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ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. 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.

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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELITech Clinical Systems ELITROL I is a multi-parametric 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 multi-parametric 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.

Device Description

ELITech Clinical Systems GLUCOSE PAP SL is available as kit only. It consists of 1 reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide.

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.

AI/ML Overview

The provided text describes three medical devices seeking 510(k) clearance: ELITech Clinical Systems GLUCOSE PAP SL reagent, ELITech Clinical Systems ELICAL 2 calibrator, and ELITech Clinical Systems ELITROL I and ELITROL II controls. The submissions focus on demonstrating substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study data presented for each device, structured according to your requested information:

1. ELITech Clinical Systems GLUCOSE PAP SL reagent

This device is a glucose reagent used for quantitative determination of glucose in human serum and plasma. The submission compares its performance to the ABX PENTRA GLUCOSE PAP CP predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	ELITech Clinical Systems GLUCOSE PAP SL (Reported Performance)	Predicate Device (ABX PENTRA GLUCOSE PAP CP)
Intended Use	Quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care.	For quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care.	For quantitative determination of glucose in serum and plasma.
Indication(s) for Use	Diagnosis and treatment of carbohydrate metabolism disorders.	Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma).	Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma).
Assay Protocol	Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).	Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).	Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).
Composition	Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase, Peroxidase, Sodium azide.	Identical composition: Phosphate buffer (pH 7.4) 13.8 mmol/L, Phenol 10 mmol/L, 4-Aminoantipyrine 0.3 mmol/L, Glucose oxidase ≥ 10 000 U/L, Peroxidase ≥ 700 U/L, Sodium azide < 0.1%.	Identical composition.
Appearance of Reagent	Liquid form, ready to use.	Liquid form, ready to use.	Same.
Sample Type	Serum, Plasma.	Serum, Plasma.	Serum, Plasma.
Reagent Storage	Store at 2-8 °C, protected from light, stable until expiry.	Store at 2-8 °C, protected from light. Stable until expiry date.	Store at 2-8 °C, stable up to expiry date (unopened cassette).
Expected Values	Serum, plasma: 74 - 106 mg/dL.	Serum, plasma: 74 - 106 mg/dL.	Serum, plasma: 74 - 106 mg/dL.
Measuring Range	Comparable range, with rerun/post-dilution capabilities.	20.0 to 400.0 mg/dL (Rerun: 800.0 mg/dL).	1.8 to 432 mg/dL (Automatic post-dilution: 1296 mg/dL).
Detection Limit	Low detection limit.	0.5 mg/dL.	1.8 mg/dL.
Precision (Within Run CV)	Low coefficient of variation (CV).	Level 36.5 mg/dL: 1.6%Level 107.4 mg/dL: 1.4%Level 301.5 mg/dL: 1.0%	Level 89.36 mg/dL: 0.41%Level 230.53 mg/dL: 0.40%Level 42.76 mg/dL: 0.62%Level 111.47 mg/dL: 0.30%Level 296.22 mg/dL: 0.49%
Precision (Total CV)	Low coefficient of variation (CV).	Level 36.5 mg/dL: 2.9%Level 107.4 mg/dL: 2.5%Level 301.5 mg/dL: 2.1%	Level 90.20 mg/dL: 1.23%Level 235.44 mg/dL: 1.12%Level 107.18 mg/dL: 1.44%Level 298.97 mg/dL: 1.05%
Method Comparison	Strong correlation ($r^2$) and acceptable bias to predicate.	y = 0.953 x + 3.05 mg/dL$r^2$ = 0.997Range: 17.9 to 417.2 mg/dL.	y = 0.98 x + 0.72 mg/dL$r^2$ = 0.9974.
Limitations (Interference)	Identified interferences at certain concentrations.	Hemoglobin: POSITIVE bias from 250 mg/dL (low serum), no significant interference up to 500 mg/dL (medium serum).Triglycerides: POSITIVE bias from 814 mg/dL.Unconjugated bilirubin: POSITIVE bias from 15 mg/dL (low serum), NEGATIVE bias from 18 mg/dL (medium serum).Conjugated bilirubin: NEGATIVE bias from 8 mg/dL (low serum), from 18 mg/dL (medium serum).Ascorbic acid: NEGATIVE bias from 2 mg/dL (low serum), from 12 mg/dL (medium serum).Uric acid: NEGATIVE bias from 19 mg/dL (low serum), no significant interference up to 24 mg/dL (medium serum).Methyldopa: NEGATIVE bias from 0.9 mg/dL (low serum), no significant interference up to 1 mg/dL (medium serum).	Hemoglobin: No significant influence up to 460 mg/dL.Triglycerides: No significant influence up to 613 mg/dL.Total bilirubin: No significant influence up to 8.19 mg/dL.Direct bilirubin: No significant influence up to 5.63 mg/dL.
Calibration Frequency	Stable calibration period.	28 days.	11 days.
On-board Stability	Reagent stability when loaded on instrument.	28 days (refrigerated area).	83 days (refrigerated area).

2. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The "Method comparison" section refers to a "range: 17.9 to 417.2 mg/dL" which implies a distribution of glucose concentrations were tested, but the number of individual samples is not provided. The data provenance is not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a clinical chemistry assay, where the "ground truth" for comparison is typically another established, validated reference method (the predicate device in this case), not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of clinical chemistry assay comparison.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a standalone diagnostic reagent, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance presented is for the device as a standalone reagent in conjunction with the specified analyzer. There is no human-in-the-loop component for interpretation in this context.
7. The type of ground truth used: The performance of the ELITech Clinical Systems GLUCOSE PAP SL was compared against the predicate device (ABX PENTRA GLUCOSE PAP CP) using patient samples, with the predicate device serving as the comparative "ground truth" for method comparison studies.
8. The sample size for the training set: Not applicable. This is a reagent for a clinical chemistry assay, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

2. ELITech Clinical Systems ELICAL 2 calibrator

This device is a multi-parametric calibrator. The submission compares its characteristics to the Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	ELITech Clinical Systems ELICAL 2 (Reported Performance)	Predicate Device (Roche Calibrator f.a.s.)
Intended Use	Multi-parametric calibrator for in vitro diagnostic use in calibration of quantitative methods on specified analyzers.	Multi-parametric calibrator for in vitro diagnostic use in calibration of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior and Flexor Junior Analyzers.	For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers.
Format	Lyophilized calibrator based on human serum with added constituents.	Lyophilized calibrator based on human serum with constituents added to obtain desired levels.	Lyophilized calibrator based on human serum with constituents added to obtain desired levels.
Level	Single level.	Single level.	Single level.
Handling	Specific instructions for reconstitution.	Carefully open vial, pipette 3 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.	Carefully open bottle, pipette 3 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.
Traceability	Traceability information provided.	Traceability information given in the value sheet.	Traceability of the target value given in the instruction for use of system reagents.
Stability (Lyophilized)	Stable at 2-8°C until expiry.	At 2-8°C and protected from light until expiry date.	At 2-8°C up to expiration date.
Stability (Reconstituted)	Specific stability periods at various temperatures.	- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at -25 to -15 °C (when frozen once).	- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at -25 to -15 °C (when frozen once). (Exceptions for bilirubin noted).
Components	List of analytes (Glucose, Total Protein included in this submission).	Includes Glucose and Total Protein.	Assumed to include similar analytes for calibration. Not explicitly listed for the predicate here.

2. Sample size used for the test set and the data provenance: Not explicitly stated. For a calibrator, "test set" would typically refer to stability studies or studies confirming assigned values, but specific numbers and provenance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Calibrator values are assigned based on reference methods and extensive testing, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance is for the calibrator as a component in a diagnostic system.
7. The type of ground truth used: The "ground truth" for a calibrator relates to its assigned values matching reference methods or being traceable to international standards. The submission states "Traceability information is given in the value sheet included in the box," implying this is how its "truth" is established.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

3. ELITech Clinical Systems ELITROL I and ELITROL II controls

These devices are two-level quality control products. The submission compares their characteristics to the Roche Diagnostics Precinorm U and Precipath U predicate devices.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	ELITech Clinical Systems ELITROL I / ELITROL II (Reported Performance)	Predicate Device (Roche Precinorm U / Precipath U)
Intended Use	Multi-parametric control serum for accuracy control of quantitative methods on specified analyzers.	Multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior and Flexor Junior Analyzers.	For in vitro diagnostic use in quality control by monitoring accuracy and precision for quantitative methods.
Format	Lyophilized human sera with added constituents.	Lyophilized human sera with constituents added to obtain desired levels.	Lyophilized human sera with constituents added to obtain desired levels.
Levels	Two levels.	Two levels.	Two levels.
Handling	Specific instructions for reconstitution.	Carefully open vial, pipette 5 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.	Carefully open bottle, pipette 5 mL distilled/deionized water, close, gently swirl to dissolve within 30 minutes, avoid foam.
Stability (Lyophilized)	Stable at 2-8°C until expiry.	At 2-8°C and protected from light until expiry date.	At 2-8°C up to expiration date.
Stability (Reconstituted)	Specific stability periods at various temperatures.	- 12 hours at 15-25 °C.	- 12 hours at 15-25 °C.
Components	List of analytes (Glucose, Total Protein included in this submission).	Includes Glucose and Total Protein.	Assumed to include similar analytes for quality control. Not explicitly listed for the predicate here.

2. Sample size used for the test set and the data provenance: Not explicitly stated. For controls, "test set" would typically refer to stability studies or studies confirming assigned values and control ranges. Specific numbers and provenance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Control values are assigned based on reference methods and extensive testing, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance is for the control materials as components in a diagnostic system.
7. The type of ground truth used: The "ground truth" for controls relates to their assigned values matching reference methods or being traceable to international standards, as well as their stability characteristics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Overall Conclusion:

For all three devices, the "acceptance criteria" appear to be meeting or demonstrating comparability to the performance and characteristics of the respective predicate devices across various parameters (intended use, composition, analytical performance, stability, etc.). The studies performed are primarily analytical performance studies and comparisons, common for in vitro diagnostic devices seeking 510(k) clearance based on substantial equivalence. The document repeatedly concludes that "The performance data and other information demonstrate that the safety and effectiveness of this device [or these devices] versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device."

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