FERRITIN-LATEX, MODELS 1418-2070, 1418-0279

K062746 · Medicon Hellas S.A · DBF · Nov 20, 2006 · Immunology

Device Facts

• Record ID: K062746
• Device Name: FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
• Applicant: Medicon Hellas S.A
• Product Code: DBF · Immunology
• Decision Date: Nov 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Medicon Ferritin – LATEX is an in vitro diagnostic reagent intended for the determination of Ferritin in human serum and plasma using Olympus AU400/600/640 automated clinical chemistry analyzers.

Device Story

Medicon Ferritin-LATEX is an immunoturbidimetric assay for quantitative determination of ferritin in human serum and plasma. Input: patient serum or plasma specimen. Principle: specimen mixed with R1 (Tris buffer, accelerator, surfactant) and R2 (latex particles coated with rabbit anti-human ferritin antibodies); ferritin-antibody reaction causes latex particle agglutination. Output: turbidity change measured at 600 nm, proportional to ferritin concentration. Used in clinical laboratories on Olympus AU 400/600/640 automated analyzers. Healthcare providers use results to assess body iron stores and aid in diagnosing iron metabolism disorders like hemochromatosis and iron deficiency anemia.

Clinical Evidence

Bench testing only. Precision study (CLSI EP5-A) showed total %CV between 0.99% and 3.94%. Linearity confirmed over 4-450 ng/mL range. Analytical specificity tested against ascorbic acid, hemoglobin, Intralipid, bilirubin, and rheumatoid factor with <10% interference. Method comparison against predicate (n=176) yielded y=1.0016x+4.3849 (R=0.9958). Matrix comparison for EDTA plasma (n=40) and LiH plasma (n=138) showed high correlation (R>0.99) with serum results.

Technological Characteristics

Particle-enhanced immunoturbidimetry. Reagents: R1 (Tris buffer, surfactant, stabilizers) and R2 (latex particles coated with rabbit anti-human ferritin). Energy source: optical (600 nm light). Form factor: liquid reagent kit. Connectivity: automated integration with Olympus AU series analyzers. Standardization: WHO 3rd International Standard (94/572).

Indications for Use

Indicated for the determination of ferritin in human serum and plasma to aid in the diagnosis of diseases affecting iron metabolism.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• Olympus Ferritin Reagent (K030124)

Submission Summary (Full Text)

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K062746

NOV 2 0 2006

## 510(k) Executive 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<br>Name, address,<br>Contact | Medicon Hellas S.A.<br>5-7 Melitona St.<br>Gerakas, Attiki<br>153 44 GREECE<br><br>Contact Person: George Psichas<br>[phone]<br><br>Date Prepared: July 12, 2006 | |
| Device Name | Proprietary name: Medicon Ferritin – LATEX | |
| | Common name: Ferritin Reagent | |
| | Classification name: Ferritin Immunological Test | |
| Device<br>Description | The Ferritin – LATEX is an immunoturbidimetric assay. When serum or plasma specimen is mixed with the appropriate buffer (R1) and latex particles coated with anti-ferritin antibodies (R2), ferritin reacts with the antibodies leading to agglutination of latex particles. This agglutination is detected as turbidity change (600 nm) and it is proportional to ferritin concentration in the sample. | |
| Reagent Composition: | | |
| | Reagent | Components |
| | R1 | 120 mM Tris buffer pH=8.2<br>Accelerator<br>Surfactant<br>Stabilizers |

Preservatives

pH=8.4 Stabilizers Preservatives

Latex particles coated with rabbit antihuman ferritin in 20 mM Tris buffer

R2

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## 510(k) Summary, Continued _ + = ( + ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

.

