(68 days)
The "Wiener lab. CK-NAC UV" test system is a device intended to measure the activity of the enzyme creatine phosphokinase in plasma and serum with manual methodology and automated clinical chemistry analyzers. Measurements of creatine phosphokinase and isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
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The provided text describes the WIENER LAB. CK-NAC UV test system, an in-vitro diagnostic device for measuring Creatine Kinase (CK) activity. The document is a 510(k) summary, demonstrating substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The study aims to demonstrate that the WIENER LAB. CK-NAC UV test system is substantially equivalent to two predicate devices: the DMA CK NAC test system and the RANDOX CK NAC-activated system. The acceptance criteria are implicitly defined by comparing the performance characteristics of the WIENER LAB. system to these predicates. While explicit "acceptance criteria" are not stated as pass/fail thresholds, the data presented illustrates that the WIENER LAB. system's performance is comparable to or better than the predicate devices across several key metrics.
Here's a table summarizing the comparison:
| Characteristic | DMA Test System | WIENER LAB. Test System | RANDOX Test System |
|---|---|---|---|
| Intended use | Quantitative determination of CK in human serum. | Quantitative determination of CK in human serum and heparinized plasma. | Quantitative determination of CK in human serum, heparinized or EDTA plasma. |
| Test principle | Creatine phosphate + ADP -> CK -> Creatine + ATP; ATP + Glucose -> HK -> ADP + Glucose-6-P; Glucose-6-P + NADP+ -> G-6-PDH -> Gluconate-6-P + NADPH + H+ | Same reaction system as DMA, with NAC as activator. | Same reaction system as DMA and WIENER LAB. |
| Essential Components | Creatine phosphate, ADP, Glucose, HK, NAD, G-6PDH, NAC | Creatine phosphate, ADP, Glucose, HK, NADP, G-6PDH, NAC | Creatine phosphate, ADP, Glucose, HK, NADP, G-6PDH, NAC |
| Reagent Deterioration | Reagent must be white powder; Reagent blank > 0.600 O.D. at 340 nm | Reagent blank > 0.800 O.D. at 340 nm | Not specified |
| Working Reagent Stability | Stable 21 days at 2-10°C | Stable 20 days at 2-10°C or 3 days at room temperature. | Stable 3 weeks at 2-8°C or 3 days at 15-25°C |
| Sample | Human serum | Human serum and heparinized plasma | Human serum, heparinized or EDTA plasma |
| Working Temperatures | 30°C or 37°C | 25°C, 30°C or 37°C | 25°C, 30°C or 37°C |
| Wavelength of reading | 340 nm | 334 nm - 340 nm - 366 nm | 334 nm - 340 nm - 365 nm |
| Linearity | 1,500 U/l (30°C) - 2,300 U/l (37°C) | 2,000 U/l (37°C) | O.D. 0.25 at 340 nm / 334 nm; O.D. 0.14 at 365 nm |
| Instructions for samples exceeding linearity | Dilution in saline and correction of result | Not specified | Dilution in saline and correction of result |
| Expected values (Male) | 7-114 U/l (30°C); 25-160 U/l (37°C) | ≤80 U/l (25°C); ≤130 U/l (30°C); ≤195 U/l (37°C) | 10-80 U/I (25°C); 15-130 U/l (30°C); 24-195 U/l (37°C) |
| Expected values (Female) | Not specified | ≤70 U/l (25°C); ≤110 U/l (30°C); ≤170 U/l (37°C) | 10-70 U/l (25°C); 15-110 U/l (30°C); 24-170 U/l (37°C) |
| Within-run precision | Normal Serum: CV = 2.7%; Abnormal Serum: CV = 3.9% | Normal Serum: CV = 2.33%; Abnormal Serum: CV = 1.33% | Not stated in insert |
| Run-to-run precision | Normal Serum: CV = 2.9%; Abnormal Serum: CV = 4.2% | Normal Serum: CV = 2.12%; Abnormal Serum: CV = 1.53% | Not stated in insert |
Study Proving Acceptance Criteria:
The study presented is a 510(k) premarket notification used to demonstrate substantial equivalence to legally marketed predicate devices. The "study" involves a detailed comparison of the WIENER LAB. CK-NAC UV test system's characteristics and performance to those of the DMA CK NAC test system and the RANDOX CK NAC-activated system. The conclusion is that "Based on the above mentioned data, 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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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 specify the sample size used for the test set.
- The document does not specify the origin of the data (e.g., country) or whether it was retrospective or prospective. It only mentions the submitter's address in Rosario, Argentina, which suggests the testing might have been conducted there.
