(79 days)
The Elecsys® SHBG CalCheck is intended for use in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys® SHBG CalCheck is a lyophilized product manufactured using SHBG in human serum/ horse serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels.
The provided text describes a medical device called "Elecsys® SHBG CalCheck," a calibration verification material. However, the document does not contain specific acceptance criteria or a detailed study demonstrating how the device meets such criteria.
The text focuses on the 510(k) submission process, stating the device's intended use, its substantial equivalence to a predicate device, and the regulatory approval. It mentions that "Performance Characteristics" were evaluated for "value assignment and stability," but it does not provide the results of these evaluations or any numerical acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as this information is not present in the provided text.
The provided text primarily serves as a regulatory approval document (510(k) summary and FDA clearance letter) and does not detail the technical performance study itself.
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AUG 2 0 2003 -
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. |
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| Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250521 - 3723Contact Person: Theresa M. AmrboseDate Prepared: May 29, 2003 |
| Device Name | Proprietary name: Elecsys® SHBG CalCheckCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| Predicate device | The Elecsys® SHBG CalCheck is substantially equivalent to the currently marketed Elecsys® proBNP CalCheck (K020883). |
| Device Description | The Elecsys® SHBG CalCheck is a lyophilized product manufactured using SHBG in human serum/ horse serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels. |
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and the comments of the comments of
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510(k) Summary, Continued
| Intended use | The Elecsys® SHBG CalCheck is used in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. |
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| Comparison to predicate device | The Elecsys® SHBG CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® proBNP CalCheck (K020883). |
| Performance Characteristics | The Elecsys® SHBG CalCheck was evaluated for value assignment and stability. |
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1999 - 1999 - 1999
and the comments of the comments of the comments of
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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AUG 2 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, Ph.D., FACB Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250
Re: K031698
Trade/Device Name: Elecsys® SHBG CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: August 5, 2003 Received: August 6, 2003
Dear Dr. Ambrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K031698 510(k) Number (if known): N/A
Device Name: Elecsys® SHBG CalCheck
Indications For Use:
Elecsys® SHBG CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined SHBG concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® SHBG CalCheck is intended for use in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
Carol C Benam for Jean Cooper, ORM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 63/698
§ 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.