ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

K052982 · Roche Diagnostics · JIT · Oct 28, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052982
• Device Name: ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Elecsys Prolactin II CalSet is used for the calibration of the Elecsys Prolactin assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

The cobas Elecsys Prolactin II CalSet is a secondary calibrator used to calibrate the quantitative Elecsys Prolactin II assay on Elecsys immunoassay systems. The device consists of a lyophilized buffered equine serum matrix containing recombinant prolactin at two concentration levels (low and high). It is intended for professional use in clinical laboratory settings. By providing known concentration values, the calibrator allows the immunoassay system to establish a calibration curve, enabling the accurate quantification of prolactin in patient samples. This process ensures the analytical performance of the assay, supporting clinical decision-making related to prolactin levels.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized buffered equine serum matrix; contains recombinant prolactin; two concentration levels (approx. 2 µIU/mL and 2,000 µIU/mL); standardized to 3rd IRP WHO Reference Standard 84/500; intended for use on Elecsys immunoassay systems.

Indications for Use

Indicated for the calibration of the Elecsys Prolactin assay on Elecsys and cobas e immunoassay analyzers.

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 Prolactin CalSet (K964748)

Submission Summary (Full Text)

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K052982

## 510(k) Summary - cobas Elecsys® Prolactin II CalSet

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| 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<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Randy Johnson<br><br>Date prepared: October 21, 2005 |
| Device Name | Proprietary name: Roche Diagnostics cobas Elecsys® Prolactin II CalSet<br><br>Common name: Prolactin II CalSet<br><br>Classification name: Calibrator, Secondary |
| Device<br>description | The cobas Elecsys® Prolactin II CalSet consists of a lyophilized buffered equine serum matrix with added recombinant prolactin in two concentration ranges. The CalSet can be used with all reagent lots. |

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## 510(k) Summary - cobas Elecsys® Prolactin II CalSet, continued

| Intended use | Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys<br>Prolactin II assay on the Elecsys immunoassay systems. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>Device | The cobas Elecsys® Prolactin II CalSet is equivalent to other devices legally<br>marketed in the United States. We claim equivalence to the Elecsys Prolactin<br>CalSet (K964748). |
| Device<br>Comparison | The table below illustrates the similarities between the Elecsys Prolactin<br>(K964748) and the cobas Elecsys Prolactin II CalSet (modified device). |

| Topic | Elecsys® Prolactin<br>(K964748) | cobas Elecsys® Prolactin II CalSet<br>(Modified Device) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys Prolactin CalSet is used for<br>calibrating the quantitative Elecsys<br>Prolactin assay on the Elecsys<br>immunoassay systems. | Elecsys Prolactin II CalSet is used for<br>calibrating the quantitative Elecsys<br>Prolactin II assay on the Elecsys<br>immunoassay systems. |
| Matrix | Buffer/protein | Buffered equine serum |
| Storage form | Liquid | Lyophilized |
| Levels | Low: approx. 2 µIU/mL<br>High: approx. 2,000 µIU/mL | Same |
| Standardization | Standardized using the 3rd IRP WHO<br>Reference Standard 84/500 | Same |
| Stability | Unopened:<br>at 2-8°C up to the expiration date. | Unopened:<br>at 2-8°C up to the expiration date. |
| | Opened:<br>at 2 - 8°C; 8 weeks<br>on the analyzers, up to 5 hours in total | Opened:<br>at -20°C; 3 months (freeze only once)<br>on the analyzers at 20 - 25°C; use only<br>once |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 8 2005

Randy Johnson MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250

Re: k052982

> Trade/Device Name: cobas Elecsys Prolactin II CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: October 21, 2005 Received: October 24, 2005

Dear Mr. Johnson:

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 (sec 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Guticarez, 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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## Indications for Use

510(k) Number (if known):

K052982

Device Name: cobas Elecsys Prolactin II CalSet

Indications For Use:

Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Harry Phillips
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Confidential

510(k) KD52982

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