(256 days)
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No
The description details a standard ELISA assay, which is a biochemical method, and there is no mention of AI/ML terms or processes.
No
This device is an in vitro diagnostic assay used for the quantitative measurement of 25-hydroxy vitamin D in human serum to assess vitamin D status; it does not provide any therapy or treatment.
Yes
The device is intended for the quantitative measurement of 25-hydroxy vitamin D in human serum, "to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient." This indicates its role in providing information for diagnosis, which is the definition of a diagnostic device.
No
The device description clearly outlines a laboratory assay kit involving chemical reactions, reagents, and a microtiter plate, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of 25hydroxy vitamin D2 and D3... in human serum." This indicates it's used to test a sample taken from the human body.
- Device Description: The description details an "enzyme linked immunosorbent assay" that detects substances "present in human serum." This is a common method used in IVD testing.
- Clinical Comparison: The performance studies include a "Method Comparison" using "356 samples" and a "Reference Range" study using "150 apparently healthy individuals." These are typical studies conducted for IVD devices to demonstrate their performance with human samples.
- Predicate Device: The mention of a "Predicate Device" with a K number (K021163) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process for IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIAsource 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.
Product codes (comma separated list FDA assigned to the subject device)
MRG
Device Description
The DIAsource 25 OH Vitamin D Total ELISA Test is an enzyme linked immunosorbent assay to detect total 25OH Vitamin D (D2 and D3) present in human serum. During the first incubation at room temperature, 25OH Vitamin D is dissociated from binding serum proteins to fix on binding sites of a specific monoclonal antibody. After washing, a fixed amount of 25OH Vitamin D-labeled with biotin in presence of horseradish peroxidase (HRP) compete with unlabeled 25OH Vitamin D2 and 25OH vitamin D3 present on the binding sites of the specific monoclonal antibody. After another incubation at room temperature, the microtiterplate is washed to stop the competition reaction. A chromogenic solution (TMB) is added and then stopped with a Stop Solution after the last incubation period. The amount of substrate turnover is determined colorimetrically by measuring the absorbance which is inversely proportional to the total 25OH Vitamin D concentration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
Calibrators and Controls:
Traceability/Calibrators Value Assignment - The master calibrator stock is an ethanolic solution prepared in house by weighing 25OH Vitamin D3. The value assignment of the stock is made by UV absorbance at 254 nm using a molar extinction coefficient of 18000 L mol" cm". The stock solution of 25OH Vitamin D is then used to make calibrators by diluting into horse serum. Calibrator values have been determined using native serum samples that have been assayed by LC/MS-MS. The LC/MS-MS method has been validated against a reference method.
Controls Value Assignment -- The mean values of 30 replicates obtained from 10 independent runs were assigned as the control target values. The controls target ranges were assigned as mean +/- 20% if the observed CV's are less than 7%; mean +/- 25% if observed CV's are 7-10%; and mean +/- 30% if the observed CV's are 10-15%.
Stability Study Protocol and Acceptance Criteria – Accelerated stability studies were performed on the kit and components. Kits and components were placed in an incubator at 37℃ for 30 days and for 2 components 42 days and 56 days then tested. Following DIAsource experience that 7 days at 37℃ is equivalent to six months at 4℃, 30 days ,42 days and 56 days at 37℃ is equivalent to 24, 36 and 48 months, respectively. The results are accepted if they fit into 3 predefined criteria when compared to an unopened kit stored at 4ºC.
These criteria are :
- The OD of the Calibrator 0 and the Calibrator 6 have to be at +/- 50% of values obtained with the component (or kit) kept at 4°C
- The (OD for Calibrator 1 / OD for calibrator 0 ) X 100 has been at +/- 15% of the value obtained with the component kept at 4°C
- The values of the Positive and Negative controls have to be in the announced range with the component (or kit) kept at 4ºC
In conclusion the stability of the kit and components was found to be 24 months with the Incubation Buffer and Conjugate Buffer at 48 months. An expiration of 18 months at 4℃ is given to the kits. Ongoing real time stability is being conducted.
