(56 days)
The "Wiener lab. ALP 405" test system is an in vitro diagnostic device intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparimized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Alkaline phosphatase (ALP or orthophosphoric monoester phosphohydrolase - EC 3.1.3.1.) hvdrolyzes colorless paranitrophenyl phosphate (pNPP) producing phosphate and p-nitrophenol at pH 9.8. The speed at which the p-nitrophenolate anion (yellow) appears, read at 405 nm, is directly proportional to the enzymatic activity of the sample.
The provided document is a 510(k) summary for the "WIENER LAB. ALP 405" test system, which is an in vitro diagnostic device for the quantitative determination of alkaline phosphatase. The document aims to demonstrate substantial equivalence to a predicate device, the RANDOX ALKALINE PHOSPHATASE OPT. test system.
The document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be structured (e.g., with defined sample sizes, ground truth establishment methods, or expert involvement for assessing performance against acceptance criteria). Instead, it relies on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, we can infer some "acceptance criteria" by looking at the performance characteristics reported for the WIENER LAB. ALP 405 test system and comparing them to the predicate device, as well as general expectations for such diagnostic systems. The "study" proving the device meets these criteria is the comparison study against the predicate device presented in the 510(k) summary.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but presents performance characteristics of the WIENER LAB. ALP 405 and compares them to the predicate device. For the purpose of this response, "Acceptance Criteria" will be interpreted as the performance characteristics shown to be comparable or superior to the predicate device, as presented in the comparative table.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (WIENER LAB. ALP 405) |
|---|---|---|
| Intended Use | Quantitative determination of ALP in human serum and heparinized plasma. | Quantitative determination of ALP in human serum and heparinized plasma. (Same) |
| Test Principle | Hydrolysis of pNPP to p-nitrophenol at pH 9.8, measured at 405 nm. | Hydrolysis of pNPP to p-nitrophenol at pH 9.8, measured at 405 nm. (Same) |
| Essential Components | p-Nitrophenylphosphate (p-NPP) - DEA | p-Nitrophenylphosphate (p-NPP) - DEA (Same) |
| Reagents | R1: p-NPP; R2: Buffer | R1: p-NPP; R2: Buffer (Same) |
| Instability/Deterioration of Reagents | Not specified for predicate | Reagent Blank Absorbance > 0.900 (Specific criterion provided for device) |
| Sample | Human serum and heparinized plasma | Human serum and heparinized plasma (Same) |
| Working Temperatures | 25 - 30 - 37°C | 25 - 30 - 37°C (Same) |
| Wavelength of Reading | 405 nm | 405 nm (Same) |
| Linearity | 825 U/I (Predicate) | 1,400 U/I (Superior to predicate) |
| Minimum Detection Limit | Not specified for predicate | 8.7 U/I (Specific criterion provided for device) |
| Expected Values (Adults, 37°C) | 98 - 279 U/l (Predicate) | 65 - 300 U/l (Similar range to predicate) |
| Within-run Precision | No stated in insert for predicate | Normal Serum Control: CV = 2.2%; Abnormal Serum Control: CV = 0.7% (Specific data provided for device) |
| Total Precision | No stated in insert for predicate | Normal Serum Control: CV = 2.4%; Abnormal Serum Control: CV = 0.9% (Specific data provided for device) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective) for the performance metrics reported.
The data presented (Linearity, Minimum Detection Limit, Expected Values, Within-run precision, Total precision) are likely derived from internal validation studies conducted by Wiener Laboratorios S.A.I.C. for the purpose of demonstrating the device's performance characteristics. This indicates the testing was done by the manufacturer. While the company is based in Argentina, it's not specified if patient samples (for expected values, for instance) or control materials were sourced from specific geographies or if the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "experts" establishing ground truth as typically understood in studies involving image interpretation or complex diagnostic algorithms is not applicable to this type of in vitro diagnostic device (IVD) based on colorimetric enzyme activity measurement.
For IVDs like the ALP 405 test system, the "ground truth" for performance characteristics (e.g., linearity, precision, detection limit) is established through analytical reference methods, certified calibrators, and quality control materials, rather than expert consensus on patient diagnoses.
4. Adjudication Method for the Test Set
Since the "ground truth" for these analytical performance characteristics (precision, linearity, etc.) is established through laboratory methods and reference standards rather than expert interpretation, there is no adjudication method described or necessary in the context of clinical expert review. The data are quantitative measurements derived from laboratory experiments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices or other human-interpreted diagnostic tools where variability between readers and across cases is a key consideration. The "WIENER LAB. ALP 405" is an automated, quantitative chemical analyzer for a specific analyte and does not involve human "readers" in the diagnostic interpretation in a way that would necessitate an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself, being an automated test system for quantitative measurement, inherently operates in a "standalone" manner in terms of its analytic performance. The reported precision, linearity, and detection limit data reflect the device's analytical performance (algorithm/assay only) without human-in-the-loop performance influencing the primary measurement. Human involvement would typically be in sample preparation, loading, and result review, but not in the determination of the ALP level by the device itself.
7. The Type of Ground Truth Used
The ground truth used for performance validation of the WIENER LAB. ALP 405 test system would be based on:
- Reference standards/Calibrators: For linearity and quantitative accuracy.
