(287 days)
Apo-Tek Lp(a)™ is an Apo(a) isoform independent enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma. The measurement of Lp(a), in conjunction with other lipoprotein tests, is of diagnostic significance when assessing atherosclerotic cardiovascular disease in specific populations.
Apo-Tek Lp(a)™ is an apolipoprotein(a) [Apo(a)] isoform independent in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitiative assessment of lipoprotein(a) [Lp(a)] in human serum or plasma. This test utilizes a sandwich ELISA format in which the Lp(a) particle is captured with a specific anti-Apo(a) monoclonal antibody and, after washing away nonbound serum or plasma components, is detected with a peroxidase conjugated anti-apolipoprotein B [Apo B] polyclonal antibody.
This prompt is asking to extract information about the acceptance criteria and the study that proves the device meets the acceptance criteria from a 510(k) summary document. However, the provided document is a 510(k) summary for a diagnostic test (Apo-Tek Lp(a)™ ELISA) and does not describe acceptance criteria in the typical sense of a medical device study (e.g., sensitivity, specificity, AUC targets). Instead, it discusses the performance characteristics and clinical utility of the assay. Because the document does not contain the requested information in a clearly defined manner, the following is a best effort to interpret and extract relevant details based on the provided text.
Here's an analysis based on the supplied text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device in a tabular format with predefined thresholds. Instead, it describes various performance characteristics and clinical correlations. Here's a table attempting to capture these:
| Performance Characteristic/Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cross-reactivity | |
| Plasminogen (up to 1 g/L) | No cross-reactivity |
| Low Density Lipoproteins (LDL, up to 10 mg/L protein) | No cross-reactivity |
| Very Low Density Lipoproteins (VLDL, up to 2 g/L protein) | No cross-reactivity |
| Interference | |
| Triglycerides (up to 8.9 g/L) | No interference |
| Hemoglobin (up to 5 g/L) | No interference |
| Bilirubin (up to 0.05 g/L) | No interference |
| Minimum Detectable Level | 0.3 mg/dL (0.72 nmol/L) |
| Reproducibility (Total CV) | 6.4% to 12.8% |
| Apo(a) phenotype heterogeneity effect on linearity | Correlation coefficient (r) of 0.997 or better for five different phenotypes (spanning entire range of molecular weights) |
| Clinical Utility (Correlation with Cardiovascular Disease) | Lp(a) levels >20 mg/dL independently increased odds of: |
| - Myocardial Infarction: 2.88-fold | |
| - >50% stenosis of at least one coronary artery: 2.88-fold | |
| - Cerebrovascular disease: 20.3-fold | |
| - Carotid artery stenosis (≥20%): 27.6-fold | |
| - (US population) Carotid artery disease (≥50% stenosis): 1.55-fold | |
| - (US population) Coronary heart disease: 1.5-fold | |
| Clinical Utility (Combined with Apo B) | Increased odds for MI (2.88 to 3.86) and >50% coronary stenosis (2.88 to 3.52) when Lp(a) > 20 mg/dL and Apo B > 178 mg/dL |
| Clinical Utility (Combined with LDL cholesterol) | Increased odds for ischemic cerebrovascular disease (20.3 to 21.9) when Lp(a) > 20 mg/dL and LDL > 130 mg/dL |
| (US population) Increased odds for CHD (1.5 to 1.61) and carotid artery stenosis (1.65 to 2.29) when Lp(a) and LDL elevated |
Note: The "acceptance criteria" column is an interpretation of the performance specifications for which data is provided, as explicit thresholds are not stated in the document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly define a "test set" in the context of an algorithm or imaging study. Instead, it refers to "two clinical evaluations" and a "cross-sectional cohort study of a well-characterized U.S. population" for clinical utility.
- Sample Size for Clinical Evaluations: Not specified.
- Sample Size for Cross-sectional Cohort Study (U.S. population): Not specified.
- Data Provenance:
- "Two clinical evaluations" - geographic origin not specified.
- "Cross-sectional cohort study of a well characterized U.S. population" - United States, retrospective (implied by "have had").
- The reproducibility study (NCCLS document EP5-T2) uses "samples ranging from 8.8 to 34.8 mg/dL", but the number of samples is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The Apo-Tek Lp(a)™ is an in vitro diagnostic ELISA kit, not an imaging or AI-driven diagnostic device that relies on expert ground truth for interpretation. The clinical utility is established through correlation with clinically determined diseases (e.g., myocardial infarction, stenosis), likely based on standard diagnostic procedures and outcomes, not expert consensus on image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the device is an ELISA kit, and its performance is assessed against clinical outcomes, not expert adjudication of classifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI tools where human readers interpret cases with and without AI assistance. The Apo-Tek Lp(a)™ is a laboratory assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance described is a standalone performance. The Apo-Tek Lp(a)™ is an automated laboratory assay. Its "performance" refers to its analytical characteristics (e.g., cross-reactivity, reproducibility) and its correlation with clinical outcomes when used as a diagnostic test. There is no "human-in-the-loop" component for its basic operation or interpretation in this context, other than the clinician interpreting the numerical result in conjunction with other clinical information.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the clinical utility of Apo-Tek Lp(a)™ appears to be based on clinical disease diagnoses or outcomes data. For example:
- Myocardial infarction
- Coronary artery stenosis (>50%)
- Cerebrovascular disease
- Carotid artery stenosis (≥20% or ≥50%)
The accuracy of these diagnoses would be established through standard medical practice (e.g., angiograms for stenosis, clinical criteria for MI).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Apo-Tek Lp(a)™ is an ELISA assay, not a machine learning algorithm that requires a "training set" to develop its logic or parameters. Its operating characteristics are inherent to its chemical and biological design.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned, there is no "training set" in the context of this diagnostic kit.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).