(62 days)
The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine Kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine kinase results are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The ATAC PAK CPK Reagent determines creatine kinase activity in the sample by measuring the rate of increase in absorbance at approximately 340 nm, which is proportional to the rate of progression of NAD to NADH.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the ATAC PAK CPK Reagent Kit:
Device: ATAC PAK CPK Reagent Kit
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Linearity/Recovery | Linear from 4 to 1,600 U/L | Range: 0 - 1,635 U/L, sy.x = 13.8 U/L, r² = 0.999 | Meets (exceeds) criteria |
| Hyperactive Range: 1,400 to 5,200 U/L | Range: 1,317 - 3,212 U/L, sy.x = 28.3 U/L | Meets the general criteria of a hyperactive range, though the reported range is narrower than what the criteria implies for the "standard dilution factors." | |
| Lower Limit of Detection | The lower limit of the linear range (4 U/L) | 1.2 U/L (documented through repetitive assay of a diluted serum control, within run precision study) | Meets (exceeds) criteria: 1.2 U/L is below the claimed 4 U/L limit. |
| Precision (Normal Range) | Not explicitly stated with numerical targets, but implied by "Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T" | Serum 1 (mean 46 U/L): Within Run 1SD = 0.7 (1.5%CV), Total 1SD = 1.4 (3.0%CV) | Performance demonstrated. |
| Serum 2 (mean 556 U/L): Within Run 1SD = 5.8 (1.0%CV), Total 1SD = 16.2 (2.9%CV) | Performance demonstrated. | ||
| Serum 3 (mean 1177 U/L): Within Run 1SD = 11.9 (1.0%CV), Total 1SD = 33.3 (2.8%CV) | Performance demonstrated. | ||
| Precision (Hyperactive Dilutions) | Not explicitly stated with numerical targets, but implied by "Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T" | Serum 1 (mean 2202 U/L): Within Run 1SD = 19 (0.9%CV), Total 1SD = 45 (2.1%CV) | Performance demonstrated. |
| Serum 2 (mean 2636 U/L): Within Run 1SD = 29 (1.1%CV), Total 1SD = 57 (2.2%CV) | Performance demonstrated. | ||
| Method Comparison | Not explicitly stated with numerical targets, but implied by comparison to a "commercially available method." | Bias = -6 U/L, Slope = 1.012, n = 232, range = 4 - 1176 U/L, r = 0.999 | Performance demonstrated. |
| Reagent Stability | Deviations in results over 30 days are less than the greater of 3 U/L or 3% for both primary and hyperactive ranges. | "deviations... over the test period are less than the greater of 3 U/L or 3% for both the primary usable range and the extended hyperactive dilution range." | Meets criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity/Recovery:
- Primary Usable Range: df = 69 (likely corresponds to 70 data points).
- Hyperactive Usable Range: df = 39 (likely corresponds to 40 data points).
- Lower Limit of Detection: Not explicitly stated, but involved "repetitive assay of a diluted serum control."
- Precision:
- Normal Range: n = 60 for each of the three serum samples.
- Hyperactive Dilutions: n = 70 for Serum 1, n = 72 for Serum 2.
- Method Comparison: n = 232 specimens.
- Data Provenance: "Mixed serum and plasma specimens, collected from adult patients." (Country of origin not specified, prospective or retrospective not explicitly stated but implies prospective collection for the comparison study).
- Reagent Stability: Not explicitly stated, but involved "assay of serum controls over the claimed period."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The device being a reagent kit for quantitative determination of creatine kinase, the "ground truth" is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the way it might apply to imaging or diagnostic algorithms. There is no mention of human experts establishing ground truth for the test set in the context of interpretation. Instead, other reference methods and statistical validation methods are used to establish performance.
4. Adjudication Method for the Test Set
Not applicable. For quantitative chemical assays, ground truth is established by a reference method or known concentrations, not through a human adjudication process.
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 typically relevant for interpretative diagnostic devices where human readers (e.g., radiologists) are involved in assessing cases. This submission is for a quantitative chemical assay.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies reported are for the standalone performance of the ATAC PAK CPK Reagent Kit combined with the ATAC 8000 Random Access Chemistry System. It measures creatine kinase levels directly and objectively.
7. The Type of Ground Truth Used
- For Linearity/Recovery: Known standard dilutions with defined concentrations of creatine kinase.
- For Lower Limit of Detection: Known low-concentration serum control.
- For Precision: Commercially available serum controls with target mean values.
- For Method Comparison: A "commercially available method" (presumably a predicate or established laboratory method) was used to assay the same patient specimens, and its results served as the reference for comparison.
- For Reagent Stability: Values from serum controls measured over time are compared against initial values or acceptable analytical variations.
8. The Sample Size for the Training Set
Not explicitly stated. For a reagent kit, "training set" doesn't apply in the same way as for an AI algorithm. Method validation studies typically establish performance characteristics rather than "train" the assay. The manufacturing process and quality control would ensure consistency.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the AI/algorithm sense. The performance characteristics (linearity, precision, stability, method comparison) are established through detailed analytical studies using known standards, controls, and patient samples compared to predicate devices/methods. The "ground truth" for these analytical methods is based on established chemical principles and metrological traceability.
§ 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.