(141 days)
The Diazyme 25-hydroxy Vitamin D Assay is designed for the quantification of total 25-hydroxy Vitamin D in human serum and plasma. The assay results are to be used in parallel with other clinical data to assess the Vitamin D status of a patient. For in vitro diagnostic use only.
The 25-hydroxy Vitamin D Assay Calibrator set is intended for use in the calibration of the Diazyme 25-OH Vitamin D Assay Kit only. For in vitro diagnostic use only.
The 25-hydroxy Vitamin D Assay Control kit is intended for use as quality controls for the Diazyme 25-OH Vitamin D Assay kit only. For in vitro diagnostic use only.
The 25-hydroxy (25-OH) Vitamin D assay is based on the principle of x-complementation of the enzyme B-galactosidase and the competition between an enzyme donor-25-OH Vitamin D conjugate, Vitamin D binding protein and the 25-OH Vitamin D content of a serum sample. Samples with higher 25-OH Vitamin D concentrations produce higher ß-galactosidase activities and vice versa. Chlorophenol red-B-D- galactopyranoside (CPRG) is used as the enzyme substrate and the accumulation of the reaction's product (chlorophenol red) is monitored at 560 nm. The 25-OH Vitamin D concentration of a patient sample is proportional to the measured ß-galactosidase activity. The assay consists of a sample extraction step during which Vitamin D is irreversibly dissociated from its serum transporter. Extracted samples are then analyzed on a microplate reader after the sequential addition of three reagents.
25-OH Vitamin D assay calibrator set is intended for use with the Diazyme 25-OH Vitamin D assay kit only. Six calibration levels are needed for each run. Calibrators are treated exactly the same as patient samples.
25-OH Vitamin D assay 2-point control set is intended for use with the Diazyme 25-OH Vitamin D assay kit only. Controls are treated exactly the same as patient samples. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received.
Here's a breakdown of the acceptance criteria and the study details for the Diazyme 25-OH Vitamin D Assay Kit, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Total CV%) | ≤ 10% | Deficient Control (24.4 ng/mL): 7.9% |
| Normal Control-1 (38.4 ng/mL): 9.7% | ||
| Normal Control-2 (61.7 ng/mL): 9.6% | ||
| Deficient Sample #1 (19.6 ng/mL): 9.4% | ||
| Deficient Sample #2 (19.0 ng/mL): 9.1% | ||
| Near Cut-off Sample (33.0 ng/mL): 8.4% | ||
| Optimal Sample (42.9 ng/mL): 8.6% | ||
| Severely Deficient Sample (7.8 ng/mL): 16.7% | ||
| Very High Sample (101.2 ng/mL): 9.7% | ||
| Linearity Range | Not explicitly stated (based on CLSI EP6-A) | 5.9 - 120.2 ng/mL |
| LoB | Not explicitly stated (based on CLSI EP17-A) | 1.0 ng/mL |
| LoD | Not explicitly stated (based on CLSI EP17-A) | 3.6 ng/mL |
| LoQ | Not explicitly stated (based on CLSI EP17-A) | 5.9 ng/mL |
| Analytical Specificity (Interference) |
§ 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.