(88 days)
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® systems. The ADVIA Centaur® VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur® Vitamin D reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
- ReadyPack® primary reagent pack containing ADVIA Centaur VitD Lite Reagent, Solid . Phase Reagent, and Ancillary Well Reagent
- ReadyPack ancillary pack containing ADVIA Centaur VitD Ancillary Reagent .
- . ADVIA Centaur VitD Low Calibrator
- . ADVIA Centaur VitD High Calibrator
- ADVIA Centaur systems VitD Master Curve card ●
- ADVIA Centaur systems VitD Calibrator Assigned Value Card ●
The VitD Reagents consists of the following:
Lite Reagent 5.0 mL/reagent pack:
The reagent contains 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 Reagent 10.0 mL/reagent pack:
The Solid Phase Reagent contains 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:
The Ancillary Well Reagent contains vitamin D-analog conjugated to fluorescein (~0.2 µg/mL) and 1-anilinonaphthalene-8-sulfonic acid in buffer with bovine serum albumin and sodium azide (< 0.1%)
Ancillary Reagent Pack 25.0 mL/reagent pack:
The Ancillary Reagent Pack contains releasing agent in buffered saline with sodium azide (<0.1%) and stabilizers
The VitD Calibrators 2 x 2.0 mL/vial:
After reconstitution, 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%).
Material Required but Not Provided
- ADVIA Centaur Wash 1 .
Optional Materials - ADVIA Centaur VitD Quality Control Material
- . ADVIA Centaur VitD Diluent
- . ADVIA Centaur VitD Master Curve Material (MCM)
The provided text describes the performance characteristics of the ADVIA Centaur® Vitamin D Total (VitD) assay and compares it to a predicate device. It primarily focuses on the analytical performance of the device and does not involve AI or human readers in the context of diagnostic interpretation.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Design Goal) | Reported Device Performance |
|---|---|---|
| Precision (Within-Run CV) | ≤ 8% for samples > 20 ng/mL | 2.3% - 6.4% |
| Precision (Total CV) | ≤ 12% for samples > 20 ng/mL | 3.6% - 9.6% |
| Detection Limit (LoB) | N/A (not explicitly stated as an acceptance criterion) | 1.7 ng/mL (4.3 nmol/L) |
| Detection Limit (LoD) | Detected with 95% probability | 3.20 ng/mL (8.0 nmol/L) |
| Detection Limit (LoQ) | Total CV of 20% | 4.2 ng/mL (10.5 nmol/L) |
| Linearity | N/A (not explicitly stated as an acceptance criterion) | 4.2 to 150 ng/mL |
| Method Comparison | N/A (not explicitly stated as an acceptance criterion, but implies strong correlation to comparable assay) | y = 1.03 (x) + 0.85 ng/ml, r = 0.99 (compared to a comparable assay) |
| Specimen Equivalence | N/A (not explicitly stated as an acceptance criterion, but implies strong correlation to serum) | Correlation coefficient (r) = 0.99 for all tested tube types vs. serum |
| Dilution Recovery | N/A (not explicitly stated as an acceptance criterion, but implies recovery between 90-110%) | 97.0% to 109.0% (mean 101.0%) |
| Reference Interval | Confirmation of established reference interval | Observed values for adult (7.4-44.0 ng/mL) and pediatric (11.4-45.8 ng/mL) populations were established. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision: 6 samples, each assayed twice a day in replicates of 2, over 20 days (n=80 replicates per sample). Data provenance not specified.
- Method Comparison: 126 samples (118 native, 8 contrived). Data provenance not specified.
- Specimen Equivalence: 66 native and 8 contrived matched set samples (total 74 matched sets) for serum, SST, Lithium Heparin, Sodium Heparin, K2 EDTA, K3 EDTA. Data provenance not specified.
- Dilution Recovery: 5 serum samples. Data provenance not specified.
- Reference Interval:
- Adult population: 291 apparently healthy male and female subjects of light and dark skin types, aged 21-93 years.
- Pediatric population: 237 male and female subjects of light and dark skin types; 32 subjects (1-3 years), 114 subjects (3-12 years), 91 subjects (12-21 years).
