(57 days)
RANDOX IRON test system.
Not Found
No
The description details a standard chemical assay for iron measurement, with no mention of AI/ML components or data processing methods that would suggest their use.
No
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of iron in serum and plasma, which aids in the diagnosis and treatment of diseases but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a quantitative in vitro diagnostic device" and describes its use in "diagnosis and treatment of diseases."
No
The device description clearly outlines a chemical reaction and measurement at a specific wavelength (570 nm), indicating a physical in vitro diagnostic test system that involves reagents and likely a spectrophotometer or similar hardware. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The 'Wiener lab. Fer-Color AA' iron test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of iron (non-heme) in serum and plasma."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The "Wiener lab. Fer-Color AA" iron test system is a quantitative in vitro diagnostic device intended for the quantitative determination of 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.
Product codes
JIY
Device Description
End point method.
Serum iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in the presence of a reducing agent (ascorbic acid). Then it reacts with the color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.
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
Not Found
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)
The document compares performance characteristics between the subject device (WIENER LAB. Test System) and the predicate device (RANDOX Test System). Key results from these comparisons are listed:
Linearity:
- RANDOX Test System: 1000 µg/dl
- WIENER LAB. Test System: Not specified
Minimum detection limit:
- RANDOX Test System: Not specified
- WIENER LAB. Test System: 6.1 µg/dl
Expected values:
- RANDOX Test System: Male 10.6 – 28.3 µmol/l (59-158 µg/dl), Female 6.6 – 26.0 µmol/l (37-145 µg/dl)
- WIENER LAB. Test System: 60 -160 µg/dl
Intra-assay precision:
- RANDOX Test System: Level 1: CV = 2.93%, Level 2: CV = 2.29%
- WIENER LAB. Test System: Normal Serum Control: CV = 1.32 %, Abnormal Serum Control: CV = 0.54%
Inter-assay precision:
- RANDOX Test System: Not specified
- WIENER LAB. Test System: Normal Serum Control: CV =1.75%, Abnormal Serum Control: CV = 1.25%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Intra-assay precision: Normal Serum Control: CV = 1.32 %, Abnormal Serum Control: CV = 0.54%
- Inter-assay precision: Normal Serum Control: CV =1.75%, Abnormal Serum Control: CV = 1.25%
- Minimum detection limit: 6.1 µg/dl
Predicate Device(s)
RANDOX IRON test system.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1410 Iron (non-heme) test system.
(a)
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.(b)
Classification. Class I (general 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.
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FER-COLOR AA Wiener lab.
NOV 1 3 2001
Image /page/0/Picture/2 description: The image is a circular seal with the text "Wiener lab." at the top. Inside the circle, there is a logo with the letters "ISO 9001" above the letters "TUV CERT". The text "SISTEMA DE CALIDAD CERTIFICADO" is written along the bottom of the circle.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized letter W inside of a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller font.
WIENER LABORATORIOS S.A.I.C. - Riobamba 2944 - 2000 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet:
Section 6 - Summary
510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"
"The assigned 510(k) number is: y
Introduction
According to the requirements of 21 CFR 862.1410, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.
6-1 Submitter Name, Address, Contact
Wiener Laboratorios S.A.I.C. Riobamba 2944 2000 - Rosario - Argentina Contact person: Viviana Cétola Date Prepared: June 20, 2001
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| 6-2 Device Name | Proprietary name: WIENER LAB FER-COLOR AA
Common name: Photometric method for Iron determination.
Classification name: Photometric method, iron (non-heme).
