The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Description

The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Elecsys T4 CalCheck 5, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Elecsys T3 CalCheck 5) rather than explicitly stating specific numerical acceptance criteria for the Elecsys T4 CalCheck 5. However, the performance characteristics section mentions "value assignment and stability" as evaluation points. From the comparison table with the predicate, we can infer some targets or expected ranges for "Check Target Values" and "Assay Measuring Range".

Characteristic	Acceptance Criteria (Inferred from Predicate/Device Spec.)	Reported Device Performance (Assumed to meet, since cleared)
Intended Use	Assayed control for calibration verification and assay range verification for Elecsys T4 reagent on Elecsys and cobas e immunoassay analyzers.	Meets the stated intended use.
Analyte	Thyroxine (T4)	Contains Thyroxine (T4).
Number of Levels	Five	Five levels provided.
Assay Measuring Range	5.40 - 320 nmol/L	The device is designed to verify this range.
Check Target Values	Check 1: <0.78 ug/dL, <10 nmol/L	The device provides these target values.
	Check 2: 7.77 ug/dL, 100 nmol/L
	Check 3: 12.43 ug/dL, 160 nmol/L
	Check 4: 19.42 ug/dL, 250 nmol/L
	Check 5: 24.86 ug/dL, 320 nmol/L
Format	Lyophilized	Lyophilized.
Handling	Reconstitution with 1.0 mL distilled/deionized water, stand 15 min, mix gently.	Designed for this handling procedure.
Stability (Unopened)	Store at 2-8°C until expiration date.	Meets this stability requirement.
Stability (Reconstituted)	20-25°C: 4 hours.	Meets this stability requirement.
Matrix	Check 1: BSA/Buffer matrix; Checks 2-5: Human serum.	Utilizes these matrices.
Traceability	Traceable to reference method ID-GC/MS using serum/plasma samples.	Traceable as described.
Value Assignment	(Implicit: Values accurately assigned for each level)	Evaluated.
Stability	(Implicit: Stable over specified conditions)	Evaluated.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the performance evaluation (test set). It only mentions that the device "was evaluated for value assignment and stability."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "traceability" section mentions "standardized against reference standards by weighing T3" for the predicate and "Thyroxine is traceable to the reference method ID-GC/MS using serum/plasma samples as reference material" for the candidate device. This suggests a more analytical approach to establishing ground truth rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. The study described is not one where human interpretation of results would require adjudication.

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

Not applicable. This device is a calibration and assay verification material, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This would also not be applicable in the context of this device. The device itself is the "algorithm" or control material for other assays. The performance evaluated would be of the control material itself, not an algorithm's output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the Elecsys T4 CalCheck 5 is based on traceability to a reference method: "Thyroxine is traceable to the reference method ID-GC/MS using serum/plasma samples as reference material." This indicates that the "true" concentration of T4 in the control levels was determined using a highly accurate and precise analytical method (Isotope Dilution Gas Chromatography/Mass Spectrometry).

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning. The evaluation would have involved multiple runs or lots of the control material, but the term "training set" is not relevant here.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" with established ground truth is not applicable to a medical device that is a quality control material. The "ground truth" for the control material's concentrations is established through its traceability to a reference method (ID-GC/MS).

Summary

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K11a528

OCT 1 8 2011

510(k) Summary	OCT 1 8 2011
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: Michael Leuther, Ph.D.Phone: 317-521-3930Fax: 317-521-2324Email: michael.leuther@roche.com
	Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com
	Date Prepared: August 29, 2011
Device Name	Proprietary name: Elecsys T4 CalCheck 5Common name: T4 CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed)
Predicatedevice	The Elecsys T4 CalCheck 5 is substantially equivalent to other products incommercial distribution intended for similar use. We claim equivalency to thecurrently marketed Elecsys T3 CalCheck 5 (K111552).
DeviceDescription	The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 inhuman serum matrix. During manufacture, the analyte is spiked into thematrix at the desired concentration levels.
Intended use	The Elecsys T4 CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys T4 reagent on the indicated Elecsys and cobas e immunoassayanalyzers, for in vitro diagnostic use only.

Continued on next page

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510(k) Summary, Continued

The table below compares Elecsys T4 CalCheck 5 with the predicate device, Comparison Table Elecsys T3 CalCheck 5 (K111552). The predicate shows that T4 CalCheck 5 is substantially equivalent to T3 CalCheck 5, with several key similarities. The shaded fields indicate similar characteristics between the candidate

device and the predicate device.

Characteristic	Elecsys T3 CalCheck 5(Predicate Device, K111552)	Elecsys T4 CalCheck 5(Candidate Device)
Intended 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 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers.	The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Analyte	Triiodothyronine (T3)	Thyroxine (T4)
Levels	Five	Five
Assay Measuring Range	0.300 - 10.0 nmol/L	5.40 - 320 nmol/L
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: <0.78ug/dL, <10 nmol/LCheck 2: 7.77ug/dL, 100 nmol/LCheck 3: 12.43ug/dL, 160 nmol/LCheck 4: 19.42ug/dL, 250 nmol/LCheck 5: 24.86ug/dL, 320 nmol/L
Format	Lyophilized	Lyophilized
Handling	Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion.	Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion.
Stability	Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20-25°C: 4 hours	Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20-25°C: 4 hours
Matrix	Human Serum matrix	Check 1: BSA/Buffer matrixChecks 2-5: Human serum
Traceability	The assayed value of each CalCheck level was standardized against reference standards by weighing T3 into an analyte free	Thyroxine is traceable to the reference method ID-GC/MS using serum/plasma samples as reference material

Performance Characteristics

The Elecsys T4 CalCheck 5 was evaluated for value assignment and stability.

. .

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring. MD 20993

OCT 1 8 2011

Roche Diagnostics c/o Dr. Michael Leuther Manager, Regulatory Affairs 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

K112528 Trade Name: Elecsys T4 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: August 30, 2011 Received: August 31, 2011

Dear Dr. Leuther:

Re:

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 vour 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); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric' s (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, 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): Kll 2528

Device Name: Elecsys T4 CalCheck 5

Indication For Use:

Prescription Use __ X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Qus

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112528

Page 1 of 1

Regulation Number and Section

§ 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.