- Data Provenance: Samples collected in different seasons and from different geographical regions of the United States. This indicates prospective recruitment for this specific study, though the general term "established" could imply previous work.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This report describes an in vitro diagnostic (IVD) assay for quantitative measurement, not an AI diagnostic imaging device that requires expert interpretation. Therefore, the concept of "experts used to establish the ground truth" in the way it applies to diagnostic imaging is not relevant here. The ground truth for this device is chemically and analytically determined concentrations of Vitamin D.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an analytical performance study of an IVD assay, not a study involving human interpretation of diagnostic data needing adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes an IVD assay, not AI software for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the ADVIA Centaur® Vitamin D Total (VitD) assay. The device measures Vitamin D levels, and its performance is assessed analytically (precision, linearity, detection limits, method comparison) without human intervention in the result determination process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the analytical performance studies (precision, linearity, limit of detection/quantitation, method comparison) is based on:
- Known concentrations: For studies like linearity, samples are prepared with known relative concentrations.
- Established reference methods: For method comparison, the device's results are compared against a "comparable assay" (which likely serves as a reference or a well-characterized method). For traceability, it mentions "ID-LC-MS/MS 25(OH)vitamin D (RMP)," indicating a highly accurate reference method.
- Statistical definitions: LoD and LoQ are defined statistically (e.g., 95% probability of detection, 20% total CV).
- Clinical populations: For establishing reference intervals, samples are drawn from defined healthy adult and pediatric populations, and inclusion criteria (normal values for PTH, calcium, TSH, no high-dose vitamin D supplements) are used to define the reference population.
8. The sample size for the training set
This document describes the validation of an IVD assay, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's operational parameters are presumably set during development and optimized based on various experiments, but these are not referred to as a "training set" in the sense of AI.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML model for this IVD assay.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 29, 2020
Siemens Healthcare Diagnostics Inc. Paul DaSilva Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K200509
Trade/Device Name: ADVIA Centaur® Vitamin D Total (VitD) Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Code: MRG Dated: February 28, 2020 Received: March 2, 2020
Dear Paul DaSilva:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
{1}------------------------------------------------
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200509
Device Name ADVIA Centaur® Vitamin D Total (VitD)
Indications for Use (Describe)
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® systems. The ADVIA Centaur® VitD assay is intended as an aid in the determination of vitamin D sufficiency.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K200509
Date Prepared 1.
May 29, 2020
Applicant Information 2.
| Contact: | Paul DaSilvaRegulatory Affairs Specialist |
|---|---|
| Address: | Siemens Healthcare Diagnostics Inc.511 Benedict AvenueTarrytown, NY 10591-5097 |
| Phone: | 914-524-3141 |
| Fax: | 914-524-2101 |
| Email: | paul.dasilva@siemens-healthineers.com |
3. Regulatory Information
| Trade Name | ADVIA Centaur® Vitamin D Total (VitD) |
|---|---|
| Classification Name | Vitamin D test system |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry |
| Product Code | MRG |
| Regulation Number | 862.1825 |
Predicate Device Information 4.
Predicate Device Name: ADVIA Centaur® Vitamin D Total (VitD) assay
510(k) Number: K133156
Intended Use / Indications for Use 5.
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® system. The ADVIA Centaur® VitD assay is intended as an aid in the determination of vitamin D sufficiency.
{4}------------------------------------------------
Device Description 6.
The ADVIA Centaur® Vitamin D reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
- ReadyPack® primary reagent pack containing ADVIA Centaur VitD Lite Reagent, Solid . Phase Reagent, and Ancillary Well Reagent
- ReadyPack ancillary pack containing ADVIA Centaur VitD Ancillary Reagent .
- . ADVIA Centaur VitD Low Calibrator
- . ADVIA Centaur VitD High Calibrator
- ADVIA Centaur systems VitD Master Curve card ●
- ADVIA Centaur systems VitD Calibrator Assigned Value Card ●
The VitD Reagents consists of the following:
Lite Reagent 5.0 mL/reagent pack:
The reagent contains 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 Reagent 10.0 mL/reagent pack:
The Solid Phase Reagent contains 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:
The Ancillary Well Reagent contains vitamin D-analog conjugated to fluorescein (~0.2 µg/mL) and 1-anilinonaphthalene-8-sulfonic acid in buffer with bovine serum albumin and sodium azide (< 0.1%)
Ancillary Reagent Pack 25.0 mL/reagent pack:
The Ancillary Reagent Pack contains releasing agent in buffered saline with sodium azide (<0.1%) and stabilizers
The VitD Calibrators 2 x 2.0 mL/vial:
After reconstitution, 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%).
Material Required but Not Provided
- ADVIA Centaur Wash 1 .
