(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.
§ 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.