(84 days)
For the quantitative calibration of WIENER LAB's clinical chemistry procedures. Calibrador A plus is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Calibrador A plus consists of Ivophilized human serum containing the compounds usually determined in clinical chemistry laboratories in the appropriate concentrations to ensure optimum calibration of clinical chemistry procedures. Such concentrations are lot-specific and are provided in product insert.
The provided text describes a 510(k) submission for a medical device called "Wiener lab. Calibrador A Plus". This is a multi-analyte calibrator and the submission focuses on demonstrating substantial equivalence to a predicate device, the ROCHE Calibrator for Automated systems (C.f.a.s.).
Here's an analysis of the requested 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" or provide performance metrics in the format of a table as typically seen for diagnostic device performance (e.g., sensitivity, specificity, accuracy, precision). Instead, the submission relies on demonstrating substantial equivalence to a predicate device.
The "performance" is implicitly demonstrated through the similarities between the Wiener lab. Calibrador A Plus and the ROCHE C.f.a.s. in terms of:
- Intended Use: Both are for the calibration of clinical chemistry procedures.
- Format: Both are lyophilized pooled human sera with added constituents.
- Constituent Analytes: Both calibrate for the same set of 16 specific analytes (Albumin, Direct bilirubin, Total bilirubin, Calcium, Cholesterol, Creatinine, HDL Cholesterol, Glucose, Iron, Magnesium, Phosphorus, Total proteins, Triglycerides, Uric acid, Urea). The ROCHE device additionally calibrates for broader categories of "Enzymes" and "Electrolytes", which are not explicitly listed for the Wiener lab. calibrator.
- Stability: The ROCHE device's stability is described (stable in refrigerator until expiration, reconstituted for 8 hours at room temp, 2 days refrigerated or 1 month frozen), but the Wiener lab. calibrator's stability information is not provided in the comparison table.
- Levels: ROCHE C.f.a.s. is a "Single Level" calibrator, and this detail is not provided for the Wiener lab. calibrator in the comparison table.
The "acceptance criterion" in this context is that the device is "substantially equivalent" to the predicate device in its intended use, form, and composition for the listed analytes. The "reported device performance" is the statement that "Above mentioned data show substantial equivalency to the predicate device."
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 describe any specific "test set" of samples or data used for an independent performance evaluation. This submission is focused on demonstrating substantial equivalence through a comparison of product characteristics and intended use, rather than presenting results from a clinical or analytical performance study with a test set. Therefore, information on sample size, data provenance, retrospective/prospective nature, and country of origin is not applicable or not provided.
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)
Since there is no described "test set" for performance evaluation, there is no mention of experts or their qualifications used to establish ground truth for such a set. Establishing ground truth typically applies to diagnostic device performance studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no "test set" with a performance evaluation is described, adjudication methods are not applicable and not mentioned in this document.
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
No MRMC study was done. This device is a calibrator, not a diagnostic imaging device with human readers or AI assistance. Therefore, this section is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a multi-analyte calibrator, not an algorithm. Therefore, this section is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Since no performance study with a test set is described, no specific "ground truth" establishment method (expert consensus, pathology, outcomes data, etc.) is mentioned. The "ground truth" in this context is the established performance and characteristics of the predicate device, to which the new device is being compared for substantial equivalence.
8. The sample size for the training set
The document does not describe a "training set" as this is a calibrator and not a machine learning or AI-based device that would require training data.
9. How the ground truth for the training set was established
As there is no described "training set," the method for establishing its ground truth is not applicable and not mentioned.
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MAR 1 8 2003
Calibrador A Plus Wiener lab.
Image /page/0/Picture/2 description: The image is a circular seal or logo, likely representing a certification or quality standard. The text "Wiener lab." appears at the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is written along the bottom. In the center of the seal, "ISO 9001" is prominently displayed above a logo that includes the letters "TUV".
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 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: _ K 0 % 4 305 33
According to the requirements of 21 CFR 862.1150, the following Introduction 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: September 15, 2002 |
|---|---|
| 6-2 Device Name | Proprietary name: Wiener lab. Calibrador A Plus.Common name: Multianalyte Calibrator.Classification name: Calibrator, Multi-Analyte Mixture.Device Class II |
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- 6-3 Predicate We claim substantial equivalence to the currently marketed ROCHE Calibrator for Automated systems (C.f.a.s.) (Cat. Device Nº759350).
Calibrador A plus consists of Ivophilized human serum 6-4 Device Description containing the compounds usually determined in clinical chemistry laboratories in the appropriate concentrations to ensure optimum calibration of clinical chemistry procedures. Such concentrations are lot-specific and are provided in product insert.
For the quantitative calibration of WIENER LAB's clinical 6-5 Intended Use chemistry procedures. Calibrador A plus is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
The WIENER LAB. Calibrador A Plus calibrator is substantially 6-6 Equivalencies equivalent to other products in commercial distribution intended and Differences for similar use. Most notably it is substantially equivalent to the currently marketed ROCHE Calibrator for Automated systems (C.f.a.s.)
The following table illustrates the similarities and differences between the WIENER LAB. Calibrador A Plus calibrator and the currently marketed ROCHE Calibrator for Automated systems (C.f.a.s.)
| ROCHEC.f.a.s. | WIENER LAB.Calibrador A Plus | |
|---|---|---|
| Intended Use | For use in the calibrationof Roche methods onclinical chemistryanalyzers. | For the quantitativecalibration of WIENERLAB's clinical chemistryprocedures. |
| Format | Lyophilized pooled human sera with constituentsadded as required to obtain desired componentslevels. | |
| Continued on next page | ||
| ROCHEC.f.a.s. | WIENER LAB.Calibrador A Plus | |
| Stability | Provided Reagents: stable in refrigerator (2-10°C)until expiration date printed on label.Reconstituted calibrator: stable for 8 hours at roomtemperature, 2 days refrigerated or 1 month frozen(-20°C), with exceptions noted in label. | |
| Levels | Single Level. | |
| Albumin | Albumin | |
| Direct bilirubin | Direct bilirubin | |
| Total bilirubin | Total bilirubin | |
| Calcium | Calcium | |
| Cholesterol | Cholesterol | |
| Creatinine | Creatinine | |
| HDL Cholesterol | HDL Cholesterol | |
| ConstituentAnalytes | Glucose | Glucose |
| Iron | Iron | |
| Magnesium | Magnesium | |
| Phosphorus | Phosphorus | |
| Total proteins | Total proteins | |
| Triglycerides | Triglycerides | |
| Uric acid | Uric acid | |
| Urea | Urea | |
| Enzymes | ||
| Electrolytes |
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Above mentioned data show substantial equivalency to the 6-7 Conclusion predicate device.
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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 image of a bird-like figure, composed of three curved lines that suggest wings and a head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 2003
Dr. Viviana Cetola QC/QA Manager Weiner Laboratorios S.A. I. C. Riobamba 2944 2000 Rosario, Santa Fe Argentina
Re: K024305
Trade/Device Name: Weiner lab. Calibrador A plus Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 13, 2002 Received: December 24, 2002
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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CDRH ODE
| Page | of____________________________________________________________________________________________________________________________________________________________________________ |
|---|---|
| ------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known): | K024305 |
|---|---|
| Device Name: | Wiener lab. |
| Calibrador A plus |
Indications For Use:
- ·
For the quantitative calibration of Wiener lab's clinical chemistry procedures. The "Calibrador A plus" is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
Iran Cooper
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K024305 |
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.