(125 days)
Not Found
No
The summary describes a standard chemiluminescent immunoassay (CLIA) for measuring vitamin D levels, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an "in vitro diagnostic device" used for quantitative determination of 25-hydroxyvitamin D to assist in assessment of vitamin D sufficiency. It is not designed to treat a disease or condition.
Yes
The "Device Description" explicitly states, "The LIAISON® 25 OH Vitamin D Assay (Cat. No. 310600) is an in vitro diagnostic device." Additionally, the "Intended Use / Indications for Use" section describes its purpose in quantitative determination of 25-hydroxyvitamin D to be used in the assessment of vitamin D sufficiency and for assisting clinicians in patient management decisions, which are characteristic functions of a diagnostic device.
No
The device description explicitly states it consists of "reagents provided in individual compartments within a plastic container called the Reagent Integral" and also includes a "Control Set" and "Specimen Diluent Set," all of which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the LIAISON® 25 OH Vitamin D TOTAL Assay is used for the "quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma". This indicates it's used to test biological samples from the human body.
- Device Description: The "Device Description" section refers to the LIAISON® 25 OH Vitamin D Assay as an "in vitro diagnostic device".
- Purpose: The assay is used to "be used in the assessment of vitamin D sufficiency" and "assist the clinician in making individual patient management decisions". This clearly indicates a diagnostic purpose.
- Control Set: The LIAISON® 25 OH Vitamin D TOTAL Control Set is intended for use as "assayed quality control samples to monitor the accuracy and precision" of the assay, which is a common component of IVD systems.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of tissues or organs, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.
The LIAISON® 25 OH Vitamin D TOTAL Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay.
The LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent Set may be used to dilute specimens with values greater that 150 ng/mL by the LIAISON® 25 OH Vitamin D TOTAL Assay.
Product codes
MRG, JJX
Device Description
The LIAISON® 25 OH Vitamin D Assay (Cat. No. 310600) is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral which allows for the performance of 100 determinations.
The LIAISON® 25 OH Vitamin D TOTAL Control Set (Cat. No. 310601) consists of two controls (2 vials each) provided in a separate box.
The LIAISON® 250H Vitamin D TOTAL Specimen Diluent Set (Cat. No. 310602) may be used to dilute specimens with values greater than 150 ng/mL.
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)
Functional Sensitivity: 4 na/mL
Linearity: Linearity over the assay measuring range (4 - 150 ng/mL) was demonstrated by diluting several serum specimens pre CLIA EP6-A. The linear regression coefficient for all sample dilutions was 0.994 and ranged from 0.988 to 0.998.
Reproducibility/Precision:
Results with serum samples showed repeatability (withinassay variability) from 2.9 to 5.5% CV over a range of mean values from 7.7 to 128 nq/mL and reproducibility (between-assay variability) from 6.3 to 12.9% CV.
Results for plasma samples showed repeatability (within-assav variability) from 3.2 to 8.1% CV over a range of mean values from 5.9 to 62.7 ng/mL and reproducibility (between-assay variability) from 6.9 to 12.7% CV.
Method Comparison/(Correlation): A method comparison study was conducted with a commercial radioimmunoassay product. The linear regression analysis demonstrated the following: LIAISON = 0.99(RIA) + 2.4, R=0.97.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
KC071480
510(k) SUMMARY
| SUBMITTED BY: | C. Donald Kafader II
Director, Regulatory Affairs
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5820
Fax (651) 351-5669
Email: donald.kafader@diasorin.com | OCT 1 " 2007 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| NAME OF DEVICE:
Trade Name: | LIAISON® 25 OH Vitamin D TOTAL Assay,
LIAISON® 25 OH Vitamin D TOTAL Control Set
LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent Set | |
| Common Names/Descriptions: | Vitamin D Test Reagents, Controls and Diluent | |
| Classification Name: | Vitamin D Test System (21 CFR 862.1825) | |
| Product Code: | MRG, JJX | |
| PREDICATE DEVICES: | LIAISON® 25 OH Vitamin D Assay and Controls
(K032844) | |
| INTENDED USE: | The LIAISON® 25 OH Vitamin D TOTAL Assay uses
chemiluminescent immunoassay (CLIA) technology for the
quantitative determination of 25-hydroxyvitamin D and
other hydroxylated vitamin D metabolites in human serum,
EDTA-plasma or lithium heparin plasma to be used in the
assessment of vitamin D sufficiency. Assay results should
be used in conjunction with other clinical or laboratory data
to assist the clinician in making individual patient
management decisions in an adult population. | |
| | The LIAISON® 25 OH Vitamin D TOTAL Control Set is
intended for use as assayed quality control samples to
monitor the accuracy and precision of the DiaSorin
LIAISON® 25 OH Vitamin D TOTAL Assay. | |
| | The LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent
Set may be used to dilute specimens with values greater
that 150 ng/mL by the LIAISON® 25 OH Vitamin D TOTAL | |
Assay.
:
1
DEVICE DESCRIPTION:
PERFORMANCE DATA: Functional Sensitivity Linearity
Reproducibility/Precision
Method Comparison/(Correlation)
CONCLUSION:
The LIAISON® 25 OH Vitamin D Assay (Cat. No. 310600) is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral which allows for the performance of 100 determinations.
The LIAISON® 25 OH Vitamin D TOTAL Control Set (Cat. No. 310601) consists of two controls (2 vials each) provided in a separate box.
The LIAISON® 250H Vitamin D TOTAL Specimen Diluent Set (Cat. No. 310602) may be used to dilute specimens with values greater than 150 ng/mL.
4 na/mL
Linearity over the assay measuring range (4 - 150 ng/mL) was demonstrated by diluting several serum specimens pre CLIA EP6-A. The linear regression coefficient for all sample dilutions was 0.994 and ranged from 0.988 to 0.998.
Results with serum samples showed repeatability (withinassay variability) from 2.9 to 5.5% CV over a range of mean values from 7.7 to 128 nq/mL and reproducibility (between-assay variability) from 6.3 to 12.9% CV. Results for plasma samples showed repeatability (within-assav variability) from 3.2 to 8.1% CV over a range of mean values from 5.9 to 62.7 ng/mL and reproducibility (between-assay variability) from 6.9 to 12.7% CV. A method comparison study was conducted with a commercial radioimmunoassay product. The linear regression analysis demonstrated the following: LIAISON = 0.99(RIA) + 2.4, R=0.97 The LIAISON 25 OH Vitamin D TOTAL Assay is substantially equivalent to the predicate assay.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three bars representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DiaSorin, Inc c/o Mr. Charles D. Kafader II Director, Regulatory Affairs 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082
OCT 1 2007
Re: K071480
Trade/Device Name: LIAISION® 25 OH Vitamin D Total Assay LIAISION® 25 OH Vitamin D Total Control Set, Specimen Diluent Set
Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Code: MRG, JJX Dated: September 14, 2007 Received: September 25, 2007
Dear Mr. Kafader:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1 legally marketed predicate device results in a classification for your device and thus, pervoits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree maber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): K071480
Device Name:
LIAISON® 25 OH Vitamin D TOTAL Assay LIAISON® 25 OH Vitamin D TOTAL Control Set LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent Set
Indication For Use:
The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of 25hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.
The LIAISON® 25 OH Vitamin D TOTAL Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay.
The LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent Set may be used to dilute specimens with values greater that 150 ng/mL by the LIAISON® 25 OH Vitamin D TOTAL Assay.
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 Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benner
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071480