(57 days)
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. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, and 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.
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.
The document describes the Wiener Lab. FER-COLOR AA test system, a photometric method for iron determination, and its equivalence to the RANDOX IRON test system for FDA 510(k) clearance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison between the Wiener Lab. FER-COLOR AA test system and the RANDOX IRON test system, which serves as the predicate device. The "acceptance criteria" are implicitly set by the performance of the predicate device, as the submission aims to demonstrate substantial equivalence.
| Performance Characteristic | Acceptance Criteria (RANDOX Test System) | Reported Device Performance (WIENER LAB. Test System) |
|---|---|---|
| Intended Use | Quantitative determination of iron in human serum and plasma | Quantitative determination of iron in human serum and plasma |
| Test Principle | End point method using ferrozine, measured at 540/580 nm | End point method using ferrozine, measured at 570 nm |
| Essential Components | Buffer acetate - Ascorbic acid - Ferrozine | 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 | Serum and plasma |
| Working Temperature Range | 25 - 37°C | 25 - 37°C |
| Stability of final color | Not specified | 5 to 60 minutes |
| Wavelength of reading | 540 - 580 nm | 570 nm |
| Linearity | 1000 µg/dl | 1000 µg/dl |
| Minimum detection limit | Not specified (predicate) | 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% |
Note: The acceptance criteria are largely implied by demonstrating performance comparable to the predicate device. For some parameters, the predicate did not specify a value (e.g., minimum detection limit, inter-assay precision), allowing the applicant to establish their own performance and still claim substantial equivalence if reasonable.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set (i.e., for the precision and comparison studies) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples). The precision data (intra-assay and inter-assay) refers to "Normal Serum Control" and "Abnormal Serum Control," but the number of samples or runs is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For in vitro diagnostic tests like this, ground truth is typically established through analytical methods and reference materials, not expert consensus on interpretations.
4. Adjudication method for the test set
This information is not applicable/provided as the study is a comparison of analytical performance of an in vitro diagnostic device, not a subjective interpretation task requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This type of study is relevant for imaging or interpretation devices where human readers are involved. The FER-COLOR AA is an in vitro diagnostic assay, an automated photometric method, and does not involve human readers for interpretation in this context. It is an "algorithm only" device for the measurement of iron concentration.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire submission focuses on the analytical performance of the "WIENER LAB. FER-COLOR AA" test system itself, demonstrating its precision, linearity, and other analytical characteristics in comparison to a predicate device. This is the definition of a standalone study for this type of device.
7. The type of ground truth used
The ground truth for parameters like linearity, minimum detection limit, and expected values would be based on:
- Reference materials/calibrators: For linearity, known concentrations of iron would be used.
- Assigned values: Control materials ("Normal Serum Control," "Abnormal Serum Control") used for precision studies would have assigned target values.
- Clinical studies/population data: "Expected values" are generally derived from studies on healthy populations.
The document does not explicitly state the specific ground truth methodologies in detail but implies these standard practices for IVD assays.
8. The sample size for the training set
This information is not applicable/provided. The FER-COLOR AA is a chemical assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and photometric measurement, not a learned model from data.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
{0}------------------------------------------------
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: 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: 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
{1}------------------------------------------------
| 6-2 Device Name | Proprietary name: WIENER LAB FER-COLOR AACommon name: Photometric method for Iron determination.Classification name: Photometric method, iron (non-heme).Device Class IProduct Code: JIY |
|---|---|
| 6-3 PredicateDevice | We claim substantial equivalence to the currently marketedRANDOX IRON test system. |
| 6-4 DeviceDescription | 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 areducing agent (ascorbic acid). Then it reacts with the colorreagent, 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 thequantitative determination of iron in human serum and plasma.Iron (non-heme) measurements are used in the diagnosis andtreatment of diseases such as iron deficiency anemia,hemochromatosis (a disease associated with widespreaddeposit in the tissues of two iron-containing pigments,hemosiderin and hemofuscin, and characterized bypigmentation of the skin), and chronic renal disease. |
| 6-6 Equivalenciesand Differences | WIENER LAB. FER-COLOR AA test system is substantiallyequivalent to other products in commercial distribution intendedfor similar use. Most notably it is substantially equivalent to thecurrently marketed RANDOX IRON test system. |
| The following table illustrates the similarities and differencesbetween WIENER LAB. FER-COLOR AA test system and thecurrently marketed RANDOX IRON test system. |
{2}------------------------------------------------
| RANDOX TestSystem | WIENER LAB. TestSystem | |
|---|---|---|
| Intended use | Quantitative determination of iron in humanserum and plasma | |
| Test principle | End point method.Serum iron is released from its specific carrierprotein (transferrin) in a pH 4.5 acetate buffer.The ferric iron is converted to the ferrous formby the action of a reducing agent (ascorbicacid). Then it reacts with the color reagent,pyridyl bis-phenyl triazine sulfonate (ferrozine)producing a colored complex measured at540/580 nm. | |
| EssentialComponents | Buffer acetate - Ascorbic acid - Ferrozine | |
| Reagents | R1: Buffer acetateR2: Ascorbic acid -Ferrozine | R1: FerrozineR2: Buffer acetateR3: Ascorbic acid(reductor) |
| Preparation ofWorking Reagent | R1 and R2 ready touse | Preparation of Buffer/Reductor |
| Instability ordeterioration ofreagents | Not specified | Change in Blankand/or StandardAbsorbances |
| Sample | Serum and plasma. | |
| WorkingTemperature Range | 25 - 37°C | |
| Stability of finalcolor | Not specified | 5 to 60 minutes |
| RANDOX TestSystem | WIENER LAB. TestSystem | |
| Wavelength ofreading. | 570 nm | 540 - 580 nm |
| Linearity | 1000 µg/dl | |
| Minimum detectionlimit | Not specified | 6.1 µg/dl |
| Expected values | Male10.6 – 28.3 µmol/l(59-158 µg/dl)Female6.6 – 26.0 µmol/l(37-145 µg/dl) | 60 -160 µg/dl |
| Intra-assayprecision | Level 1:CV = 2.93%Level 2:CV = 2.29% | Normal Serum Control:CV = 1.32 %Abnormal SerumControl:CV = 0.54% |
| Inter-assayprecision | Not specified | Normal Serum Control:CV =1.75%Abnormal SerumControl:CV = 1.25% |
:
{3}------------------------------------------------
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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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
{6}------------------------------------------------
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
§ 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.