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K Number
K133156
Device Name
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
Manufacturer
Siemens Healthcare Diagnostics Inc.
Date Cleared
2014-07-24

(280 days)

Product Code
MRGJITJJX
Regulation Number
862.1825
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency. The ADVIA Centaur Vitamin D Total (VitD) Calibrators are for in vitro diagnostic use in calibrating ADVIA Centaur systems Vitamin D Total (VitD) assay. The ADVIA Centaur Vitamin D Total (VitD) OC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur VitD assay on the ADVIA Centaur systems. The ADVIA Centaur Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
Device Description
The ADVIA Centaur VitD reagent kit comes in two configurations (100 or 500 test kit) and each kit consists of the following: 1. ReadyPack primary reagent: Lite Reagent: 5.0 mL/reagent pack: anti-VitD (monoclonal mouse) antibody labeled with acridinium ester (~0.8 µg/mL) in buffer with bovine serum albumin, mouse IgG, and sodium azide (<0.1%). Solid Phase: 10.0 mL/reagent pack: anti-fluorescein (monoclonal mouse)-coated paramagnetic particles (PMP) (~0.60 mg/mL) in buffer with bovine serum, albumin, surfactant, and sodium azide (<0.1%). Ancillary Well Reagent: 5.0 mL/reagent pack: vitamin D-analog conjugated to fluorescein (~0.2 ug/mL) and 1-anilinoaphthatlene-8-sulfonic acid in buffer with bovine serum albumin and sodium azide (<0.1%). 2. The ADVIA Centaur Vitamin D Total calibrators are lyophilized human plasma with 2 levels of 25 (OH) vitamin D concentrations. After reconstitution, calibrators contain low or high levels of 25 (OH) vitamin D in buffered, defibrinated human plasma with bovine serum albumin, cholesterol, preservatives, and sodium azide (< 0.1%). The ADVIA Centaur Vitamin D Total QC and The ADVIA Centaur Master Curve Materials (MCM) are sold separately and are described below. 3. The ADVIA Centaur Vitamin D Total QC (sold separately) are lyophilized human plasma with 2 levels of 25 (OH) vitamin D concentrations. After reconstitution, calibrators contain low or high levels of 25 (OH) vitamin D in buffered, defibrinated human plasma with bovine serum albumin, cholesterol, preservatives, and sodium azide (< 0.1%). 4. The ADVIA Centaur Master Curve Materials (MCM) (sold separately) are lyophilized bovine serum albumin with 5 levels of 25 (OH) vitamin D concentrations. After reconstitution, materials contain different levels of 25 (OH) vitamin D in buffered, defibrinated human plasma with bovine serum albumin, cholesterol, preservatives, and sodium azide (< 0.1%). The ADVIA Centaur Vitamin D Total (VitD) calibrators, controls and MCMs were prepared from human blood components tested using FDA approved methods and shown to be negative for hepatitis B surface antigen, anti-hepatitis C and anti-HIV 1 and 2 antibodies. The ADVIA Centaur VitD calibrators, controls, and master curve verifier have been previously cleared in k110586. There are no reagent or material changes for the calibrators, controls, and master curve verifier, just a change in the traceability. The calibrators are no longer sold in separate package but sold together with the reagent kit.
More Information

K110586

Not Found

No
The document describes a standard in vitro diagnostic immunoassay for measuring vitamin D levels. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance evaluation (e.g., regression, CV calculation).

No.
The device is an in vitro diagnostic (IVD) assay intended for the quantitative determination of total 25 (OH) vitamin D. It aids in the determination of vitamin D sufficiency and is not used to treat or prevent a disease.

Yes

The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma" and "is intended as an aid in the determination of vitamin D sufficiency." This clearly indicates its role in diagnosing or assessing a medical condition.

No

The device description clearly outlines physical components including reagents, paramagnetic particles, and lyophilized human plasma, which are not software. The intended use also describes an in vitro diagnostic assay performed on a specific hardware system (ADVIA Centaur XP system).

