(169 days)
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.
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.
The provided text describes the 510(k) premarket notification for the Elecsys Anti-TSHR CalCheck, a quality control material. However, it does not contain detailed information regarding acceptance criteria, specific study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence to a predicate device (Elecsys C-Peptide CalCheck K040157) based on intended use, levels, format, handling, and stability. While it mentions that "The Elecsys Anti-TSHR CalCheck was evaluated for value assignment and Performance Characteristics stability," it does not provide the results of these evaluations or specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be inferred or stated based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (The document mentions evaluation for "value assignment and Performance Characteristics stability" but does not report the results or specific criteria met.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. The study was conducted by Roche Diagnostics, but the origin of the samples (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a quality control material for an immunoassay analyzer. The "ground truth" for a quality control material typically refers to its assigned value and stability characteristics, which are determined through laboratory testing and characterization. It does not typically involve human expert interpretation in the same way an imaging diagnostic device might. Therefore, the concept of "experts establishing ground truth" in this context is not directly applicable, and no information on such experts is provided.
4. Adjudication method for the test set
- Not applicable as this is a quality control material and not a diagnostic algorithm requiring human adjudication of test results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This is a quality control material, not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a quality control material (like Elecsys Anti-TSHR CalCheck) would be its assigned values for the analyte, determined through rigorous laboratory characterization and potentially traceability to reference materials. The document states it was "evaluated for value assignment," implying this type of ground truth was established by the manufacturer.
8. The sample size for the training set
- Not applicable. This is a quality control material, not an AI or machine learning algorithm that requires a training set. The "samples" described would be batches of the CalCheck material itself, which are characterized for their properties.
9. How the ground truth for the training set was established
- Not applicable, as no training set for an algorithm is involved.
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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-2458 |
| 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
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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 thecalibration established by theElecsys C-Peptide reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | For use in the verification of thecalibration established by the ElecsysAnti-TSHR reagent on the indicatedElecsys and cobas e immunoassayanalyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mLdistilled or deionized water andallow standing closed for 15minutes, then mixing gently. | Same |
| Stability | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20 - 25°C : 4 hrs | Unopened:• Store at 2-8°C until expiration dateReconstituted:• 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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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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
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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
§ 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.