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The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. 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.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

Device Description

The Alinity c Glucose Reagent Kit contains Reagent 1 with ATP •2Na, NAD, G-6-PDH, and Hexokinase as reactive ingredients, and sodium azide as a preservative. The kit is available in two sizes: 400 tests per cartridge (10 cartridges per kit, 4000 tests per kit) and 1100 tests per cartridge (10 cartridges per kit, 11,000 tests per kit). The reagent container is made of black polypropylene with a black high density polyethylene closure.

The Alinity c Multiconstituent Calibrator Kit contains Cal 1 and Cal 2, prepared from a human-based matrix containing multiple analytes, including glucose, with sodium azide as a preservative. The calibrators are standardized for glucose using NIST SRM 965 and the ID-GC/MS reference method.

The Alinity c System is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. It uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration. The system features robotic sample handling, continuous reagent access, continuous bulk solution access, and priority sample loading on all carrier positions.

AI/ML Overview

This document describes the analytical performance of the Alinity c Glucose Reagent Kit and the Alinity c System for measuring glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). The studies evaluate various performance characteristics against predefined acceptance criteria to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Precision
Serum Samples	Within-laboratory imprecision (within-run, between-run, between-day) ≤ 5 %CV for samples targeted between 80 to 281 mg/dL.	For Control Level 2 (128 mg/dL): Lot 1 - 0.8% CV (within-run), 1.0% CV (within-laboratory); Lot 2 - 0.7% CV (within-run), 1.0% CV (within-laboratory). For Panel B (106 mg/dL): 0.8% CV (within-run), 0.9% CV (within-laboratory). All reported values for samples within the specified range (80-281 mg/dL) are well within the 5% CV criterion. Alinity c Glucose assay demonstrated acceptable precision.
Urine Samples	Within-laboratory imprecision (within-run, between-run, between-day) ≤ 6 %CV for samples targeted between 30 to 306 mg/dL.	For Control Level 1 (38 mg/dL): Lot 1 - 1.0% CV (within-run), 1.3% CV (within-laboratory); Lot 2 - 0.9% CV (within-run), 1.4% CV (within-laboratory). For Panel B (60 mg/dL): 1.6% CV (within-run), 2.1% CV (within-laboratory). For Panel C (110 mg/dL): 2.2% CV (within-run), 2.8% CV (within-laboratory). All reported values for samples within the specified range (30-306 mg/dL) are well within the 6% CV criterion. Alinity c Glucose assay demonstrated acceptable precision.
CSF Samples	Within-laboratory imprecision (within-run, between-run, between-day) ≤ 5 %CV for samples targeted between 29 to 60 mg/dL.	For Control Level 1 (60 mg/dL): Lot 1 - 0.9% CV (within-run), 1.1% CV (within-laboratory); Lot 2 - 0.7% CV (within-run), 1.0% CV (within-laboratory). For Control Level 2 (30-31 mg/dL): Lot 1 - 0.9% CV (within-run), 1.1% CV (within-laboratory); Lot 2 - 1.1% CV (within-run), 1.3% CV (within-laboratory). For Panel B (57 mg/dL): 0.8% CV (within-run), 0.9% CV (within-laboratory). All reported values for samples within the specified range (29-60 mg/dL) are well within the 5% CV criterion. Alinity c Glucose assay demonstrated acceptable precision.