Open Vial Stability - Calibrators and Controls come in lyophilized form. Once reconstituted with DI water, they were stored at 4℃ for 7 days, and frozen at -20℃ for one months and three months with one thawing. The results after 7 days at 4℃ and after one, two, and three months at -20℃ were acceptable, when compared to a new kit. In conclusion the Calibrators and Controls can be used up to 7 days when stored at 4℃ or up to three months when stored at -20℃.
Precision: Precision studies were evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP5-A Guideline. Precision was calculated by running four serum samples at the given n value for 20 days on 3 different lots in singlicate. The reproducibility of the assay was done by testing 60 serum samples each at 3 concentrations duplicate for five days, twice a day, at three sites with two technicians per site.
Limit of Detection: The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ), were determined in accordance with the CLSI guideline EP17-A.
The LoB was calculated by measuring the blank several times and calculating the 95th percentile of the distribution of the test values. The LoB was calculated to be 1.69ng/ml.
The LoD was calculated by using the formula LoD = LoB + 1.65 x SDs (from the CLSI EP17-A) where SDs is the standard deviation of a low value serum. The LoD was calculated to be 2.8 I ng/ml.
The LoQ was calculated by testing 5 samples of low value 10 times in different test. The mean value was put in the X axis and the CV values on the Y axis. The LoQ was calculated to be 4.32ng/ml.
Recovery: Recovery was assessed by adding different levels of 25OH Vitamin D to samples.
Results: For 25OH-Vit D3, recovery was 95% at 25 ng/ml added and 92% at 50 ng/ml added. For 25OH-Vit D2, recovery was 105% at 25 ng/ml added and 95% at 50 ng/ml added.
Linearity: Two samples with concentrations known to be distributed throughout the measurable range were tested at equidistant dilutions to determine the linear range of the assay. A linear regression analysis was performed.
Results: Sample 1 had a slope of 1.015 and R2 of 0.99. Sample 2 had a slope of 1.005 and R2 of 0.99. The linear range of the assay was found to be 7.7 ng/ml to 122.9 ng/ml.
Time Delay: Time delay test between the last Calibrator and sample dispensing results.
Results: Assay results remain accurate even when incubation buffer is dispensed 10 and 20 minutes after the Calibrator has been added in the coated wells.
Analytical Specificity: Cross reactivity of the 25OH Vitamin D Total ELISA assay was determined by testing sera with spiked and unspiked cross reactants. The effect of potential interfering substances on samples using the DIAsoure 25 OH Vitamin D Total ELISA test was evaluated.
Results: The tested substances (Hemoglobin, Bilirubin Conjugated, Bilirubin Unconjugated, Trygliceride, Vitamin C, Biotin, Zemplar) did not affect the performance of the DIAsoure 25 OH Vitamin D Total ELISA test, with interference of less than 10%.
6(b2): Clinical Comparison:
Method Comparison: The performance of the DIAsource 25OH Vitamin D Total ELISA test was determined by conducting a correlation study tested at three different sites using a total of 356 samples. The samples were tested on both the DIAsource 25OH Vitamin D Total ELISA test and a commercially available 25OH Vitamin D ELISA test manufactured by ImmunoDiagnostics System (IDS).
Results: The results ranged from 8.0ng/ml to 123.0 ng/ml, the correlation coefficient between the two methods was 0.917, with the 95% confidence interval of 87.6% to 93.6%, a slope of 0.954 and the y-intercept of 3.05.
Reference Range: To determine the reference range, the total 25OH Vitamin D of 150 apparently healthy individuals were measured. The individual patient serum samples used were obtained from a certified commercial source (Dx Biosamples, San Diego, CA.) and were collected from an FDA Licensed Donor Center with informed consent. 50 samples were from Northern US (Pennsylvania), 50 samples were from Central US (Tennessee), and 50 samples were from Southern US (Florida). All samples met specific criteria related to age, geographical location, collection season, lack of vitamin D supplements, skin tone, and medical history.
