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510(k) Data Aggregation
(333 days)
CKMB UDR ASSAY
The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC 600 System of the CK-MB isoenzyme activity of creatine kinase in serum and Liheparin plasma by inhibition method. The assay is intended for professional use only. Creatine Kinase (CK) catalyses the reversible phosphorylation of creatine by ATP. CK is a dimer composed of two subunits which form three active isoenzymes: BB (CK-1), MB (CK-2), MM (CK-3). CK-BB isoenzyme only rarely appears in serum.
Elevated CK values are due to muscular damages and associated pathologies. CK determination, usually performed with CK2 (also called CK-MB), is used for the diagnosis and follow-up of AMI (acute myocardial infarction) and some muscular diseases.
Anti CK-M mouse monoclonal antibodies in the reagent 1 inhibit the CK-M subunit in the sample without affecting the CK-B subunits. The CK-B activity is determined by the CK-NAC method and corresponds to half the CK-MB activity.
The provided text describes the performance characteristics of the CKMB UDR Assay, focusing on its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Method Comparison with Predicate Device: | |
| High correlation coefficient (r) with predicate device | r = 0.999 |
| Slope close to 1 with predicate device | Slope = 0.96 |
| Small intercept value with predicate device | Intercept = 2.40 U/L |
| Imprecision (within-run and inter-assay): | |
| Acceptable %CV values for various concentrations | 20-day Inter-assay Imprecision: |
| - Human sera pool #1 (Mean 10.7 U/L): Total Imprecision CV% = 4.2%, Within run CV% = 4.2% | |
| - Human sera pool #2 (Mean 19.0 U/L): Total Imprecision CV% = 2.6%, Within run CV% = 2.6% | |
| - Human sera pool #3 (Mean 25.4 U/L): Total Imprecision CV% = 2.0%, Within run CV% = 2.0% | |
| - Human sera pool #4 (Mean 33.4 U/L): Total Imprecision CV% = 3.6%, Within run CV% = 3.6% | |
| - Spiked Human sera pool (Mean 584.1 U/L): Total Imprecision CV% = 0.9%, Within run CV% = 0.6% | |
| Analytical Measurement Range (AMR): | |
| A defined and clinically relevant range of accurate measurement. | Found lower limit: 7.4 U/L; Found upper limit: 600.0 U/L. Claimed AMR: 9.0 to 600.0 U/L. |
Study Proving Acceptance Criteria (Type of Study):
The study described is a comparative performance study to demonstrate substantial equivalence to a predicate device (Roche CK-MB assay K003158). This is primarily an analytical validation study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: 306 human sera samples (for method comparison).
- Data Provenance: The text does not specify the country of origin. It implicitly describes a prospective study in the sense that samples were tested with both the new device and the predicate for comparison. However, the exact collection method (e.g., whether samples were collected specifically for this study or were existing banked samples) is not explicitly stated. It is referred to as "human sera samples," suggesting clinical samples.
3. 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 is not applicable to this type of analytical device validation. The "ground truth" for an assay like CKMB is established by the reference method (in this case, the predicate device) and the intrinsic chemical/biological properties being measured, not by expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication of results. The comparison is quantitative between two analytical instruments.
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 assay, not an imaging device or AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone (algorithm/assay only) performance assessments. The device measures CK-MB activity directly, and its performance is evaluated based on its analytical characteristics (correlation, precision, range) against a predicate device, without human intervention in the result determination.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche CK-MB assay K003158). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate device. For the imprecision and AMR studies, the ground truth is implicitly the inherent biological measurement of the samples at various concentrations using the new device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device that requires a training set in that sense. It is a chemical assay.
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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