Accuracy	Not explicitly stated as a single numerical acceptance criterion for each NIST level, but the performance is presented through mean, SD, %CV, bias, and %bias. The overall "Total Error" is also reported.	NIST level 1 (Target: 33.08): Mean 33 mg/dL, 0.2% Bias, 2.3% Total Error. NIST level 2 (Target: 75.56): Mean 76 mg/dL, 1.2% Bias, 2.5% Total Error. NIST level 3 (Target: 118.5): Mean 120 mg/dL, 1.1% Bias, 2.1% Total Error. NIST level 4 (Target: 294.5): Mean 306 mg/dL, 3.8% Bias, 4.7% Total Error.
Limit of Quantitation (LoQ)	Lowest concentration at which a maximum allowable precision of 20 %CV was met.	Serum/Plasma LoQ: 2.25 mg/dL. Urine/CSF LoQ: 0.86 mg/dL.
Linearity	Meet the limits of acceptable performance for linearity (part of Measuring Interval definition).	Serum/Plasma: Mean observed linear range 0 to 828 mg/dL. Urine: Mean observed linear range 0 to 843 mg/dL. CSF: Mean observed linear range 0 to 887 mg/dL.
Measuring Interval	Defined as the range of values which meets the limits of acceptable performance for linearity, imprecision, and bias.	Serum/Plasma: 5 mg/dL to 800 mg/dL. Urine/CSF: 1 mg/dL to 800 mg/dL.
Interference	Serum/Plasma: Bias of >6% or >1 mg/dL was considered significant interference. Urine: Bias of >10% or >1 mg/dL was considered significant interference.	The Alinity c Glucose assay (serum application) is not susceptible to interference from Unconjugated Bilirubin (≤ 30 mg/dL), Conjugated Bilirubin (≤ 60 mg/dL), Hemoglobin (≤ 2,000 mg/dL), Triglycerides (≤ 2,000 mg/dL), Ascorbic Acid (≤ 6 mg/dL), Acetaminophen (≤ 20 mg/dL), Ibuprofen (≤ 50 mg/dL), Acetylcysteine (≤ 167 mg/dL), Acetylsalicylic Acid (≤ 66 mg/dL), Sodium Salicylate (≤ 70 mg/dL). The Alinity c Glucose assay (urine application) is not susceptible to interference from Protein (≤ 50 mg/dL), Ascorbate (≤ 200 mg/dL), 8.5 N Acetic Acid (< 6.25 mL/dL), Boric Acid (≤ 250 mg/dL), 6 N Hydrochloric Acid (< 2.5 mL/dL), 6 N Nitric Acid (< 5.0 mL/dL), Sodium Oxalate (≤ 60 mg/dL), Sodium Carbonate (≤ 1.25 g/dL), Sodium Fluoride (≤ 400 mg/dL), Acetaminophen (≤ 20 mg/dL), Ibuprofen (≤ 50 mg/dL), Acetylcysteine (< 167 mg/dL).
Method Comparison	Acceptable correlation and agreement with the predicate device.	Serum (N=98): Correlation Coefficient 1.00, Intercept -1.78, Slope 1.00 (mg/dL) / Intercept -0.09, Slope 1.00 (mmol/L). Urine (N=118): Correlation Coefficient 1.00, Intercept 0.24, Slope 0.99 (mg/dL) / Intercept 0.01, Slope 0.99 (mmol/L). CSF (N=90): Correlation Coefficient 1.00, Intercept 0.50, Slope 1.00 (mg/dL) / Intercept 0.03, Slope 1.00 (mmol/L). The results were deemed acceptable.
Auto Dilution	Difference in measured concentration within ± 10% when comparing auto-diluted samples on the Alinity c analyzer to auto-diluted samples on the ARCHITECT c 8000 System.	Mean % difference -0.4% (range: -5.1% to 2.6%). Demonstrated acceptable performance.
Tube Type Equivalency	Acceptable for specified tube types.	Serum, Serum separator, dipotassium EDTA, lithium heparin, sodium heparin, sodium fluoride/potassium oxalate tubes were determined acceptable.

