(169 days)
Not Found
No
The summary describes a lyophilized product used for calibration verification, not a device that processes data or images using AI/ML.
No
The device is described as a lyophilized product used for verifying the calibration of a reagent on immunoassay analyzers, indicating it's a calibration control rather than a therapeutic device.
No
The device is described as a "lyophilized product consisting of human anti-TSHR antibodies in human serum matrix" used for "verification of the calibration established by the Elecsys Anti-TSHR reagent." This indicates it's a calibration/quality control material for an immunoassay, not a device that directly diagnoses a patient's condition.
No
The device description explicitly states it is a "lyophilized product consisting of human anti-TSHR antibodies in human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys Anti-TSHR reagent).
- Device Description: The description mentions it's a "lyophilized product consisting of human anti-TSHR antibodies in human serum matrix." This is a typical format for a control or calibrator used in laboratory testing.
- Predicate Device: The predicate device listed, "Elecsys C-Peptide CalCheck," is also a CalCheck product, which are commonly used as IVD calibrators or controls.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and device description clearly align with the definition of an IVD product used in a laboratory setting to ensure the accuracy of a diagnostic test.
N/A
Intended Use / Indications for Use
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys Anti-TSHR CalCheck is a lyophilized product consisting of human anti-TSHR antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
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
The Elecsys Anti-TSHR CalCheck was evaluated for value assignment and Performance Characteristics stability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 2 2008
| 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 |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-2458 | |
| Contact Person: Stephanie Greeman | |
| Date Prepared: March 5, 2008 | |
| Device Name | Proprietary name: Elecsys Anti-TSHR CalCheck |
| Common name: Anti-TSHR CalCheck | |
| Classification name: Single (specified) analyte controls (assayed and unassayed) | |
| Predicate device | The Elecsys Anti-TSHR CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck (K040157). |
| Device Description | The Elecsys Anti-TSHR CalCheck is a lyophilized product consisting of human anti-TSHR antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Continued on next page |
510(k) Summary
1
510(k) Summary, Continued
Comparison Table
The table below compares Elecsys Anti-TSHr CalCheck with the predicate device, Elecsys C-Peptide Calcheck (K040157).
| Characteristic | Elecsys C- Peptide CalCheck
(K040157) | Elecsys Anti-TSHR CalCheck |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the
calibration established by the
Elecsys C-Peptide reagent on the
indicated Elecsys and cobas e
immunoassay analyzers. | For use in the verification of the
calibration established by the Elecsys
Anti-TSHR reagent on the indicated
Elecsys and cobas e immunoassay
analyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mL
distilled or deionized water and
allow standing closed for 15
minutes, then mixing gently. | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20 - 25°C : 4 hrs | Unopened:
• Store at 2-8°C until expiration date
Reconstituted:
• 15 - 25°C : 5 hrs |
| Matrix | equine serum matrix | Human serum |
The Elecsys Anti-TSHR CalCheck was evaluated for value assignment and Performance Characteristics stability. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with an emblem in the center. The emblem features a stylized bird with outstretched wings, resembling an eagle or a similar avian creature. The bird is depicted in a minimalist, abstract style. Encircling the emblem is text, which appears to be part of the seal's official designation. The seal is rendered in black and white, giving it a formal and official appearance.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics c/o Ms. Stephanie Greeman 9115 Hague Road Indianapolis, IN 46250
AUG 2 2 2008
Re: K080643
Trade Name: Elecsys Anti-TSHR CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Codes: JJX Dated: July 29, 2008 Received: July 31, 2008
Dear Ms. Greeman:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
Device Name: Elecsys Anti-TSHR CalCheck
Indication For Use:
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
CA
Division Sign-Off Office of/In Vitro Diagnostic Device Evaluation and Safety
510(k) /C080643