(67 days)
Not Found
No
The device description details a standard immunoturbidimetric assay for measuring ferritin, which relies on chemical reactions and optical detection, not AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
This device is an in vitro diagnostic (IVD) reagent used for the determination of Ferritin in human serum and plasma, which aids in the diagnosis of diseases affecting iron metabolism. It does not provide any therapeutic benefit or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The measurement of ferritin may aid in the diagnosis of diseases affecting iron metabolism" and "For in vitro diagnostic use."
No
The device description clearly states it is a "reagent" and an "immunoturbidimetric assay" involving "latex particles coated with anti-ferritin antibodies," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Purpose: The device is intended for the "determination of Ferritin in human serum and plasma." This is a test performed on biological samples taken from the body, which is a key characteristic of an IVD.
- Clinical Application: The measurement of ferritin is stated to "aid in the diagnosis of diseases affecting iron metabolism." This indicates the results are used for clinical purposes.
- Device Description: The description details an "immunoturbidimetric assay" that reacts with components in the sample (ferritin in serum or plasma) to produce a measurable result. This is a typical mechanism for an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DBF
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infants - 1 month: 6-400 ng/ml
1 month - 6 months: 6-410 ng/ml
6 months - 12 months: 6-80 ng/ml
1 year - 5 years: 6-60 ng/ml
6 years - 19 years: 6-320 ng/ml
adult men: 20-250 ng/ml
adult women: 20-200 ng/ml
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision
Within run CV
3.20% @ 38.0 ng/ml
1.31% @ 108.1 ng/ml
0.99% @ 224.1 ng/ml
Total CV
3.94% @ 38.0 ng/ml
1.62% @ 108.1 ng/ml
1.43% @ 224.1 ng/ml
Analytical sensitivity (LDL)
4ng/ml
Linearity
4 - 450 ng/ml
Method Comparison
Linear regression analysis:
Ferritin-LATEX v.s. commercially available ferritin assay on patient serum samples
y= 1,0016x+4,3849
R= 0.9958
Ferritin-LATEX between patient serum and EDTA plasma
y= 0,9847x-1.1275
R= 0.9987
Ferritin-LATEX between patient serum and Li-Heparine plasma
y= 0,9778x + 1.2886
R= 0.9988
Interferences
Haemolysis: Less than 5% up to 500 mg/dl hemoglobin.
Lipemic: Less than 10% up to 400mg/L Intralipid®.
Icterus: Less than 5% up to 20mg/dl bilirubin.
Rheumatoid Factor: Less than 5% up to 900 IU/ml RF.
Ascorbic acid: Less than 5% up to 3 mg/dl ascorbic acid.
Prozone Effect
No hook effect observed up to 10000 ng/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5340 Ferritin immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 | ||
| Name, address, | ||
| Contact | Medicon Hellas S.A. | |
| 5-7 Melitona St. | ||
| Gerakas, Attiki | ||
| 153 44 GREECE |
Contact Person: George Psichas
+30210-6606140
Date Prepared: July 12, 2006 | |
| Device Name | Proprietary name: Medicon Ferritin – LATEX | |
| | Common name: Ferritin Reagent | |
| | Classification name: Ferritin Immunological Test | |
| Device
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
Accelerator
Surfactant
Stabilizers |
Preservatives
pH=8.4 Stabilizers Preservatives
Latex particles coated with rabbit antihuman ferritin in 20 mM Tris buffer
R2
1
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 | |
| Ferritin in human serum and plasma using Olympus AU | ||
| 400/600/640 automated clinical chemistry analyzers. | ||
| 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. | ||
| Substantial | ||
| Equivalance | The Ferritin - LATEX is substantially equivalent to other devices | |
| legally marketed in the United States. We claim equivalence to | ||
| the Olympus Ferritin Reagent (K030124). Both products are | ||
| intended for use in the quantitative determination of Ferritin | ||
| on Olympus AU 400/600/640 automated clinical chemistry | ||
| analyzers. |
| Substantial
equivalence-
Similarities | The following table compares the Medicon Ferritin - LATEX with
the predicate device. |
| --------------------------------------------- | ----------------------------------------------------------------------------------------- |
|---|
| Feature | Ferritin - LATEX | Ferritin
(predicate) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent
intended for the determination of
Ferritin in human serum and
plasma using Olympus AU
400/600/640 automated clinical
chemistry analyzers. | In vitro diagnostic reagent
intended for the
determination of Ferritin in
human serum using
automated Olympus clinical
chemistry analyzers. |
2
| Indication for Use | Medicon Ferritin -LATEX reagent
is for the determination o
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. | Reagent for the determination
of ferritin concentrations in
human serum using Olympus
family of clinical chemistry
analyzers.
