metrics (e.g., accuracy, precision, bias, stability over time, or comparison to a reference method) are detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document describes the manufacturing and quality control of the calcheck material [0] but does not mention the origin or type of data used for performance evaluation beyond general "value assignment and stability."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not specified. This device is a calibration verification material. Its "ground truth" would likely be derived from a validated reference method or primary standard for ferritin concentration rather than expert consensus on diagnostic images or clinical cases. The text mentions "quality controlled against ID-GC/MS" during manufacturing [0], which suggests an analytical reference method for concentration assignment, but details are not provided for the test set.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. The concept of adjudication (e.g., 2+1, 3+1 for clinical diagnoses) is not relevant for a calibration verification material whose performance is assessed through analytical measurements against established values.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is typically done for diagnostic or screening devices that involve human interpretation of results (e.g., medical images). The Elecsys® CalCheck™ Ferritin is a calibration verification solution for an automated immunoassay, meaning it does not directly involve human "readers" interpreting test results in a diagnostic context.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study Done: Yes, in an analogous sense. The "value assignment and stability" evaluation of the CalCheck™ Ferritin itself would represent a standalone assessment of its analytical performance (e.g., is the assigned concentration accurate, and does it remain stable over time?). However, the specifics of this study (methods, results, acceptance criteria) are not detailed in the provided text. The device itself is "algorithm only" in the sense that its performance is purely analytical, not based on human input for interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: Analytical reference methods for ferritin concentration. The text mentions the material is "quality controlled against ID-GC/MS" [0], which is a highly accurate analytical technique (Isotope Dilution Gas Chromatography/Mass Spectrometry) often used as a reference method for determining the concentration of substances in a matrix. This suggests that the "ground truth" for the assigned ferritin values in the CalCheck material would be established through such highly accurate analytical techniques.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a calibration verification material, not an AI/ML algorithm that is "trained" on data. It is a physical product with assigned values. Its manufacturing and quality control processes are established, but there isn't a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set." The "ground truth" for the CalCheck's assigned values is established through rigorous analytical measurement processes, likely against primary reference standards using methods like ID-GC/MS, as suggested in the document [0].
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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.Submittername,address,contact | Roche Diagnostics/Boehringer Mannheim Corporation4300 Hacienda DrivePleasanton, CA 94566-0900(925) 730 - 8215Fax number: (925) 225 - 0654Contact Person: Patricia M. KlimleyDate Prepared: April 6, 1998 |
| 2.Device Name | Proprietary name: Elecsys® CalCheckTM FerritinCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.Predicatedevice | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is substantially equivalent to the currently marketed Elecsys® CalCheckTM TSH. |
| 4.DeviceDescription | 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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§ 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.