(191 days)
The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes. For in vitro diagnostic use only.
ELITech Clinical Systems AST/GOT 4+1 SL is a reagent for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate Amino Transferase (AST) in human serum and plasma on ELITech Clinical Systems Selectra ProM analyzer. Aspartate Amino Transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Clinical Systems Selectra ProM analyzers.
ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in accuracy and precision of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (Cl-) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
ISE Sodium Electrode: The sodium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of sodium in serum and plasma. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate anticluretic hormone secretion or other diseases involving electrolyte imbalance.
ISE Potassium Electrode: The potassium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of potassium in serum and plasma. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
ISE Chloride Electrode: The Chloride electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of chloride in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Selectra ProM is an automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically: the analyzer also has an ISE module for measuring sodium, potassium and chloride electrometrically. The Selectra ProM instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an ion selective electrodes (ISE).
AST/GOT 4+1 SL 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 α-Ketoglutarate, NADH and sodium azide.
The Sodium, Potassium and Chloride ISE Electrodes are comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.
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 FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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 HV according to FDA-approved methods in compliance with the European Directive 98/79/EC, Annex II, List A.
This document describes a 510(k) premarket notification for the ELITech Clinical Systems Selectra ProM, an automated in-vitro diagnostic analyzer, along with associated reagents and calibrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel performance. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of comparative performance to established predicate devices.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The document presents performance characteristics for the ELITech Clinical Systems Selectra ProM analyzer, the AST/GOT 4+1 SL reagent, and the ISE module (Sodium, Potassium, Chloride electrodes) by comparing them to predicate devices. The "acceptance criteria" are implied to be that the new device's performance is comparable to or better than the predicate's, thus demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit "acceptance criteria" (e.g., target CV% or r-squared values that must be met) are not directly stated as pass/fail thresholds but rather implied by comparison to predicates, I will present the comparative data provided. The reported performance of the ELITech device is compared directly against its predicate.
| Performance Metric | ELITech Clinical Systems Selectra ProM (and AST/GOT 4+1 SL reagent) | Predicate (HORIBA ABX PENTRA 400 & ABX PENTRA AST CP) | ELITech Clinical Systems Selectra ProM (ISE Module) | Predicate (ROCHE cobas c111 ISE Module) |
|---|---|---|---|---|
| AST Reagent | ISE Sodium | |||
| Measuring Range | 10 to 250 U/L | 3.70 U/L to 600 U/L (with auto post-dilution: 1800 U/L) | Method Comparison (y) | y = 1.042x - 6.9 mEq/L |
| Limit of Detection (LoD) | 0.8 U/L | 4 U/L | Method Comparison (r) | r = 0.996 |
| Limit of Quantification (LoQ) | 5.0 U/L | Not specified | Method Comparison (range) | 83 to 196.2 mEq/L |
| Precision (Within run) | Level 21.0 U/L CV=1.6% | Level 42 U/L CV=2.7% | ISE Potassium | |
| Level 54.1 U/L CV=0.6% | Level 123 U/L CV=1.4% | Method Comparison (y) | y = 1.008x - 0.08 mEq/L | |
| Level 201.0 U/L CV=0.2% | Level 22 U/L CV=2.3% | Method Comparison (r) | r = 0.997 | |
| Level 38 U/L CV=2.0% | Method Comparison (range) | 2.06 to 11.75 mEq/L | ||
| Level 145 U/L CV=1.1% | ISE Chloride | |||
| Precision (Total) | Level 21.0 U/L CV=2.1% | Level 42 U/L CV=3.1% | Method Comparison (y) | y = 0.950x + 3.5 mEq/L |
| Level 54.1 U/L CV=1.5% | Level 126 U/L CV=2.5% | Method Comparison (r) | r = 0.992 | |
| Level 201.0 U/L CV=1.4% | Level 43 U/L CV=3.6% | Method Comparison (range) | 70.2 to 166.8 mEq/L | |
| Level 348 U/L CV=5.0% | ||||
| Method Comparison (y) | y = 1.028x - 0.16 U/L | y = 0.99x + 1.01 U/L | ||
| Method Comparison (r²) | r² = 0.996 | r² = 0.9966 | ||
| Method Comparison (range) | 9.9 to 248.1 U/L | 3.70 to 671.80 U/L | ||
| Calibration Frequency | 28 days | 8 days | Recommended to recalibrate every 4 hours or after certain events (e.g., changing solution) | 24 hours (main calibration) or after certain events |
Interpretation: The reported performance indicators (e.g., CV for precision, r and r² for method comparison) are comparable to the predicate devices, supporting the claim of substantial equivalence. For instance, the AST reagent shows competitive precision and a strong correlation with the predicate method. Similarly, the ISE module demonstrates high correlation coefficients (r-values) when compared to its predicate.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the test sets (e.g., for method comparison or precision studies). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. It only mentions testing on "human serum and plasma."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For in-vitro diagnostic devices like clinical chemistry analyzers, "ground truth" is typically established by reference methods or established laboratory practices, not by expert consensus from medical professionals in a qualitative assessment sense. The document refers to "IFCC formulation" and "manual measurement" for AST traceability, and "primary calibrators prepared gravimetrically from purified salts" for ISE traceability, indicating reliance on established scientific and metrological standards rather than expert panel consensus for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective expert review is involved (e.g., imaging diagnostics). For an in-vitro diagnostic device performing quantitative measurements, performance is typically evaluated against gold standard methods or established predicate devices using quantitative statistical comparisons.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of in-vitro diagnostic device. MRMC studies are primarily used for evaluating diagnostic imaging systems where human readers interpret images. This device performs automated chemical analysis, not human-interpreted diagnostic output. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the studies presented are effectively standalone performance evaluations for the ELITech Clinical Systems Selectra ProM analyzer and its reagents. The device is an automated system designed to perform measurements without direct human intervention in the analytical process. The method comparison and precision studies demonstrate the algorithm's (device's) performance in generating quantitative results. The human element is in operating the device and interpreting the results within a clinical context, but the performance data provided directly reflects the automated system's capabilities.
7. The Type of Ground Truth Used:
The ground truth for the performance evaluations (e.g., method comparison studies) relies on:
- Reference Measurement Procedures/Established Methods: For AST, it mentions "IFCC formulation (Schumann, 2002), manual measurement" and comparison to a predicate that uses "IFCC modified method."
- Primary Calibrators/Metrological Traceability: For the ISE module, it states that the method has been standardized "against primary calibrators prepared gravimetrically from purified salts" and traces to "NIST SRM 919b" and "NIST SRM 918b" for Sodium and Potassium, respectively, and "NIST SRM 918b/919b" for Chloride.
- Predicate Device Measurements: In comparison studies, the results from the predicate devices (HORIBA ABX PENTRA 400 and ROCHE cobas c111 ISE) serve as the comparative standard.
8. The Sample Size for the Training Set:
This information is not applicable or not provided. Clinical chemistry analyzers and their reagents are typically developed and validated using a combination of laboratory-prepared samples, spiked samples, and patient samples. The term "training set" is more commonly associated with machine learning or artificial intelligence algorithms. While the instrument and reagent parameters are "trained" or optimized during development, specific sample sizes for such an internal "training set" are not disclosed in regulatory submissions of this type. The provided document details validation (test set) performance, not internal development/training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or not provided for the reasons stated above in point 8. The "ground truth" for optimizing instrument parameters and reagent formulations during development would implicitly come from rigorous internal testing against known standards, reference materials, and established laboratory methods to ensure accuracy and precision across the measuring range.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.