Optional Materials
- ADVIA Centaur VitD Quality Control Material
- . ADVIA Centaur VitD Diluent
- . ADVIA Centaur VitD Master Curve Material (MCM)
{5}------------------------------------------------
7. Comparison of Technological Characteristics with the Predicate Device
Similarities:
| Item | Modified ADVIA Centaur®Vitamin D Total (VitD) assay(Candidate Device) | ADVIA Centaur® Vitamin D Total(VitD) assay(Predicate Device - K133156) | |
|---|---|---|---|
| Intended Use | The ADVIA Centaur® Vitamin DTotal (VitD) assay is for in vitrodiagnostic use in the quantitativedetermination of total 25(OH)vitaminD in human serum and plasma(EDTA, lithium heparin, sodiumheparin) using the ADVIA Centaur®systems. The ADVIA Centaur VitDassay is intended as an aid in thedetermination of vitamin Dsufficiency. | same | |
| Measurement | Quantitative | same | |
| Assay Principle | Competitive immunoassay | Same | |
| Methodology | Chemiluminescence | Same | |
| Detection Antibody | Monoclonal mouse antibodylabeled with acridinium ester(AE) | Same | |
| Capture Antibody | Anti-fluorescein monoclonal mouseantibody covalently bound toparamagnetic particles (PMP) | Same | |
| Assay Range | 4.2 - 150 ng/mL | Same | |
| Expected Values(adult) | 7.4-44.0 ng/dL | Same | |
| Expected Values(pediatric) | 11.4 - 45.8 ng/mL | Same | |
| Sample Volume | 20 µL | Same | |
| Traceability/Standardization | ID-LC-MS/MS 25(OH)vitamin D(RMP) | Same | |
| Calibration | 2-point | Same | |
| Calibrators | ADVIA Centaur VitD Calibrators | Same | |
| Number of calibrators | Two (2) levels | Same | |
| Use of Controls | Yes (recommended) | Same | |
| Number of controls | Two levels | Same | |
| Item | Modified ADVIA Centaur®Vitamin D Total (VitD) assay(Candidate Device) | ADVIA Centaur® Vitamin D Total(VitD) assay(Predicate Device – K133156) | |
| Ancillary ReagentPack | Buffering agent (high molarity) andenhanced releasing agent (lowmolecular weight) | Buffering agent (low molarity) andenhanced releasing agent (highmolecular weight) |
{6}------------------------------------------------
Differences:
8. Performance Characteristics: Modified ADVIA Centaur Vitamin D
8.1 Detection Limit
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) were determined as described in CLSI Document EP17-A2.31 The ADVIA Centaur VitD assay had an LoB of 1.7 ng/mL (4.3 nmol/L), an LoD of 3.20 ng/mL (8.0 nmol/L), and an LoQ of 4.2 ng/mL (10.5 nmol/L). The LoD is defined as the lowest concentration of 25(OH)vitamin D that can be detected with 95% probability. The LoQ is defined as the lowest concentration of 25(OH)vitamin D that can be detected at a total CV of 20%.
8.2 Linearity
Linearity was evaluated according to the CLSI protocol EP6-A.35 A sample containing high levels of total 25(OH)vitamin D was mixed in various proportions with a sample containing low levels of total 25(OH)vitamin D. The resulting sample mixtures were assayed for total vitamin D. On the ADVIA Centaur systems, the VitD assay is linear from 4.2 to 150 ng/mL.
8.3 Precision
The ADVIA Centaur VitD assay is designed to have a Within-Run precision CV of ≤ 8%, and a Total CV of ≤ 12%, with samples > 20 ng/mL.
{7}------------------------------------------------
Precision was evaluated according to the CLSI protocol EP5-A2.32 Six samples were assayed twice a day in replicates of 2, over 20 days (n = 80 replicates per sample) using the ADVIA Centaur VitD assay. The following results were obtained:
| Mean | Within-Run Repeatability | Total Precision(Within-Lab) | ||
|---|---|---|---|---|
| (ng/mL) | SD | %CV | SD | %CV |
| 21.29 | 1.36 | 6.4 | 2.04 | 9.6 |
| 26.10 | 1.56 | 6.0 | 2.37 | 9.1 |
| 32.16 | 1.71 | 5.3 | 2.38 | 7.4 |
| 65.47 | 2.52 | 3.8 | 3.60 | 5.5 |
| 84.12 | 1.90 | 2.3 | 3.34 | 4.0 |
| 132.32 | 3.13 | 2.4 | 4.76 | 3.6 |
8.4 Method Comparison
For 126 samples (118 native, 8 contrived) in the range of 5.9 - 130.8 ng/mL (14.8 - 327.0 nmol/L), the relationship between the ADVIA Centaur VitD (y) and a comparable assay (x) is described using Deming regression:
ADVIA Centaur VitD (y) = 1.03 (x) + 0.85 ng/ml_, r = 0.99
8.5 Specimen Equivalence
Specimen equivalency was determined using a Weighted-Deming regression analysis in accordance with CLSI Document EP9-A2.
