(127 days)
The Diazyne 25-OH Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of 25hydroxywiamin D (25-OH-D) in human serum and plasma on automated chemistry analyzer. Measurement of 25-hydroxy wiamin D (25-OH-D) is for assessment of vitamin D sufficiency. For in vitro diagnostic use only.
The 25-0H Vitamin D Control Ser is intended for use as quality controls for Diazyne 25-0H Viamin D Assay Kit only. For in vitro diagnostic use only.
The Diazyme 25-OH Vitamin D Assay is a direct competitive colorimetric immunoassay for the quantitative determination of total 25-OH vitamin D in serum and plasma. The assay is based on the principle of alpha-complementation of the enzyme beta-galactosidase and the competition between an enzyme donor-25-OH Vitamin D conjugate, an anti-Vitamin D antibody and the 25-OH Vitamin D content of a serum sample. Samples with higher 25-OH Vitamin D concentrations produce higher beta-galactosidase activities and vice versa. A nitro-phenyl-0-galactoside derivative (NPG) is used as the enzyme substrate. The reaction's product has maximum absorbance at 415 nm. The 25-OH Vitamin D concentration of a specimen is proportional to the measured Bgalactosidase activity. Five calibration levels are needed for each run. Calibrators are treated exactly the same as patient samples.
The Diazyme 25-OH Vitamin D Control Set (2 levels) is intended for use with the Diazyme 25-OH Vitamin D Assay kit only. Controls are treated exactly the same as patient samples. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. Users are instructed to verify the calibration curve with the controls.
Here's a breakdown of the acceptance criteria and study information for the Diazyme 25-OH Vitamin D Assay, based on the provided text:
Acceptance Criteria and Device Performance
The provided 510(k) summary sets acceptance criteria implicitly through performance studies designed to meet CLSI (Clinical and Laboratory Standards Institute) guidelines and demonstrate substantial equivalence to a predicate device. While there isn't a single table explicitly titled "Acceptance Criteria," the performance studies detail the performance required for different analytical characteristics, and the reported results meet or exceed these implied criteria.
| Performance Study | Implied Acceptance Criteria (Based on CLSI guidelines and typical assay performance standards) | Reported Device Performance |
|---|---|---|
| Precision | Generally, total CV should be <10-15% for clinical assays, especially for analytes like Vitamin D. Within-run and Between-run CVs should also be within acceptable limits. | - Total CVs: Ranged from 2.9% to 14.0% across 11 specimen levels. Most values were well within typical acceptance ranges (e.g., 2.9-8.8% for all samples except very low levels which were 13.9-14.0%). - Within-run CVs: Ranged from 2.2% to 14.2%. - Between-run CVs: Ranged from 2.0% to 10.4%. |
| Linearity | Must demonstrate linearity across the claimed analytical measurement range. Statistical analysis (e.g., using EP Evaluator with specified allowable error) would confirm this. | Found to be linear between 7.6 ng/mL and 147.8 ng/mL, processed with an allowable systematic error of 8.9%. |
| LoB/LoD/LoQ | Limits of Blank, Detection, and Quantitation must be established and clinically appropriate. | - LoB: 2.0 ng/mL - LoD: 3.5 ng/mL - LoQ: 7.6 ng/mL |
| Analytical Specificity (Interference) | Interference from common endogenous and exogenous substances should be <10% deviation at specified concentrations. | Less than 10% deviation observed from numerous interfering substances, including Conjugated Bilirubin (40 mg/dL), Free Bilirubin (40 mg/dL), Hemoglobin (100 mg/dL), Triglycerides (750 mg/dL), Ascorbic Acid (176 mg/dL), Uric Acid (20 mg/dL), Biotin (2 mg/dL), and various common medications. |
| Analytical Specificity (Cross-Reactivity) | Cross-reactivity with related Vitamin D metabolites should be quantified; ideally, low for inactive forms and high for active forms (25-OH D2/D3). | - 25-OH Vitamin D3: 100%- 25-OH Vitamin D2: 92.3%- Vitamin D3: 1.0%- Vitamin D2: 2.9%- 1,25-(OH)2 Vitamin D3: 2.5%- 1,25-(OH)2 Vitamin D2: -1.5%- 24R,25-(OH)2 Vitamin D3: 5.1%- 3-epi-25-OH Vitamin D3: 61.7%- 3-epi-25-OH Vitamin D2: 55.1%- Paricalcitol: 4.1% |
| Method Comparison | Strong correlation with a predicate device (e.g., correlation coefficient >0.95, slope near 1, intercept near 0). | - Correlation Coefficient (r): 0.984 (95% CI: 0.976 to 0.989) - Slope: 1.005 (95% CI: 0.969 to 1.041) - Intercept: -0.21 (95% CI: -2.15 to 1.73) |