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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)
- This information is not applicable as the document describes an in-vitro diagnostic device for enzyme activity measurement, not a device requiring expert interpretation for ground truth. The 'ground truth' for such devices typically refers to the accuracy and precision of the chemical measurements against established analytical standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as the document describes an in-vitro diagnostic device for enzyme activity measurement, not a device requiring human interpretation and adjudication.
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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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic aid devices that assist human readers, which is not the case for this in-vitro diagnostic test kit.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The WIENER LAB. CK-NAC UV test system itself is a standalone test system, performing the analysis without human interpretation of its core enzymatic reaction. The performance metrics (precision, linearity, expected values) reflect the standalone performance of the assay.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this in-vitro diagnostic device, the "ground truth" would be established by the accuracy and precision of the chemical measurement methods against known standards or reference methods. The document does not explicitly detail how the ground truth was established but implies standard laboratory practices for determining assay performance for parameters like linearity, precision, and expected values. The comparison tables serve as the primary evidence of performance against established, legally marketed predicate devices.
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The sample size for the training set
- The document does not specify a sample size for a training set. This is generally not relevant for traditional in-vitro diagnostic kits that rely on chemical reagents and spectrophotometric measurements, rather than machine learning algorithms that require training data.
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How the ground truth for the training set was established
- This information is not applicable as there is no mention of a training set for a machine learning algorithm.
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3 2002
CK-NAC UV Wiener lab.
Image /page/0/Picture/2 description: The image is a circular seal or logo. The text "WIENER lab." is arranged around the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is arranged around the bottom. In the center of the circle, there is a stylized "W" logo, followed by the text "ISO 9001" and a "TUV CERT" logo.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a circular emblem with the letter W inside, 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: _2 3 3 3 3 3 3 3 3 3 3 2 3 3 2 3 2 3 2
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According to the requirements of 21 CFR 862.1215, the follow-Introduction ing information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Lab Group 6-1 Submitter Name, Address. Riobamba 2944 2000 - Rosario - Argentina Contact Contact person: Viviana Cétola Date Prepared: March 28, 2002. -
Proprietary name: WIENER LAB. CK-NAC UV 6-2 Device Name Common name: Creatine Phosphokinase/Creatine Kinase test svstem. Classification name: NAD Reduction/NADH Oxidation, CPK or lsoenzymes. Device Class II
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6-3 Predicate De-We claim substantial equivalence to the currently marketed DMA CK NAC test system (Cat. Nº 1380-200) and RANDOX vice CK NAC-activated kit (Cat. Nº CK522).
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Image /page/1/Figure/1 description: This image describes the device and intended use of the WIENER LAB. CK-NAC UV test system. The reaction system involves creatine phosphate, ADP, ATP, glucose, glucose-6-P, and NADP+. The test system measures creatine phosphokinase activity in plasma and serum and is substantially equivalent to other products like DMA CK NAC and RANDOX CK NAC.
currently marketed DMA CK NAC test system.
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| OMATest System | WIENER LAB. TestSystem | ||
|---|---|---|---|
| Intended use | Quantitative determina-tion of Creatine Kinasein human serum. | Quantitative determina-tion of Creatine Kinasein human serum andheparinized plasma. | |
| The reaction system is as follows: | |||
| Test principle | Creatine phosphate + ADP | скCreatine + ATP | |
| HKATP + GlucoseGlucose-6-P + NADP+ | ADP + Glucose-6-PG-6-PDH | ||
| Gluconate-6-P + NADPH + H*In the reaction system. NAC works as activator ofthe Creatine Kinase, recommended by the IFCC. | |||
| CK: Creatine KinaseHK: HexokinaseG-6-PDH: Glucose-6-phosphate dehydrogenase | |||
| Essential Compo-nents | Creatine phosphate -ADP - Glucose - HK -NAD - G-6PDH - NAC | Creatine phosphate -ADP - Glucose - HK -NADP - G-6PDH - NAC | |
| Reagent Deterio-ration | Reagent must be awhite powderReagent blank > 0.600O.D. at 340 nm | Reagent blank > 0.800O.D. at 340 nm | |
| Working ReagentStability | Stable 21 days at 2-10°C | Stable 20 days at 2-10°C or 3 days at roomtemperature. | |
| Sample | Human serum | Human serum and hepa-rinized plasma | |
| Continued on next page | |||
| DMATest System | WIENER LAB. TestSystem | ||
| Working Tem-peratures | 30°C or 37°C | 25°C, 30°C or 37°C | |
| Wavelength ofreading. | 340 nm | 334 nm - 340 nm - 366nm | |
| Linearity | 1,500 U/l (30°C) -2,300 U/l (37°C) | 2,000 U/l (37°C) | |
| Instructions forsamples exceed-ing linearity | Dilution in saline and correction of result | ||
| Expected values | 7-114 U/l (30°C)25-160 U/l (37°C) | Male:≤80 U/l (25°C)≤130 U/l (30°C)≤195 U/l (37°C)Female:≤70 U/l (25°C)≤110 U/l (30°C)≤170 U/l (37°C) | |
| Within-run preci-sion | Normal Serum:CV = 2.7%Abnormal Serum:CV = 3.9% | Normal Serum:CV = 2.33%Abnormal Serum:CV = 1.33% | |
| Run-to-run preci-sion | Normal Serum:CV = 2.9%Abnormal Serum:CV = 4.2% | Normal Serum:CV = 2.12%Abnormal Serum:CV = 1.53% | |
| Continued on next page |
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The following table illustrates the similarities and differences between the WIENER LAB. CK-NAC UV test system and the currently marketed RANDOX CK NAC-activated system.
