ELECSYS CORTISOL CALCHECK by ROCHE DIAGNOSTICS CORP.

The Elecsys® Cortisol CalCheck is a lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

AI/ML Overview

This document is a 510(k) premarket notification for the Elecsys® Cortisol CalCheck, a quality control material. It describes the device's indications for use, its substantial equivalence to a predicate device, and some performance characteristics. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria vs. performance, sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth.

Therefore, I cannot fulfill the request as the detailed information about acceptance criteria, study design, and performance metrics are not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

If this were a study report, the typical information would include:

A table of acceptance criteria and the reported device performance: This would list quantitative thresholds (e.g., accuracy > 95%, CV < 5%) and the actual values achieved by the device.
Sample size used for the test set and the data provenance: This would state the number of samples, their origin (e.g., specific hospitals, geographic regions), and whether the data was collected prospectively or retrospectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would specify how many experts, their specialties (e.g., clinical chemists, endocrinologists), and their experience levels.
Adjudication method for the test set: This would describe the process of resolving disagreements among experts when establishing ground truth (e.g., a 2+1 system where two agree or a third expert decides, or simple majority).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: If applicable, this would detail the design of such a study and the measured improvement in human reader performance with the device's assistance.
If a standalone performance study was done: This would describe the results of the device operating independently without human intervention.
The type of ground truth used: For a quality control material, this might involve certified reference materials or established laboratory methods.
The sample size for the training set: (If it were an AI/ML device)
How the ground truth for the training set was established: (If it were an AI/ML device)

The document provided focuses on regulatory substantial equivalence, which assesses if a new device is as safe and effective as a legally marketed predicate device. It mentions "Performance Characteristics" related to "value assignment and stability" for the CalCheck, but does not provide the specific data or a study design.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, suggesting a sense of community and care. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2016

ROCHE DIAGNOSTICS CORP. KAY TAYLOR 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS IN 46250-0457

RE: K000576

Trade/Device Name: Elecsys Cortisol CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJX Dated: February 18, 2000 Received: February 22, 2000

Dear Ms. Taylor:

This letter corrects our substantially equivalent letter of March 21, 2000.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Katherine Serrano" in a large, bold font. Below the name, there is a large letter "S" on the left side. In the background, there is a faint, stylized logo that appears to be the FDA logo.

For :

Courtney H. Lias Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): NIA 40005 74

Device Name: Elecsys® Cortisol CalCheck

Indications For Use:

Elecsys® Cortisol CalCheck calibration verification solutions comprise three levels low, mid, and high - each with a defined Cortisol concentration. The low solution low, lind, and migh - caen with a stection limit of the assay. The middle solution is in the concentration is near the lower actooint of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Coogee

(Division Sign-Off)
Division of Clinical Labora
510(k) Number 4000576

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K000576

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	Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 576 - 3544Contact Person: Kay A. TaylorDate Prepared: February 18, 2000
Device Name	Proprietary name: Elecsys® Cortisol CalCheckCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed)
Predicate device	The Elecsys® Cortisol CalCheck is substantially equivalent to the currently marketed Elecsys CalCheck TSH.
Device Description	The Elecsys® Cortisol CalCheck is a lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

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510(k) Summary, Continued

Intended use	The Elecsys® Cortisol CalCheck is used to verify the calibration of theElecsys® Cortisol assay.
Comparison topredicatedevice	The Elecsys® Cortisol CalCheck is substantially equivalent to other productsin commercial 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® Cortisol CalCheck was evaluated for value assignment andstability.

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.