| Kit Format: | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Cat No. | Quantity | Storage |
| 1418-0270 | 4x6 ml R1+4x1.25ml R2 | |
| | | 2-8°C |
| 1418-0279 | 4x24ml R1+4 x 5ml R2 | |
| Intended use | In vitro diagnostic reagent intended for the determination of<br>Ferritin in human serum and plasma using Olympus AU<br>400/600/640 automated clinical chemistry analyzers. | |
| Indications<br>For Use | Medicon Ferritin -LATEX reagent is for the determination of<br>Ferritin in human serum and plasma using automated clinical<br>chemistry analyzers. | |
| | The measurement of ferritin may aid in the diagnosis of diseases<br>affecting iron metabolism. | |
| Substantial<br>Equivalance | The Ferritin - LATEX is substantially equivalent to other devices<br>legally marketed in the United States. We claim equivalence to<br>the Olympus Ferritin Reagent (K030124). Both products are<br>intended for use in the quantitative determination of Ferritin<br>on Olympus AU 400/600/640 automated clinical chemistry<br>analyzers. | |

| Substantial<br>equivalence-<br>Similarities | The following table compares the Medicon Ferritin - LATEX with<br>the predicate device. |
|---------------------------------------------|-----------------------------------------------------------------------------------------|
|---------------------------------------------|-----------------------------------------------------------------------------------------|

| Feature | Ferritin - LATEX | Ferritin<br>(predicate) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent<br>intended for the determination of<br>Ferritin in human serum and<br>plasma using Olympus AU<br>400/600/640 automated clinical<br>chemistry analyzers. | In vitro diagnostic reagent<br>intended for the<br>determination of Ferritin in<br>human serum using<br>automated Olympus clinical<br>chemistry analyzers. |

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| Indication for Use | Medicon Ferritin -LATEX reagent<br>is for the determination o<br>Ferritin in human serum and<br>plasma using automated clinical<br>chemistry analyzers.<br>The measurement of ferritin may<br>aid in the diagnosis of diseases<br>affecting iron metabolism. | Reagent for the determination<br>of ferritin concentrations in<br>human serum using Olympus<br>family of clinical chemistry<br>analyzers.<br>Serum ferritin is an indicator<br>of body iron stores: it has<br>been shown to correlate with<br>stainable bone marrow iron.<br>Measurements of ferritin aid<br>in the diagnosis of diseases<br>affecting iron metabolism,<br>such as hemochromatosis<br>(iron overload) and iron<br>deficiency anemia. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Protocol | Particle enhanced<br>Immunoturbidometric | Particle enhanced<br>Immunoturbidometric |
| Instrument | Olympus Clinical Chemistry<br>Analyzers | Olympus Clinical Chemistry<br>Analyzers |
| Formulation | Final reactive ingredients:<br>Tris Buffer pH: 8.2<br>Latex particles coated with rabbit<br>anti-human ferritin<br>Preservative | Final reactive ingredients:<br>Tris Buffer pH: 8.2<br>Latex particles coated with<br>rabbit anti-human ferritin<br>Preservative |
| Calibrator | Olympus Serum Protein Multi<br>Calibrator ODR3021 | Olympus Serum Protein<br>Multi-Calibrator ODR3021 |
| Controls | Olympus ITA Control Sera,<br>ODC0014, ODC 0015, ODC 0016 | Olympus ITA Control Sera,<br>ODC0014, ODC 0015, ODC<br>0016 |

Substantial The following table compares the Ferritin – LATEX with the equivalenceSimilarities predicate device.

| Feature | Ferritin - LATEX | Ferritin<br>(predicate) |
|----------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Reagent Stability | On board: 30 days | On board: 30 days |
| Calibration Interval | After each lot and 14 days | After each lot and 14 days |
| Traceability/<br>Standardization | Standardized against the 3rd<br>International Standard for ferritin,<br>Recombinant NBSC code:94/572. | Standardized against the 3rd<br>International Standard for<br>ferritin, Recombinant NBSC<br>code:94/572 |

