VITALAB IRON REAGENT

K033983 · Clinical Data, Inc. · JIY · May 21, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033983
• Device Name: VITALAB IRON REAGENT
• Applicant: Clinical Data, Inc.
• Product Code: JIY · Clinical Chemistry
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Vitalab Iron Reagent is for the quantitative determination of total iron in serum and plasma using the Vitalab Selectra Analyzer.

Device Story

Vitalab Iron Reagent Kit and Vitalab Selectra Analyzer function as a system for quantitative iron measurement in serum and plasma. Principle of operation: photometric measurement of iron concentration via increase in absorbance at 578 nm. Used in clinical laboratory settings by trained personnel. Output: iron concentration values (µg/dL). Healthcare providers use results to diagnose and monitor iron deficiency anemia, hemochromatosis, and chronic renal disease. Benefits include accurate assessment of iron status to guide clinical management.

Clinical Evidence

Bench testing only. Precision evaluated via NCCLS EP3-T (n=66 per sample, CVs 0.4-2.7%). Linearity confirmed 0-1,000 μg/dL. Detection limit 2.4 μg/dL. Interference testing showed minimal bias for bilirubin (≤4.1%) and Intralipid (≤-2.3%). Method comparison (n=118) against predicate device yielded slope 0.988 and intercept 1.1 μg/dL, demonstrating equivalence.

Technological Characteristics

Photometric iron test system; measures absorbance at 578 nm. Includes reagent and calibrator. Designed for use with Vitalab Selectra Analyzer. Analytical method based on iron dissociation and indicator reaction.

Indications for Use

Indicated for the quantitative determination of total iron in serum and plasma for patients suspected of iron deficiency anemia, hemochromatosis, or chronic renal disease.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Predicate Devices

• Beckman Synchron Systems Iron (Fe) and Total Iron Binding Capacity (IBCT) Reagents (K960485)

Submission Summary (Full Text)

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## Clinical Data

MAY 2 1 2004

K033983

1075 W. Lambert Road Suite D Brea, CA 92821 F [phone] T [phone]

Summary of 510(k) Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Gold inon Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantiative and of total inon The Vitalab Iron Keagent Kir and the Villal Selection of Cased and as iron deficiency and as iron deficiency and mind promotes in serum and plasma. Tron results may be used to the tissues of two iron-containing pigments, hemosiderin hemochromatosis (a disease associated with with stimes renal disease. The Virgin I read to neagent and hemousing and characterized by pigilished of the time the transferrin using actical in charges at 678 mg is measures iron photometrically. Tron in the specifical is triculsed from indicator. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.

Vitalab Iron Reagent Kit, which contains an iron calibrator, is equivalent to the Beakman Iron Reagent Kit, calibrated with Vitalab Iron Reagent Kri, which ecinanis an arented by Beckman Coulter, Inc. of Brea, CA.

The effectiveness of Vitalab Iron Reagent Kit and the Vitalab Selectra is shown in the following studies.

The recovery of iron using the Vitalab Iron Reagent is linear from 10 to at least 1000 pages associated of stophers I he recovery of tron using the Vialab Iroll Reaguit is intent regression statistics compare recoveries to standard concentrations. These statistics are shown below.

(Vitalab Recoveries) = 0 ug/dL + 1.017 x (Concentration), n = 44

Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated I recision is demonstration escribed in NCCLS Guideline EP3-T, are shown below.

| Sample | n | mean | Within Run | | Total | |
|---------|----|------|------------|------|-------|------|
| | | | 1SD | %CV | 1SD | %CV |
| Serum 1 | 66 | 57 | 0.9 | 1.6% | 1.5 | 2.7% |
| Serum 2 | 66 | 158 | 0.9 | 0.6% | 3.0 | 1.9% |
| Serum 3 | 66 | 260 | 1.0 | 0.4% | 5.2 | 2.0% |

Mixed serum and plasma specimens collected from adult patients were assayed for iron using the Vitalab Selectra and Mixed setum and plasma specificals conceed from additions were compared by Deming statistics were obtained.

> Selectra = 1.1 µg/dL + 0.988 x Competitive Reagent \$(y.x) = 2.3 µg/dL range = 9 - 287 µg/dL

The claimed detection limit is documented through the repetitive assay of a diluted serum pool. The observed standard I he claimed decection inni is documents in ought is 2,8 µg/d., which supports a detection limit claim of 8,2 µg/dL iron.

The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum THE 14 day offer the claimed periods. In all cases, statistical estimates of coefficient of variation are less than 2%.

Wynn Stocking Manager of Regulatory Affairs Clinical Data, Brea CA

510(k) Notification, Vitalab Iron Reagent Kit, 22 November 2003, p 49

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that are meant to represent a human figure.

MAY 21 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Clinical Data, Inc. c/o Mr. Ned Devine Responsible Official Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

k033983 Re:

Trade/Device Name: Vitalab Iron Reagent and Calibrator Regulation Number: 21 CFR 862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I Product Code: JIY Dated: May 10, 2004 Received: May 13, 2004

Dear Mr. Devine:

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 markcted 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 docs 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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## Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organizatial equivalence of your device of your device to a legally promatics noticated 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, If you desire specific miration and advertising of your device, please contact the Office of or questions on the Promise 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 Tou may obtain other generers, 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.

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. 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): K033983

Device Name: Vitalab Iron Reagent and Calibrator

Indications For Use:

The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for The Vitalab from Rouger An, which exercas a system for the quantitative defermination of total iron in serum and plasma. Iron results may be used for the diagnosis and or total from in ocrain and plass iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Quill Cheler for Jen Cooper

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K033983