(60 days)
The "Wiener lab. Albumina AA" albumin test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of albumin in human sera. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Albumin reacts specifically with bromcresol green to produce a colored complex. Increase of absorbance at 625 nm with respect to the reagent Blank is proportional to the albumin concentration in sample.
The provided text describes a 510(k) summary for the "WIENER LAB ALBUMINA AA" test system, which is intended for the quantitative determination of albumin in human sera. The document aims to demonstrate substantial equivalence to a predicate device, the ABBOTT ALBUMIN BCG test system.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but provides comparative performance characteristics between the WIENER LAB ALBUMINA AA test system and its predicate, the ABBOTT ALBUMIN BCG test system. These can be inferred as the performance metrics the device aimed to meet or be comparable to.
| Performance Characteristic | Predicate Device (ABBOTT ALBUMIN BCG) | WIENER LAB ALBUMINA AA (Reported Performance) |
|---|---|---|
| Intended Use | Quantitative determination of albumin in human sera and plasma. | Quantitative determination of albumin in human sera. |
| Test Principle | Albumin reacts specifically with bromcresol green (BCG) to produce a colored complex. Increase of absorbance at 625 nm with respect to the reagent Blank is proportional to the albumin concentration in sample. | Albumin reacts specifically with bromcresol green to produce a colored complex. Increase of absorbance at 625 nm with respect to the reagent Blank is proportional to the albumin concentration in sample. |
| Essential Components | BCG | BCG |
| Reagents | Single reagent ready to use | Single reagent ready to use |
| Storage and Stability | Stable until expiration date printed on the labels when stored at room temperature. | Stable until expiration date printed on the labels when stored at room temperature. |
| Serum Controls | Available - provided separately | Available - provided separately |
| Sample | Human sera and plasmas | Human sera |
| Wavelength of reading | 600 nm | 600 to 650 nm |
| Linearity | up to 7 g/dl | up to 7 g/dl (Implied, as it's not explicitly different) |
| Minimum Detection Limit | 0.1 g/dl | 0.02 g/dl |
| Analytical Sensitivity | 0.2 g/dl | 0.7 g/dl |
| Expected values | Male: 4.2-5.5 g/dl, Female: 3.7-5.3 g/dl, Hospitalized Adult: 3.5-5.0 g/dl | 3.5 - 4.8 g/dl |
| Intra-assay Precision (Normal Serum Control) | CV = 1.8 - 1.2 - 1.5% (in different analyzers) | CV = 2.10 % |
| Intra-assay Precision (Abnormal Serum Control) | CV = 1.7-1.4-0.8% (in different analyzers) | CV = 2.48 % |
| Inter-assay Precision (Normal Serum Control) | CV = 2.1 - 1.9 - 2.0 % (in different analyzers) | CV = 3.57 % |
| Inter-assay Precision (Abnormal Serum Control) | CV = 2.3 - 2.2 - 1.6 % (in different analyzers) | CV = 3.99 % |
Note: For "Linearity," "Test Principle," "Essential Components," "Reagents," "Storage and Stability," and "Serum Controls," the document implies substantial equivalence without providing distinct values for the new device if they are the same as the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It mentions precision studies (intra-assay and inter-assay) were conducted using "Normal Serum Control" and "Abnormal Serum Control," but the number of samples or runs is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The device is an in-vitro diagnostic test for albumin measurement, not an imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document, as it pertains to expert reviews of diagnostic interpretations, which is not the nature of this device.
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
This information is not applicable. The device is a laboratory assay for quantitative albumin measurement and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The "WIENER LAB ALBUMINA AA" test system is a standalone in-vitro diagnostic device. Its performance characteristics listed (precision, sensitivity, detection limit) are inherently standalone performance measures of the assay itself without human-in-the-loop performance modifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance metrics presented (precision, linearity, sensitivity, detection limit), the "ground truth" would be established by reference methods or validated calibrated controls used in the laboratory setting. The document does not specify the exact methods or materials used to establish these reference values for the studies, but it is characteristic of clinical chemistry assays to use certified reference materials and established analytical techniques.
8. The sample size for the training set
This information is not applicable and not provided. The development of a chemical assay like this typically involves formulation and optimization rather than "training" an algorithm with a dataset in the way machine learning models are trained.
9. How the ground truth for the training set was established
This information is not applicable. As explained above, the concept of a "training set" and "ground truth" for a training set does not directly apply to the development of this type of chemical assay. Assay development involves optimizing reagent concentrations, reaction conditions, and calibration procedures to achieve desired analytical performance characteristics.