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The following table compares the Ferritin – LATEX with the Substantial equivalencepredicate device. differences

| Feature | Ferritin - LATEX | Ferritin<br>(predicate) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring Range | 4-450 ng/ml | 8-450 µg/l |
| Sample type | Serum and plasma | Serum |
| Reference Intervals | Serum / Plasma:<br>Infants - 1 month: 6-400 ng/ml<br>1 month - 6 months: 6-410 ng/ml<br>6 months - 12 months: 6-80<br>ng/ml<br>1 year - 5 years: 6-60 ng/ml<br>6 years - 19 years: 6-320 ng/ml<br>adult men: 20-250 ng/ml<br>adult women: 20-200 ng/ml | Serum:<br>New born infants - 6 months:<br>25- 200µg/l<br>6 months - 15 years:<br>7-142 µg/l<br>Adult male: 20-300µg/l<br>Adult female: 10-120µg/l |

The performance characteristics of the Ferritin-LATEX and the Substantial predicate device are compared in the table below: equivalence-Performance Characteristics

| Feature | Ferritin - LATEX | Ferritin<br>(predicate) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV<br>3.20% @ 38.0 ng/ml<br>1.31% @ 108.1 ng/ml<br>0.99% @ 224.1 ng/ml<br>Total CV<br>3.94% @ 38.0 ng/ml<br>1.62% @ 108.1 ng/ml<br>1.43% @ 224.1 ng/ml | Within run CV<br>2.25% @ 40.0 ng/ml<br>2.00% @ 101 ng/ml<br>1.25% @ 383 ng/ml<br>Total CV<br>3.43% @ 40.0 ng/ml<br>2.81% @ 101 ng/ml<br>2.12% @ 383 ng/ml |
| Analytical sensitivity<br>(LDL) | 4ng/ml | 6.4 µg/L |
| Linearity | 4 - 450 ng/ml | 8.0 - 450 µg/L |

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| Method Comparison | Linear regression analysis:<br>Ferritin-LATEX v.s. commercially<br>available ferritin assay on patient<br>serum samples<br>$y= 1,0016x+4,3849$<br>$R= 0.9958$<br><br>Ferritin-LATEX between patient<br>serum and EDTA plasma<br>$y= 0,9847x-1.1275$<br>$R= 0.9987$<br><br>Ferritin-LATEX between patient<br>serum and Li-Heparine plasma<br>$y= 0,9778x + 1.2886$<br>$R= 0.9988$ | Linear regression analysis:<br>Predicate device v.s.<br>commercially available ferritin<br>assay on patient serum<br>samples<br>$y= 0,964x-2,549$<br>$R= 0.995$ |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences | Haemolysis: Less than<br>5% up to 500 mg/dl<br>hemoglobin. Lipemic: Less than 10%<br>up to 400mg/L<br>Intralipid®. Icterus: Less than 5% up<br>to 20mg/dl bilirubin. Rheumatoid Factor: Less<br>than 5% up to 900 IU/ml<br>RF. Ascorbic acid: Less than<br>5% up to 3 mg/dl ascorbic<br>acid. | Haemolysis: Less<br>than 10% up to 5 g/L<br>hemoglobin. Lipemic: Less than<br>10% up to 400mg/dL<br>Intralipid®. Icterus: Less than 5%<br>up to 40mg/dL or 684<br>µmol/l bilirubin. Rheumatoid Factor:<br>Less than 5% up to<br>500 IU/ml RF. |
| Prozone Effect | No hook effect observed up to<br>10000 ng/ml. | No hook effect observed up<br>to 5000 ng/ml. |

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mecicon Hellas S.A. c/o Mr. Daniel W. Lehtonen 2307 East Aurora Road Twinsburg, OH 44087

NOV 2 0 2006

Rc: k062746

Trade/Device Name: Medicon Ferritin-LATEX Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: DBF Dated: September 13, 2006 Received: September 14, 2006

Dear Mr. Lchtonen:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

ia m Chan for
Sr. Robert Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices 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): K062746

Device Name: Medicon Ferritin - LATEX

Indications for Use:

Medicon Ferritin -- LATEX reagent is for the determination of Ferritin in human serum and plasma using automated clinical chemistry analyzers.

The measurement of ferritin may aid in the diagnosis of diseases affecting iron metabolism.

For in vitro diagnostic use.

Prescription Use ------(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 Device Evaluation (ODE)

Mana M Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062746