(34 days)
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.
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.
The provided text describes the Wiener lab. Standatrol S-E 2 niveles, a quality control material, and its substantial equivalence to a predicate device, ROCHE Precinorm U and Precipath U. It does not contain information about studies proving the device meets specific acceptance criteria in the way a diagnostic device performance study would. Instead, the focus is on demonstrating "substantial equivalence" to a legally marketed predicate device.
Here's an attempt to answer based on the provided text, acknowledging that some requested information for a typical diagnostic device performance study is not present:
This submission demonstrates the substantial equivalence of the "Wiener lab. Standatrol S-E 2 niveles" to existing predicate devices, rather than a study proving the device meets specific performance criteria through novel testing.
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A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria or reported device performance in terms of sensitivity, specificity, accuracy, etc. for the Wiener lab. Standatrol S-E 2 niveles. Instead, it provides a comparative table highlighting similarities and some minor differences with the predicate device, ROCHE Precinorm U and Precipath U, to establish substantial equivalence.
Feature / Characteristic Predicate Device (ROCHE Precinorm U and Precipath U) Wiener LAB. Standatrol S-E 2 niveles Acceptance (based on equivalence) 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. Equivalent (minor wording difference, same underlying purpose) Format Lyophilized pooled human sera with constituents added as required to obtain desired components levels. Lyophilized pooled human sera with constituents added as required to obtain desired components levels. Equivalent Stability (Provided Reagents) Stable in refrigerator (2-8°C) until expiration date. Stable in refrigerator (2-10°C) until expiration date. Equivalent (slight temperature range difference but within typical refrigerated storage) Stability (Reconstituted) Stable for 12 hours at 25°C, 5 days at 4°C or 1 month frozen (-20°C), with exceptions noted in label. Stable for 5 days at 2 - 10°C or 1 month frozen (-20°C), with exceptions noted in label. Equivalent (differences are noted in product labeling) Levels Two Levels. Two Levels. Equivalent Constituent Analytes and Enzymes Includes a list of 25 analytes/enzymes. Includes a list of 24 analytes/enzymes (missing total Iron-binding capacity, other electrolytes, other enzymes present in predicate; adds HDL-Cholesterol). Substantially Equivalent (minor differences in specific analytes, but overall scope of use is similar) -
Sample size used for the test set and the data provenance
The document does not describe a "test set" for performance evaluation in the typical sense of a diagnostic device. The evaluation is based on comparing the characteristics of the new device to a predicate device. There is no mention of a specific sample size of materials tested from different countries or whether the comparison was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set was established by experts in this context. The claim is based on the characteristics of the control material itself and its similarity to an established product.
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Adjudication method for the test set
Not applicable. No adjudication method for a test set was described.
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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
Not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a quality control material, not an algorithm.
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The type of ground truth used
The concept of "ground truth" as typically used in diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable here. The "evidence" for substantial equivalence is derived from a direct comparison of the physical and functional characteristics of the new device with the predicate device, as presented in the comparative table. This relies on the established and accepted performance and safety profile of the predicate device.
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The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set.
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How the ground truth for the training set was established
Not applicable. See point 8.
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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: 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: ______________________________________________________________________________________________________________________________________________ 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 SubmitterName, Address,Contact | Wiener Laboratorios S.A.I.C.Riobamba 29442000 – Rosario – ArgentinaTel: 54 341 4329191Fax: 54 341 4851986Contact person: Viviana CétolaDate Prepared: November 15, 2002 |
|---|---|
| 6-2 Device Name | Proprietary name: Wiener lab. Standatrol S-E 2 niveles.Common name: Quality Control Material (assayed andunassayed).Classification name: Multi-Analyte Controls, all kinds (assayedand unassayed).Device Class I |
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- 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.
| ROCHEPrecinorm U andPrecipath U. | WIENER LAB.Standatrol S-E2 niveles | |
|---|---|---|
| Intended Use | For quality control inthe quantitativedetermination ofsubstrates,electrolytes, lipids,enzymes and proteins. | Intended for use asassayed controlmaterial for automatedand manual clinicalchemistry methods. |
| ROCHEPrecinorm U andPrecipath U. | WIENER LAB.Standatrol S-E2 niveles | |
| Format | Lyophilized pooled human sera withconstituents added as required to obtaindesired components levels. | |
| Stability | Provided Reagents:stable in refrigerator(2-8°C) until expirationdate printed on label.Reconstituted controlserum: stable for 12hours at 25°C, 5 daysat 4°C or 1 monthfrozen(-20°C), withexceptions noted inlabel. | Provided Reagents:stable in refrigerator(2-10°C) untilexpiration date printedon label.Reconstituted controlserum: stable for 5days at 2 - 10°C or 1month frozen (-20°C),with exceptions notedin label. |
| Levels | Two Levels. | |
| Albumin | Albumin | |
| Bilirubin, Direct | Bilirubin, Direct | |
| Bilirubin, Total | Bilirubin, Total | |
| Calcium | Calcium | |
| Cholesterol | Cholesterol | |
| - | HDL-Cholesterol | |
| Chloride | Chloride | |
| ConstituentAnalytes andEnzymes | Creatinine | Creatinine |
| Glucose | Glucose | |
| Iron | Iron | |
| total Iron-bindingcapacity | - | |
| Magnesium | Magnesium | |
| Inorganic Phosphorus | Inorganic Phosphorus | |
| Potassium | Potassium | |
| Protein, total | Protein, total | |
| Sodium | Sodium | |
| Continued on next page | ||
| ROCHEPrecinorm U andPrecipath U. | WIENER LAB.Standatrol S-E2 niveles | |
| ConstituentAnalytes andEnzymes | Triglycerides | Triglycerides |
| Urea | Urea | |
| Uric acid | Uric acid | |
| Alkaline Phosphatase | Alkaline Phosphatase | |
| α-Amylase | α-Amylase | |
| AlanineAminotransferase | AlanineAminotransferase | |
| AspartateAminotransferase | AspartateAminotransferase | |
| Cholinesterase | Cholinesterase | |
| Creatine Kinase | Creatine Kinase | |
| γ-Glutamyltransferse | γ-Glutamyltransferse | |
| LactateDehydrogenase | LactateDehydrogenase | |
| Other electrolytes | - | |
| Other enzymes | - |
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6-7 Conclusion
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Above mentioned data show substantial equivalency to the predicate device.
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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).
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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
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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
I
CH
§ 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.