Serum ferritin is an indicator
of body iron stores: it has
been shown to correlate with
stainable bone marrow iron.
Measurements of ferritin aid
in the diagnosis of diseases
affecting iron metabolism,
such as hemochromatosis
(iron overload) and iron
deficiency anemia. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Protocol | Particle enhanced
Immunoturbidometric | Particle enhanced
Immunoturbidometric |
| Instrument | Olympus Clinical Chemistry
Analyzers | Olympus Clinical Chemistry
Analyzers |
| Formulation | Final reactive ingredients:
Tris Buffer pH: 8.2
Latex particles coated with rabbit
anti-human ferritin
Preservative | Final reactive ingredients:
Tris Buffer pH: 8.2
Latex particles coated with
rabbit anti-human ferritin
Preservative |
| Calibrator | Olympus Serum Protein Multi
Calibrator ODR3021 | Olympus Serum Protein
Multi-Calibrator ODR3021 |
| Controls | Olympus ITA Control Sera,
ODC0014, ODC 0015, ODC 0016 | Olympus ITA Control Sera,
ODC0014, ODC 0015, ODC
0016 |
Substantial The following table compares the Ferritin – LATEX with the equivalenceSimilarities predicate device.
| Feature | Ferritin - LATEX | Ferritin
(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/
Standardization | Standardized against the 3rd
International Standard for ferritin,
Recombinant NBSC code:94/572. | Standardized against the 3rd
International Standard for
ferritin, Recombinant NBSC
code:94/572 |
3
The following table compares the Ferritin – LATEX with the Substantial equivalencepredicate device. differences
| Feature | Ferritin - LATEX | Ferritin
(predicate) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring Range | 4-450 ng/ml | 8-450 µg/l |
| Sample type | Serum and plasma | Serum |
| Reference Intervals | Serum / Plasma:
Infants - 1 month: 6-400 ng/ml
1 month - 6 months: 6-410 ng/ml
6 months - 12 months: 6-80
ng/ml
1 year - 5 years: 6-60 ng/ml
6 years - 19 years: 6-320 ng/ml
adult men: 20-250 ng/ml
adult women: 20-200 ng/ml | Serum:
New born infants - 6 months:
25- 200µg/l
6 months - 15 years:
7-142 µg/l
Adult male: 20-300µg/l
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
(predicate) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV
3.20% @ 38.0 ng/ml
1.31% @ 108.1 ng/ml
0.99% @ 224.1 ng/ml
Total CV
3.94% @ 38.0 ng/ml
1.62% @ 108.1 ng/ml
1.43% @ 224.1 ng/ml | Within run CV
2.25% @ 40.0 ng/ml
2.00% @ 101 ng/ml
1.25% @ 383 ng/ml
Total CV
3.43% @ 40.0 ng/ml
2.81% @ 101 ng/ml
2.12% @ 383 ng/ml |
| Analytical sensitivity
(LDL) | 4ng/ml | 6.4 µg/L |
| Linearity | 4 - 450 ng/ml | 8.0 - 450 µg/L |
4
| Method Comparison | Linear regression analysis:
Ferritin-LATEX v.s. commercially
available ferritin assay on patient
serum samples
$y= 1,0016x+4,3849$
$R= 0.9958$
Ferritin-LATEX between patient
serum and EDTA plasma
$y= 0,9847x-1.1275$
$R= 0.9987$
Ferritin-LATEX between patient
serum and Li-Heparine plasma
$y= 0,9778x + 1.2886$
$R= 0.9988$ | Linear regression analysis:
Predicate device v.s.
commercially available ferritin
assay on patient serum
samples
$y= 0,964x-2,549$
$R= 0.995$ |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences | Haemolysis: Less than
5% up to 500 mg/dl
hemoglobin. Lipemic: Less than 10%
up to 400mg/L
Intralipid®. Icterus: Less than 5% up
to 20mg/dl bilirubin. Rheumatoid Factor: Less
than 5% up to 900 IU/ml
RF. Ascorbic acid: Less than
5% up to 3 mg/dl ascorbic
acid. | Haemolysis: Less
than 10% up to 5 g/L
hemoglobin. Lipemic: Less than
10% up to 400mg/dL
Intralipid®. Icterus: Less than 5%
up to 40mg/dL or 684
µmol/l bilirubin. Rheumatoid Factor:
Less than 5% up to
500 IU/ml RF. |
| Prozone Effect | No hook effect observed up to
10000 ng/ml. | No hook effect observed up
to 5000 ng/ml. |
:
,
5
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
6
Page 2 –
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 (240) 276-0484. 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 (800) 638-2041 or (240) 276-3150 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
7
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