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

Device Description

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

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Elecsys LH CalCheck 5, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Value Assignment	On Master Platform (MODULAR ANALYTICS E170): - Assigned range: ±30% of the assigned value for levels 2-5. - % CV: ≤10% for levels 2-5 (level 1 free of analyte). (For other non-master analyzers: Elecsys 2010, cobas e 411, cobas e 601, cobas e 602): - Median value on additional analyzers must be within 10% of the master platform assigned value.	Value assignment testing was conducted and must pass pre-defined acceptance criteria. The text states: "After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the..." implying successful performance. The exact performance values are not explicitly stated, but the passing of criteria is confirmed.
Open-Vial Stability	Reconstituted product stable up to 4 hours at 20-25°C.	"Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys LH CalCheck 5 is stable up to 4 hours at 20-25°C."
Shelf-Life Stability	Initial shelf-life claim of 18 months at 2-8°C. (Real-time testing ongoing for 36 months claim).	"The accelerated stability testing performed at 35℃ supports an initial shelflife claim of 18 months at 2-8°C."

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

Sample Size: Not explicitly stated as a single "test set" in the traditional sense for algorithm evaluation.
- For Value Assignment: "at least 6 determinations" (duplicate runs on at least 3 analyzer measuring cells) for each CalCheck level. This was done for the master platform and for each of the four additional analyzer platforms.
- For Stability: The sample size for real-time and accelerated stability testing (number of lots, vials, or replicates) is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted internally by Roche Diagnostics. This appears to be prospective data generated specifically for device validation.

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

This device is a control material, not a diagnostic algorithm that interprets complex data. Therefore, the concept of "ground truth" derived from expert consensus by radiologists or similar specialists is not applicable. The "ground truth" here is the assigned value and stability of the control, which is determined through rigorous laboratory testing protocols executed by skilled laboratory personnel using standardized methods and instruments.

4. Adjudication Method for the Test Set

Not applicable as this is not an expert-driven adjudication of medical images or patient outcomes. The "adjudication" is inherent in the pre-defined acceptance criteria for the analytical performance of the control material (e.g., median values, % CV, and acceptable deviations between platforms).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a laboratory control material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a standalone product (a control material) whose performance is evaluated analytically, not an "algorithm" in the sense of AI or image analysis. Its performance is its standalone performance in providing accurate and stable target values for calibration verification.

7. The Type of Ground Truth Used

The "ground truth" for the Elecsys LH CalCheck 5 is:

Target Concentration Values: Established by laboratory testing against the 2nd International Standard (NIBSC) 80/552.
Stability: Determined through real-time and accelerated laboratory stability studies.

8. The Sample Size for the Training Set

There is no "training set" in the context of machine learning for this device. The values and performance characteristics are established through analytical testing and standardization, not by training an algorithm on a dataset.

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

As there is no training set for an AI algorithm, this question is not applicable. The device's "ground truth" (its assigned values and stability) is established through precise laboratory measurements and standardization against recognized international reference standards.

Summary

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121279

510(k) Summary

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, P.O. Box 50416 Indianapolis, IN 46250-0416 317-521-3501

Contact Person: K. Colleen Adams Phone: 317-521-3577 Fax: 317-521-2324 Email: colleen.adams@roche.com

Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com

Date Prepared: April 27, 2012

Device Name

Proprietary name: Elecsys LH CalCheck 5 Common name: LH CalCheck 5 Classification: 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed), Product Code: JJX

Predicate device

commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys N-MID Osteocalcin CalCheck 5 (K112104).

The Elecsys LH CalCheck 5 is substantially equivalent to other products in

Device Description

Intended use

Continued on next page

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510(k) Summary, Continued

The table below compares Elecsys LH CalCheck 5 with the predicate devices, Comparison Table Elecsys N-MID Osteocalcin CalCheck 5 (K112104).

Characteristic	Elecsys LH CalCheck 5(Candidate)	Elecsys N-MID OsteocalcinCalCheck 5 (K112104)
Differences
Intended Use	The Elecsys LH Calcheck 5 is anassayed control for use in calibrationverification and for use in theverification of the assay rangeestablished by the Elecsys Myoglobinreagent on the indicated Elecsys andcobas e immunoassay analyzers.	The Elecsys N-MID OsteocalcinCalCheck 5 is an assayed control foruse in calibration verification and foruse in the verification of the assayrange established by the Elecsys N-MID Osteocalcin reagent on theindicated Elecsys and cobas eimmunoassay analyzers.
Analyte	Luteinizing Hormone (LH)	Osteocalcin
Similarities
Matrix	Human serum matrix	Same
Levels	Five	Same
Format	Lyophilized	Same
Handling	Reconstitute Check 1, Check 2, Check3, Check 4, and Check 5 with exactly1.0 mL distilled or deionized water.Allow to stand closed for 15 minutes,then mix gently by inversion.	Same
Stability	Unopened:• Store at 2-8°C until expiration dateOpened:• 20-25°C: 4 hours	Same

Performance Characteristics

The Elecsys LH CalCheck 5 was evaluated for value assignment and stability. See the following sections for details.

Traceability

The Elecsys LH CalCheck 5 was standardized against the 2nd International Standard (NIBSC) 80/552.

Continued on next page

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510(k) Summary, Continued

Value Assignment

ジ

Value assignment testing was conducted and must pass pre-defined acceptance criteria. For each Elecsys LH CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzer measuring cells) of the respective CalCheck. The target value for each CalCheck is the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range is calculated as ±30% of the assigned value for levels 2 through 5. The % CV is 10% for levels 2 through 5, while level 1 is free of the analyte. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use.

To ensure the values assigned using the master platform are transferrable and valid for the other instrument platforms, the same value assignment procedure is performed on the Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 analyzers. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICES E170. The median value obtained on the four additional analyzers must be within 10% of the master platform assigned value (10% for between analyzer platform tolerances). After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers.

Stability

Real-time and accelerated stability tests were conducted to establish the shelflife and open-vial claims.

Open-Vial Stability After Reconstitution:

Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys LH CalCheck 5 is stable up to 4 hours at 20-25°C.

Shelf-Life Stability:

The accelerated stability testing performed at 35℃ supports an initial shelflife claim of 18 months at 2-8°C. Real-time testing at 2-8°C is on-going to support a claim of 36 months.

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10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o K. Colleen Adams Roche Professional Diagnostics 9115 Hague Road Indianaopolis, IN 46250-0416

MAY 1 0 2012

K121279 Re:

Trade Name: Elecsys LH 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: April 27, 2012 Received: April 30, 2012

Dear Ms Adams:

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); 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, J 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/Medical

Devices/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,

$\qquad$

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

K121279 510(k) Number (if known):

Device Name: Elecsys LH 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 (OIVD)

Ruta Chian

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

510(k) (2\279

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.