Results:
Highest Conc. (ng/mL): 88.6 (overall)
Lowest Conc. (ng/ml): 4.9 (overall)
Median Conc. (ng/ml): 17.2 (overall)
Only Central 95% (2.5% - 97.5%) of the results observed were used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
0
DIA Source
JUL 1 5 2013
510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | DIAsource ImmunoAssays |
|---|---|
| Address: | Rue du Bosquet, 2 B-1348 Louvain-la Neuve, Belgium |
| Phone Number: | +32(0)1084991 |
| Contact Person: | Napoleon Monce (Tel: 530-759-8000) |
| Date: | May 29, 2013 |
| 2) Name of Device: | 25OH Vitamin D Total ELISA Test |
|---|---|
| Trade Name: | 25OH Vitamin D Total ELISA Test |
| Common Name: | Vitamin D Assay |
| Device Classification Name: | Vitamin D Test System |
| Product Code: | MRG - Vitamin D Test System |
| Panel: | Chemistry (75) |
| Regulation Number: | 21 CFR 862.1825 - Vitamin D Test System - Class I |
-
- Legally marketed device to which the submitter claims equivalence (Predicate Device): Immuno diagnostic systems 25-Hydroxy Vitamin D EIA for the quantitative determination of 25hydroxy vitamin D and other hydroxylated metabolites in serum or plasma. K021163.
4) Description of the device:
The assay requires a total of 165 minutes incubation time. The DIAsource 25 OH Vitamin D Total ELISA Test is an enzyme linked immunosorbent assay to detect total 250H Vitamin D (D2 and D3) present in human serum. During the first incubation at room temperature, 250H Vitamin D is dissociated from binding serum proteins to fix on binding sites of a specific monoclonal antibody. After washing, a fixed amount of 250H Vitamin D-labeled with biotin in presence of horseradish peroxidase (HRP) compete with unlabeled 250H Vitamin D2 and 250H vitamin D3 present on the binding sites of the specific monoclonal antibody. After another incubation at room temperature, the microtiterplate is washed to stop the competition reaction. A chromogenic solution (TMB) is added and then stopped with a Stop Solution after the last incubation period. The amount of substrate turnover is determined colorimetrically by measuring the absorbance which is inversely proportional to the total 250H Vitamin D concentration.
1
5) Intended use of the device:
The DIAsoure 25 OH Vitamin D Total ELISA is intended for the quantitative measurement of 25hydroxy vitamin D2 and D3 (25 OH-D2 and 25 OH-D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.
6) Comparison with the predicate device:
The DIAsource 25OH Vitamin D Total ELISA Test Kit was compared to a commercially available 25OH Vitamin D ELISA kit manufactured by ImmunoDiagnostic Systems (IDS) (K021163). Below is a table comparing the two kits.
