(260 days)
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.
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.
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 ( |
§ 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.