| Matrix Comparison | Acceptable agreement between different sample matrices (serum, plasma). Slopes near 1, intercepts near 0, and high R-squared values. | - Li-Heparin plasma vs. Serum: y = 0.9657 x - 0.6596, R² = 0.9736 - K3-EDTA plasma vs. Serum: y = 0.9948x - 0.7057, R² = 0.9866 |
| Reference Range | Establish a representative reference interval. | Observed range (2.5th to 97.5th percentile): 15.0 to 45.9 ng/mL. Median: 25.6 ng/mL. Lowest: 12.6 ng/mL. Highest: 51.4 ng/mL. |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Precision Study: 11 different precision levels (2 controls, 9 serum samples). Each specimen was measured 80 times (20 days, 3 reagent lots, 1 analyzer, 2 measurements per run). The origin of these samples (country of origin, retrospective/prospective) is not explicitly stated, but they are referred to as "serum controls" and "serum samples."
- Linearity Study: 11 levels prepared from a high serum sample and Vitamin D-depleted serum. Tested in triplicates. Data provenance not specified.
- LoB/LoD/LoQ Study: Not specified, but generally involves multiple measurements of blank, low-level, and higher-level samples. Data provenance not specified.
- Interference Study: Not specified how many replicates or individual samples per interferent were tested, but it involved adding substances to blood samples. Data provenance not specified.
- Cross-Reactivity Study: Not specified how many replicates or individual samples per metabolite were tested, but it involved adding these to "serum pool samples." Data provenance not specified.
- Method Comparison: 98 unaltered human serum samples. Data provenance not specified (country, retrospective/prospective).
- Matrix Comparison: 66 matched sets of serum, K3-EDTA plasma, and Li-Heparin plasma samples (including 7 spiked patient samples). Data provenance not specified.
- Reference Range Study: 157 apparently healthy individuals. Origin: 47 samples from Pennsylvania (Northern U.S.), 56 from Tennessee (Central U.S.), and 54 from Texas (Southern U.S.). All collected during Oct-Nov (fall season). These were prospective collections based on an IRB approved protocol where stated, and obtained from commercial sources/FDA Licensed Donor Center with informed consent.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The device is an in vitro diagnostic (IVD) assay for measuring a biomarker. The "ground truth" for such devices is typically established through reference methods, certified calibrators, or comparison to legally marketed predicate devices, rather than expert human interpretation. In this case, comparison to theLIAISON® 25-OH Vitamin D TOTAL Assay(K112725, K071480) served as the primary reference for method comparison. The concentrations of Vitamin D in controls and calibrators are pre-assigned based on standardized methods.
Therefore, no human experts are directly involved in establishing the "ground truth" for the test set in the same way they would be for an imaging AI device. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of IVD chemical assay. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data (e.g., medical images), and disagreements need resolution. For quantitative assays, results are numerical and compared directly to reference values or predicate device results. -
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 is an IVD assay, not an AI imaging or diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the entire performance testing described (precision, linearity, LoB/LoD/LoQ, analytical specificity, method comparison, matrix comparison, reference range) represents the standalone performance of the Diazyme 25-OH Vitamin D Assay. It is an automated assay intended to provide a quantitative measurement without human interpretation of the primary result. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" concept for this device is primarily established through:- Reference Methods/Standardization: The assay provides quantitative values of 25-OH Vitamin D. The accuracy of these values is assessed by comparing them against certified calibrators, controls with known concentrations, and correlation with a legally marketed predicate device (LIAISON® 25-OH Vitamin D TOTAL Assay) which itself would have been validated against reference standards.
