(276 days)
The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use.
ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
The reagent device for this submission is available as kit only. It consists of 2 reagents:
Reagent 1 contains Tris buffer, L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide.
Reagent 2 contains alpha-Ketoglutarate, NADH and sodium azide
The Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 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 or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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 an analysis of the provided text to extract the acceptance criteria and study information for the ELITech Clinical Systems AST/GOT 4+1 SL device:
Device: ELITech Clinical Systems AST/GOT 4+1 SL reagent on Vital Scientific Selectra Junior Analyzer.
1. Table of Acceptance Criteria and Reported Device Performance
This submission focuses on demonstrating substantial equivalence to a predicate device (ABX PENTRA AST CP and Vitalab Flexor). The acceptance criteria are implicitly defined by demonstrating comparable performance to the predicate device within acceptable ranges for clinical diagnostic assays. The table below summarizes the performance metrics reported for the subject device.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems AST/GOT 4+1 SL) | Comments |
|---|---|---|---|
| Precision | Comparable to predicate | Within-run: |
- Level 21.2 U/L: CV=2.3%
- Level 46.4 U/L: CV=0.8%
- Level 203.4 U/L: CV=0.5% | These CVs (Coefficient of Variation) demonstrate good within-run reproducibility. |
| | | Total: - Level 21.2 U/L: CV=3.8%
- Level 46.4 U/L: CV=1.2%
- Level 203.4 U/L: CV=2.7% | These CVs demonstrate good total precision. |
| Method Comparison | Strong correlation with predicate (e.g., R² > 0.98, slope ~1, intercept ~0) | $y = 1.016x - 1.86$ U/L
$R^2 = 0.9998$
Range: 9.5 to 234.4 U/L | Excellent correlation ($R^2=0.9998$) to the predicate method, indicating substantial agreement over the tested range. The slope is very close to 1 and the intercept close to 0. |
| Measuring Range | Comparable to predicate for clinical utility (Predicate: 3.70 U/L to 600 U/L) | 10 to 250 U/L (with automatic post-dilution up to 1800 U/L) | While the initial measuring range is narrower than the predicate, the automatic post-dilution extends it significantly, indicating broader clinical utility or comparable range with dilution. |
| Calibration Frequency | Clinically acceptable stability (Predicate: 8 days) | 28 days | Improved calibration frequency compared to the predicate, indicating better stability. |
| On-board Stability | Clinically acceptable stability (Predicate: 55 days) | 28 days (refrigerated area) | Slightly shorter, but still well within typical clinical laboratory operational periods for on-board reagents. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample sizes used for the precision and method comparison studies. However, for diagnostic device submissions, "levels" (e.g., Level 21.2 U/L, Level 46.4 U/L, Level 203.4 U/L for precision studies) typically refer to replicates of control materials or pooled patient samples at different concentrations. A method comparison study using a range of 9.5 to 234.4 U/L implies a set of patient samples covering a broad clinical range.
- Sample Size for Test Set: Not explicitly stated for each study, but implied to be sufficient for statistical analysis of precision (CVs) and method comparison ($R^2$ and linear regression parameters).
- Data Provenance: The submitter is SEPPIM S.A.S. located in France. The studies were likely conducted in a setting compliant with regulatory standards (e.g., GLP/GCP-like principles) for diagnostic device validation. The document does not explicitly state if the samples were retrospective or prospective, nor does it specify the country of origin for the patient samples, but given the manufacturer's location, the data most likely originates from France or other European countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The device is a quantitative clinical chemistry assay for AST. For such assays, "ground truth" is typically established by comparing the results of the new device to a legally marketed predicate device or a reference method, rather than through expert consensus on individual results.
- The ground truth for the method comparison study was established by the predicate device (ABX PENTRA AST CP) or a method traceable to IFCC formulation.
- Number of Experts: Not applicable in the context of establishing ground truth for a quantitative biochemical assay. Experts are involved in setting the performance specifications and interpreting the results, but not in generating the "ground truth" values for the samples themselves in this type of study.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or other diagnostic scenarios where human interpretation is subjective and consensus among experts is needed to establish a definitive "ground truth" diagnosis.
- Adjudication Method: Not applicable. For quantitative biochemical assays, the comparison is made directly between the numerical results of the candidate device and the predicate/reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with/without AI
- MRMC Study: No, this is not an MRMC comparative effectiveness study. This device is a fully automated in vitro diagnostic (IVD) reagent and analyzer system, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation involving multiple readers.
- Effect Size of Human Improvement with/without AI: Not applicable, as there is no human-in-the-loop interaction or AI component discussed for this specific diagnostic device in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the performance data presented (precision, method comparison, measuring range, calibration frequency, on-board stability) represents the standalone performance of the ELITech Clinical Systems AST/GOT 4+1 SL reagent when used on the Vital Scientific Selectra Junior Analyzer. It describes the direct analytical capabilities of the system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The primary type of ground truth used for performance evaluation (specifically, method comparison) is comparison to a legally marketed predicate device/method (ABX PENTRA AST CP, optimized UV test according to IFCC modified method without pyridoxal phosphate). For precision, it's based on repeated measurements of control materials or pooled samples.
8. The Sample Size for the Training Set
This submission describes a diagnostic reagent and analyzer system, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The development of such chemical reagents and assay protocols does not involve machine learning training data.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this type of IVD device, this question is not applicable. The development of the reagent assay formulation (Modified IFCC method without pyridoxal-phosphate) is based on established biochemical principles and extensive R&D, rather than machine learning on a dataset with pre-established ground truth.
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.