| The DIAsource 25OH Vitamin D Total ELISA | IDS 25OH Vitamin D ELISA |
|---|---|
| Intended Use - For the quantitative determination of | |
| 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used | |
| in conjunction with other clinical and laboratory | |
| findings to assess the Vitamin D status of a patient. | Intended Use - For the quantitative |
| determination of 25-hydroxyvitamin D (25-OH | |
| D) in human serum. The results are to be used | |
| in conjunction with other clinical and laboratory | |
| data to assist the clinician in the assessment of | |
| Vitamin D sufficiency in adult populations. | |
| Platform - ELISA plate read on a plate reader | Same |
| Microtiter Plate - 96 wells coated with monoclonal | |
| anti 25OH D₂ and D₃ | Microtiter Plate - 96 wells coated with sheep |
| polyclonal anti 25OH D | |
| Wash Solution Concentrate - 200x | Wash Solution Concentrate - 20x |
| Incubation Buffer - Proprietary buffer for | |
| dissociating vitamin D | Same |
| Conjugate Concentrate - 100x | None |
| HRP Concentrate - 200x | HRP Conjugate - Ready to Use |
| Conjugate Buffer - Use to dilute Conjugate and | |
| HRP Concentrate | None |
| Substrate -- Tetramethylbenzidine (TMB) | Same |
| Stop Solution - Acid mixture | Same |
| Calibrators 0-5 - Lyophilized | Calibrators 0-6 - Ready to Use |
| Controls 1-2 - Lyophilized | Same |
| Interpretation of Results - Standard Curve | Same |
| Expected Values: Deficient 100ng/ml | Same |
Table 1: Kit Comparison
Nonclinical tests: 6(b1)
Calibrators and Controls:
Traceboility/Calibrators Value Assignment - The master calibrator stock is an ethanolic solution prepared in house by weighing 250H Vitamin D3. The value assignment of the stock is made by UV absorbance at 254 nm using a molar extinction coefficient of 18000 L mol" cm". The stock solution of 250H Vitamin D is then used to make calibrators by diluting into horse serum. Calibrator values
2
have been determined using native serum samples that have been assayed by LC/MS-MS. The LC/MS-MS method has been validated against a reference method.
Controls Value Assignment -- The mean values of 30 replicates obtained from 10 independent runs were assigned as the control target values. The controls target ranges were assigned as mean +/- 20% if the observed CV's are less than 7%; mean +/- 25% if observed CV's are 7-10%; and mean +/- 30% if the observed CV's are 10-15%.
Stability Study Protocol and Acceptance Criteria – Accelerated stability studies were performed on the kit and components. Kits and components were placed in an incubator at 37℃ for 30 days and for 2 components 42 days and 56 days then tested. Following DIAsource experience that 7 days at 37℃ is equivalent to six months at 4℃, 30 days ,42 days and 56 days at 37℃ is equivalent to 24, 36 and 48 months, respectively. The results are accepted if they fit into 3 predefined criteria when compared to an unopened kit stored at 4ºC.
These criteria are :
-
The OD of the Calibrator 0 and the Calibrator 6 have to be at +/- 50% of values obtained with the component (or kit) kept at 4°C
-
The (OD for Calibrator 1 / OD for calibrator 0 ) X 100 has been at +/- 15% of the value obtained with the component kept at 4°C
-
The values of the Positive and Negative controls have to be in the announced range with the component (or kit) kept at 4ºC
In conclusion the stability of the kit and components was found to be 24 months with the Incubation Buffer and Conjugate Buffer at 48 months.
An expiration of 18 months at 4℃ is given to the kits.
Ongoing real time stability is being conducted.
Open Vial Stability - Calibrators and Controls come in lyophilized form. Once reconstituted with DI water, they were stored at 4℃ for 7 days, and frozen at -20℃ for one months and three months with one thawing. The results after 7 days at 4℃ and after one, two, and three months at -20℃ were acceptable, when compared to a new kit.
In conclusion the Calibrators and Controls can be used up to 7 days when stored at 4℃ or up to three months when stored at -20℃
Precision:
Precision studies were evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP5-A Guideline.