- Defined Concentrations: For studies like linearity, interference, and cross-reactivity, known concentrations of the analyte or interferent are spiked into samples to determine the device's response.
-
The sample size for the training set:
Not applicable. This is a traditional in vitro diagnostic assay, not a machine learning or AI algorithm that requires a separate "training set." The assay's performance is determined by its chemical and enzymatic reactions, not by being "trained" on data. -
How the ground truth for the training set was established:
Not applicable, as no training set was used.
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg CourtPoway, CA 92064 |
| Name of Contact Person: | Dr. Abhijit DattaDirector, Technical OperationsDiazyme Laboratories12889 Gregg CourtPoway, CA 92064Email: abhijit.datta@diazyme.comPhone: 858-455-4762Fax: 858-455-2120 |
| Date the Summary was Prepared: | November 04, 2013 |
| Name of the Device | Diazyme 25-OH Vitamin D Assay KitDiazyme 25-OH Vitamin D Control Set |
| Trade Name: | Diazyme 25-OH Vitamin D AssayDiazyme 25-OH Vitamin D Control Set |
| Common/Usual Name | Vitamin D Assay |
| Device Classification Name | Vitamin D Test System |
| Product code: | MRG - Vitamin D Test SystemJJX – Single (specified) Analyte Controls (Assayed andUnassayed) |
| Panel: | Chemistry (75) |
| Submission Type | 510k |
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| Regulation Number | 21 CFR 862.1825 - Vitamin D Test System21 CFR 862.1660 - Quality Control material (Assayedand Un-assayed) |
|---|---|
| Device Class | II (Assay)I (Control) |
| Predicate Device: | The Diazyme 25-OH Vitamin D Assay Kit and ControlSet is substantially equivalent to the currently marketedLIAISON® 25-OH Vitamin D TOTAL Assay(K112725, K071480). |
| Manufacturing Address | Diazyme Laboratories12889 Gregg CourtPoway, CA 92064USA |
| Establishment Registration | 2032900 |
DESCRIPTION OF THE DEVICE
The Diazyme 25-OH Vitamin D Assay is a direct competitive colorimetric immunoassay for the quantitative determination of total 25-OH vitamin D in serum and plasma. The assay is based on the principle of α-complementation of the enzyme β-galactosidase and the competition between an enzyme donor-25-OH Vitamin D conjugate, an anti-Vitamin D antibody and the 25-OH Vitamin D content of a serum sample. Samples with higher 25-OH Vitamin D concentrations produce higher ß-galactosidase activities and vice versa. A nitro-phenyl-0-galactoside derivative (NPG) is used as the enzyme substrate. The reaction's product has maximum absorbance at 415 nm. The 25-OH Vitamin D concentration of a specimen is proportional to the measured Bgalactosidase activity. Five calibration levels are needed for each run. Calibrators are treated exactly the same as patient samples.
The Diazyme 25-OH Vitamin D Control Set (2 levels) is intended for use with the Diazyme 25-OH Vitamin D Assay kit only. Controls are treated exactly the same as patient samples. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. Users are instructed to verify the calibration curve with the controls.
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INDICATIONS FOR USE
The Diazyme 25-OH Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of total 25-OH Vitamin D in human serum and plasma on automated chemistry analyzer. Measurement of 25-hydroxyvitamin D (25-OH-D) is for the assessment of vitamin D sufficiency. For in vitro diagnostic use only.
