(261 days)
ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.
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 ELITech Clinical Systems Analyzers.
ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide
The provided document describes the analytical performance of the ELITech Clinical Systems GLUCOSE HK SL reagent, ELICAL 2 calibrator, and ELITROL I/II controls. It does not describe an AI/ML powered device, therefore no information is available regarding expert consensus, MRMC studies, or multi-reader performance. The study described focuses on demonstrating substantial equivalence to predicate devices for in vitro diagnostic use.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines acceptance criteria implicitly through the study design (e.g., acceptance bias for interference studies) and generally through comparison to a predicate device. Performance is reported through various analytical studies.
ELITech Clinical Systems GLUCOSE HK SL Reagent Performance Summary:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (CV%) | Not explicitly stated as acceptance criteria, but predicate device performance or general IVD standards for reproducibility would be implied. | Serum: |
- Level 1 (45.5 mg/dL): Within-run CV% 1.1, Total CV% 2.0
- Level 2 (119.5 mg/dL): Within-run CV% 0.9, Total CV% 1.7
- Level 3 (251.5 mg/dL): Within-run CV% 0.9, Total CV% 2.0
- Level 4 (522.5 mg/dL): Within-run CV% 0.4, Total CV% 1.8
Urine: - Level 1 (18.0 mg/dL): Within-run CV% 0.9, Total CV% 2.0
- Level 2 (204.4 mg/dL): Within-run CV% 0.7, Total CV% 1.7
- Level 3 (497.4 mg/dL): Within-run CV% 0.6, Total CV% 1.7 |
| Linearity/Assay Range | Serum: Demonstrated linearity for reported range (20 - 720 mg/dL).
Urine: Demonstrated linearity for reported range (10 - 720 mg/dL). | Serum: Linear range: 20 - 720 mg/dL (y = 1.025x - 2.0 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.0 mg/dL). Auto-dilution to 3600 mg/dL.
Urine: Linear range: 10 - 720 mg/dL (y = 1.0155x - 1.6 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 3.5 mg/dL). Auto-dilution to 3600 mg/dL. |
| On-board Stability | 28 days for the reagent. | Reagent: 28 days on-board.
Shelf-life: 27 months (real-time studies for 36 months). |
| Limit of Detection (LoD) | Not explicitly stated, but clinical relevance and comparison to predicate device would be implicit. | Serum: 0.3 mg/dL
Urine: 0.2 mg/dL |
| Limit of Quantification (LoQ) | Serum: Acceptable Total Error ≤ 0.32 mg/dL; value must be ≥ LoD.
Urine: Acceptable Total Error ≤ 0.8 mg/dL; value must be ≥ LoD. | Serum: 5.00 mg/dL
Urine: 5.00 mg/dL |
| Interference/Analytical Specificity | Accepted bias of ±10% in sample pools with low (50.0 mg/dL for serum, 18.0 mg/dL for urine) or high (120.0 mg/dL for serum, 200.0 mg/dL for urine) nominal activity. Specific interferent concentrations are also listed in the table. | Serum: No significant interference up to listed concentrations for unconjugated bilirubin (30.0 mg/dL), conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), triglycerides (600 mg/dL - note: negative bias observed at higher levels), ascorbic acid (20.0 mg/dL), uric acid (20.0 mg/dL), methyl dopa (2.0 mg/dL), L-dopa (30.0 mg/dL), Tolazamide (50.0 mg/dL), and acetaminophen (30 mg/dL).
Urine: No significant interference up to listed concentrations for conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), uric acid (100 mg/dL), and urea (6000 mg/dL). No significant interference for pH (2.5 to 12.0) and specific gravity (1.000 to 1.030). |
| Method Comparison (Correlation) | Demonstrate substantial equivalence to the predicate device (Roche Diagnostics Cobas C111 Glucose HK). | Serum: Against Cobas C111: y = 1.008 x + 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.7 mg/dL.
Urine: Against Cobas C111: y = 0.996 x - 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 3.5 mg/dL.
Plasma (Lithium Heparin): y = 1.001x - 0.7 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 1.9 mg/dL.
Plasma (Sodium Fluoride/Oxalate): y = 1.016x - 0.9 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 7.0 mg/dL. |
2. Sample Size Used for the Test Set and Data Provenance:
-
Precision Studies:
- Serum: 80 measurements for each of 4 levels (total of 320 measurements). Samples were human sera and control sera.
- Urine: 80 measurements for each of 3 levels (total of 240 measurements). Samples were urine pools.
- Provenance: Not specified, but likely from laboratory samples as part of a method validation. Neither retrospective nor prospective status is explicitly stated, but analytical performance studies are generally conducted prospectively on prepared samples or collected patient samples.
-
Linearity Studies:
- Serum: 11 levels of mixed samples.
- Urine: 11 levels of mixed samples.
- Provenance: Not specified, but likely prepared in a laboratory.
-
Interference Studies:
- Serum: Two serum sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations (e.g., 9 for triglycerides, 7 for bilirubin). Each point measured in triplicate per run. Two levels of control materials also tested.
- Urine: Two urine sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations. Each point measured in triplicate per run. Two levels of control materials also tested.
- Provenance: Not specified, but laboratory prepared spiked samples.
-
Method Comparison Studies (Test Set):
- Serum: 100 serum patient samples (ranging from 20.5 to 707.5 mg/dL).
- Urine: 40 urine patient samples (with glacial acetic acid as preservative, ranging from 10.1 to 703.9 mg/dL).
- Plasma (Lithium Heparin): 40 plasma patient samples (ranging from 24.3 to 710.1 mg/dL).
- Plasma (Sodium Fluoride/Oxalate): 40 plasma patient samples (ranging from 21.2 to 701.4 mg/dL).
- Provenance: "patient samples" implies retrospective or prospectively collected clinical samples. The country of origin is not specified but given the submitter's address (France and USA), it could be either.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as this is an in-vitro diagnostic test measuring a quantitative analyte (glucose). The "ground truth" for the test set is established by the reference method (Roche Diagnostics Cobas C111 Glucose HK) or known values/concentrations for engineered samples in analytical studies.
4. Adjudication Method for the Test Set:
Not applicable, as this is an in-vitro diagnostic test. Results are quantitative measurements compared against a reference method or known values, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:
Not applicable, as this is an in-vitro diagnostic test. There is no human reader involvement in interpreting the device's quantitative output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are all "standalone" in the sense that they evaluate the analytical performance of the device (reagent, calibrator, controls) on an automated analyzer (ELITech Clinical Systems Selectra ProM Analyzer) without human intervention in the result determination process.
7. The Type of Ground Truth Used:
- Known concentrations: For linearity, LoD/LoQ, and interference studies, samples were prepared to have known or target concentrations of glucose and interferents.
- Reference method/device: For method comparison studies, the predicate device (Roche Diagnostics Cobas C111 Glucose HK) was used as the comparative "ground truth" for patient samples.
- NIST Traceability: For calibration, the glucose value assigned to the calibrator (ELICAL 2) is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML powered device, so there is no "training set." The device performance is based on the chemical reagent's properties and the analyzer's measurement capabilities.
9. How the Ground Truth for the Training Set was Established:
Not applicable (no training set).
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.