(251 days)
ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II on ELITech Clinical Systems Selectra analyzers for the quantitative in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: Good's buffer, Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), Ascorbate oxidase (bacterial), N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator. Reagent R2 contains: Good's buffer, Cholesterol esterase (CHE bacterial), 4-Amino-Antipyrine (4-AA), detergent.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including high density lipoproteins and sodium azide as preservative. CHOLESTEROL HDL 2G CALIBRATOR is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), 4-Amino-Antipyrine (4-AA), Ascorbate oxidase (vegetal). Reagent R2 contains: MES buffer, Detergent 2, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT).
ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including low density lipoproteins and sodium azide as preservative. CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor units tested individually by FDA - approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
Here's a breakdown of the acceptance criteria and study information for the ELITech Clinical Systems CHOLESTEROL HDL SL 2G device, based on the provided text. Please note that the document is a 510(k) summary, which focuses on substantial equivalence to a predicate device rather than providing a detailed study protocol and raw data. Therefore, some information, especially regarding sample sizes for training sets or expert qualifications, may not be explicitly stated.
Device(s) being evaluated:
- ELITech Clinical Systems CHOLESTEROL HDL SL 2G (Reagent)
- ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
- ELITech Clinical Systems ELITROL I and ELITROL II (Controls)
Predicate Devices:
- ABX PENTRA HDL Direct CP (K060854) for CHOLESTEROL HDL SL 2G
- Genzyme Ultra N-Geneous CHOLESTEROL HDL Calibrator for CHOLESTEROL HDL 2G CALIBRATOR
- Roche Diagnostics Precinorm U (K041227) and Roche Diagnostics Precipath U (K041227) for ELITROL I and ELITROL II
1. Table of Acceptance Criteria and Reported Device Performance
Device: ELITech Clinical Systems CHOLESTEROL HDL SL 2G (Reagent)
| Acceptance Criteria Category | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ELITech Clinical Systems CHOLESTEROL HDL SL 2G) |
|---|---|---|
| Measuring Range | 5.4 to 151.9 mg/dL (Predicate) | 5 to 105 mg/dL |
| Limit of Detection (LoD) | 1.16 mg/dL (Predicate) | 0.7 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated for predicate in direct comparison, but likely inferred from measuring range. | 5.0 mg/dL |
| Precision (Within Run) | Level 35.82 mg/dL CV=1.29% | |
| Level 81.72 mg/dL CV=0.79% | ||
| Level 27.94 mg/dL CV=1.32% | ||
| Level 48.59 mg/dL CV=1.91% | ||
| Level 97.39 mg/dL CV=0.62% (Predicate) | Level 31 mg/dL CV=1.4% | |
| Level 56 mg/dL CV=0.7% | ||
| Level 87 mg/dL CV=1.4% | ||
| Precision (Total) | Level 35.85 mg/dL CV=2.88% | |
| Level 80.35 mg/dL CV=3.06% | ||
| Level 47.07 mg/dL CV=3.52% | ||
| Level 80.16 mg/dL CV=2.69% (Predicate) | Level 31 mg/dL CV=3.0% | |
| Level 56 mg/dL CV=2.8% | ||
| Level 87 mg/dL CV=3.3% | ||
| Method Comparison | y=0.91x + 1.98 mg/dL, r^2 = 0.9768 (Predicate) | y=1.09x - 2.5 mg/dL, r^2 = 0.972 |
| Interference | Hemoglobin: No significant influence up to 479 mg/dL. | |
| Triglycerides: No significant influence up to 612.5 mg/dL. | ||
| Total bilirubin: No significant influence up to 11.7 mg/dL. | ||
| Direct bilirubin: No significant influence up to 28.1 mg/dL. (Predicate) | Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Hemoglobin (up to 500 mg/dL): No significant interference. | |
| Turbidity: Negative bias from 439 mg/dL triglycerides equivalent. | ||
| On-board Stability | 31 days (Predicate) | 28 days |
Device: ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
| Acceptance Criteria Category | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR) |
|---|---|---|
| Stability (Lyophilized) | Up to expiry date at 2-8 °C, protected from light (Predicate) | Up to expiry date at 2-8 °C, protected from light |
| Stability (Reconstituted) | 14 days between 2 - 8 °C. | |
| 4 weeks between -70 °C (when frozen once) (Predicate) | 14 days between 2 - 8 °C. | |
| 4 weeks at less than - 80 °C (when frozen once) |
Device: ELITech Clinical Systems ELITROL I and ELITROL II (Controls)
| Acceptance Criteria Category | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ELITech Clinical Systems ELITROL I / ELITROL II) |
|---|---|---|
