(109 days)
Not Found
No
The summary describes a standard immunoassay kit and system for measuring vitamin D levels. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for performance evaluation.
No
Explanation: The device is an immunoassay kit used for diagnosing vitamin D sufficiency, not for treating any condition.
Yes
Explanation: The device is intended for the quantitative determination of 25-hydroxyvitamin D in human serum and is to be used as an aid in the assessment of vitamin D sufficiency. This directly indicates its use in aiding medical diagnosis.
No
The device description clearly lists physical components (vials of beads, buffers, conjugates) that are part of the kit, indicating it is a physical diagnostic kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of 25-hydroxyvitamin D in human serum" and is to be used "as an aid in the assessment of vitamin D sufficiency." This involves testing a sample taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description details reagents and components used to perform a test on a biological sample (human serum).
- Performance Studies: The document includes extensive performance studies (Precision, Reproducibility, Linearity, Detection Limit, Analytical Specificity, Method Comparison) which are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K141114; BioPlex 2200 25-OH Vitamin D Kit) is a strong indicator that this device is being compared to a previously cleared IVD.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.
Product codes
MRG
Device Description
BioPlex 2200 25-OH Vitamin D kit includes the following components:
- One (1) 10 mL vial of Bead Set containing dyed beads coated with anti-25-0H Vitamin D antibody (sheep), an Internal Standard bead (ISB), and a Serum Verification bead (SVB) in buffer with protein stabilizers (bovine). ProClin 950 (100%), Paricalcitol (>100%).
Method Comparison with Predicate Device
- Study Type: Method comparison studies performed following CLSI EP09-A3 guideline.
- Sample Size: 201 human samples (182 unaltered, 19 spiked) spanning the measuring range.
- Key Results:
- N: 184
- Slope (95% CI): 1.048 (1.009 - 1.088)
- Intercept (95% CI): -0.885 (-2.211 - 0.441)
- Correlation Coefficient (r) (95% CI): 0.987 (0.983 - 0.990)
- Measured Range (ng/mL): Candidate: 11.2 - 136.2; Predicate: 9.1 - 122.8
Method Comparison to Reference Method
- Study Type: Method comparison to reference method (VDSP RMP at CDC).
- Sample Size: 120 native single donor patient serum samples.
- Key Results:
- N: 119
- Slope (95% CI): 0.993 (0.913 - 1.073)
- Intercept (95% CI): -0.775 (-2.705 - 1.155)
- Correlation Coefficient (r) (95% CI): 0.949 (0.927 - 0.964)
- Measured Range (ng/mL): Candidate 9.0 - 158.4; VDSP: 7.4 - 153.2
Bias at Vitamin D Medical Decision Levels
- Study Type: Bias analysis using Bland-Altman analysis.
- Sample Size: Samples at medical decision levels of 20, 30, and 100 ng/mL.
- Key Results:
- 19-21 ng/mL: Mean Bias -7.3% (95% CI: -19.94 – 5.26)
- 29-31 ng/mL: Mean Bias -0.2% (95% CI: -6.08 - 5.69)
- 95-105 ng/mL: Mean Bias 3.5% (95% CI: -9.76 – 16.80)
- Overall: Mean Bias 1.0% (95% CI: -0.79 - 2.78)
Expected Values/Reference Range
- Study Type: Expected Values study conducted following CLSI EP28-A3c guideline.
- Sample Size: 288 samples from apparently healthy donors (161 males, 127 females), aged 21 to 79. Collected from three regions in the US (Northern, Central, Southern) in spring, summer, and winter.