The Diazyme 25-OH Vitamin D Control Set is intended for use as quality controls for the Diazyme 25-OH Vitamin D Assay Kit only. For in vitro diagnostic use only.
| LIAISON® 25-OH Vitamin D TOTAL Assay | Diazyme 25-OH Vitamin D Assay |
|---|---|
| (predicate K112725)Kit can be only used for the 25-OH Vitamin Dquantification on the Diasorin Liaison® analyzer. | Kit can be used for the 25-OH Vitamin D quantifi-cation on the Roche Modular P Chemistry Analyz-er and similar chemistry analyzer systems. |
| Magnetic Particles:Magnetic particles coated with antibody against25-OH Vitamin D, protein, phosphate buffer, <0.1% sodium azide. | Dilution buffer:Sheep Antibody against 25-OH Vitamin D, pro-teins, phosphate buffer, < 0.1% sodium azide. |
| Assay Buffer:Buffer with 10% ethanol, surfactants and preserva-tives. | Reagent R1:Proprietary dissociation solution with surfactantsand preservatives. |
| Conjugate:25-OH Vitamin D conjugated to an isoluminolderivative, in phosphate buffer with 10% ethanol,EDTA, surfactant and preservatives. | Reagent R2:Enzyme Donor-Vitamin D conjugate, proteins,surfactants and preservatives. |
| LIAISON Starter 1:Catalyst in 4% NaOH. | Reagent R3:Enzyme Acceptor, proteins, surfactants and pre-servatives. |
| LIAISON Starter 2:0.12% peroxide solution. | N/A |
| LIAISON Wash/System Liquid:Phosphate buffer solution (10x concentrate). Pre-servative: sodium azide. | N/A |
| LIAISON 25-OH Vitamin D diluent:Human serum with buffer salts and <0.1% sodiumazide. | N/A |
| Calibrator Set (K071480) | Calibrator set |
| 1 x 1.0 mL Calibrator 11 x 1.0 mL Calibrator 2 | 1 x 1.0 mL Calibrator 11 x 1.0 mL Calibrator 21 x 1.0 mL Calibrator 31 x 1.0 mL Calibrator 41 x 1.0 mL Calibrator 5 |
Table 1 Summary of Assay Kit Components
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| Control set (K071480) | Diazyme Control set |
|---|---|
| 1 x 1.0mL Control 1 | 1 x 1.0mL Control 1 |
| 1 x 1.0mL Control 2 | 1 x 1.0mL Control 2 |
| Serum-based controls | Serum-based controls |
| Liquid form | Liquid form |
| Stable for at least 12 months at 2-8C. | Stable for at least 12 months at 2-8C. |
| Assigned range is mean +/- 25%. | Assigned range is mean +/- 25%. |
PERFORMANCE TESTING SUMMARIES ON THE ROCHE MODULAR-P CHEMIS-TRY ANALYZER
Precision Study
The precision of the Diazyme 25-OH Vitamin D Assay was evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline. A total of 11 precision levels were used in the study:
- . Two serum controls (containing 23.1 ng/mL and 45.7 ng/mL).
- Nine serum samples distributed across the dynamic range of the assay. ●
Controls and samples were measured daily over the span of 20 days, using three lots of reagents and one chemistry analyzer. A total of 40 independents run were performed on each specimen. Each run produced two measurements. A total of 80 data points were obtained per specimen.
