CA 125 II CALSET II

K140112 · Roche Diagnostics · JIT · Jun 6, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140112
• Device Name: CA 125 II CALSET II
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

CA 125 II CalSet II is a two-level calibration kit used to calibrate Elecsys CA 125 II assays on Elecsys and cobas e immunoassay analyzers. The device consists of lyophilized equine serum (0 U/mL) and human serum (500 U/mL) matrices. Operators reconstitute the material and load it onto the analyzer; the system reads lot-specific values via barcode. The device ensures analytical accuracy of the CA 125 assay, which is used by clinicians to monitor disease states. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed reconstituted shelf-life (12 weeks at 2-8°C; 20 weeks at -15 to -25°C) and on-board stability (5 hours at 20-25°C). Value assignment was validated across multiple analyzer platforms (cobas e 411 and Modular Analytics E170) using master calibrators.

Technological Characteristics

Lyophilized calibrator; human CA 125 analyte in equine (Cal 1) and human (Cal 2) serum matrix. Two levels: 0 U/mL and 500 U/mL. Reconstitution requires 1.0 mL distilled or deionized water. Standardized against Enzymun Test CA 125 II method and Fujirebio CA 125 II RIA.

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys CA 125 II assay on Elecsys and cobas e immunoassay analyzers in a clinical laboratory setting.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Elecsys CA 125 II CalSet (k003969)

Submission Summary (Full Text)

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K14/0112

## JUN 0 6 2014

## 510(k) Summary

Device Name

| Proprietary name: | CA 125 II CalSet 11 |
|----------------------|-----------------------|
| Common name: | CA 125 II CalSet II |
| Classification name: | Calibrator, secondary |

For the CA 125 II CalSet II, the establishment registration number (Roche Diagnostics GmbH Mannheim) is 9610126. The establishment registration

Diagnostics Only Internation United States is 1823260. Registration

Classification The FDA has classified the product as a Class II device.

| Panel | Product<br>Code | Classification Name | Regulation<br>Citation |
|--------------------|-----------------|-----------------------|------------------------|
| Clinical Chemistry | JIT | Calibrator, Secondary | 862.1150 |

| Predicate<br>Device | The CA 125 II CalSet II is substantially equivalent to other products in<br>commercial distribution intended for similar use. We claim equivalency to<br>the currently marketed CA 125 CalSet (k003969). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The CA 125 II CalSet II is a lyophilized product consisting of human CA 125<br>in an equine (Cal 1) and a human (Cal 2) serum matrix. During manufacture,<br>the analyte is spiked into the matrix at the desired concentration levels. |
| Intended Use | CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II<br>assay on the Elecsys and cobas c immunoassay analyzers. |
| Reason for<br>Submission | The CA 125 II CalSet II is being changed from a liquid to lyophilized<br>material. In addition, we are decreasing the concentration of Cal 1 to 0 U/mL<br>by using equine serum. |

Continued on next page

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### 510(k) Summary

Table 1 below compares CA 125 II CalSet II with the predicate device, CA Comparison 125 II CalSct (k003969). Table

> Changes in the new product include lowering Cal 1 to no CA 125 (by using equine serum), and going from liquid calibrators to lyophilized.