- Key Results:
- N: 288
- Mean: 31.9 ng/mL (79.8 nmol/L)
- Median: 29.2 ng/mL (72.9 nmol/L)
- 2.5th - 97.5th percentile: 14.0 – 76.3 ng/mL (35.1 – 190.7 nmol/L)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BioPlex 2200 25-OH Vitamin D Kit, K141114
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
Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
June 22, 2018
Bio-Rad Laboratories Arlene Carillo Regulatory Affairs Specialist 5500 East Second Street Benicia. CA 94510
Re: K180577
Trade/Device Name: BioPlex 2200 25-OH Vitamin D Kit Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: May 15, 2018 Received: May 16, 2018
Dear Arlene Carillo:
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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180577
Device Name BioPlex 2200 25-OH Vitamin D Kit
Indications for Use (Describe)
BioPlex 2200 25-OH Vitamin D Kit
The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.
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
BioPlex 2200 25-OH Vitamin D 510(k) Summary
Bio-Rad Laboratories hereby submits this 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This summary of 510(k) safety and effectiveness information provides detail as a basis for a determination of substantial equivalence for the BioPlex 2200 25-OH Vitamin D kit. The BioPlex 2200 25-OH Vitamin D was originally cleared under K141114. Bio-Rad has modified the kit by re-assigning the calibrators and standardizing the assay in accordance with the Vitamin D Standardization Program (VDSP).
510(k) Number: K180577
Summary Preparation Date: June 18, 2018
Applicant: Bio-Rad Laboratories
Contact:
Arlene Carillo Regulatory Affairs Specialist 5500 East Second Street Benicia, CA 94510
Measurand:
25-hydroxyvitamin D
Type of Test:
Quantitative multiplexed flow immunoassay
Proprietary and Established Names:
BioPlex 2200 25-OH Vitamin D
Regulatory Information:
-
- Regulation section: 21 CFR §862.1825 – Vitamin D test system
-
- Product code: MRG, System, Test, Vitamin D
4
3. Panel:
Clinical Chemistry (75)
Intended Use:
-
- Intended use(s):
The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
- Intended use(s):
The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.
-
- Indication(s) for use: Same as Intended Use
-
- Special conditions for use statement(s): For prescription use only
- Special instrument requirements: 4. Bio-Rad BioPlex 2200 System
Device Description:
BioPlex 2200 25-OH Vitamin D kit includes the following components:
- One (1) 10 mL vial of Bead Set containing dyed beads coated with anti-25-0H ● Vitamin D antibody (sheep), an Internal Standard bead (ISB), and a Serum Verification bead (SVB) in buffer with protein stabilizers (bovine). ProClin 950 ( 25 ng/mL.
| Serum
Panel | N | Mean
(ng/mL) | Within Run | | Between-Run | | Between-Day | | Total Precision | |
|----------------|----|-----------------|------------|-----|-------------|-----|-------------|-----|-----------------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 16.4 | 1.02 | 6.2 | 1.19 | 7.2 | 0.45 | 2.7 | 1.62 | 9.9 |
| Sample 2 | 80 | 18.9 | 1.36 | 7.2 | 0.76 | 4.0 | 0.73 | 3.9 | 1.72 | 9.1 |
| Sample 3 | 80 | 37.2 | 1.66 | 4.4 | 1.61 | 4.3 | 0.00 | 0.0 | 2.31 | 6.2 |
| Sample 4 | 80 | 46.5 | 3.66 | 7.9 | 3.07 | 6.6 | 1.35 | 2.9 | 4.96 | 10.7 |
| Sample 5 | 80 | 81.4 | 2.79 | 3.4 | 3.42 | 4.2 | 0.00 | 0.0 | 4.41 | 5.4 |
| Sample 6 | 80 | 100.4 | 3.89 | 3.9 | 5.34 | 5.3 | 0.00 | 0.0 | 6.60 | 6.6 |
| Control 1 | 80 | 21.5 | 0.88 | 4.1 | 1.75 | 8.1 | 0.00 | 0.0 | 1.96 | 9.1 |
| Control 2 | 80 | 54.1 | 1.62 | 3.0 | 2.45 | 4.5 | 0.00 | 0.0 | 2.94 | 5.4 |
BioPlex 2200 25-OH Vitamin D - CLSI EP5-A3 Precision
Reproducibility Studies
A reproducibility panel, consisting of eight (8) panel members made using serum matrix and BioPlex 2200 25-OH Vitamin D QC controls were tested in replicates of two (2) on two (2) runs per day over five (5) days at one (1) site (2 replicates x 2 run x 5 days x 1 Site = 20 replicates per panel member). The serum sample panel includes two (2) samples representing the following concentrations: 7 and 20 ng/mL, 21 and 40 ng/mL, 41 and 80 ng/mL and 81 and 150 ng/mL.
