(17 days)
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.
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.
The provided text describes the 510(k) summary for the Elecsys® CalCheck™ Vitamin B12, a calibration verification material. This device is not an AI/ML powered device, and thus many of the requested fields are not applicable (N/A) for this type of product. The information focuses on its intended use for verifying the calibration of a Vitamin B12 assay and its substantial equivalence to a predicate device, Elecsys® CalCheck™ TSH.
Here's an analysis of the provided text with respect to your requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as would be expected for a diagnostic device predicting an outcome. Instead, it states the device "was evaluated for value assignment and stability." The performance reported is that it "comprise[s] three levels - low, mid, and high - each with a defined Vitamin B12 concentration" and that these levels are positioned appropriately relative to the clinical deficiency range and the measuring range of the assay. This implies the acceptance criteria would be that the assigned values for low, mid, and high fall within specified ranges relative to the associated Elecsys Vitamin B12 assay's performance characteristics, and that the product remains stable over its shelf life. However, the specific numerical values or ranges are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Defined Vitamin B12 concentrations at low, mid, and high levels. | The Elecsys CalCheck Vitamin B12 comprises three levels - low, mid, and high - each with a defined Vitamin B12 concentration. |
| Low concentration near the clinical deficiency range. | The low solution concentration is near the clinical deficiency range of the assay. |
| Mid concentration in the middle point of the measuring range. | The mid solution is in the middle point of the measuring range. |
| High concentration near the upper limit of the measuring range. | The high solution is near the upper limit of the measuring range. |
| Stability of the material. | The Elecsys® CalCheck™ Vitamin B12 was evaluated for value assignment and stability. (Specific stability data or acceptance criteria for stability are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test set or the data provenance. It mentions "Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5," but this attachment is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a calibration verification material, not a diagnostic device that requires expert interpretation for a "ground truth" diagnosis in the clinical sense. The "ground truth" for this device relates to the accurately assigned concentrations of Vitamin B12 within the material, which would be established through metrological traceability and standard laboratory methods, not expert consensus on medical images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a calibration verification material.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML powered device, nor a diagnostic device requiring human reader interpretation in the context of a clinical study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device or an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this product would be the assigned analyte concentrations derived from reference methods or traceable standards. The document states: "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." This indicates an analytical ground truth based on spiking and internal quality control.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set.
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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 Corporation4300 Hacienda DrivePleasanton, CA 94588-2722(510) 730-8215Fax number: (510)-225-0654Contact Person: Patricia M. KlimleyDate Prepared: November 14, 1997 |
| 2.Device Name | Proprietary name: Elecsys® CalCheck™ Vitamin B12Common name: Calibration Verification MaterialClassification 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 |
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510(k) Summary, Continued
| 5.Intended use | The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is used toverify the calibration assignment for the Boehringer Mannheim ElecsysVitamin B12 assay. | ||
|---|---|---|---|
| 6.Comparison topredicatedevice | The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 issubstantially equivalent to other products in commercial distribution intendedfor similar use. Most notably, it is substantially equivalent to the currentlymarketed Elecsys® CalCheck™ TSH Calibration Verification Test(K963147). | ||
| Both products are intended to be used for the verification of calibration foranalytes on automated immunoassay analyzers. | |||
| The following table compares the Elecsys® CalCheck™ Vitamin B12 withthe predicate device, Elecsys® CalCheck™ TSH. Specific data on theperformance of the test have been incorporated into the draft labeling inattachment 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: | |||
| FeatureMatrix typeAnalyte | CalCheck Vitamin B12Human serum albuminVitamin B12 | CalCheck TSHHorse serumTSH | |
| 7. PerformanceCharacteristics | The Elecsys® CalCheck™ Vitamin B12 was evaluated for value assignmentand 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
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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
§ 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.