(48 days)
The Elecsys T3 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys T3 CalCheck 5, an assayed control for use in calibration verification and assay range verification on Elecsys and cobas e immunoassay analyzers. However, the document provided is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.
Therefore, much of the requested information, such as detailed acceptance criteria with reported device performance values, sample sizes for test and training sets, expert qualifications, and specific study designs (MRMC, standalone), is not explicitly available in this summary.
Here's a breakdown of what can be extracted and what is missing:
-
Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a typical performance study. Instead, it compares the characteristics of the candidate device (Elecsys T3 CalCheck 5) with a predicate device (Elecsys T3 CalCheck, K963167) to demonstrate substantial equivalence.
The "Performance Characteristics" section only states: "The Elecsys T3 CalCheck 5 was evaluated for value assignment and stability." It does not provide the results of these evaluations or specific acceptance criteria for them.
Characteristic Elecsys T3 CalCheck 5 (Candidate Device) Elecsys T3 CalCheck (K963167) Acceptance Criteria (not explicitly stated in document) Reported Device Performance (not explicitly stated in document) Intended Use Assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For use in the verification of the calibration established by the Elecsys T3 regent on indicated Elecsys and cobas e immunoassay analyzers. Equivalent to predicate Equivalent Analyte T3 T3 Identical to predicate Identical Levels Five Three Acceptable difference Five levels Assay Measuring Range 0.300 - 10.0 nmol/L 0.300 - 10.0 nmol/L Identical to predicate Identical Check Target Values Check 1: ≤ 0.2 nmol/LCheck 2: 2.0 nmol/LCheck 3: 5 nmol/LCheck 4: 8 nmol/LCheck 5: 10 nmol/L Check 1: 0 ng/mlCheck 2: 1.6 ng/mlCheck 3: 5.8 ng/ml Within expected range Specified values Format Lyophilized Lyophilized Identical to predicate Identical Handling Reconstitute with 1.0 mL distilled or deionized water, stand 15 minutes, mix gently. Reconstitute with 1.0 mL distilled or deionized water, stand 15 minutes, mix gently. Equivalent to predicate Equivalent Stability (Unopened) Store at 2-8°C until expiration date Store at 2-8°C until expiration date Identical to predicate Identical Stability (Reconstituted) 20-25°C: 4 hours 15-25°C: 4 hours Within acceptable range 20-25°C: 4 hours Matrix Human serum matrix Human serum matrix Identical to predicate Identical -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "value assignment and stability" evaluations but does not detail the methodology, sample sizes, or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a quality control material for an immunoassay, not an AI/imaging device requiring expert interpretation for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and study description.
-
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
Not applicable. This device is a quality control material, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a quality control material, not an algorithm. The "performance" here refers to the chemical and physical characteristics of the control material (value assignment, stability) rather than diagnostic accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" for value assignment would typically be established through reference methods or highly calibrated and validated primary assays on the manufacturing end. The document does not specify the exact methods for value assignment, only that it was "evaluated for value assignment."
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The sample size for the training set
Not applicable. This device is a quality control material, not an AI model that requires a training set.
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How the ground truth for the training set was established
Not applicable.
In summary, the provided 510(k) document is for a medical device (a quality control material) that does not involve AI or human interpretation in the way that would necessitate the study details requested in questions 2-9. Its clearance is based on substantial equivalence to a predicate device, focusing on similar intended use, analyte, matrix, and performance characteristics (which are not fully detailed in this summary). The "studies" mentioned refer to evaluations of the product's physicochemical properties (value assignment and stability) rather than clinical performance or diagnostic accuracy.
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| JUL 2 1 2011 | |
|---|---|
| 510(k) Summary | K111552 |
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3577 |
| Contact Person: Kelly FrenchPhone: 317-521-3208Fax: 317-521-2324Email: kelly.french@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: June 2, 2011 | |
| Device Name | Proprietary name: Elecsys T3 CalCheck 5Common name: T3 CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys T3 CalCheck 5 is substantially equivalent to other products incommercial distribution intended for similar use. We claim equivalency to thecurrently marketed T3 CalCheck (K963167). |
| DeviceDescription | The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 inhuman serum matrix. During manufacture, the analyte is spiked into thematrix at the desired concentration levels. |
| Intended use | The Elecsys T3 CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobase immunoassay analyzers, for in vitro diagnostic use only. |
Continued on next page
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510(k) Summary, Continued
The table below compares Elecsys T3 CalCheck 5 with the predicate device, Comparison Elecsys T3 CalCheck (K963167). The predicate shows that T3 CalCheck 5 is Table substantially equivalent to T3 CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.
| Characteristic | Elecsys T3 CalCheck 5(Candidate Device) | Elecsys T3 CalCheck(K963167) |
|---|---|---|
| Intended Use | The Elecsys T3 Calcheck 5is an assayed control foruse in calibrationverification and for use inthe verification of theassay range established bythe Elecsys T3 quantitativeassay reagent on theindicated Elecsys andcobas e immunoassayanalyzers. | For use in the verification ofthe calibration established bythe Elecsys T3 regent onindicated Elecsys and cobas eimmunoassay analyzers. |
| Analyte | T3 | T3 |
| Levels | Five | Three |
| Assay MeasuringRange | 0.300 - 10.0 nmol/L | 0.300 - 10.0 nmol/L |
| Check TargetValues | Check 1: ≤ 0.2 nmol/LCheck 2: 2.0 nmol/LCheck 3: 5 nmol/LCheck 4: 8 nmol/LCheck 5: 10 nmol/L | Check 1: 0 ng/mlCheck 2: 1.6 ng/mlCheck 3: 5.8 ng/ml |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1,Check 2, Check 3, Check4, and Check 5 withexactly 1.0 mL distilled ordeionized water. Allow tostand closed for 15minutes, then mix gentlyby inversion. | Reconstitute Check 1, Check2, and Check 3 with exactly1.0 mL distilled or deionizedwater. Allow to stand closedfor 15 minutes, then mixgently by inversion. |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 15-25°C: 4 hours |
| Matrix | Human serum matrix | Human serum matrix |
Continued on next page
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510(k) Summary, Continued
Performance The Elecsys T3 CalCheck 5 was evaluated for value assignment and Characteristics stability.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with stylized feathers.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 2 1. 2011
Roche Diagnostics c/o Ms. Kelly French Manager, Regulatory Affairs 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
Re: k11552
·
Trade Name: Elecsys T3 CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: June 2, 2011 Received: June 3, 2011
Dear Ms. French:
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 10 woo varior 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 Acts 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. 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):
KIII FRA
Device Name: Elecsys T3 CalCheck 5
Indication For Use:
The Elecsys T3 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use X (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 (OIVD)
Richard Glenn Coffey
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 111 552
§ 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.