Device Class I
Product Code: JIY |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-3 Predicate
Device | We claim substantial equivalence to the currently marketed
RANDOX IRON test system. |
| 6-4 Device
Description | End point method. |
| | Serum iron is released from its specific carrier protein
(transferrin) in a pH 4.5 acetate buffer, and in the presence of a
reducing agent (ascorbic acid). Then it reacts with the color
reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine)
producing a colored complex measured at 570 nm. |
| 6-5 Intended Use | FER-COLOR AA test system is intended to be used in the
quantitative determination of iron in human 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. |
| 6-6 Equivalencies
and Differences | WIENER LAB. FER-COLOR AA test system is substantially
equivalent to other products in commercial distribution intended
for similar use. Most notably it is substantially equivalent to the
currently marketed RANDOX IRON test system. |
| | The following table illustrates the similarities and differences
between WIENER LAB. FER-COLOR AA test system and the
currently marketed RANDOX IRON test system. |
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| | RANDOX Test
System | WIENER LAB. Test
System |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended use | Quantitative determination of iron in human
serum and plasma | |
| Test principle | End point method.
Serum iron is released from its specific carrier
protein (transferrin) in a pH 4.5 acetate buffer.
The ferric iron is converted to the ferrous form
by the action of a reducing agent (ascorbic
acid). Then it reacts with the color reagent,
pyridyl bis-phenyl triazine sulfonate (ferrozine)
producing a colored complex measured at
540/580 nm. | |
| Essential
Components | Buffer acetate - Ascorbic acid - Ferrozine | |
| Reagents | R1: Buffer acetate
R2: Ascorbic acid -
Ferrozine | R1: Ferrozine
R2: Buffer acetate
R3: Ascorbic acid
(reductor) |
| Preparation of
Working Reagent | R1 and R2 ready to
use | Preparation of Buffer/
Reductor |
| Instability or
deterioration of
reagents | Not specified | Change in Blank
and/or Standard
Absorbances |
| Sample | Serum and plasma. | |
| Working
Temperature Range | 25 - 37°C | |
| Stability of final
color | Not specified | 5 to 60 minutes |
| | RANDOX Test
System | WIENER LAB. Test
System |
| Wavelength of
reading. | 570 nm | 540 - 580 nm |
| Linearity | 1000 µg/dl | |
| Minimum detection
limit | Not specified | 6.1 µg/dl |
| Expected values | Male
10.6 – 28.3 µmol/l
(59-158 µg/dl)
Female
6.6 – 26.0 µmol/l
(37-145 µg/dl) | 60 -160 µg/dl |
| Intra-assay
precision | Level 1:
CV = 2.93%
Level 2:
CV = 2.29% | Normal Serum Control:
CV = 1.32 %
Abnormal Serum
Control:
CV = 0.54% |
| Inter-assay
precision | Not specified | Normal Serum Control:
CV =1.75%
Abnormal Serum
Control:
CV = 1.25% |
:
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6-7 Conclusion
Based on the data above mentioned, we believe that the extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle symbol, represented by three curved lines that form the shape of a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Viviana Cetola QC/QA Manager Wiener Laboratorios S. A. I.C. Riobamba 2944, Rosario, Santa Fe Argentina
NOV 1 3 2001
K013097 Re: Trade/Device Name: Fer-Color AA Regulation Number: 21 CFR 862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I, reserved Product Code: JIY Dated: July 26, 2001
Received: September 17, 2001
Dear Dr. Cetola:
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.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Dr 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 and 1 IT you desire spoolite as in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 dditionally, for questions on the promotion and advertising of your device, (301) 594-1560. I radiation f Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CDRH ODE
NOV 1 3 2001
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Wiener lab For-Color An
Indications For Use:
The "Wiener lab. Fer-Color AA" iron test system is a quantitative in The Wiener Tab. I CF-Ooler 70 t Tren coure iron (non-heme) in serum vitro diagnostic device intonation to urements are used in the diagnosis treatment of diseases such as iron deficiency anemia, and hemochromatosis (a disease associated with widespread deposit in the nemochromatosis (a discuss aporomants, hemosiderin and hemofuscin,
tissues of two iron-containing pigments, hemosiderin, and obronic repal tissues of two frontoning pigmentation of the skin), and chronic renal disease.
Division of Clinical La Gratory Levices
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDBED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
() 2011
0 M (Division Sign-Off)
510(k) Number_K
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
SK27