Precision was calculated by running four serum samples at the given n value for 20 days on 3 different lots in singlicate. The results are summarized in the table below:
3
| Intra-Assay | Inter-Assay | ||||||
|---|---|---|---|---|---|---|---|
| Sample | n | ± SD (ng/ml) | CV (%) | Sample | n | ± SD (ng/ml) | CV (%) |
| A | 24 | 5.6 ± 0.4 | 7.8 | A | 42 | 17.7 ± 1.3 | 7.4 |
| B | 35 | 27.4 ± 1.5 | 5.5 | B | 10 | 26.3 ± 1.3 | 4.7 |
| C | 35 | 43.0 ± 1.2 | 2.7 | C | 10 | 42.0 ± 1.9 | 4.5 |
| D | 24 | 81.2 ± 2.0 | 2.5 | D | 21 | 85.4 ± 7.8 | 9.4 |
The reproducibility of the assay was done by testing 60 serum samples each at 3 concentrations duplicate for five days, twice a day, at three sites with two technicians per site. The mean results are summarized in the table below:
| Sample | n | ng/ml | | Within-
Run | Between-
Run | Between-
Day | Between-
Tech | Between-
Site | Total |
|--------|----|-------|----|----------------|-----------------|-----------------|------------------|------------------|-------|
| 1 | 60 | 25.5 | SD | 0.217 | 0.611 | 0.975 | 1.537 | 2.206 | 2.593 |
| | | | CV | 0.3% | 0.9% | 3.8% | 6.0% | 8.7% | 10.2% |
| 2 | 60 | 52.9 | SD | 0.638 | 1.571 | 1.108 | 2.285 | 4.310 | 5.192 |
| | | | CV | 0.9% | 2.3% | 2.1% | 4.3% | 8.2% | 9.8% |
| 3 | 60 | 124.8 | SD | 1.00 | 1.735 | 1.834 | 3.391 | 4.906 | 6.190 |
| | | | CV | 1.4% | 2.5% | 1.5% | 2.7% | 3.9% | 5.0% |
Limit of Detection:
The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ), were determined in accordance with the CLSI guideline EP17-A.
The LoB was calculated by measuring the blank several times and calculating the 95th percentile of the distribution of the test values. The LoB was calculated to be 1.69ng/ml.
The LoD was calculated by using the formula LoD = LoB + 1.65 x SDs (from the CLSI EP17-A) where SDs is the standard deviation of a low value serum. The LoD was calculated to be 2.8 I ng/ml.
The LoQ was calculated by testing 5 samples of low value 10 times in different test. The mean value was put in the X axis and the CV values on the Y axis. The LoQ was calculated to be 4.32ng/ml.
Recovery:
Recovery was assessed by adding different levels of 250H Vitamin D to samples. The results are summarized in the table below:
| Recovery Test | |
|---|---|
| Added 25OH-Vit D3 | |
| (ng/ml) | Recovery |
| (%) |
4
| 0 | 100 |
|---|---|
| 25 | 95 |
| 50 | 92 |
| Added 25OH-Vit D₂ | |
| (ng/ml) | Recovery |
| (%) | |
| 0 | 100 |
| 25 | 105 |
| 50 | 95 |
Linearity:
Two samples with concentrations known to be distributed throughout the measurable range were tested at equidistant dilutions to determine the linear range of the assay. A linear regression analysis was performed. The results are summarized in the following table:
Sample 1
| Sample
Dilution | Theoretical
Concentration
(ng/ml) | Measured
Concentration
(ng/ml) | Slope | Y-
Intercept | R2 | Recovery
(%) |
|--------------------|-----------------------------------------|--------------------------------------|-------|-----------------|------|-----------------|
| 1/1 | 96.7 | 96.7 | | | | 100 |
| 1/2 | 48.5 | 47.6 | | | | 98.1 |
| 1/4 | 24.2 | 24.5 | 1.015 | -0.298 | 0.99 | 101.2 |
| 1/8 | 12.1 | 11.1 | | | | 91.7 |
| 1/16 | 6.0 | 6.2 | | | | 103 |
Sample 2
| Sample
Dilution | Theoretical
Concentration
(ng/ml) | Measured
Concentration
(ng/ml) | Slope | Y-
Intercept | R2 | Recovery
(%) |
|--------------------|-----------------------------------------|--------------------------------------|-------|-----------------|------|-----------------|
| 1/1 | 122.9 | 122.9 | 1.005 | 0.435 | 0.99 | 100 |
| 1/2 | 61.5 | 64.5 | | | | 105 |
| 1/4 | 30.7 | 31.5 | | | | 103 |
| 1/8 | 15.4 | 15.0 | | | | 97.4 |
| 1/16 | 7.7 | 7.6 | | | | 98.7 |
The linear range of the assay was found to be 7.7 ng/ml to122.9 ng/ml.