| RANDOXTest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended use | Quantitative determina-tion of Creatine Kinasein human serum, hepa-rinized or EDTA plasma. | Quantitative determina-tion of Creatine Kinasein human serum andheparinized plasma. |
| Test principle | The reaction system is as follows:$Creatine phosphate + ADP \xrightarrow{CK} Creatine + ATP$ $ATP + Glucose \xrightarrow{HK} ADP + Glucose-6-P$ $Glucose-6-P + NADP^+ \xrightarrow{G-6-PDH} Gluconate-6-P + NADPH + H^+$ CK: Creatine KinaseHK: HexokinaseG-6-PDH: Glucose-6-phosphate dehydrogenase | |
| Essential Compo-nents | Creatine phosphate – ADP – Glucose – HK –NADP – G-6PDH – NAC | |
| Working ReagentStability | Stable 3 weeks at 2-8°Cor 3 days at 15-25°C | Stable 20 days at 2-10°C or 3 days at roomtemperature. |
| Sample | Human serum, heparin-ized or EDTA plasma | Human serum and hepa-rinized plasma |
| RANDOXTest System | WIENER LAB. TestSystem | |
| Working ReagentStability | Stable 3 weeks at 2-8ºCor 3 days at 15-25ºC | Stable 20 days at 2-10℃ or 3 days at roomtemperature. |
| Sample | Human serum, heparin-ized or EDTA plasma | Human serum and hepa-rinized plasma |
| Working Tem-peratures | 25°C, 30°C or 37°C | |
| Wavelength ofreading. | 334 nm - 340 nm - 365nm | 334 nm - 340 nm - 366nm |
| Linearity | O.D. 0.25 at 340 nm /334 nmO.D. 0.14 at 365 nm | 2,000 Ull (37°C) |
| Instructions forsamples exceed-ing linearity | Dilution in saline and correction of result | |
| Expected values | Male:10-80 U/I (25°C)15-130 UN (30°C)24-195 UI (37°C)Female:10-70 UJI (25°C)15-110 U/I (30ºC)24-170 U/l (37°C) | Male:<80 Ull (25°C)<130 Ull (30°C)<195 Ull (37°C)Female:<70 Ull (25°C)<110 Ull (30°C)<170 U/I (37°C) |
| Within-run preci-sion | Not stated in insert | Normal Serum:CV = 2.33%Abnormal Serum:CV = 1.33% |
| Run-to-run preci-sion | Not stated in insert | Normal Serum:CV = 2.12%Abnormal Serum:CV = 1.53% |
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- 6-7 Conclusion Based on the above mentioned data, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image is a seal or logo for the Department of Health & Human Services (CA). The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (CA)" arranged around the perimeter. In the center of the seal is a stylized graphic that resembles a bird in flight or a flowing design, possibly representing movement or progress. The overall design is simple and uses a monochrome color scheme.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 2002 ប្រជ
JUL. 3 2003
Dr. Viviana Cetola OC/OA Manager Weiner Laboratorios S.A. I.C. Riobamba 2944 Rosario, Santa Fe Argentina
Re: K021332
Trade/Device Name: CK-NAC UV Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: April 17, 2002 Received: April 26, 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 vour 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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Page 2 -
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/cdch/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
Page
DUPLICATE
510(k) Number (if known):
Device Name: Wiener lab.
. UV
Indications For Use:
The "Wiener lab. CK-NAC UV" test system is a device" Theended to measure the activity of the enzyme creatine phosphokinase in Masma and serum with manual methodology and automated clining chemistry analyzers. Measurements of creatine phosphokinase and isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Cooper
(Division 3.2-01)
Division of Clinical Laboratory
510(k) Number K021332
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBO)
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)
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.