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use..." and "The ADVIA Centaur Vitamin D Total (VitD) Calibrators are for in vitro diagnostic use..." and "The ADVIA Centaur Vitamin D Total (VitD) OC is for in vitro diagnostic use..." and "The ADVIA Centaur Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use...". This is the most direct confirmation.
  • Nature of the Test: The device performs a quantitative determination of total 25 (OH) vitamin D in human serum and plasma. This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic test.
  • Intended Use: The assay is intended as an aid in the determination of vitamin D sufficiency, which is a diagnostic purpose.
  • Components: The description details reagents, calibrators, controls, and master curve materials, all of which are typical components of an IVD system used for laboratory testing.
  • Regulatory Information: The mention of a predicate device with a K number (K110586) indicates that this device has gone through a regulatory process for medical devices, specifically IVDs, in the United States (K numbers are associated with FDA 510(k) clearances).

N/A

Intended Use / Indications for Use

The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.

The ADVIA Centaur Vitamin D Total (VitD) Calibrators are for in vitro diagnostic use in calibrating ADVIA Centaur systems Vitamin D Total (VitD) assay.

The ADVIA Centaur Vitamin D Total (VitD) OC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur VitD assay on the ADVIA Centaur systems.

The ADVIA Centaur Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.

Product codes (comma separated list FDA assigned to the subject device)

MRG, JJX, JIT

Device Description

The ADVIA Centaur VitD reagent kit comes in two configurations (100 or 500 test kit) and each kit consists of the following:

    1. ReadyPack primary reagent:
      Lite Reagent: 5.0 mL/reagent pack: anti-VitD (monoclonal mouse) antibody labeled with acridinium ester (~0.8 µg/mL) in buffer with bovine serum albumin, mouse IgG, and sodium azide (

§ 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) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:

K133156

B. Purpose for Submission:

Modification of traceability for standardization, and addition of pediatric reference range

C. Measurand:

25-hydroxyvitamin D

D. Type of Test:

Quantitative chemiluminescent

E. Applicant:

Siemens Healthcare Diagnostics

F. Proprietary and Established Names:

ADVIA Centaur Vitamin D Total (VitD) Assay

ADVIA Centaur Vitamin D Total (VitD) Calibrators

ADVIA Centaur Vitamin D Total (VitD) Quality Control (QC)

ADVIA Centaur Vitamin D Total Master (VitD) Curve Material

G. Regulatory Information:

    1. Regulation section:
    • 21 CFR 862.1825, Vitamin D Test System
    • 21 CFR 862.1150, Calibrator
    • 21 CFR 862.1660, Quality Control Material (Assayed and Unassayed)
    1. Classification:

1

Class II

Class II

Class I, reserved

    1. Product code:
      MRG, Vitamin D Test System

JJX, Single (specified) Analyte Controls

JIT, Calibrator, secondary

    1. Panel:
      Clinical Chemistry (75)

H. Intended Use:

    1. Intended use(s):
      See Indications for use below
    1. Indication(s) for use:
      The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.

The ADVIA Centaur Vitamin D Total (VitD) Calibrators are for in vitro diagnostic use in calibrating ADVIA Centaur systems Vitamin D Total (VitD) assay.

The ADVIA Centaur Vitamin D Total (VitD) OC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur VitD assay on the ADVIA Centaur systems.

The ADVIA Centaur Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.

    1. Special conditions for use statement(s):
      For prescription use only

2

4. Special instrument requirements:

For use on the ADVIA Centaur XP instrument

I. Device Description:

The ADVIA Centaur VitD reagent kit comes in two configurations (100 or 500 test kit) and each kit consists of the following:

    1. ReadyPack primary reagent:
      Lite Reagent: 5.0 mL/reagent pack: anti-VitD (monoclonal mouse) antibody labeled with acridinium ester (~0.8 µg/mL) in buffer with bovine serum albumin, mouse IgG, and sodium azide (150 | NA |
      | 1.56 | 118.7 | 142% |
      | 0.78 | 78.9 | 61% |
      | 0.39 | 60.4 | 23% |
      | 0.20 | 55.7 | 14% |
      | 0.10 | 52.7 | 7% |

The sponsor concluded that the study demonstrated that at a sodium fluorescein level of ≥ 0.10 mcg/mL will cause significant interference.

The following limitation statement has been added to the labeling:

"Do not use samples which contain fluorescein levels > 0.10 ug/mL can produce falsely elevated results in this assay. Interference testing with varying levels of sodium fluorescein as high as 3.13 ug/mL at clinically relevant concentrations of 25(OH) vitamin D (~ 25 - 50 ng/mL) can result in 25(OH) vitamin D concentrations to be greater than 150 ng/mL. Evidence suggests that patients undergoing retinal fluorescein angiography can retain amounts of fluorescein in the body for up to 48 to 72 hours post-treatment. In the cases of patients with renal insufficiency, including many diabetics, retention could be much longer. Such samples can produce falsely elevated values when tested with this assay, and should not be tested.

