ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK

K053059 · Roche Diagnostics · JJX · Nov 28, 2005 · Clinical Chemistry

Device Facts

• Record ID: K053059
• Device Name: ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.

Device Story

Elecsys Prolactin II CalCheck consists of three levels (low, mid, high) of buffered equine serum solutions with defined Prolactin concentrations. Used in clinical laboratory settings to verify calibration of Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 analyzers. Low level near lower detection limit; mid and high levels span measuring range. Healthcare providers use output to confirm analyzer calibration accuracy, ensuring reliable patient Prolactin testing results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Calibration verification material; three levels (low, mid, high); buffered equine serum matrix; lyophilized storage form; traceable to WHO Standard 84/500; compatible with Elecsys 1010/2010 and MODULAR ANALYTICS E170 systems.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 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.

Predicate Devices

• Elecsys Prolactin CalCheck (K970147)

Submission Summary (Full Text)

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## 510(k) Summary - Elecsys Prolactin II CalCheck

| <b>Introduction</b> | 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 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Submitter name, address, contact</b> | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Randy Johnson<br>Date prepared: October 28, 2005 |
| <b>Device name</b> | Proprietary name: Roche Diagnostics Elecsys Prolactin II CalCheck |
| | Common name: Calibration Verification Material |
| | Classification name: Single (specified) Analyte Controls (Assayed and Unassayed) |
| <b>Device description</b> | The Elecsys Prolactin II CalCheck calibration verification solutions comprise three levels - low, mid and high - each with a defined Prolactin concentration range. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle and the high solution is near the upper limit of the measuring range. Roche Diagnostics has validated that these materials are matrix compatible for use on the Elecsys systems. |

Continued on next page·

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## 510(k) Summary - Elecsys Prolactin II CalCheck, Continued

| Intended use | For use in the verification of the calibration established by the Elecsys<br>Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS<br>E170 Immunoassay analyzers. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>device | The Elecsys Prolactin II CalCheck is equivalent to other devices legally<br>marketed in the United States. We claim equivalence to the Elecsys Prolactin<br>CalCheck (K970147). |
| Device<br>comparison | The table below illustrates the similarities between the Elecsys Prolactin<br>CalCheck (K970147) and the Elecsys Prolactin II CalCheck (modified<br>device). |

| Topic | Elecsys Prolactin CalCheck<br>(K970147) | Elecsys Prolactin II CalCheck<br>(Modified Device) |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in the verification of the<br>calibration established by the Elecsys<br>Prolactin reagent on Elecsys® 2010<br>Immunoassay analyzers. | For use in the verification of the<br>calibration established by the Elecsys<br>Prolactin II reagent on Elecsys<br>1010/2010 and MODULAR<br>ANALYTICS E170 Immunoassay<br>analyzers. |
| Matrix | Human serum | Buffered equine serum |
| Storage form | Lyophilized | Same |
| Target values | Low = 500 µIU/mL<br>Mid = 5,000 µIU/mL<br>High = 8,000 µIU/mL | Same |
| Traceability | Calibrated against the WHO Standard<br>84/500 | Same |
| Stability | Unopened:<br>Up to the printed expiration date on<br>the bottle labels at 2 - 8°C<br><br>Reconstituted:<br>4 hours at 15 - 25°C | Unopened:<br>Up to the printed expiration date on<br>the bottle labels at 2 - 8°C<br><br>Reconstituted:<br>4 hours at 15 - 25°C |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

NOV 2 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Randy Johnson, MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250

k053059 Re:

Trade/Device Name: Elecsys Prolactin II CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 28, 2005 Received: October 31, 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 (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); 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, 11 you atons 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 vours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, 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): K053059

Device Name: Elecsys Prolactin II CalCheck

Indications For Use:

For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD53059

Confidential

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