9
Reproducibility testing was performed at one (1) US testing facility using one (1) lot of the BioPlex 2200 25-OH Vitamin D Reagent Pack, one (1) lot of BioPlex 2200 25-OH Vitamin D Calibrator Set and one (1) lot of BioPlex 2200 25-OH Vitamin D Control Set. The data were analyzed for within-run (repeatability), between-run, between-day, between-site and total precision according to the principles described in Clinical Laboratory Standards Institute (CLSI) EP15-A3.
| Serum Panel | N | Mean (ng/mL) | Within-Run | Between-Run | Between-Day | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Sample 1 | 20 | 15.9 | 0.96 | 6.0 | 0.72 | 4.5 | 0.00 | 0.0 | 1.20 | 7.6 |
| Sample 2 | 20 | 17.3 | 1.22 | 7.0 | 0.90 | 5.2 | 0.00 | 0.0 | 1.52 | 8.8 |
| Sample 3 | 20 | 23.7 | 2.22 | 9.4 | 0.00 | 0.0 | 0.84 | 3.6 | 2.37 | 10.0 |
| Sample 4 | 20 | 25.5 | 1.49 | 5.8 | 1.29 | 5.1 | 0.00 | 0.0 | 1.97 | 7.7 |
| Sample 5 | 20 | 52.4 | 1.86 | 3.5 | 1.82 | 3.5 | 1.74 | 3.3 | 3.13 | 6.0 |
| Sample 6 | 20 | 56.5 | 3.58 | 3.7 | 0.00 | 0.0 | 1.88 | 3.3 | 4.04 | 7.1 |
| Sample 7 | 20 | 88.9 | 3.66 | 4.1 | 0.00 | 0.0 | 1.64 | 1.8 | 4.01 | 4.5 |
| Sample 8 | 20 | 94.9 | 4.27 | 4.5 | 0.00 | 0.0 | 0.57 | 0.6 | 4.31 | 4.5 |
| QC Control L1 | 20 | 23.4 | 1.28 | 5.5 | 1.06 | 4.5 | 0.00 | 0.0 | 1.67 | 7.1 |
| QC Control L2 | 20 | 67.9 | 2.04 | 3.0 | 0.00 | 0.0 | 2.46 | 3.6 | 3.19 | 4.7 |
| Range | ||||||||||
| (SD:≤25ng/mL; | ||||||||||
| %CV:>25ng/mL) | 15.9 - 94.9 | 0.96 - | ||||||||
| 2.22 | 3.5 - | |||||||||
| 5.8 | 0.00 - | |||||||||
| 1.06 | 0.0 - | |||||||||
| 5.1 | 0.00 - | |||||||||
| 0.84 | 0.0 - | |||||||||
| 3.6 | 1.20 - | |||||||||
| 2.37 | 4.5 - | |||||||||
| 7.7 |
BioPlex 2200 25-OH Vitamin D - CLSI EP15-A3 Reproducibility
b. Linearity/assay reportable range:
Five high patient serum samples with 20% higher than upper limit of the assay range were tested to demonstrate linearity. These samples were serially diluted with low levels of human sample near LoQ in accordance with CLSI EP06-A guideline. Each sample and dilution was evaluated in replicates of four using one BioPlex 2200 25-OH Vitamin D reagent lot on one instrument. Linear and polynomial regression analysis of 25-OH Vitamin D recovery vs. sample dilution was performed to determine if the dilution curves exhibit statistically significant non-linear regression based on the CLSI guideline EP06-A.