- Quality control materials: For precision (within-run and total precision).
- Analytically derived values: For minimum detection limit.
- Clinical studies or literature: For establishing expected reference ranges (e.g., 65 - 300 U/l for adults).
It is not based on expert consensus, pathology, or direct patient outcomes data in the same way a diagnostic imaging device might be. For Expected Values, literature references or studies on specific populations would typically be used, but the document doesn't detail this.
8. The Sample Size for the Training Set
The document does not specify a sample size for a "training set." As an in vitro diagnostic device based on a chemical reaction, it does not involve machine learning or AI models that typically require training sets. The "development" of such a system involves chemical and engineering optimization, not algorithmic training on data.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning for this device, the concept of establishing ground truth for a training set does not apply. The performance characteristics are validated through standard analytical chemistry and clinical laboratory procedures.
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Image /page/0/Picture/1 description: The image is a circular logo or seal, likely representing a certification or quality standard. The text "Wiener lab." is arranged along the top curve of the circle, while "SISTEMA DE CALIDAD CERTIFICADO" is along the bottom curve. In the center of the circle, there is a symbol resembling a stylized "W" above the text "ISO 9001" and the "TÜV CERT" logo.
JAN 2 8 2002
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 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: _ K013983 99
According to the requirements of 21 CFR 862.1050, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.
6-1 Submitter Wiener Laboratorios S.A.I.C. Name, Address, Riobamba 2944 Contact 2000 - Rosario - Argentina
Contact person: Viviana Cétola Date Prepared: February 23, 2001
| 6-2 Device Name | Proprietary name: | WIENER LAB. ALP 405 |
|---|---|---|
| Common name: | Alkaline phosphatase test system. | |
| Classification name: | Nitrophenylphosphate, AlkalinePhosphatase or Isoenzymes | |
| Device Class II |
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We claim substantial equivalence to the currently marketed 6-3 Predicate RANDOX ALKALINE PHOSPHATASE OPT. test system (Cat. Device Nº AP307).
Alkaline phosphatase (ALP or orthophosphoric monoester 6-4 Device phosphohydrolase - EC 3.1.3.1.) hvdrolyzes colorless Description paranitrophenyl phosphate (pNPP) producing phosphate and p-nitrophenol at pH 9.8. The speed at which the p-nitrophenolate anion (yellow) appears, read at 405 nm, is directly proportional to the enzymatic activity of the sample.
6-5 Intended Use The ALP 405 test system is intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparinized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
6-6 Equivalencies The WIENER LAB. ALP 405 test system is substantially equivalent to other products in commercial distribution and Differences intended for similar use. Most notably it is substantially equivalent to the currently marketed RANDOX ALKALINE PHOSPHATASE OPT test system.
The following table illustrates the similarities and differences between the WIENER LAB. ALP 405 test system and the currently marketed RANDOX ALKALINE PHOSPHATASE OPT test system.
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| RANDOXTest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended use | Quantitative determination of alkaline phosphatasein human serum and heparinized plasma. | |
| Test principle | Alkaline phosphatase (ALP or orthophosphoricmonoester phosphohydrolase - EC 3.1.3.1.)hydrolyzes colorless paranitrophenyl phosphate(pNPP) producing phosphate and p-nitrophenol atpH 9.8. The speed at which the p-nitrophenolateanion (yellow) appears, read at 405 nm, is directlyproportional to the enzymatic activity of the sample. | |
| EssentialComponents | p-Nitrophenylphosphate (p-NPP) - DEA | |
| Reagents | R1: p-NPPR2: Buffer | R1: p-NPPR2: Buffer |
| Instability ordeterioration ofreagents | Not specified | Reagent BlankAbsorbance > 0.900 |
| Sample | Human serum and heparinized plasma | |
| WorkingTemperatures | 25 - 30 - 37°C | |
| Wavelength ofreading. | 405 nm | |
| Linearity | 825 U/I | 1,400 U/I |
| Minimumdetection limit | Not specified | 8.7 U/I |
| Continued on next page | ||
| RANDOXTest System | WIENER LAB. TestSystem | |
| Expected values | Adults:98 - 279 U/l (37°C) | Adults:65 - 300 U/l (37°C)Children:until 645 (37°C) |
| Within-runprecision | No stated in insert. | Normal Serum Control:CV = 2.2%Abnormal Serum Control:CV = 0.7% |
| Total precision | No stated in insert. | Normal Serum Control:CV = 2.4%Abnormal Serum Control:CV = 0.9% |
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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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 8 2002
Dr. Vivianna Cetola QC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944. Rosairo 2000 Santa Fe Argentina
K013983 Re:
Trade/Device Name: Weiner Lab. ALP 405 Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE Dated: November 14, 2001 Received: December 3, 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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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 1 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/odrb/dsma/dsmamain.html".
Sincerely yours,
Steven Dutman
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
K0/3983
Page / of /
| 510(k) Number (if known): | K013983 |
|---|---|
| Device Name: | Wiener lab. |
| ALP 405 |
Indications For Use:
The "Wiener lab. ALP 405" test system is an in vitro diagnostic device intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparimized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used Measurements of alkaline proophalas of liver, bone, parathyroid, and intestinal diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBOD
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benson for Jean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K013983 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
H
C
SKEE
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.