Sixty-six (66) native and 8 contrived matched set samples (serum, SST, Lithium Heparin, Sodium Heparin, K2 EDTA, K3 EDTA) for a total n=74 matched set samples. Weighted-Deming fit was used for regression analysis comparing all tube types to serum. The following results were obtained:
| Tube (y) vs. Serum (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|
| Gel-barrier tube (serum) | y = 0.97x + 0.87(y = 2.43x + 2.18) | 13.03-142.85 ng/mL(32.58-357.13 nmol/L) | 74 | 0.99 |
| dipotassium EDTA (plasma) | y = 0.97x + 0.64(y = 2.43x + 1.60) | 13.03-142.85 ng/mL(32.58-357.13 nmol/L) | 74 | 0.99 |
| tripotassium EDTA (plasma) | y = 0.96x + 0.68(y = 2.40x + 1.70) | 13.03-142.85 nq/mL(32.58-357.13 nmol/L) | 74 | 0.99 |
| lithium heparin (plasma) | y = 0.99x - 0.18(y = 2.48x - 0.45) | 13.03-142.85 ng/mL(32.58-357.13 nmol/L) | 74 | 0.99 |
| sodium heparin (plasma) | y = 1.02x - 1.13(y = 2.55x - 2.83) | 13.03-142.85 nq/mL(32.58-357.13 nmol/L) | 74 | 0.99 |
a Number of samples tested.
b Correlation coefficient
{8}------------------------------------------------
8.6 Dilution Recoverv
Five serum samples in the range of (186.0-211.0 ng/mL (465.0-527.5 nmol/L) of total 25(OH)vitamin D were diluted 1:2 with ADVIA Centaur VitD diluent and assayed for recovery and parallelism. The recoveries ranged from 97.0 to 109.0% with a mean of 101.0%.
| Sample | Dilution | Observedng/mL | Expectedng/mL | Recovery % |
|---|---|---|---|---|
| 1 | 1:2 | 96.0 | 97.5 | 98.0 |
| 2 | 1:2 | 96.3 | 93.0 | 103.0 |
| 3 | 1:2 | 102.6 | 103.5 | 99.0 |
| 4 | 1:2 | 102.5 | 105.5 | 97.0 |
| 5 | 1:2 | 102.1 | 93.5 | 109.0 |
| Mean | 101.0 |
8.7 Reference Interval
A study was performed referencing CLSI EP28-A3c confirming that the previously established Reference Interval could be transferred to the modified VitD assay.
Observed reference values were obtained for the ADVIA Centaur VitD assay using serum samples collected from adult and pediatic populations. The adult population consisted of 291 apparently healthy male and female subiects of light and dark skin types ranging in age from 21-93 years. The pediatric population consisted of 237 male and female subjects of light and dark skin types: 32 subjects between the ages of 1-3 years, 114 subjects between 3-12 years, and 91 subjects between 12 and up to 21 years.
The samples were collected in different seasons and from different geographical regions of the United States. Adult samples from subjects not taking supplements containing vitamin D >2000 IU per day, and with normal values for PTH, calcium, and TSH were included in this study.
Pediatric samples with normal values for PTH and TSH were included in this study. Based on the 95% confidence interval, the following values were established following CLSI guideline C28-A2.30
| Observed Values, Adult ng/mL(nmol/L) | Observed Values, Pediatric(12 months up to 21 years) | |
|---|---|---|
| Median25(OH)vitamin D | 22.5 ng/mL (56.3 nmol/L) | 23.8 ng/mL (59.5 nmol/L) |
| Observed Range 2.5th to97.5th Percentile | 7.4-44.0 ng/mL (18.5-110.0 nmol/L) | 11.4-45.8 ng/mL (28.5-114.5 nmol/L) |
As with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient samples.30 Consider these values as guidelines only.
{9}------------------------------------------------
Conclusions 9.
Based on the results of comparative testing, the Modified ADVIA Centaur® Vitamin D Total (VitD) is substantially equivalent to the currently marketed predicate device, the ADVIA Centaur® Vitamin D Total (VitD) assay (K133156).
§ 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.