(68 days)
The WIENER LAB GOT (AST) UV test system is an I.V.D. device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The principle is based on the following reaction system: GOT L-aspartate + 2-oxoglutarate -> oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H+ -> I-Malate + NAD+ AST or GOT: Aspartate Amino transferase MDH: Malate Dehydrogenase
This document describes the 510(k) summary for the "WIENER LAB. GOT(AST) UV" test system, an in vitro diagnostic device for quantitative determination of aspartate amino transferase (AST/GOT) in human serum and plasma. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the sense of a standalone performance study with predefined acceptance thresholds.
However, based on the provided text, we can extract information regarding what would constitute "acceptance" for this type of device in the context of a 510(k) submission, which is demonstrating substantial equivalence to a predicate device. The performance characteristics of the WIENER LAB. device are presented in comparison to the predicate device (RANDOX AST ASAT GOT OPT. test system) to show this equivalence.
Here's an attempt to structure the information based on your request, understanding that the "acceptance criteria" here are implicitly linked to the predicate device's performance and the demonstration of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are often relative to the predicate device's performance. The WIENER LAB. GOT (AST) UV device is designed to be substantially equivalent to the RANDOX AST ASAT GOT OPT. test system. The table below compares key performance characteristics. The implicit acceptance criterion is that the WIENER LAB. device's performance characteristics are comparable or better than the predicate device, or within acceptable clinical limits.
| Performance Characteristic | Predicate Device (RANDOX AST ASAT GOT OPT.) | WIENER LAB. GOT (AST) UV Device Performance | Implicit Acceptance Condition |
|---|---|---|---|
| Intended Use | Quantitative determination of aspartate amino transferase in human serum and plasma. | Same | Substantially equivalent. |
| Test Principle | Kinetic method | Kinetic method (with detailed reaction system provided). | Substantially equivalent. |
| Essential Components | L-aspartate, NADH, MDH, LDH, 2-oxoglutarate | Same (components not explicitly listed for Wiener Lab but implied by reaction system). | Substantially equivalent. |
| Formula | Optimized according to IFCC | Optimized according to IFCC (implied). | Substantially equivalent. |
| Reagents | R1: L-aspartate - TRIS (Buffer); R2: NADH - MDH - LDH - 2-oxoglutarate | Same (implied). | Substantially equivalent. |
| Preparation of Working Reagent | Dissolution of R2 with R1 | Same (implied). | Substantially equivalent. |
| Instability or Deterioration of Reagents | Not specified | Reagent Blank Absorbance <0.800 or >1.800 | Specific criteria provided for Wiener Lab, indicating controlled stability. This is an improvement or clarification relative to the predicate. |
| Sample | Human serum, heparinized plasmas, or EDTA plasmas | Human serum or heparinized plasmas | Wiener Lab device has a slightly narrower acceptable sample range (omits EDTA plasma) but is still substantially equivalent for its stated use. |
| Working Temperature Range | 25 - 30 - 37°C | 25 - 30 - 37°C | Same. |
| Wavelength of Reading | 334 - 340 - 366 nm | 334 - 340 - 366 nm | Same. |
| Linearity | 279 U/l | 470 U/l | Wiener Lab device shows wider linearity, which is usually considered an improvement. |
| Minimum Detection Limit | No stated in insert | 1.2 U/l | Wiener Lab device provides a specific MDL, where the predicate did not, indicating a more thoroughly characterized device. |
| Expected Values (37°C) | Male: until 37 U/l; Female: until 31 U/l | Male: until 38 U/l; Female: until 32 U/l | Expected values are very close, demonstrating substantial equivalence in reference ranges. |
| Within-run Precision | No stated in insert | Normal Serum Control: CV = 4.4%; Abnormal Serum Control: CV = 1.3% | Wiener Lab device provides specific precision data, indicating robust performance. |
| Total Precision | No stated in insert | Normal Serum Control: CV = 4.9%; Abnormal Serum Control: CV = 1.6% | Wiener Lab device provides specific precision data, indicating robust performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly specify a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical validation study in the traditional sense. The data provided in the table are performance characteristics typically derived from analytical verification studies (e.g., linearity, precision, detection limit). These studies are generally conducted by the manufacturer as part of product development and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement, not an AI or imaging device requiring expert interpretation for ground truth establishment. The ground truth for performance characteristics like precision and linearity comes from established laboratory methods and statistical analysis.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves quantitative chemical measurement, not expert adjudication of results.
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
Not applicable. This is an in vitro diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers/clinicians.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a standalone diagnostic test system. Its performance characteristics (linearity, precision, detection limit) are measured directly from the assay without human interpretation in the results generation process. The "standalone" performance is the data presented in the table.
7. The Type of Ground Truth Used
The ground truth for the performance characteristics (linearity, precision, detection limit, expected values) is established through accepted analytical chemistry and laboratory standards. For instance:
- Linearity: Determined by testing known concentrations of analytes and assessing the correlation between measured and expected values.