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ALBUMINA AA Wiener lab.
SEP 2 1 2001
Image /page/0/Picture/2 description: The image is a circular seal with the words "Wiener lab." at the top and "SISTEMA DE CALIDAD CERTIFICADO" around the bottom. In the center of the seal, there is a logo with the letters "ISO 9001" above the letters "TUV CERT". The seal appears to be a certification mark, possibly indicating that the product or organization meets certain quality 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." 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: ______________________________________________________________________________________________________________________________________________ 93
According to the requirements of 21 CFR 862.1580, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence. Wiener Laboratorios S.A.I.C. 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: March 19, 2001
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| 6-2 Device Name | Proprietary name: WIENER LAB ALBUMINA AACommon name: Albumin test system.Classification name: Bromcresol Green Dye-Binding, AlbuminDevice Class II |
|---|---|
| 6-3 Predicate Device | We claim substantial equivalence to the currently marketedABBOTT ALBUMIN BCG test system. |
| 6-4 Device Description | Albumin reacts specifically with bromcresol green to produce acolored complex. Increase of absorbance at 625 nm withrespect to the reagent Blank is proportional to the albuminconcentration in sample. |
| 6-5 Intended Use | The WIENER LAB ALBUMINA AA test system is intended tobe used in the quantitative determination of albumin in humansera. Albumin measurements are used in the diagnosis andtreatment of numerous diseases involving primarily the liver orkidneys. |
| 6-6 Equivalencies and Differences | The WIENER LAB ALBUMINA AA test system is substantiallyequivalent to other products in commercial distributionintended for similar use. Most notably it is substantiallyequivalent to the currently marketed ABBOTT ALBUMIN BCGtest system.The following table illustrates the similarities and differencesbetween the WIENER LAB ALBUMINA AA test system andthe currently marketed ABBOTT ALBUMIN BCG test system. |
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| ABBOTT TestSystem | WIENER LAB. TestSystem | |
|---|---|---|
| Intended Use | Quantitativedetermination ofalbumin in human seraand plasma. | Quantitativedetermination ofalbumin in humansera. |
| Test Principle | Albumin reacts specifically with bromcresolgreen (BCG) to produce a colored complex.Increase of absorbance at 625 nm with respectto the reagent Blank is proportional to thealbumin concentration in sample. | |
| EssentialComponents | BCG | |
| Reagents | Single reagent ready to use | |
| Storage andStability ofReagent | Stable until expiration date printed on the labelswhen stored at room temperature | |
| Serum Controls | Available - provided separately | |
| Sample | Human sera andplasmas | Human sera |
| Wavelength ofreading. | 600 nm | 600 to 650 nm |
| Linearity | up to 7 g/dl | |
| MinimumDetection Limit | 0.1 g/dl | 0.02 g/dl |
| Analyticalsensitivity | 0.2 g/dl | 0.7 g/dl |
| Continued on next page | ||
| ABBOTT TestSystem | WIENER LAB. TestSystem | |
| Expected values | Male: 4.2-5.5 g/dlFemale: 3.7-5.3 g/dlHospitalized Adult: 3.5-5.0 g/dl | 3.5 - 4.8 g/dl |
| Intra-assayPrecision | Normal Serum Control:CV = 1.8 - 1.2 - 1.5%Abnormal SerumControl:CV = 1.7-1.4-0.8%(in different analyzers) | Normal Serum Control:CV = 2.10 %Abnormal SerumControl:CV = 2.48 % |
| Inter-assayPrecision | Normal Serum Control:CV = 2.1 - 1.9 - 2.0 %Abnormal SerumControl:CV = 2.3 - 2.2 - 1.6 %(in different analyzers) | Normal Serum Control:CV = 3.57 %Abnormal SerumControl:CV = 3.99 % |
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes a stylized caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 1 2001
Dr. Viviana Cetola QA/QC Manager Weiner Laboratories S.A.I.C. Riobamba 2944 2000 - Rosairo - Argentina
K012329 Re: Trade/Device Name: Albumina AA Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CIX Dated: July 16, 2001 Received: July 23, 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 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 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of 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 Manufacturers 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/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
| Page | of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 510(k) Number (if known): | K012329 |
|---|---|
| Device Name: | Wiener lab. |
| Albumina. AA. |
Indications For Use:
The "Wiener lab. Albumina AA" albumin test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of albumin in human sera. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kusin Alexander for Sean Cooper
(Division Sign
Division of Culatory Devices
510(k) number K012329
Prescription Use
(Per 21 CFR 801.109)
510(k) Number
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.