(28 days)
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Not Found
No
The summary describes a calibration product for a diagnostic assay, not a device that processes data or makes decisions using AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a CalCheck, intended for the verification of calibration of an assay, not for diagnosis, treatment, or prevention of disease.
No
Explanation: The device is a "CalCheck" used for periodic verification of the calibration of an assay. It does not directly diagnose a patient's condition.
No
The device description explicitly states it is a "lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys® Cortisol CalCheck is not an IVD (In Vitro Diagnostic) device itself, but rather a component used in conjunction with an IVD assay.
Here's why:
- Intended Use: The intended use is "periodic verification of the calibration of the Elecsys® Cortisol assay." This indicates it's a quality control or calibration material, not a device that directly diagnoses a condition or provides a clinical result.
- Device Description: It's described as a "lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative." This is consistent with a calibration or control material, not a diagnostic instrument or test kit.
- Role in the Diagnostic Process: It's used to ensure the accuracy of the Elecsys® Cortisol assay, which is the actual IVD device that measures cortisol levels in patient samples.
Think of it like this: The Elecsys® Cortisol assay is the thermometer that measures the patient's temperature (the diagnostic test). The Elecsys® Cortisol CalCheck is like a known temperature standard used to make sure the thermometer is reading correctly (the calibration/quality control material).
Therefore, while the CalCheck is essential for the proper functioning of the IVD assay, it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The Elecsys® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys® Cortisol CalCheck was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Elecsys® Cortisol CalCheck is substantially equivalent to the currently marketed Elecsys CalCheck TSH.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Coogee
(Division Sign-Off)
Division of Clinical Labora
510(k) Number 4000576
3
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 Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 576 - 3544 |
Contact Person: Kay A. Taylor
Date Prepared: February 18, 2000 |
| Device Name | Proprietary name: Elecsys® Cortisol CalCheck
Common name: Calibration Verification Material
Classification 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. |
:
4
510(k) Summary, Continued
| Intended use | The Elecsys® Cortisol CalCheck is used to verify the calibration of the
Elecsys® Cortisol assay. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
predicate
device | The Elecsys® Cortisol 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® CalCheck™
TSH. |
| | Both products are intended to be used for the verification of calibration for
analytes on the Elecsys® Immunoassay Analyzers. |
| Performance
Characteristics | The Elecsys® Cortisol CalCheck was evaluated for value assignment and
stability. |