  • Inloes R, Clark, D and Drobnies A: Interference of fluorescein, used in retinal angiography with certain clinical laboratory tests. Clin Chem 1987, 33:2126-2127.
  • Assay cut-off: f.
    Not applicable

2. Comparison studies:

  • a. Method comparison with predicate device:

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A method comparison study was performed to compare the modified (standardized) ADVIA Centaur Vitamin D assay (candidate device) to the non-standardized ADVIA Centaur Vitamin D assay (predicate device), one hundred and seventy-seven native human serum samples with 25 (OH) vitamin D values ranging from 5.0 ng/ml to 140.0 ng/mL were assaved in singlicate using one reagent lot of the candidate device and predicate device. Deming regression was used for the regression analysis and the results are summarized below:

y=0.78x + 3.34, r=0.99

The slope showed an approximate bias of -22% between the candidate device and the predicate device; however, this shift is expected because the purpose of the device modification was to adjust the calibration to better align with the VDSP reference sample concentration target levels. Therefore, test results from the candidate device do not, and are not expected to, directly correlate with test results from the predicate device. Laboratories that use the ADVIA Centaur Vitamin D assay should be aware of the significantly different performance of the modified assay.

An additional method comparison study was conducted to evaluate the accuracy between the candidate device and the RMP, University of Ghent's ID-LC/MS/MS method. The method comparison against the RMP was the basis of the substantial equivalence determination.

A method comparison study was performed to compare the 25-0H vitamin D concentrations of serum samples using the candidate device and the University of Ghent ID-LC/MS/MS 25-OH vitamin D Reference Measurement Procedure (RMP). One hundred and twenty-two independent serum samples, composed of 116 native and 6 spiked samples, with RMP assigned concentrations ranging from 7.8 ng/mL to 148.1 ng/mL were assayed in a singlicate using one lot of the candidate device. Deming regression was used for the regression analysis and results are summarized below:

y= 0.93x + 2.89, r=0.99

Results correlate well around medical decision range of 10 to 30 ng/mL; however results above 50 ng/mL starts to show some scatter. However, the scatter in that part of the assay range is clinically insignificant.

  • b. Matrix comparison:
    See K110586.

    1. Clinical studies:
    • a. Clinical Sensitivity:

Not applicable

12

  • b. Clinical specificity:
    Not applicable

  • c. Other clinical supportive data (when a. and b. are not applicable):
    Not applicable

    1. Clinical cut-off:
      Not applicable
    1. Expected values/Reference range:
      Expected Values for Adults:

A reference range study was conducted using adult subjects aged between 21 to 93 years. Samples from 291 apparently healthy adults from the North and South of the U.S. were tested. These samples were collected during different seasons (summer and winter). The samples numbers were split evenly between the North and South, summer and winter, and with and without supplements containing vitamin D. Samples were only included in this study if the samples had normal PTH, TSH, and calcium values. Based on the 95% confidence interval, the following values were established following CLSI guideline C28-A2.

Median 25(OH) vitamin DObserved Range (2.5th to 97.5th percentile)
22.5 ng/L7.4 to 44.0 ng/mL

Expected Values for Pediatric patients:

A reference range study was conducted using samples collected from 237 pediatric patients aged between 1 year and up to 21 years. These samples were collected from apparently healthy pediatric subjects from the North and South of the U.S. as well as from different seasons (summer and winter). Serum samples from pediatric patients meeting the following criteria were included:

    1. Subjects aged 1 year up to 21-year-old.
    1. No active chronic diseases, with the exception of allergic diseases for which no allergy medication has been taken within the last 7 days preceding sample collection.
    1. No active acute disease.
    1. No prescribed medications in the 7 days preceding sample collection.
    1. No contraceptive medication in the 90 days preceding sample collection.

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    1. No over the counter medications in the 7 days preceding sample collection.
    1. No suspicion of premature of delayed puberty, based on physical examination.
    1. No pregnant female subjects.
    1. Ages 1 yr to 2yr: Length, weight, and weight for length all within the 10th and 90th percentiles, based on WHO growth charts.