2. Sample sizes and data provenance for the test set:

Precision (20-Day Within-Laboratory):
- Serum Samples: 260-264 replicates for control levels, 523-528 replicates for panel samples (across reagent lots and instrument combinations).
- Urine Samples: 260-264 replicates for control levels, 525-528 replicates for panel samples (across reagent lots and instrument combinations).
- CSF Samples: 263-264 replicates for control levels, 526-528 replicates for panel samples (across reagent lots and instrument combinations).
- Data Provenance: Not explicitly stated, but typically these are prospective studies conducted in a controlled laboratory setting (likely within the manufacturer's R&D facilities or a collaborating lab).
Accuracy (NIST Standards):
- 22 replicates for each of the 4 NIST levels.
- Data Provenance: Conducted in a controlled laboratory setting.
Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ):
- LoB: n ≥ 60 replicates of zero-analyte samples.
- LoD & LoQ: n ≥ 60 replicates of low-analyte level samples.
- Data Provenance: Conducted in a controlled laboratory setting.
Linearity:
- Sample sets used to cover the linear range. Specific 'n' for each sample type not individually quantified beyond "sample set."
- Data Provenance: Conducted in a controlled laboratory setting.
Interference:
- Specific numbers of samples or replicates for interference studies are not provided, but the evaluation was conducted based on CLSI document EP07-A2.
- Data Provenance: Conducted in a controlled laboratory setting.
Method Comparison:
- Serum: 98 samples.
- Urine: 118 samples.
- CSF: 90 samples.
- Data Provenance: Human serum, urine, and CSF specimens. Not explicitly stated if retrospective or prospective, or country of origin, but generally for device clearance, these are often prospective collections or carefully selected archived samples from diverse populations to ensure representativeness.
Auto Dilution:
- Glucose serum specimens. Specific 'n' not provided beyond being a set of specimens.
- Data Provenance: Not explicitly stated, likely laboratory-prepared or clinical samples.
Tube Type Equivalency:
- Minimum of 40 donors.
- Data Provenance: Samples collected from human donors.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document describes the analytical performance of an in vitro diagnostic (IVD) device for measuring glucose. For such devices, "ground truth" is typically established by:

Reference Methods: Such as NIST (National Institute of Standards and Technology) certified reference materials (e.g., SRM 965 Glucose in Human Serum) and reference methods (e.g., ID-GC/MS - Isotope Dilution-Gas Chromatography Mass Spectrophotometry). These are highly accurate, traceable methods, and do not involve human "experts" in the diagnostic interpretation sense.
Predicate Devices: The ARCHITECT c System and its associated Glucose assay (K060383) serve as the comparator (or "ground truth" surrogate) for method comparison studies.
Clinical Laboratory Standards: The performance is evaluated against established clinical laboratory standards and guidelines (e.g., CLSI documents EP05-A2, EP17-A2, EP06-A, EP07-A2, EP09-A3). These standards define acceptable performance metrics.

Therefore, for this type of IVD device, there isn't a team of experts (like radiologists or pathologists) establishing a visual interpretation ground truth. The 'ground truth' is analytical, based on certified reference materials and established reference methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of medical images or clinical cases by multiple human readers (e.g., radiologists, pathologists) to establish a consensus ground truth. For an automated quantitative assay like a glucose test, the "ground truth" is objective and measured via reference methods or predicate devices, as described above.

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. An MRMC study is relevant for AI-powered diagnostic imaging or interpretation tools where human readers' performance is compared with and without AI assistance across multiple cases. This document is for a fully automated in vitro diagnostic (IVD) chemistry analyzer and reagent kit, which does not involve human "readers" interpreting results in the same way.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies presented here are for the standalone performance of the Alinity c Glucose Reagent Kit and the Alinity c System. The device measures glucose levels automatically, and the performance characteristics (precision, accuracy, linearity, interference, method comparison) are evaluated for the device itself. There is no "human-in-the-loop" aspect to the actual measurement process of the device as an IVD analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used is primarily reference measurements derived from:

Certified Reference Materials: Specifically, NIST SRM 965 (Glucose in Human Serum), analyzed by a reference method (ID-GC/MS - Isotope Dilution-Gas Chromatography Mass Spectrophotometry) for accuracy studies.
Comparator (Predicate) Device: The predicate Glucose assay (K060383) run on the ARCHITECT c System for method comparison studies. This serves as the comparative standard of care.
Clinical Laboratory Standards (CLSI guidelines): These provide the framework and accepted ranges for evaluating various analytical performance characteristics (e.g., precision, linearity, LoQ).

8. The sample size for the training set:

The document does not explicitly mention a "training set" in the context of machine learning. This is an IVD device, and its analytical performance is validated against established laboratory standards and predicate devices. The development of such a device involves extensive R&D, calibration, and optimization using various samples, but these are not typically referred to as "training sets" in the same way as for AI/ML algorithms. The reported studies are for performance validation (test set).

9. How the ground truth for the training set was established:

Not applicable, as a "training set" as defined for AI/ML models is not directly addressed or implied for this type of IVD device. The development process would rely on precise chemical and enzymatic reactions, spectrophotometric detection principles, and calibration against reference materials to ensure accurate measurements across the analytical range.

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