(127 days)
ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na heparinized or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.
The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.
The AIA-PACK 25-OH Vitamin D Control Set is.intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK 25-OH Vitamin D assay.
The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK 25-OH Vitamin D test cup. Sample pretreatment reagents (containing sodium hydroxide) disassociate 25-OH vitamin D from its binding proteins in the test sample. 25-0H vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzyme-labeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-0H vitamin D competes with 25-0H vitamin D for binding to the antibody on magnetic beads in the reaction mixture.
After the second incubation, the magnetic beads are washed to remove the unbound enzymelabeled 25-OH vitamin D and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-OH vitamin D concentration in the test sample. A standard curve is constructed, and unknown 25-OH vitamin D concentrations are calculated using this curve.
Here's a breakdown of the acceptance criteria and the study details for the ST AIA-PACK 25-OH Vitamin D device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for precision, linearity, or correlation. Instead, it presents the results of these performance characteristics studies. The implied acceptance is that the reported performance is acceptable for the intended use and demonstrates substantial equivalence to the predicate device. For the purpose of this table, I will use the "Differences" table from the substantial equivalence section as a proxy for some acceptance criteria where direct comparisons were made to the predicate. For other performance characteristics, the reported results are presented.
| Performance Characteristic | Acceptance Criteria (Implied/Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Assay Technology | Fluorescence Immunoassay (or comparable) | Fluorescence Immunoassay |
| Incubation Time | Shorter than predicate (110 min) | 10 minute cycle |
| Reference Range | Comparable to predicate (9.0 - 37.6 ng/mL) | 10.8 to 54.75 ng/mL |
| Limit of Detection | Comparable to predicate (1.5 ng/mL) | 2.6 ng/mL |
| Detection Range | Comparable to predicate (4.8 - 100.0 ng/mL) | 4.0 ng/mL - 120.0 ng/mL |
| Calibrator Format | Lyophilized (or comparable to predicate) | Lyophilized |
| Calibrator Range | 0-100 ng/mL (or comparable to predicate) | 0-165 ng/mL |
| Controls Format | Lyophilized (or comparable to predicate) | Lyophilized |
| Controls Levels | Similar to predicate (e.g., 2 levels) | Two levels at approximately 20 and 80 ng/mL |
| Intra-assay Precision (CV%) | Not explicitly stated, typically 0.95 (typical) | Slope: 0.934, Intercept: 2.53, R: 0.944 (Deming) |
| Matrix Comparison (Serum vs Na Heparin) | Slope ~1, Intercept ~0, R > 0.95 (typical) | Slope: 0.993, Intercept: -0.390, R: 0.995 (Deming) |
| Matrix Comparison (Serum vs EDTA Plasma) | Slope ~1, Intercept ~0, R > 0.95 (typical) | Slope: 1.041, Intercept: 0.091, R: 0.994 (Deming) |
| Cross-reactivity | Minimal for non-target analytes ( |
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.