(88 days)
Not Found
No
The description details a standard in vitro diagnostic immunoassay kit and its components, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is for in vitro diagnostic use, intended to determine vitamin D levels to aid in assessing vitamin D sufficiency, not to treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use" and is "intended as an aid in the determination of vitamin D sufficiency," which are characteristics of a diagnostic device.
No
The device description clearly outlines physical reagent kits, calibrators, and other material components required for the assay, indicating it is not a software-only device.
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 assay is "for in vitro diagnostic use".
- Device Description: The description details reagents and calibrators used to perform a test on human biological samples (serum and plasma).
- Performance Studies: The document includes performance studies like detection limit, linearity, precision, and method comparison, which are standard for IVD devices to demonstrate their analytical performance.
- Intended User / Care Setting: It specifies "in vitro diagnostic use," indicating it's intended for use in a laboratory or clinical setting to diagnose or aid in the diagnosis of a condition.
The device is designed to be used in vitro (outside the body) to analyze human biological specimens for the purpose of providing information about a person's health status (vitamin D sufficiency). This aligns directly with the definition of an In Vitro Diagnostic device.
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® systems. The ADVIA Centaur® VitD assay is intended as an aid in the determination of vitamin D sufficiency.
Product codes (comma separated list FDA assigned to the subject device)
MRG
Device Description
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 ( 20 ng/mL.
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.
8.6 Dilution Recovery
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%.
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 pediatric populations. The adult population consisted of 291 apparently healthy male and female subjects 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- LoB: 1.7 ng/mL (4.3 nmol/L)
- LoD: 3.20 ng/mL (8.0 nmol/L)
- LoQ: 4.2 ng/mL (10.5 nmol/L)
- Linearity: 4.2 to 150 ng/mL
- Within-Run precision CV: ≤ 8%
- Total CV: ≤ 12%
- Method Comparison Coefficient (r): 0.99
- Dilution Recovery: 97.0 to 109.0% with a mean of 101.0%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
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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) |
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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 DaSilva
Regulatory Affairs Specialist |
|----------|----------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, 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 ( 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
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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 | Observed
ng/mL | Expected
ng/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) |
|----------------------------------------------|------------------------------------------|----------------------------------------------------------|
| Median
25(OH)vitamin D | 22.5 ng/mL (56.3 nmol/L) | 23.8 ng/mL (59.5 nmol/L) |
| Observed Range 2.5th to
97.5th 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).