(79 days)
Not Found
No
The summary describes a calibration check product for an immunoassay analyzer, which is a standard laboratory control material. There is no mention of AI, ML, or any computational analysis beyond standard immunoassay processing.
No.
The device is a calibration verification product for an immunoassay analyzer and is not intended for the treatment or diagnosis of disease in a patient.
No.
The device is a calibration verification product used to verify the calibration of an immunoassay analyzer. It is not used to diagnose a medical condition in a patient.
No
The device description explicitly states it is a "lyophilized product manufactured using SHBG in human serum/ horse serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys® SHBG CalCheck is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers." This indicates it's used in a laboratory setting to ensure the accuracy of a diagnostic test (the Elecsys® SHBG reagent).
- Device Description: It's a "lyophilized product manufactured using SHBG in human serum/ horse serum matrix." This describes a biological material used for testing purposes.
- Predicate Device: The mention of a predicate device (K020883; Elecsys® proBNP CalCheck) strongly suggests that this device is also regulated as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
While it doesn't directly diagnose a disease, it is a critical component used with an IVD test (the Elecsys® SHBG reagent) to ensure the reliability of the diagnostic results. Devices used for calibration and quality control of IVD tests are themselves considered IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys® SHBG CalCheck was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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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. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 521 - 3723 |
Contact Person: Theresa M. Amrbose
Date Prepared: May 29, 2003 |
| Device Name | Proprietary name: Elecsys® SHBG CalCheck
Common name: Calibration Verification Material
Classification 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. |
:
:
and the comments of the comments of
1
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. |
|---|---|
| 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. |
:
:
1999 - 1999 - 1999
and the comments of the comments of the comments of
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a black and white logo. The logo features a circular arrangement of text around the perimeter, though the text is not legible. Inside the circle, there are three curved lines that appear to be stylized representations of waves or flowing water. There is also a small dot inside the circle.
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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Page 2 –
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