| Stability (Lyophilized) | Stable at 2-8°C up to expiration date (Predicate) | Stable at 2-8°C up to expiry date, protected from light |
| Stability (Reconstituted) | 12 hours at 15-25 °C. | |
| 5 days at 2-8 °C. | ||
| 4 weeks at (-25)-(-15) °C (when frozen once) (Predicate) | 12 hours between 15-25 °C. | |
| 5 days between 2-8 °C. | ||
| 4 weeks between -25 and -15 °C (when frozen once) |
2. Sample Size Used for the Test Set and Data Provenance
Given the nature of a 510(k) summary for an in vitro diagnostic (IVD) device, specific sample sizes for particular experiments (like method comparison, precision, or interference studies) are often summarized rather than detailed with exact numbers of individual patient samples.
- Test Set Sample Size: The document does not explicitly state the total number of samples used across all validation studies. However, for the method comparison for CHOLESTEROL HDL SL 2G, a range of "5 to 105 mg/dL" is mentioned for the ELITech device, implying that samples covering this range were used. Similar ranges are noted for the predicate.
- Data Provenance: Not explicitly stated. For IVDs, data typically comes from clinical laboratories. Without further information, it's difficult to determine the country of origin or if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided for this type of device (in vitro diagnostic reagent, calibrator, and controls). The "ground truth" for these devices is established by reference methods or comparison to a legally marketed predicate device, not by expert human interpretation like in imaging or pathology. The performance is assessed by quantitative analytical metrics (e.g., precision, linearity, method correlation).
4. Adjudication Method for the Test Set
This is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used when there's subjective human interpretation involved (e.g., in diagnostic imaging or pathology assessments by multiple readers) to resolve disagreements and establish a consensual ground truth. This is not how the performance of an IVD reagent is evaluated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human readers (e.g., radiologists, pathologists) interpreting images or data, and are designed to assess the impact of AI assistance on human diagnostic performance. This submission is for an IVD diagnostic reagent, calibrator, and controls, which are intended for automated analytical measurement and do not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The documented studies are essentially "standalone" in the context of the device's function: they assess the analytical performance of the reagent system (algorithm being the chemical reactions and measurement process) without human interpretive input affecting the core measurement. The performance data presented (precision, linearity, method comparison, interference) are all measures of the device's inherent analytical capability.
7. The Type of Ground Truth Used
The "ground truth" for an IVD reagent and its associated calibrators/controls is established by:
- Comparison to a Legally Marketed Predicate Device: The primary method for proving substantial equivalence in a 510(k) submission. Performance characteristics of the new device are compared directly against those of the predicate device (ABX PENTRA HDL Direct CP, Genzyme Ultra N-Geneous CHOLESTEROL HDL Calibrator, Roche Diagnostics Precinorm U / Precipath U).
- Established Analytical Methods: For parameters like linearity, precision, and limit of detection, the "ground truth" is based on recognized statistical and analytical chemistry principles and established reference measurement procedures, where applicable, to demonstrate the device's inherent analytical accuracy and reliability.
- Reference Materials: For calibrators, the assigned values are based on established reference methods and reference materials.
8. The Sample Size for the Training Set
Not applicable/Not provided. This submission is for an IVD reagent and associated components, not an AI/ML model that typically requires a discrete training set. The "development" or "training" of such a chemical reagent involves formulation, optimization, and characterization through various analytical experiments rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, there isn't a "training set" in the context of an AI/ML model for this type of IVD device. The development process relies on chemical principles, enzymatic reactions, and analytical validation against international standards or established methods.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.