ELECSYS LH CALCHECK 5

K121279 · Roche Diagnostics · JJX · May 10, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121279
• Device Name: ELECSYS LH CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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 Story

Elecsys LH CalCheck 5 is a lyophilized, human serum-based control containing luteinizing hormone (LH). It is used by laboratory professionals to verify calibration and assay range for Elecsys LH reagents on Roche immunoassay analyzers (Elecsys 2010, cobas e 411, 601, 602, and MODULAR ANALYTICS E170). The product is reconstituted with distilled or deionized water. It provides five levels of analyte concentration (level 1 is analyte-free) to confirm instrument performance across the analytical measurement range. By comparing measured values against assigned target values, clinicians ensure the accuracy and reliability of patient LH test results, facilitating appropriate clinical management of endocrine conditions.

Clinical Evidence

Bench testing only. Evidence includes value assignment testing performed in duplicate on at least three E170 analyzer measuring cells, with target values defined by the median of at least 6 determinations. Acceptance criteria required assigned values on additional platforms (Elecsys 2010, cobas e 411, 601, 602) to be within 10% of the master platform. Stability testing (real-time and accelerated) supports a 4-hour open-vial stability at 20-25°C and an initial 18-month shelf-life at 2-8°C.

Technological Characteristics

Lyophilized human serum matrix containing luteinizing hormone. Five concentration levels. Reconstitution required with 1.0 mL distilled/deionized water. Standardized against 2nd International Standard (NIBSC) 80/552. Compatible with Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys LH reagent on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

Secondary Contact: Stephanie Greeman Phone: [phone] Fax: [phone] Email: [e-mail]

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

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.

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.

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<br>(Candidate) | Elecsys N-MID Osteocalcin<br>CalCheck 5 (K112104) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Intended Use | The Elecsys LH Calcheck 5 is an<br>assayed control for use in calibration<br>verification and for use in the<br>verification of the assay range<br>established by the Elecsys Myoglobin<br>reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. | The Elecsys N-MID Osteocalcin<br>CalCheck 5 is an assayed control for<br>use in calibration verification and for<br>use in the verification of the assay<br>range established by the Elecsys N-<br>MID Osteocalcin reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. |
| Analyte | Luteinizing Hormone (LH) | Osteocalcin |
| Similarities | | |
| Matrix | Human serum matrix | Same |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check<br>3, Check 4, and Check 5 with exactly<br>1.0 mL distilled or deionized water.<br>Allow to stand closed for 15 minutes,<br>then mix gently by inversion. | Same |
| Stability | Unopened:<br>• Store at 2-8°C until expiration date<br>Opened:<br>• 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.

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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 [phone]. 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 [phone]. 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 [phone] or [phone] 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:

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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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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