IRON STANDARD

K052002 · Roche Diagnostics Corp. · JIT · Aug 22, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052002
• Device Name: IRON STANDARD
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. For Prescription Use only

Device Story

Iron Standard is a single-level, ready-to-use aqueous solution of Ferrous Ammonium Sulfate Hexahydrate; used as a calibrator for quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. The product is gravimetrically prepared and assigned a target value of 500 µg/dL, traceable to NIST SRM 937 Iron Metal. It is intended for professional use in clinical laboratory settings to ensure the accuracy of UIBC assay measurements. The healthcare provider uses the calibrator to establish the calibration curve on the analyzer, which subsequently affects the accuracy of patient iron binding capacity results used in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability verified via real-time (up to 12 months) and accelerated (5 days at 45°C) studies. Traceability established against NIST SRM 937 Iron Metal. Performance confirmed by comparing new batch replicates against NIST standards and previously released lots on Hitachi analyzers.

Technological Characteristics

Aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. Single-level calibrator. Ready-to-use. Storage at 15-25°C. Traceable to NIST SRM 937.

Indications for Use

Indicated for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry 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® C-Peptide Calset (K033873)

Submission Summary (Full Text)

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K052002

AUG 2 2 2005

# 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's name, address, and contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3831 |
| | Contact Person: Corina Harper |
| | Date Prepared: July 22, 2005 |
| Device name | Proprietary name: Iron Standard |
| | Common name: Calibrator |
| | Classification name: Calibrator, Secondary, Class II |
| Predicate device | The Iron Standard is substantially equivalent to the currently marketed Elecsys® C-Peptide Calset (K033873). |
| Device description | The Iron Standard is a single-level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. |
| Intended use | Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. |
| | Continued on next page |

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## 510(k) Summary, Continued

| Substantial<br>equivalence:<br>Similarities | The Iron Standard is substantially equivalent to the currently marketed<br>Elecsys® C-Peptide Calset (K033873). The below tables compare Iron<br>Standard with the predicate device, Elecsys® C-Peptide Calset. |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Characteristic | Iron Standard | Predicate Device<br>Elecsys® C-Peptide<br>Calset (K033873) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the<br>calibration of<br>quantitative<br>Unsaturated Iron<br>Binding Capacity<br>(UIBC) assays on<br>Roche clinical<br>chemistry analyzers. | For calibrating the<br>quantitative Elecsys®<br>C-Peptide assay on the<br>Elecsys® immunoassay<br>systems. |
| Levels | One | Two |

:

,

Continued on next page

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### 510(k) Summary, Continued

Substantial equivalence: Differences

The below tables compare Iron Standard with the predicate device, Elecsys® C-Peptide Calset.

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| Characteristic | Iron Standard | Predicate Device<br>Elecsys® C-Peptide<br>Calset (K033873) |
|----------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Format | Aqueous solution | Lyophilized |
| Handling | Ready to use | Add exactly 1.0 ml distilled water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam. |
| Stability | Unopened:<br>• Store at 15-25°C until expiration date<br>After opening:<br>• 15-25°C: until expiration date | Unopened:<br>• Store at 2-8°C until expiration date<br>Reconstituted:<br>• -20°C: 1 month (freeze only once)<br>• On the analyzers at 20-25°C: use only once |
| | Matrix | Gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 2 2005

Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250

Re: k052002

> Trade/Device Name: Iron Standard Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 22, 2005 Received: July 25, 2005

Dear Ms. Harper:

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) I mis letter mif anony you we 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, n you don't 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,

Carol C. Benson

Carol C. Benson, M.A. 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):

Device Name:

Iron Standard

Indications For Use:

Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.

Koszood

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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

| Roche Diagnostics Confidential | Office of In Vitro Diagnostic Device Evaluation and Safety |
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| 510(k) | k052002 |

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