(125 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The provided text describes the LIAISON® 25 OH Vitamin D TOTAL Assay, a medical device for quantitatively determining 25-hydroxyvitamin D. The document outlines its intended use, a brief description of the device components, and performance data used to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance metric as distinct pass/fail thresholds. Instead, it presents performance data from various studies. However, the implicit acceptance criterion for a 510(k) submission is that the device demonstrates comparable performance to a legally marketed predicate device. The "Conclusion" section explicitly states that the device is "substantially equivalent to the predicate assay."
| Performance Metric | Reported Device Performance | Implicit Acceptance Criterion (based on substantial equivalence) |
|---|---|---|
| Functional Sensitivity | 4 ng/mL | Comparable to predicate device's functional sensitivity |
| Linearity (Measuring Range) | Demonstrated linearity over 4 - 150 ng/mL. Linear regression coefficient for all sample dilutions was 0.994 and ranged from 0.988 to 0.998. | Demonstrated linearity over its stated measuring range, comparable to predicate. |
| Reproducibility/Precision: - Serum Samples (Repeatability) - Serum Samples (Reproducibility) - Plasma Samples (Repeatability) - Plasma Samples (Reproducibility) | Repeatability (within-assay variability): 2.9 to 5.5% CV (mean 7.7 to 128 ng/mL) Reproducibility (between-assay variability): 6.3 to 12.9% CV Repeatability (within-assay variability): 3.2 to 8.1% CV (mean 5.9 to 62.7 ng/mL) Reproducibility (between-assay variability): 6.9 to 12.7% CV | Precision (CV) comparable to the predicate device. |
| Method Comparison | LIAISON = 0.99(RIA) + 2.4, R=0.97 (compared with a commercial radioimmunoassay product) | Strong correlation (R-value) and comparable results to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each performance test (e.g., how many individual serum or plasma samples were used for precision or method comparison).
- Linearity: "several serum specimens"
- Reproducibility/Precision: No specific numbers, only ranges of mean values (e.g., "over a range of mean values from 7.7 to 128 ng/mL").
- Method Comparison: No specific number for the “test set” of samples; a regression equation is provided.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It describes general laboratory performance evaluation studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device (an in vitro diagnostic immunoassay). The "ground truth" for an assay like this is typically established by reference methods or validated comparative methods, not by human experts interpreting images or complex clinical scenarios.
4. Adjudication Method for the Test Set
This is not applicable to this type of device. Adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers interpret medical images or clinical data and their interpretations need to be reconciled to establish a ground truth. For an immunoassay, the "ground truth" is derived from the result of the reference or comparative method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study assesses human reader performance, often in interpreting images or making clinical diagnoses, sometimes with and without AI assistance. This device is an automated immunoassay and does not involve human readers for interpretation in the same way.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, the entire performance data presented (functional sensitivity, linearity, reproducibility/precision, method comparison) represents the standalone performance of the LIAISON® 25 OH Vitamin D TOTAL Assay. This assay is designed to operate without human "in-the-loop" decision-making regarding the assay results themselves, beyond standard laboratory quality control and result reporting. The device generates quantitative values directly.
7. Type of Ground Truth Used
The ground truth for demonstrating the performance of the LIAISON® 25 OH Vitamin D TOTAL Assay was primarily established by:
- Comparative Method: For the method comparison study, a "commercial radioimmunoassay product" was used as the comparator or "ground truth" against which the new device's results were evaluated. The linear regression analysis (LIAISON = 0.99(RIA) + 2.4, R=0.97) demonstrates the correlation with this established method.
- Internal Validation/Reference Methods: For other metrics like linearity and precision, the "ground truth" is derived from rigorous internal validation studies using well-characterized samples and established laboratory protocols (e.g., CLIA EP6-A for linearity).
8. Sample Size for the Training Set
This information is not applicable or not explicitly provided. Immunoassays like this are typically developed through biochemical and analytical optimization, not by "training" a machine learning algorithm on a "training set" of data in the same way an AI/ML device would be.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and "ground truth" for training is generally not applicable in the context of a traditional immunoassay device. The assay's analytical characteristics are established through chemical and biological principles and then validated through performance studies.
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KC071480
510(k) SUMMARY
| SUBMITTED BY: | C. Donald Kafader IIDirector, Regulatory AffairsDiaSorin Inc.1951 Northwestern AvenueP.O. Box 285Stillwater, MN 55082-0285Phone (651) 351-5820Fax (651) 351-5669Email: 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 SetLIAISON® 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 useschemiluminescent immunoassay (CLIA) technology for thequantitative determination of 25-hydroxyvitamin D andother hydroxylated vitamin D metabolites in human serum,EDTA-plasma or lithium heparin plasma to be used in theassessment of vitamin D sufficiency. Assay results shouldbe used in conjunction with other clinical or laboratory datato assist the clinician in making individual patientmanagement decisions in an adult population. | |
| The LIAISON® 25 OH Vitamin D TOTAL Control Set isintended for use as assayed quality control samples tomonitor the accuracy and precision of the DiaSorinLIAISON® 25 OH Vitamin D TOTAL Assay. | ||
| The LIAISON® 25 OH Vitamin D TOTAL Specimen DiluentSet may be used to dilute specimens with values greaterthat 150 ng/mL by the LIAISON® 25 OH Vitamin D TOTAL |
Assay.
:
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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.
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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).
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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
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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
§ 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.