(57 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device called "WIENER LAB FER-COLOR TRANSFERRINA", which is a photometric method for Total-Iron Binding Capacity determination. The document indicates that this device is substantially equivalent to a predicate device, the RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, rather than detailing a study against predefined acceptance criteria for novel claims.
Here's a breakdown of why the information isn't available in the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present. A 510(k) summary primarily focuses on comparing the new device to a predicate device to demonstrate substantial equivalence, not on establishing performance against specific acceptance criteria through a dedicated study with quantified results.
- Sample Size and Data Provenance: Not mentioned for any test set. The document does not describe a performance study with a distinct test set.
- Number of Experts and Qualifications: Not applicable as no expert-based ground truth establishment is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. The device is a laboratory assay.
- Standalone Performance Study: A standalone performance study against explicit acceptance criteria with quantitative results is not detailed in this 510(k) summary. The comparison is between the new device and a predicate device.
- Type of Ground Truth Used: Not described. For laboratory assays, ground truth often involves reference methods or established clinical diagnoses, which are not outlined here as part of a formal study.
- Sample Size for Training Set: Not mentioned. The device appears to be a reagent-based assay, not a machine learning algorithm that would typically require a training set.
- How Ground Truth for Training Set was Established: Not applicable.
The document primarily states:
- Device Name: WIENER LAB FER-COLOR TRANSFERRINA
- Intended Use: Quantitative determination of Total Iron binding capacity in human serum and plasma. Used in the diagnosis and treatment of anemia.
- Predicate Device: RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system.
- Equivalencies and Differences: A table comparing the intended use, test principle, reagents, and expected values between the new device and the predicate. The expected values for the Wiener Lab device are stated as 250 - 400 µg/dl. The RANDOX device states 46.0 - 69.5 µmol/l (259 - 388 µg/dl). This comparison serves as the basis for claiming substantial equivalence, implying that similar performance is expected.
To answer your request, a detailed performance study report with specific acceptance criteria and detailed statistical analysis would be required, which is beyond the scope of this 510(k) summary.
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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: http://www.wiener-lab.com.ar
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
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| 6-2 Device Name | Proprietary name: WIENER LAB FER-COLOR TRANSFERRINACommon name: Photometric method for Total – Iron BindingCapacity determination.Classification name: Ferrozine (colorimetric) Iron BindingCapacityDevice Class IProduct Code: JMO |
|---|---|
| 6-3 PredicateDevice | We claim substantial equivalence to the currently marketedRANDOX TOTAL-IRON BINDING CAPACITY / IRON testsystem. |
| 6-4 DeviceDescription | End point method.Transferrin or specific iron carrier protein is assayed through itsphysiologic activity of binding Fe (III) (TIBC) at a pH higher than7.2 in which transferrin is saturated in the presence of excess Fe(III). The remaining unbound Fe (III) is totally removed bycoprecipitation with magnesium carbonate. After centrifugation,iron in the supernatant is determined as follows: iron bound totransferrin is released and colorimetrically measured according toFer-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.
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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 AuxiliaryReagents for TIBC | WIENER LAB.Auxiliary Reagentsfor TIBC | |
|---|---|---|
| Intended use | Quantitative determination of Total - IronBinding Capacity (TIBC) in human serum. | |
| Test Principle | An excess of iron is added to the sample tosaturate the transferrin. The unbound iron isprecipitated with magnesium carbonate. Aftercentrifugation the iron in the supernatant isdetermined with ferrozine. | |
| Reagents for IronBinding capacity | R1 Iron SolutionR2 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
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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.
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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 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
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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
§ 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.