(15 days)
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CA 125II assay.
Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II 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™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay.
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck CA 125II is manufactured using human serum albumin, CA 125, 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 is for a 510(k) summary for a calibration verification material (Elecsys® CalCheck™ CA 125II), not a medical device in the typical sense of diagnosing or treating a disease. Therefore, many of the requested categories related to clinical performance studies (e.g., expert ground truth, MRMC studies, standalone performance) are not applicable or would not be performed for such a product.
However, I can extract information related to its "performance characteristics" as described for this type of product.
Here's the breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a calibration verification material, "performance" typically refers to its value assignment and stability to ensure it can accurately verify the calibration of an assay. The document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Value Assignment | Evaluated (Implied satisfactory for clearance) |
| Stability | Evaluated (Implied satisfactory for clearance) |
Note: The document states these were "evaluated" but does not provide specific numerical criteria or results. For a calibration verification material, the acceptance criteria would typically involve demonstrating that the assigned values are accurate and that the material remains stable over its declared shelf life when stored properly.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical images or patient data. For a calibration verification material, testing involves manufacturing lots and stability studies.
- Sample Size for Test Set: Not specified in the provided text, but it would pertain to the number of lots or units of the Elecsys® CalCheck™ CA 125II manufactured and tested.
- Data Provenance: Not explicitly stated, but assumed to be from internal lab studies conducted by Roche Diagnostics/Boehringer Mannheim Corporation. This would be prospective manufacturing and stability testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable for a calibration verification material. "Ground truth" for this product type is established through analytical methods for assigning analyte concentrations and stability assessments, not expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable for a calibration verification material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study is not applicable for a calibration verification material. MRMC studies are used for diagnostic devices involving human interpretation of clinical data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a consumable for laboratory assay calibration.
7. The Type of Ground Truth Used
For this device (calibration verification material):
- Ground Truth: Established by analytical methods for determining the concentration of CA 125II in the material (e.g., against reference methods or highly accurate internal standards) and stability studies to confirm the integrity of these concentrations over time. The document mentions it is "in process checked and quality controlled against ID-GC/MS," which implies a rigorous analytical method for quantification, likely for components or precursors, and overall quality control.
8. The Sample Size for the Training Set
Not applicable in the context of machine learning or AI models. The "training set" for this product would be the historical data and expertise used in developing the formulation and manufacturing process of the calibration verification material, and the initial validation batches.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of machine learning. The "ground truth" for developing this product would stem from:
- Analytical chemistry principles: To formulate a stable matrix and spike it with known concentrations of CA 125.
- Method validation expertise: To design studies for value assignment and stability testing.
- Manufacturing and Quality Control standards: To ensure consistency across production lots.
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APR 23 1998
1
,
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1.Submittername,address,contact | Roche Diagnostics/Boehringer Mannheim Corporation4300 Hacienda DrivePleasanton, CA 94566-0900(925) 730 - 8215Fax number: (925) 225 - 0654 |
| Contact Person: Patricia M. Klimley | |
| Date Prepared: April 7, 1998 | |
| 2.Device Name | Proprietary name: Elecsys® CalCheck™ CA 125IICommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.Predicatedevice | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys®CalCheck™ CA 125II is substantially equivalent to the currently marketedElecsys® CalCheck™ TSH. |
| 4.DeviceDescription | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheckCA 125II is manufactured using human serum albumin, CA 125, stabilizers,and preservatives. The analyte is appropriately spiked into the calcheckmatrix to the correct calcheck concentration levels. The calcheck are inprocess checked and quality controlled against ID-GC/MS. |
| 5.Intended use | The Roche Diagnostics/Boehringer Mannheim CorporationElecsys®CalCheck™CA 125II is used to verify the calibration assignment for theRoche Diagnostics/Boehringer Mannheim CorporationElecsys CA 125IIassay. |
| 6.Comparisonto predicatedevice | The Roche Diagnostics/Boehringer Mannheim CorporationElecsys®CalCheck™ CA 125II is substantially euivalent to other products incommercial distribution intended for similar use. Most notably, it issubstantially equivalent to the currently marketed Elecsys® CalCheck™TSH. |
| Both products are intended to be used for the verification of calibration foranalytes on automated immunoassay analyzers. | |
| 7. PerformanceCharacteristics | The Elecsys® CalCheck™ CA 125II was evaluated for value assignment andstability. |
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510(k) Summary, Continued
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 3 1998
Patricia M. Klimley Manager, Elecsys Regulatory Affairs Roche Diaqnostics/Boehringer Manneim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K981278 Elecsys® CalCheck™ CA 125II 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ನ್ನ 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 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 Bitman
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 Corporation Elecsys® CalCheck™ CA 125II
Indications For Use:
Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II 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™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay. . . . . . . . . . . . . . . . . . . . . . . . .
(Division Sign-off)
Division of Clinical Cancer vices
510(k) Number k98 298
(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) |
page 22
§ 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.