See one example below for the regression parameters (slope, intercept and r') of the observed values vs. predicted values.
| Concentration
(ng/mL) | Slope | Intercept | r2 | Dilution Range
(ng/mL) |
|--------------------------|--------|-----------|--------|---------------------------|
| 166.5 | 1.0002 | 0.0143 | 0.9956 | 5.4-166.5 |
The BioPlex 2200 25-OH Vitamin D assay has demonstrated that the assay range supports up to 160.0 ng/mL.
Over-Range (OR) results may be generated for values greater than the reportable measuring range and results are reported as > 160.0 ng/mL.
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Calibrator Traceability
The BioPlex 2200 25-OH Vitamin D Calibrators are traceable to the liquid chromatography tandem mass spectrometry (LC-/MS/MS) 25-OH Vitamin D Reference Method Procedure (RMP) that is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 2972a.
Kit Stability:
BioPlex 2200 25-OH Vitamin D Kit: Real Time (unopened) Kit Stability, 24 months or until the date of expiration when stored unopened on the instrument or at 2 to 8℃; the open kit claim is 60 days.
Sample Stability:
Fresh sample stability (2 to 8°C), 7 days; Frozen sample stability (-20 or -70°C), 24 months; Sample Freeze-thaw (-20 or -70°C), up to 5 freeze thaw cycles at -20℃ and 2 freeze thaw cycles at -70℃ acceptable.
d. Detection limit:
The study was conducted in accordance with CLSI EP17-A2 guideline for determining the Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ).
Limit of Blank (LoB)
Five blank samples were tested with two BioPlex 2200 25-OH Vitamin D reagent lots on one instrument in 4 replicates per day for 5 days yielding 100 data points per reagent lot.
A non-parametric statistical analysis at 95th percentile is used to calculate LoB.
Limit of Detection (LoD)
Six human samples with low level of 25-OH vitamin D in the range of 5 to 30 ng/mL were tested with two BioPlex 25-OH Vitamin D reagent lots on one instrument in 10 replicates per day for five days yielding 50 data points per sample per reagent lot. LoD is then calculated by the equation:
LoD = LoB + c , SD + c , SD is a multiplier to give the 95th percentile of a normal distribution and SD is from the linear regression of standard deviation versus 25-OH Vitamin D mean value.
Limit of Quantitation (LoQ)
The LoQ was evaluated based on the accuracy goal which was defined as precision ≤ 20% CV. The %CV was calculated using the same measurement results of the 6 low level samples used for determining the LoD.
11
| LoB | LoD | LoQ |
|---|---|---|
| 5.4 | 7.0 | 7.0 |
The results of LoB, LoD, and LoQ in ng/mL are summarized in the table below.
e. Analytical specificity:
Interfering Substances
An interfering substances study was conducted to evaluate the potential interference of specific endogenous and exogenous substances with the BioPlex 2200 25-OH Vitamin D kit according to CLSI EP07-A2 guideline. No interference was observed with any of the substances tested.
The substances and the maximum levels tested are shown in the table below:
| Substance | Concentration |
|---|---|
| Hemoglobin | 100% |
| 3-epi 25-hydroxyvitamin D3 | 30 |
| 24,25-dihydroxyvitamin D3 | 20 |
| Paricalcitol (Zemplar) | 24 |
To avoid potential under reporting of 25(OH) D2 cross reactivity due to endogenous binding characteristics of the metabolites in a sample, the observed % cross reactivity was normalized to 25(OH) D3. Assuming the normalized 25(OH) D3 value of 100%, the 25(OH) D2 cross reactivity is 103%.
2. Comparison studies:
- Method comparison with predicate device: a. Method comparison studies were performed following CLSI EP09-A3 guideline.
