MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

K043320 · Roche Diagnostics Corp. · JJX · Dec 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043320
• Device Name: MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 17, 2004
• 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 Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

Elecsys Folate II CalCheck II; calibration verification material for immunoassay analyzers. Modification of previously cleared Elecsys Folate CalCheck. Changes include: matrix shift from buffer with human albumin to human serum; removal of 0.1% azide preservative; storage form transition from liquid to lyophilized; updated target values; product name change. Used in clinical laboratory settings by laboratory technicians to verify calibration of Folate II assays. Output provides verification of assay calibration accuracy; supports clinical decision-making by ensuring reliable patient folate test results.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Calibration verification material; three-level set; human serum matrix; lyophilized form; stored at 2-8°C. Designed for use with Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys Folate II reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. No specific patient population, age, or disease state contraindications are defined as this is an in vitro diagnostic control material.

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 Folate CalCheck (K974384)

Submission Summary (Full Text)

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K043320

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# DEC 17 2004

## 510(k) Summary - Elecsys® Folate II CalCheck II

| 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Kay A. Taylor |
| | Date prepared: December 1, 2004 |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® Folate II CalCheck II |
| | Common name: Calibration Verification Material |
| | Classification name: Single (specified) Analyte Controls (Assayed and Unassayed) |
| Device description | The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys Folate CalCheck. (K974384). |
| Device Comparison | The table below illustrates the similarities between the Elecsys Folate CalCheck (K974384) and the Elecsys Folate II CalCheck II (modified device). |

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### 510(k) Summary - Elecsys® Folate II CalCheck II, continued

:

| Topic | Elecsys® Folate CalCheck<br>(K974384) | Elecsys® Folate II CalCheck II<br>(Modified Device) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | For use in the verification of the<br>calibration established by the... Elecsys Folate reagent on the<br>Elecsys 2010 Elecsys Folate II reagent on the<br>MODULAR ANALYTICS E170. | For use in the verification of the<br>calibration established by the Elecsys<br>Folate II reagent on the Elecsys 2010<br>and MODULAR ANALYTICS E170<br>immunoassay analyzers. |
| Matrix | Buffer with human albumin | Human serum |
| Storage Form | Liquid | Lypholized |
| Levels | Low: 1.5 ng/ml<br>Mid: 8.7 ng/ml<br>High: 16.0 ng/ml | Low: 2.0 ng/ml<br>Mid: 7.5 ng/ml<br>High:15.3 ng/ml |
| Standardization | The Elecsys Folate II assay has been<br>standardized against the Elecsys<br>Folate assay. The Elecsys Folate<br>assay was standardized against a<br>commercially available radiobinding<br>folate assay. Note: the previously used<br>radiobinding folate assay is no longer<br>available. | The Elecsys Folate II assay has been<br>standardized against the Elecsys<br>Folate assay. |
| Stability | Store at 2-8°C unopened up to the<br>expiration date.<br>Opened: 5 hours at 20-25°C | Same |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### DEC 17 2004

Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Principal Roche Diagnostics Corp. Centralized Diagnostics 9115 Hague Road Indianapolis, IN 46250

k043320 Re:

Trade/Device Name: Roche Elecsys Folate II CalCheckII Regulation Number: 21 CFR 862.1660 Regulation Name: Control Material Regulatory Class: Class I Product Code: JJX Dated: December 1, 2004 Received: December 2, 2004

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviewed your we 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, 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/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelia B. Lorks

Cornelia B. Rooks, MA Acting 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): K043320

Device Name: Roche Elecsys Folate II CalCheck II

Indications For Use:

For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Prescription Use XXX (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)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K043320