(57 days)
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Not Found
No
The device description details a chemical assay based on colorimetric measurement, with no mention of AI or ML technologies.
No
The device is described as a quantitative in vitro diagnostics device intended to measure iron-binding capacity, which is used in the diagnosis and treatment of anemia. This is an IVD (in-vitro diagnostic) device, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a quantitative in vitro diagnostics device intended to measure iron-binding capacity in serum or plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia." This directly indicates its role as a diagnostic tool.
No
The device description clearly outlines a chemical assay process involving reagents, centrifugation, and colorimetric measurement, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The 'Wiener lab. Fer-Color Transferrina' iron-binding capacity test system is a quantitative in vitro diagnostics device intended to measure iron-binding capacity in serum or 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 Transferrina" iron-binding capacity test system is a quantitative in vitro diagnostics device intended to measure iron-binding capacity in serum or plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
Product codes (comma separated list FDA assigned to the subject device)
JMO
Device Description
End point method. Transferrin or specific iron carrier protein is assayed through its physiologic activity of binding Fe (III) (TIBC) at a pH higher than 7.2 in which transferrin is saturated in the presence of excess Fe (III). The remaining unbound Fe (III) is totally removed by coprecipitation with magnesium carbonate. After centrifugation, iron in the supernatant is determined as follows: iron bound to transferrin is released and colorimetrically measured according to Fer-Color procedure. Such measurement proceeds as follows: iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in presence of a reducing agent (ascorbic acid). Then it reacts with 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
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(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.
0
NOV 1 3 2001
Image /page/0/Picture/2 description: The image is a black and white circular seal or logo. The text "Wiener lab." is at the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is at the bottom. The seal also contains the text "ISO 9001" and the logo of "TÜV CERT" in the center. The seal appears to be a certification mark, possibly indicating that Wiener lab. meets the ISO 9001 quality management standards.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." to the right. Below the company name is the text "Especialidades para Laboratorios Clinicos".
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: | 01310 7-リア
Introduction
According to the requirements of 21 CFR 862.1415, 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
1
| 6-2 Device Name | Proprietary name: WIENER LAB FER-COLOR TRANSFERRINA
Common name: Photometric method for Total – Iron Binding
Capacity determination.
Classification name: Ferrozine (colorimetric) Iron Binding
Capacity
Device Class I
Product Code: JMO |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-3 Predicate
Device | We claim substantial equivalence to the currently marketed
RANDOX TOTAL-IRON BINDING CAPACITY / IRON test
system. |
| 6-4 Device
Description | End point method.
Transferrin or specific iron carrier protein is assayed through its
physiologic activity of binding Fe (III) (TIBC) at a pH higher than
7.2 in which transferrin is saturated in the presence of excess Fe
(III). The remaining unbound Fe (III) is totally removed by
coprecipitation with magnesium carbonate. After centrifugation,
iron in the supernatant is determined as follows: iron bound to
transferrin is released and colorimetrically measured according to
Fer-Color procedure.
Such measurement proceeds as follows: iron is released from its |
specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in presence of a reducing agent (ascorbic acid). Then it reacts with color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.
Wiener lab FER-COLOR TRANSFERRINA is used for the 6-5 Intended Use quantitative determination of Total Iron binding capacity in human serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
2
WIENER LAB. FER-COLOR TRANSFERRINA test system is 6-6 Equivalencies WIENER END equivalent to other products in commercial and Differences distribution intended for similar use. Most notably it is distantially equivalent to the currently marketed RANDOX IRON test system.
The following table illustrates the similarities and differences The Tollowing Lable Fifastials FER-COLOR TRANSFERRINA/ FER-COLOR AA test system and the currently marketed FER-COLOR TOTAL-IRON BINDING CAPACITY/IRON test system.
| | RANDOX Auxiliary
Reagents for TIBC | WIENER LAB.
Auxiliary Reagents
for TIBC |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended use | Quantitative determination of Total - Iron
Binding Capacity (TIBC) in human serum. | |
| Test Principle | An excess of iron is added to the sample to
saturate the transferrin. The unbound iron is
precipitated with magnesium carbonate. After
centrifugation the iron in the supernatant is
determined with ferrozine. | |
| Reagents for Iron
Binding capacity | R1 Iron Solution
R2 Magnesium Carbonate | |
| Expected values | 46.0 -69.5 µmol/l
(259 - 388 µg/dl) | 250 - 400 µg/dl |
Based on the data above mentioned, we believe that the 6-7 Conclusion extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use.
6 - 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2001
Dr. Viviana Cetola OC/OA Manager Wiener Laboratorios S. A. I.C. Riobamba 2944, Rosario, Santa Fe Argentina
K013102 Re:
Trade/Device Name: Fer-Color Transferrina Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I, reserved Product Code: JMO 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 wt have teviewed your becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the excreen. 976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, are occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Free (110.) the device, subject to the general controls provisions of the Act. The I ou may, dicrorore, mains 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 If your device is elabilional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and the fi may or subject to back areas 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 r lease oc advisou that i Drimination that your device complies with other requirements of the Act that I Dr has intact and regulations administered by other Federal agencies. You must or any I vith 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 Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality by over of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 notification. The I Dri Imania of succioin 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 (2) CFR Part 801 and 1 IT you desire specific advices from your astic devices), please contact the Office of Compliance at additionally 607.10 for m Prive craguestions on the promotion and advertising of your device, (301) 594-4500. Traditionally, 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 information on your responsibilities and er Assistance at its toll-free number (800) 638-2041 or Manufactors International and Solass "http://www.fda.gov/cdrh/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
5
CDRH ODE
KD13102
NOV 1 3 2001
Page 1 of 1
| 510(k) Number (if known): | K013102 |
|---|---|
| Device Name: | Wiener lab. |
| Fer-Color Trausferrina |
Indications For Use:
The "Wiener lab. Fer-Color Transferrina" iron-binding capacity test The "Wiener Tab. Fel-Color" Transformine "weae intended to measure
system is a quantitative in vitro diagnostics device intended to measure system is a quantitative in vitro unagnosia. Iron-binding capacity
iron-binding capacity in serum or plasma. Iron-binding capacity iron-binding "Capacity" in "Scrain" of "practice" (freatment of anemia.
Jean Cooper
(Division Sign-Off)
Division of Medical Laboratory I
510(k) number: K013102
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
RECEIVED
SE 17
FDA/CDRH/ODE
12 32 PM 01
Prescription Usc (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
C.H.
I
SK28