Time Delay:
Time delay test between the last Calibrator and sample dispensing results is shown in the following table.
| Time Delay | |||
|---|---|---|---|
| 0 min | |||
| (ng/ml) | 10 min | ||
| (ng/ml) | 20 min | ||
| (ng/ml) | |||
| Sample 1 | 27.9 | 30.5 | 30.2 |
| Sample 2 | 49.5 | 47.5 | 49.0 |
5
Assay results remain accurate even when incubation buffer is dispensed 10 and 20 minutes after the Calibrator has been added in the coated wells.
Analytical Specificity:
Cross reactivity of the 250H Vitamin D Total ELISA assay was determined by testing sera with spiked and unspiked cross reactants. The results are summarized in the following table:
| Spiked Vitamin D | Unspiked Vitamin | % Cross | |
|---|---|---|---|
| Compound and Concentration | (ng/ml) | D (ng/ml) | Reaction |
| 1,25(OH)2-Vitamin D3 at 200 ng/ml | 57.3 | 16.7 | 20.3 |
| 1,25(OH)2-Vitamin D2 at 690 ng/ml | 29.9 | 16.7 | 1.9 |
| Vitamin D3 at 200 ng/ml | 22.5 | 16.7 | 2.9 |
| Vitamin D2 at 200 ng/ml | 19.3 | 16.7 | 1.3 |
| 24,25(OH)2-Vitamin D3 at 20 ng/ml | 87.9 | 16.7 | >100 |
| 25,26(OH)2-Vitamin D3 at 4 ng/ml | 31.1 | 16.7 | >100 |
| 3-epi-25 hydroxy Vitamin D 3 at20 µg/ml | 31.58 | 16.7 | 0.07 |
| 25 OH Vitamin D3 at 10 ng/ml | 26.7 | 16.7 | 100 |
| 25 OH Vitamin D2 at 10 ng/ml | 25.0 | 16.7 | 83 |
The effect of potential interfering substances on samples using the DIAsoure 25 OH Vitamin D Total ELISA test was evaluated. Different levels of Hemoglobin, Bilirubin, Triglyceride, Vitamin C, Bilirubin Conjugate and Unconjugated and Zemplar in serum samples were tested on samples with different 250H Vitamin D Concentration. Our acceptance criteria was to have interference of less than 10%. The tested substances did not affect the performance of the DIAsoure 25 OH Vitamin D Total ELISA test.
| Substance | 25OH Vitamin D
Concentration (ng/ml) | Concentration of
Interferent
(mg/dL) | Mean Percent
Variation |
|---------------------------|-----------------------------------------|--------------------------------------------|---------------------------|
| Hemoglobin | 7.6 | 250 | -0.5% |
| | | 500 | |
| | 29.3 | 250 | |
| | | 500 | |
| | 42.5 | 250 | |
| | | 500 | |
| Bilirubin
Conjugated | 6.0 | 50 | -3.5% |
| | | 100 | |
| | 21.5 | 50 | |
| | | 100 | |
| | 38.6 | 50 | |
| | | 100 | |
| Bilirubin
Unconjugated | 7.6 | 50 | 2.5% |
| | 29.3 | 100 | |
| | 42.5 | 50 | |
| Trygliceride | 7.6 | 7.5 | -4.3% |
| | 29.3 | 125 | |
| | 42.5 | 250 | |
| Vitamin C | 6.0 | 500 | 4.5% |
| | 21.5 | 7.5 | |
| | 38.6 | 125 | |
| Biotin | 8.7 | 250 | 4.6% |
| | 19.8 | 500 | |
| | 36.1 | 1 | |
| Zemplar | 17.6 | 10 | -4.3% |
| | 33.5 | 100 | |
6
.
.