A total of two hundred and one (201) human samples spanning the entire measuring assay range were tested in one replicate with both the BioPlex 2200 25-OH Vitamin D kit and the predicate assay. Of the 201 samples, there were 182 unaltered samples and 19 samples spiked with 25-hydroxyvitamin D3 to supplement the assay range. Sample values lower or higher than the measuring range of either the test or comparator method were not included in the analysis. Mean values of 25-OH Vitamin D results were plotted using Weighted Deming regression analysis on the Analyse-it software for all samples spanning the measuring range of both assays. Results of the regression slope, intercept, and coefficient of correlation (r) are summarized in the table below.
| Number of
Results
Analyzed | Slope
(95% CI) | Intercept
(95% CI) | Correlation
Coefficient (r)
(95% CI) | Measured Range
(ng/mL) |
|----------------------------------|--------------------------|-------------------------------|--------------------------------------------|---------------------------------------------------------|
| 184 | 1.048
(1.009 - 1.088) | -0.885
(-2.211 -
0.441) | 0.987
(0.983 - 0.990) | Candidate: 11.2 -
136.2
Predicate: 9.1 -
122.8 |
13
b. Method comparison to reference method:
A total of one hundred and twenty (120) native single donor patient serum samples (reference sample set provided by the Vitamin D Standardization and Certification Program with assigned values by the RMP at CDC, independent from the samples used for standardization) spanning the entire measuring assay range were tested with one replicate on the BioPlex 2200 25-OH Vitamin D kit. Sample values lower or higher than the measuring range of the BioPlex 2200 25-OH Vitamin D assay were not included in the analysis. Results of the Weighted Deming regression slope, intercept, and coefficient of correlation (r) are summarized in the table below.
| Number of
Results
Analyzed | Slope
(95% CI) | Intercept
(95% CI) | Correlation
Coefficient (r)
(95% CI) | Measured Range
(ng/mL) |
|----------------------------------|--------------------------|----------------------------|--------------------------------------------|-----------------------------------------------|
| 119 | 0.993
(0.913 - 1.073) | -0.775
(-2.705 - 1.155) | 0.949
(0.927 - 0.964) | Candidate 9.0 -
158.4
VDSP: 7.4 - 153.2 |
- Bias at Vitamin D Medical Decision Levels C. Samples at medical decision levels of 20, 30 and 100 ng/mL were analyzed to determine mean bias and 95% confidence interval using Bland-Altman analysis on the Analyse-it software. The data is summarized in the table below.
| Medical Decision Range
(ng/mL) | Average
(ng/mL) | N | Mean Bias | 95% CI |
|-----------------------------------|--------------------|-----|-----------|---------------|
| 19-21 | 20.0 | 7 | -7.3% | -19.94 – 5.26 |
| 29-31 | 29.7 | 20 | -0.2% | -6.08 - 5.69 |
| 95-105 | 101.7 | 6 | 3.5% | -9.76 – 16.80 |
| Overall | 41.8 | 303 | 1.0% | -0.79 - 2.78 |
- d. Matrix comparison: Serum only
-
- Expected values/Reference range:
The Expected Values study was conducted following CLSI EP28-A3c guideline.
Two hundred and eighty-eight (288) samples from apparently healthy donors including 161 males ranging in age from 21 to 79 and 127 females ranging in age from 21 to 66 were collected from three regions (Northern, Central, and Southern) in the US in spring, summer and winter, including African Americans, Hispanics and Caucasians.
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The 288 samples from apparently healthy donors met the following inclusion/exclusion criteria as follows and tested with the BioPlex 2200 25-OH Vitamin D kit in singlicate.
- Age from 21 to 90 ●
- . Roughly 50% female and 50% male
- 20% from Northern, 20% from Central and 60% from Southern region
- 40% collected in Spring, 30% in Summer and 30% in Winter
- . At least 30% African Americans and 30% Caucasians
- 90% not taking Vitamin D supplements and