(27 days)
Not Found
No
The summary describes a standard chemiluminescent immunoassay (CLIA) for measuring vitamin D metabolites. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on standard analytical validation metrics for an in vitro diagnostic assay.
No
This device is an in vitro diagnostic (IVD) assay used to quantitatively determine vitamin D metabolites in human samples, which aids in assessing vitamin D sufficiency. It does not treat or alleviate a disease, but rather provides diagnostic information.
Yes
The "Intended Use" section states that the device is "to be used as an aid in the assessment of vitamin D sufficiency in adults," which clearly indicates a diagnostic purpose.
No
The device description clearly states it consists of physical components like magnetic particles, assay buffer, conjugate, and calibrators, which are chemical reagents. It is an in vitro diagnostic (IVD) 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 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA and Lithium heparin plasma." This involves testing biological samples in vitro (outside the body).
- Aid in Assessment: The assay is intended to be used "as an aid in the assessment of vitamin D sufficiency in adults." This indicates its use in a clinical context to provide information for diagnosis or assessment of a health condition.
- Device Description: The description details reagents and components used to perform the assay on biological samples.
- Performance Studies: The performance studies involve testing human serum and plasma samples to evaluate the assay's performance characteristics.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The LIAISON® 25 TOTAL-D assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA and Lithium heparin plasma. The LIAISON® 25 TOTAL-D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The DiaSorin LIAISON® 25 TOTAL-D is intended to be used on the LIAISON® XL Analyzer.
The DiaSorin LIAISON® 25 TOTAL-D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 TOTAL-D assay.
The DiaSorin LIAISON® 25 TOTAL-D Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® 25 TOTAL-D assay when performed on the LIAISON® XL Analyzer.
Product codes
MRG, JJX
Device Description
The LIAISON® 25 TOTAL-D consists of one Reagent Intergral with calibrators, which consists of:
Magnetic Particles (2.4 mL): Magnetic particles coated with goat antibody against 25 OH Vitamin D, protein, phosphate buffer,
§ 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
510(k) SUMMARY
SUBMITTED BY:
Mari Meyer Director, Regulatory Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 439-9710 Fax (651) 351-5669 Email: mari.meyer@diasorin.com
SEP 0 5 2013
DATE PREPARED:
PURPOSE OF SUBMISSION:
NAME OF DEVICE:
Trade Name:
LIAISON® 25 TOTAL-D LIAISON® 25 TOTAL-D Control Set LIAISON® 25 TOTAL-D Calibration Verifiers
Common Names/Descriptions:
Classification Names:
Vitamin D
August 28, 2013
New Device
Vitamin D Test System: Class II 21 CFR 862.1825; Clinical Chemistry (75) Quality Control Material: Class I, reserved 21 CFR 862.1660; Clinical Chemistry (75)
Product Code:
PREDICATE DEVICE:
MRG, JJX
LIAISON® 25 OH Vitamin D TOTAL K112725 LIAISON® 25 OH Vitamin D Control K112725 LIAISON® 25 OH Vitamin D Calibration Verifier K090104
DEVICE DESCRIPTION:
The LIAISON® 25 TOTAL-D consists of one Reagent Intergral with calibrators, which consists of:
| Magnetic Particles | Magnetic particles coated with goat antibody against 25 |
|---|---|
| (2.4 mL) | OH Vitamin D, protein, phosphate buffer, The LIAISON® 25 TOTAL-D assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum. EDTA and Lithium heparin plasma. The LIAISON® 25 TOTAL-D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The DiaSorin LIAISON® 25 TOTAL-D is intended to be used on the LIAISON® XL Analyzer. |
The DiaSorin LIAISON® 25 TOTAL-D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 TOTAL-D assay.
The DiaSorin LIAISON® 25 TOTAL-D Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® 25 TOTAL-D assay when performed on the LIAISON® XL Analyzer.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung.W.Chan -S
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) kl32492