7
6(b2): Clinical Comparison:
Method Comparison:
The performance of the DIAsource 250H Vitamin D Total ELISA test was determined by conducting a correlation study tested at three different sites using a total of 356 samples. The samples were tested on both the DIAsource 250H Vitamin D Total ELISA test and a commercially available 250H Vitamin D ELISA test manufactured by ImmunoDiagnostics System (IDS). The results ranged from 8.0ng/ml to 123.0 ng/ml, the correlation coefficient between the two methods was 0.917, with the 95% confidence interval of 87.6% to 93.6%, a slope of 0.954 and the y-intercept of 3.05. The following plots summarizes the results:
Image /page/7/Figure/3 description: This image is a scatter plot. The title of the plot is "Scatter Plot". The equation of the trend line is y = 0.954x + 3.05, and the R-squared value is 0.917.
Image /page/7/Figure/4 description: The image is a difference plot showing the difference between two devices, DiaSource and Predicate Device, on the y-axis and the mean of concentration on the x-axis. The y-axis ranges from -20 to 20, while the x-axis ranges from 0 to 140. The plot shows a scatter of data points, with most points clustered between 0 and 60 on the x-axis. The title of the plot is "Difference Plot".
2.8
8
Reference Range:
To determine the reference range, the total 250H Vitamin D of 150 apparently healthy individuals were measured. The individual patient serum samples used were obtained from a certified commercial source (Dx Biosamples, San Diego, CA.) and were collected from an FDA Licensed Donor Center with informed consent. 50 samples were from Northern US (Pennsylvania), 50 samples were from Central US (Tennessee), and 50 samples were from Southern US (Florida).
All samples met the following criteria:
- Age between 21-90 years old. .
- Subjects from three different geographical locations. .
- Samples collected in the Winter season (January, February, and March) .
- Subjects were not taking any vitamin D supplements .
- Subjects were of different skin tones .
- Subjects had no family history of parathyroid, or calcium regulatory disease. .
- Subjects had no history or Kidney, Liver, Parathyroid, Calcium related disease or bariatric . surgery.
- Subjects were not taking any medications known to affect absorption or catabolism of Vitamin D. . The following results were obtained:
- Ages between 20-62 years old. .
- Population consisted of 75 light skin (50%) and 75 dark skin (50%). .
- No subjects were taking vitamin D supplements. .
- No subjects had a family history of parathyroid, or calcium regulatory disease. .
- No subjects had a history of Kidney, Liver, Parathyroid, Calcium related disease or bariatric . surgery.
- No subjects were taking any medications known to affect absorption or catabolism of Vitamin D. .
- The following table is the summary or results: .
| Florida | Tennessee | Pennsylvania | Overall | |
|---|---|---|---|---|
| Highest Conc. (ng/mL) | 88.6 | 71.7 | 54.6 | 88.6 |
| Lowest Conc. (ng/ml) | 6.1 | 4.9 | 5.9 | 4.9 |
| Median Conc. (ng/ml) | 20.8 | 15.9 | 14.3 | 17.2 |
Only Central 95% (2.5% - 97.5%) of the results observed were used.
6(b3) Conclusion:
From the data and comparison above, it is our contention that the DIAsource 250H Vitamin D Total ELISA Test Kit is substantially equivalent to the commercially available 250H Vitamin D ELISA kit manufactured by ImmunoDiagnostic Systems (IDS) (K021163).
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure. The figure is composed of three curved lines that form the head, body, and legs.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2013
DIAsource Immunoassays, S.A. c/o Napoleon Monce c/o Gold Standard Diagnostics 2851 Spafford Street DAVIS CA 95618
Re: K123364
Trade/Device Name: 250H Vitamin D Total ELISA Test Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG Dated: June 12, 2013 Received: June 13, 2013
Dear Mr. Monce:
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); medical device reporting (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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Monce
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 You desite specific advisour PDA/CentersOffices/CDRH/CDRHOffices/ucm | 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -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
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Indications for Use
510(k) Number (if known): K123364
Device Name: 250H Vitamin D Total ELISA Test
Indications for Use:
The DIAsource 250H Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.
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 Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123364
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