(154 days)
Not Found
No
The description details a standard chemiluminescent immunoassay (CLIA) technology, which is a traditional laboratory method and does not involve AI or ML. The performance studies and metrics are also typical for this type of assay.
No
This device is an in vitro diagnostic (IVD) assay designed for the quantitative determination of 25-hydroxyvitamin D, which is used for assessment and not for treatment or prevention of disease.
Yes
Explanation: The device is intended for the "quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency," and its results are to be used "in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions." This clearly indicates its role in diagnosis and assessment of a medical condition.
No
The device description clearly outlines a chemiluminescent immunoassay (CLIA) technology that involves physical components like magnetic particles, antibodies, and reagents, and a process of incubation, washing, and light signal measurement. This is a hardware-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: The description details a "direct, competitive chemiluminescence immunoassay (CLIA)" method that uses "human serum or plasma" samples. This is a laboratory-based test performed on biological specimens.
- Purpose: The results are "to be used in the assessment of vitamin D sufficiency" and "to assist the clinician in making individual patient management decisions". This indicates the test provides diagnostic information.
N/A
Intended Use / Indications for Use
The LIAISON® 25 OH Vitamin D Assay uses chemiluminescent immunoassay (CLIA) technology intended for the quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
The LIAISON® Control 25 OH Vitamin D Set is intended for use as assayed quality control material to monitor the accuracy and precision of the LIAISON® 25 OH Vitamin D immunoassay.
Product codes (comma separated list FDA assigned to the subject device)
MRG; JJX
Device Description
The method for quantitative determination of 25 OH Vitamin D is a direct, competitive chemiluminescence immunoassay (CLIA). Specific antibody to Vitamin D is used for coating magnetic particles (solid phase) and Vitamin D is linked to an isoluminol derivative. During the incubation, 25 OH Vitamin D is dissociated from its binding protein, and competes with labeled Vitamin D for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of 25 OH Vitamin D present in calibrators, controls, or samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity (analytical):
§ 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.
0
FEB 1 2 2004
510(k) Summary
SUBMITTED BY:
David Ikeda DiaSorin Inc. 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082-0285 651.351.5592 Voice 651.351.5669 Fax May 05, 2003
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
NAME OF DEVICE: Trade Name Common Names/Descriptions:
Classification Name:
LIAISON® 25 OH Vitamin D Assay Automated chemiluminescent immunoassay for the quantitative determination of 25 OH Vitamin D Vitamin D Test System
PREDICATE DEVICE:
DiaSorin 25-Hydroxyvitamin D 1231 RIA
INTENDED USE: The LIAISON® 25 OH Vitamin D Assay uses chemiluminescent immunoassay (CLIA) technology intended for the quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population
DEVICE DESCRIPTION: The method for quantitative determination of 25 OH Vitamin D is a direct, competitive chemiluminescence immunoassay (CLIA). Specific antibody to Vitamin D is used for coating magnetic particles (solid phase) and Vitamin D is linked to an isoluminol derivative. During the incubation, 25 OH Vitamin D is dissociated from its binding protein, and competes with labeled Vitamin D for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of 25 OH Vitamin D present in calibrators, controls, or samples.
1
| Feature | 25 OH Vitamin D RIA | LIAISON® 25 OH Vitamin D Assay |
|---|---|---|
| Analyte | 25-(OH)-D2/D3 | 25-(OH)-D2/D3 |
| Intended | ||
| Use | FOR IN VITRO DIAGNOSTIC USE. | |
| This kit is intended for the quantitative | ||
| determination of 25-hydroxyvitamin D | ||
| (25-OH-D) and other hydroxylated | ||
| vitamin D metabolites in human serum or | ||
| plasma to be used in the assessment of | ||
| vitamin D sufficiency. Assay results | ||
| should be used in conjunction with other | ||
| clinical and laboratory data to assist the | ||
| clinician in making individual patient | ||
| management decisions in an adult | ||
| population | FOR IN VITRO DIAGNOSTIC USE. | |
| The LIAISON® 25 OH Vitamin D Assay | ||
| uses chemiluminescent immunoassay | ||
| (CLIA) technology for the quantitative | ||
| determination of 25-hydroxyvitamin D | ||
| (25-OH-D) and other hydroxylated | ||
| vitamin D metabolites in human serum or | ||
| plasma to be used in the assessment of | ||
| vitamin D sufficiency. Assay results | ||
| should be used in conjunction with other | ||
| clinical and laboratory data to assist the | ||
| clinician in making individual patient | ||
| management decisions in an adult | ||
| population | ||
| Antisera | Polyclonal specific for 25-(OH)-D2/D3 | Polyclonal specific for 25-(OH)-D2/D3 |
| Tracer | 125I radiolabeled 25-(OH)-D analog | Chemiluminescent ABEI labeled 25- |
| (OH)-D analog | ||
| Standards | Five concentrations, human serum based, | |
| extracted identically to controls and | ||
| patient samples | Stored Master Curve based on 10 points, | |
| derived from serum based standards | ||
| extracted identically to controls and | ||
| patient samples | ||
| Kit | Two levels, human serum based, | |
| extracted identically to standards and | ||
| patient samples | Two levels, horse serum based, extracted | |
| identically to patient samples | ||
| Controls | Two levels, human serum based, | |
| extracted identically to standards and | ||
| patient samples | Two levels, horse serum based, extracted | |
| identically to patient samples |
TECHNOLOGICAL COMPARISON TO PREDICATE:
PERFORMANCE DATA: A summary of performance data is shown below.
| Parameter | Performance Results |
|---|---|
| Sensitivity (analytical) |