The Elecsys PTH 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 PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

Device Description

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

AI/ML Overview

The provided text describes the Elecsys PTH CalCheck 5, an assayed control used for calibration verification and assay range verification. It is not an AI/ML-driven medical device, but rather a control material for laboratory instruments. Therefore, many of the requested criteria related to AI/ML device testing (e.g., sample sizes for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models) are not applicable to this product.

The performance evaluation described focuses on "value assignment and stability" of the control material, and its substantial equivalence to a predicate device.

However, I can extract information relevant to the acceptance criteria and the study proving it meets these criteria, interpreting them within the context of a laboratory control product rather than an AI/ML diagnostic tool.

Acceptance Criteria for Elecsys PTH CalCheck 5 (Implicit via Comparison to Predicate):

The acceptance criteria for the Elecsys PTH CalCheck 5 are primarily established by demonstrating its substantial equivalence to the predicate device, Elecsys PTH CalCheck (K993642). This means the new device must perform comparably for its intended use, analyte, format, and matrix, and meet or exceed the performance characteristics of the predicate, particularly regarding stability and the ability to serve its control function.

While explicit numerical acceptance criteria are not provided in the text for performance, the comparison table implies that the new device's characteristics must align well with the predicate.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is the performance evaluation of the Elecsys PTH CalCheck 5, which included "value assignment and stability." The core of this proof lies in the detailed comparison with the predicate device.

Table 1: Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria are not stated for all aspects, the table below reflects the characteristics compared between the candidate and predicate devices, implying these characteristics form the basis of "acceptance" for substantial equivalence. "Reported Device Performance" here refers to the characteristics of the Elecsys PTH CalCheck 5.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Elecsys PTH CalCheck 5)
Intended Use	Periodic verification of calibration of the Elecsys Parathyroid Hormone test.	An assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only. (Broader scope than predicate)
Analyte	PTH	PTH
Levels	Three	Five (Increased levels compared to predicate)
Assay Measuring Range	1.20 - 5000 pg/mL	1.20 - 5000 pg/mL
Check Target Values	Check 1: < 5 pg/mL, Check 2: 60 pg/mL, Check 3: 3000 pg/mL	Check 1: ≤ 1 pg/mL, Check 2: 60 pg/mL, Check 3: 2500 pg/mL, Check 4: 4000 pg/mL, Check 5: 5000 pg/mL (More targets and different specific values for some checks)
Format	Lyophilized	Lyophilized
Handling	Reconstitute with 1.0 mL distilled/deionized water, stand 15 min, mix gently.	Reconstitute with exactly 1.0 mL distilled/deionized water, stand 15 min, then mix gently by inversion. (Similar with minor wording differences)
Unopened Stability	Store at 2-8°C until expiration date.	Store at 2-8°C until expiration date.
Reconstituted Stability	20-25°C: 4 hours	20-25°C: 5 hours (Improved stability compared to predicate)
Matrix	Human serum matrix	Human serum matrix

Since this is a control material and not an AI/ML medical device, the following points are not applicable or the information is not provided in the document:

Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The performance evaluation mentioned generally involves laboratory testing of the control material, but specific sample sizes (e.g., number of batches, number of replicates) are not detailed in this summary for "value assignment and stability." The data provenance would be internal laboratory testing, likely based in the US (Indianapolis, IN, where Roche Diagnostics is located). It would be prospective testing of the manufactured control lots.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a control material is established through precise analytical methods during manufacturing and assay validation, not typically by expert human interpretation in the way AI/ML diagnostics are evaluated.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a control material, the "ground truth" (or reference value) for the PTH concentration in each check level is established during the manufacturing process through quantitative analytical methods and confirmed through a process of value assignment. This is an objective, quantitative measurement, not based on expert consensus, pathology, or outcomes data.
The sample size for the training set: Not applicable. There is no AI/ML model to train.
How the ground truth for the training set was established: Not applicable.

Summary

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K103162

NOV 1 8 2010

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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3577 Contact Person: Kelly French Phone: 317-521-3208 Fax: 317-521-2324 Email: kelly.french@roche.com Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com Date Prepared: October 11, 2010 Device Name Proprietary name: Elecsys Parathyroid Hormone CalCheck 5 Common name: PTH CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassaved) Predicate The Elecsys PTH CalCheck 5 is substantially equivalent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed PTH CalCheck (K993642). Device The Elecsys PTH CalCheck 5 is a lyophilized product consisting of human Description PTH in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys PTH 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 PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

510(k) Summary

Continued on next page

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510(k) Summary, Continued

Comparison Table

The table below compares Elecsys PTH CalCheck 5 with the predicate device, Elecsys PTH CalCheck (K993642). The predicate shows that PTH CalCheck 5 is substantially equivalent to PTH CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.

Characteristic	Elecsys PTH CalCheck5(Candidate Device)	Elecsys PTH CalCheck(K993642)
Intended Use	The Elecsys PTh Calcheck5 is an assayed control foruse in calibrationverification and for use inthe verification of theassay range established bythe Elecsys PTHquantitative assay reagenton the indicated Elecsysand cobas e immunoassayanalyzers. For in vitrodiagnostic use only.	For use in periodicverification of the calibrationof the Elecsys ParathyroidHormone test.
Analyte	PTH	PTH
Levels	Five	Three
Assay MeasuringRange	1.20 - 5000 pg/mL	1.20 - 5000 pg/mL
Check TargetValues	Check 1: ≤ 1 pg/mLCheck 2: 60 pg/mLCheck 3: 2500 pg/mLCheck 4: 4000 pg/mLCheck 5: 5000 pg/mL	Check 1: < 5 pg/mLCheck 2: 60 pg/mLCheck 3: 3000 pg/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: 5 hours	Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours
Matrix	Human serum matrix	Human serum matrix

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Performance The Elecsys PTH CalCheck 5 was evaluated for value assignment and Characteristics stability.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

. '

Roche Professional Diagnostics c/o Ms. Kelly French, Regulatory Affairs Consultant 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Re: K103162

NOV 1 8 2010

Trade/Device Name: Elecsys PTH CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: 26 October, 2010 Received: 27 October, 2010

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 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 class II (Special Controls), 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 not 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). 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.

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Page 2

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 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Signature

Courtney C. 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

NQV. 1 8 2010

K103162 510(k) Number (if known):

Device Name: Elecsys PTH CalCheck 5

Indication For Use:

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 (OVD)

Carol C. Benson

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

510(k) K103162

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.