(54 days)
The Elecsys® CalCheck IgE is intended for use in periodic verification of the calibration of the Elecsys IgE assay.
The Elecsys CalCheck IgE is manufactured using a human serum matrix, human IgE, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
The provided text is a 510(k) summary for the "Elecsys CalCheck IgE" device, which is a calibration verification material. This type of device does not typically involve the complex clinical studies or AI performance metrics requested in the prompt. Therefore, several of the requested categories are not applicable or cannot be extracted from this document.
Here's an attempt to answer the questions based on the provided text, while noting limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Elecsys® CalCheck IgE was evaluated for value assignment and stability." However, specific quantitative acceptance criteria or detailed performance data for "value assignment" and "stability" are not provided in this 510(k) summary. These would typically be found in a more detailed study report or in the submission itself, not necessarily summarized in the public 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided 510(k) summary. For a calibration verification material, the "test set" would refer to the samples used during the validation of the material's properties (value assignment, stability). The document does not specify the number of samples or their origin (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This is not applicable for a calibration verification material. Ground truth in this context would likely refer to the assigned values of the IgE concentrations, which are determined through a manufacturing and assay process, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable for a calibration verification material. Adjudication typically refers to resolving discrepancies in expert interpretations, which isn't relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This is not applicable. An MRMC study assesses the performance of human readers, with or without AI assistance, on diagnostic tasks. The "Elecsys CalCheck IgE" is a calibration material, not a diagnostic imaging or interpretive device that human readers would use in this way.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a physical calibration material, not an algorithm.
7. The Type of Ground Truth Used
For a calibration verification material, the "ground truth" would be the assigned target values for the IgE concentrations within the CalCheck IgE material. These values are established through the manufacturing process and metrology, not typically through expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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· FEB 2 1999
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
. K9 84419
ﻫ
| 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. |
| Submitter name, address, contact | Boehringer Mannheim Corporation9115 Hague RoadIndianapolis, IN 46250(317) 845 - 3723 |
| Contact Person: Priscilla A. Hamill | |
| Date Prepared: December 9, 1998 | |
| Device Name | Proprietary name: Elecsys CalCheck IgE |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| Predicate device | The Elecsys CalCheck IgE is substantially equivalent to the currently marketed Elecsys CalCheck TSH. |
| Device Description | The Elecsys CalCheck IgE is manufactured using a human serum matrix, human IgE, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels. |
Continued on next pageﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
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510(k) Summary, Continued
| Intended use | The Elecsys® CalCheck IgE is used to verify the calibration assignment forthe Elecsys IgE assay. |
|---|---|
| Comparison topredicatedevice | The Elecsys® CalCheck™ IgE is substantially equivalent 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 the Elecsys immunoassay analyzers. | |
| PerformanceCharacteristics | The Elecsys® CalCheck IgE was evaluated for value assignment andstability. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its head and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
FEB ■ 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K984419 Re: Trade Name: Elecsys CalCheck IgE Regulatory Class: I Product Code: JJY Dated: January 20, 1999 Received: January 25, 1999
Dear Ms. Hamill:
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 legally marketed predicate 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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 regulations.
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Page 2
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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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8984419 510(k) Number (if known): N/A
Device Name: Elecsys® CalCheck IgE
Indications For Use:
Elecsys CalCheck IgE calibration verification solutions comprise three levels - low, mid, and Elecsys CalCheck IgE concentration. The low solution concentration is near the lower mgn - cach with a domicalle 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 IgE is intended for use in periodic verification of the calibration of the Elecsys IgE assay.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices ¥984419
510(k) Number
§ 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.