- Precision: Determined by repeatedly measuring samples (e.g., control sera) and calculating statistical measures like Coefficient of Variation (CV).
- Expected Values: Established through studies of healthy populations using established reference methods.
8. The Sample Size for the Training Set
Not applicable. This document describes an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
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GOT (AST) UV Wiener lab.
NOV 2 7 2001
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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 i
f This summary of 510(K) safety and effectiveness informants hary of of of of the requirements of SMDA 1990 and 21CFR 807.92"
gg "The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
According to the requirements of 21 CFR 862.1100, the Introduction According information provides sufficient details to understand following information of substantial equivalence.
6-1 Submitter Name, Address, Contact
Wiener Lab Group Riobamba 2944 2000 - Rosario - Argentina
Contact person: Viviana Cétola
Date Prepared: February 27, 2001
Proprietary name: WIENER LAB. GOT(AST) UV 6-2 Device Name
Common name: Aspartate amino transferase (AST/SGOT)test system.
Classification name: NADH Oxidation / NAD Reduction, AST / SGOT
Device Class II
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| 6-3 PredicateDevice | We claim substantial equivalence to the currently marketedRANDOX AST ASAT GOT OPT. test system (Cat. N°AS1204). |
|---|---|
| 6-4 DeviceDescription | The principle is based on the following reaction system:GOTL-aspartate + 2-oxoglutarate → oxaloacetate + L-glutamateMDHOxalacetate + NADH + H + → I-Malate + NAD +AST or GOT: Aspartate Amino transferaseMDH: Malate Dehydrogenase |
| 6-5 IntendedUse | The WIENER LAB GOT (AST) UV test system is an I.V.D.device intended to be used in the quantitative determination ofaspartate amino transferase (AST or GOT) in human serum andplasma. Aspartate amino transferase measurements are usedin the diagnosis and treatment of certain types of liver and heartdiseases. |
| 6-6Equivalenciesand differences | The WIENER LAB. GOT (AST) UV test system is substantiallyequivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the |
| currently marketed RANDOX AST ASAT GOT OPT test system. |
| RANDOXTest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended use | Quantitative determination of aspartate aminotransferase in human serum and plasma. | |
| Continued on next page | ||
| RANDOXTest System | WIENER LAB. TestSystem | |
| Kinetic method | The principle is based on the following reactionsystem:L-aspartate + 2-oxoglutarateoxaloacetate + L-glutamateOxalacetate + NADH + H+L-Malate + NAD+AST or GOT: Aspartate Amino transferaseMDH: Malate Dehydrogenase | |
| Test principle | ||
| EssentialComponents | L-aspartate - NADH - MDH – LDH -2-oxoglutarate | |
| Formula | Optimized according to IFCC | |
| Reagents | R1: L-aspartate - TRIS (Buffer)R2: NADH - MDH - LDH - 2-oxoglutarate | |
| Preparation ofWorking Reagent | Dissolution of R2 with R1 | |
| Instability ordeterioration ofreagents | Not specified | Reagent BlankAbsorbance <0.800 or> 1.800 |
| Continued on next page | ||
| RANDOXTest System | WIENER LAB. TestSystem | |
| Sample | Human serum,heparinized plasmas orEDTA plasmas | Human serum orheparinized plasmas |
| WorkingTemperature Range | 25 - 30 - 37°C | |
| Wavelength ofreading. | 334 - 340 - 366 nm | |
| Linearity | 279 U/l | 470 U/l |
| Minimum detectionlimit | No stated in insert | 1.2 U/l |
| Expected values | Male: until 37 U/lFemale: until 31 U/l(37°C) | Male: until 38 U/lFemale: until 32 U/l(37°C) |
| Within-run precision | No stated in insert | Normal Serum Control:CV = 4.4%Abnormal SerumControl:CV = 1.3% |
| Total precision | No stated in insert | Normal Serum Control:CV = 4.9%Abnormal SerumControl:CV = 1.6% |
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6-7 Conclusion Based on the data above mentioned, we believe that the Based on the continue to support substantial equivalence to extended claims oonlines to cappension intended for similar use
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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.
Food and Drug Àdministration 2098 Gaither Road Rockville MD 20850
NOV 2 7 2001
Dr. Viviana Cetola OC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944 Roasario, Santa Fe Argentina
Re: K013145
Trade/Device Name: GOT(AST) UV Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: Class II Product Code: CIT Dated: September 9, 2001 Received: September 20, 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 10 mos been and 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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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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| 510(k) Number (if known): | K013145 |
|---|---|
| Device Name: | Wiener lab. |
| GOT (ASST) UV |
Indicatious For Use:
The "Wiener lab. GOT (AST) UV" test system is an in vitro diagnostic device intended to be used in the quantitative determination of device intonusa transferase (AST or GOT) in human serum and aspartate amino transferase measurements are used in the prasma: 7 lopantato annt of certain types of liver and heart diseases.
Thomas C. Duda (acting)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013145
iseases.
SEP
12 52 PM
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBORD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Tox 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
C.H
II
SK17
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(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.