(34 days)
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No
The summary describes a quality control material (lyophilized human serum) used for calibrating and monitoring the performance of clinical chemistry analyzers. There is no mention of AI or ML in the intended use, device description, or any other section. The function is purely as a reference standard, not an analytical or interpretive tool.
No
The device is a quality control material used in a test system for clinical chemistry laboratories to monitor accuracy and precision; it is not intended for direct treatment or diagnosis of a patient.
No
This device is a quality control material used to estimate test precision and detect analytical deviations, rather than to diagnose a patient's condition. While it is used in a clinical setting, its purpose is to monitor the accuracy of diagnostic tests, not to perform diagnosis itself.
No
The device description clearly states it consists of "lyophilized human serum," which is a physical substance and not software.
Based on the provided information, the "Wiener lab. Standatrol S-E 2 niveles" is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations... This quality control material is used for monitoring accuracy and precision... in clinical chemistry laboratories." This aligns directly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control material and not a diagnostic test itself, it is an essential component within an IVD test system.
- Device Description: It consists of "lyophilized human serum containing the analytes usually determined in clinical chemistry laboratories." This is a biological material used in laboratory testing.
- Intended User / Care Setting: It is used in "clinical chemistry laboratories" by professionals performing laboratory tests.
- Predicate Device(s): The mention of predicate devices (ROCHE Precinorm U and Precipath U) which are known IVD control materials further supports its classification as an IVD.
Therefore, the "Wiener lab. Standatrol S-E 2 niveles" functions as a quality control material, which is a type of IVD device used to ensure the accuracy and reliability of other diagnostic tests performed in a laboratory setting.
N/A
Intended Use / Indications for Use
The "Wiener lab. Standatrol S-E 2 niveles" is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys. This quality control material is used for monitoring accuracy and precision both for manual techniques and assays on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Standatrol S-E 2 niveles consists of lyophilized human serum containing the analytes usually determined in clinical chemistry laboratories. The exact concentrations and acceptable ranges of the components are lot-specific and are provided in the product insert.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
ROCHE Precinorm U and Precipath U (Cat. Nº171735 and Device 1446096 )
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.
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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).
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
MAR 1 9 2003
Standatrol S-E 2 niveles Wiener lab.
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 is a logo that looks like a "W" and the words "ISO 9001" and "TUV CERT". The seal appears to be a quality certification mark.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name, there is the text "Especialidades para Laboratorios Clínicos" 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: ______________________________________________________________________________________________________________________________________________ ע
Introduction According to the requirements of 21 CFR 862.1660, 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
Tel: 54 341 4329191
Fax: 54 341 4851986
Contact person: Viviana Cétola
Date Prepared: November 15, 2002 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-2 Device Name | Proprietary name: Wiener lab. Standatrol S-E 2 niveles.
Common name: Quality Control Material (assayed and
unassayed).
Classification name: Multi-Analyte Controls, all kinds (assayed
and unassayed).
Device Class I |
1
- We claim substantial equivalence to the currently marketed 6-3 Predicate ROCHE Precinorm U and Precipath U (Cat. Nº171735 and Device 1446096 ).
- Standatrol S-E 2 niveles consists of lyophilized human serum 6-4 Device containing the analytes usually determined in clinical chemistry Description laboratories. The exact concentrations and acceptable ranges of the components are lot-specific and are provided in the product insert.
- Standatrol S-E 2 niveles is a device intended for medical 6-5 Intended Use purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys. This quality control material is used for monitoring accuracy and
precision both for manual techniques and assays on automated clinical chemistry analyzers.
The WIENER LAB. Standatrol S-E 2 niveles is substantially 6-6 Equivalencies and Differences equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed ROCHE Precinorm U and Precipath U.
The following table illustrates the similarities and differences between the WIENER LAB. Standatrol S-E 2 niveles quality control material and the currently marketed ROCHE Precinorm U and Precipath U.
| | ROCHE
Precinorm U and
Precipath U. | WIENER LAB.
Standatrol S-E
2 niveles |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For quality control in
the quantitative
determination of
substrates,
electrolytes, lipids,
enzymes and proteins. | Intended for use as
assayed control
material for automated
and manual clinical
chemistry methods. |
| | ROCHE
Precinorm U and
Precipath U. | WIENER LAB.
Standatrol S-E
2 niveles |
| Format | Lyophilized pooled human sera with
constituents added as required to obtain
desired components levels. | |
| Stability | Provided Reagents:
stable in refrigerator
(2-8°C) until expiration
date printed on label.
Reconstituted control
serum: stable for 12
hours at 25°C, 5 days
at 4°C or 1 month
frozen
(-20°C), with
exceptions noted in
label. | Provided Reagents:
stable in refrigerator
(2-10°C) until
expiration date printed
on label.
Reconstituted control
serum: stable for 5
days at 2 - 10°C or 1
month frozen (-20°C),
with exceptions noted
in label. |
| Levels | Two Levels. | |
| | Albumin | Albumin |
| | Bilirubin, Direct | Bilirubin, Direct |
| | Bilirubin, Total | Bilirubin, Total |
| | Calcium | Calcium |
| | Cholesterol | Cholesterol |
| | - | HDL-Cholesterol |
| | Chloride | Chloride |
| Constituent
Analytes and
Enzymes | Creatinine | Creatinine |
| | Glucose | Glucose |
| | Iron | Iron |
| | total Iron-binding
capacity | - |
| | Magnesium | Magnesium |
| | Inorganic Phosphorus | Inorganic Phosphorus |
| | Potassium | Potassium |
| | Protein, total | Protein, total |
| | Sodium | Sodium |
| | | Continued on next page |
| | ROCHE
Precinorm U and
Precipath U. | WIENER LAB.
Standatrol S-E
2 niveles |
| Constituent
Analytes and
Enzymes | Triglycerides | Triglycerides |
| | Urea | Urea |
| | Uric acid | Uric acid |
| | Alkaline Phosphatase | Alkaline Phosphatase |
| | α-Amylase | α-Amylase |
| | Alanine
Aminotransferase | Alanine
Aminotransferase |
| | Aspartate
Aminotransferase | Aspartate
Aminotransferase |
| | Cholinesterase | Cholinesterase |
| | Creatine Kinase | Creatine Kinase |
| | γ-Glutamyltransferse | γ-Glutamyltransferse |
| | Lactate
Dehydrogenase | Lactate
Dehydrogenase |
| | Other electrolytes | - |
| | Other enzymes | - |
2
:
3
6-7 Conclusion
·
Above mentioned data show substantial equivalency to the predicate device.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a series of flowing lines, creating a sense of movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2003
Dr. Viviana Cetola QC/QA Manager Weiner Laboratorios S.A. I. C. Riobamba 2944 2000 Rosario, Santa Fe Argentina
K030482 Re:
Trade/Device Name: Weiner Lab. Standatrol S-E 2 niveles Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 30, 2002 Received: February 13, 2003
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman
Steven I. Gutman, M.D., M.B.A. . . . Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Page_
| 510(k) Number (if known): | K030482 |
|---|---|
| Device Name: | Wiener lab. |
| Standatrol S-E 2 niveles |
Indications For Use:
The "Wiener lab. Standatrol S-E 2 niveles" is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys.
This quality control material is used for monitoring accuracy and precision both for manual techniques and assays on automated clinical chemistry analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBO)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR ...
Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices In 19 36 510(k) Number -
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Over-The-Counter Use_
SKO3
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