### Table 1. Comparison of Candidate and Predicate Devices

| Characteristic | CA 125 II CalSet II<br>(Candidate Device) | Elecsys ® CA 125 II CalSet<br>(k003969) |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | CA 125 II CalSet II is used for<br>calibrating the quantitative Elecsys<br>CA 125 II assay on the Elecsys and<br>cobas e immunoassay analyzers. | Same |
| Format | Lyophilized | Liquid |
| Analyte | Human CA 125 | Same |
| Matrix | Equine serum (Call) and Human<br>serum (Cal 2) | Same |
| Levels | Two | Same |
| Target<br>Ranges | Cal 1: 0 U/mL<br>Cal 2: 500 U/mL | Cal 1: 35 U/mL<br>Cal 2: 500 U/mL |
| Stability | Lyophilized:<br>• Up until labeled expiration date<br><br>Reconstituted:<br>• -20°C: 20 weeks (freeze only once)<br>• 2-8248C: 12 weeks<br>• on the Elecsys 2010 and cobas e411<br>(20-25°C): up to 5 hours<br>• on the MODULAR ANALYTICS<br>E170, cobas e601 and cobas e602<br>analyzers: use only once | Unopened:<br>• Store at 2-8°C until expiration date<br><br>Opened:<br>• at 2-8°C: 12 weeks<br>• on the Elecsys 2010 and cobas e411<br>(20-25°C): up to 5 hours<br>• on the MODULAR ANALYTICS<br>E170, cobas e601 and cobas e602<br>analyzers: use only once |
| Characteristic | CA 125 II CalSet II<br>(Candidate Device) | Elecsys® CA 125 II CalSet<br>(k003969) |
| Handling | Carefully dissolve the contents of<br>one bottle by adding exactly 1.0 mL<br>of distilled or deionized water and<br>allow to stand closed for 15 minutes<br>to reconstitute. Mix carefully,<br>avoiding foam formation.<br><br>Transfer the reconstituted calibrators<br>into the supplied empty labeled snap-<br>cap bottles.<br><br>Elecsys 2010 and cobas e 411<br>analyzers: The reconstituted<br>calibrators should only be left on the<br>analyzers during calibration at 20-<br>25°C. After use, close the bottles as<br>soon as possible and store upright at<br>2-8°C. Due to possible evaporation<br>effects, not more than 5 calibration<br>procedures per bottle set should be<br>performed.<br><br>If necessary, freeze in aliquots.<br><br>MODULAR ANALYTICS, cobas e<br>601 and cobas e 602 analyzers:<br>Unless the entire volume is necessary<br>for calibration on the analyzers,<br>transfer aliquots of the reconstituted<br>calibrators into empty snap-cap<br>bottles (CalSet Vials). Attach the<br>supplied labels to these additional<br>bottles. Aliquots intended for<br>storage at -20°C should be frozen<br>immediately.<br><br>Perform only one calibration<br>procedure per aliquot. | The calibrators are supplied ready-<br>for-use in bottles compatible with the<br>system.<br><br>Elecsys 2010 and cobas e 411<br>analyzers: The calibrators should<br>only be left on the analyzers during<br>calibration at 20-25°C. After use,<br>close the bottles as soon as possible<br>and store at 2-8°C.<br><br>Due to possible evaporation effects,<br>not more than 5 calibration<br>procedures per bottle set should be<br>performed.<br><br>MODULAR ANALYTICS E170,<br>cobas e 601 and cobas e 602<br>analyzers: Unless the entire volume<br>is necessary for calibration on the<br>analyzers, transfer aliquots of the<br>ready-for-use calibrators to empty<br>snap-cap bottles (CalSet Vials).<br>Attach the supplied labels to these<br>additional bottles. Store the aliquots<br>at 2-8°C for later use.<br><br>Perform only one calibration<br>procedure per aliquot. |
| Characteristic | CA 125 II CalSet II<br>(Candidate Device) | Elecsys CA 125 II CalSet<br>(k003969) |
| Traceability | The Elecsys CA 125 II assay has<br>been standardized against the<br>Enzymun Test CA 125 II method.<br>This in turn was standardized against<br>the CA 125 II RIA from Fujirebio<br>Diagnostics. | Same |

Continued on next page

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## 510(k) Summary, Continued

## Table 1. Comparison of Candidate and Predicate Devices, continued

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:

| Performance<br>Characteristics | The CA 125 II CalSet II was evaluated for value assignment, stability, and<br>reconstitution. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The data demonstrate that the performance of the CA 125 II CalSet II is<br>substantially equivalent to that of the predicate device, Elecsys® CA 125 II<br>CalSet. |

. . . . . . .

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 109113 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 6, 2014

ROCHE DIAGNOSTICS C/O DR. JANE ELLEN PHILLIPS REGULATORY PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS, IN 46250

Re: K140112

Trade/Device Name: CA 125 II CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: May 16, 2014 Received: May 19, 2014

Dear Dr. Phillips:

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 commerce provide to may no may and 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be it may be subject to numbers, Title 21, Parts 800 to 898. In addition, FDA may round in the announcements concerning your device in the Federal Register.

Please be advised that FDA is 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 mat I DA has made a sold regulations administered by other Federal agencies. You must of any I cochi statutes and regenments. including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements medical device-related adverse events) (2) carren (21 CFR Part 820); and if application (201 as set form in the qualify by actions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2-Dr. Jane Ellen Phillips

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdagov/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140112

Device Name Elecsys CA 125 II CalSet II

Indications for Use (Describe) CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II assay on the Elecsys and cobas e immunoassay analyzers.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth A. Stafford -S

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