The mean value (Mean), standard deviation, within-run imprecision and total imprecision are calculated and summarized in the following tables:
| 25-OH Vitamin D (ng/mL) | Within-run | Between-run | Total | |||||
|---|---|---|---|---|---|---|---|---|
| Specimen | n | Mean | SD | CV | SD | CV | SD | CV |
| (ng/mL) | (ng/mL) | (%) | (ng/mL) | (%) | (ng/mL) | (%) | ||
| Control #1 | 80 | 23.1 | 1.47 | 6.4 | 1.04 | 4.5 | 1.68 | 7.3 |
| Control #2 | 80 | 45.7 | 2.06 | 4.5 | 1.67 | 3.7 | 2.12 | 4.6 |
| Sample #1 | 80 | 22.6 | 1.19 | 5.3 | 1.11 | 4.9 | 1.45 | 6.4 |
| Sample #2 | 80 | 31.7 | 1.42 | 4.5 | 1.59 | 5.0 | 1.81 | 5.7 |
| Sample #3 | 80 | 40.6 | 1.42 | 3.5 | 1.59 | 3.9 | 1.66 | 4.1 |
| Sample #4 | 80 | 48.6 | 2.32 | 4.8 | 1.71 | 3.5 | 2.41 | 4.9 |
| Sample #5 | 80 | 55.8 | 2.14 | 3.8 | 1.73 | 3.1 | 2.34 | 4.2 |
| Sample #6 | 80 | 65.4 | 2.03 | 3.1 | 1.79 | 2.7 | 2.42 | 3.7 |
| Sample #7 | 80 | 69.7 | 2.02 | 2.9 | 1.99 | 2.9 | 2.55 | 3.7 |
| Sample #8 | 80 | 92.8 | 2.52 | 2.7 | 2.02 | 2.2 | 3.40 | 3.7 |
| Sample #9 | 80 | 134.6 | 2.97 | 2.2 | 2.69 | 2.0 | 3.87 | 2.9 |
| Very lowSample #1 | 80 | 9.4 | 1.22 | 13.0 | 0.98 | 10.4 | 1.31 | 14.0 |
| Very lowSample #2 | 80 | 11.2 | 1.58 | 14.2 | 0.88 | 7.9 | 1.55 | 13.9 |
Linearity/Reportable Range
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To establish the linearity of the 25-OH Vitamin D assay, a study design was used based on the CLSI protocol EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline.
Eleven levels of linearity were prepared by diluting a high serum sample containing 147.8 ng/mL of 25-OH Vitamin D with Vitamin D-depleted serum (0 ng/mL, Seracare Life Sciences). These samples were tested with the Diazyme 25-OH Vitamin D assay, in triplicates. The results were processed using the EP Evaluator Software (Version 8.0) parameterized to an allowable systematic error of 8.9%. The assay was found to be linear between 7.6 ng/mL and 147.8 ng/mL.
LoB/LoD/LoO
The Limit of Blank (LoB), the Limit of Detection (LoD) and the Limit of Quantitation (LoQ) of the Diazyme 25-OH Vitamin D assay on microplate were determined according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation. The following are the limits determined with the Diazyme 25-OH Vitamin D Assay:
LoB = 2.0 ng/mL
LoD = 3.5 ng/mL
LoQ = 7.6 ng/mL
Analytical specificity
Interference Study
The Diazyme 25-OH Vitamin D Assay was subjected to an interference study according the CLSI EP7-A2 protocol. The following substances normally present in the blood produced less than 10% deviation when tested at levels equal to the concentrations listed below:
| Interference | Concentration |
|---|---|
| Conjugated Bilirubin | 40 mg/dL |
| Free Bilirubin | 40 mg/dL |
| Hemoglobin | 100 mg/dL |
| Ascorbic Acid | 176 mg/dL |
| Triglycerides | 750 mg/dL |
| Uric Acid | 20 mg/dL |
| Biotin | 2 mg/dL |
| Human Serum Albumin | 9 g/dL |
| N-Acetyl Cysteine Amide | 1663 ng/mL |
| Ampicillin | 1000 ng/mL |
| Cyclosporine C | 105 ng/mL |
| Cefoxitin | 660 ng/mL |
| Acetylsalicylic Acid | 1000 ng/mL |
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| Rifampicin | 64 ng/mL |
|---|---|
| Acetaminophen | 200 ng/mL |
| Ibuprofen | 500 ng/mL |
| Theophylline | 100 ng/mL |
Cross Reactivity
Cross-reactivity of the Diazyme 25-OH Vitamin D Assay was determined by adding Vitamin D metabolites to serum pool samples. Based on the results in the table below, the assay did not cross react with Vitamin D2 and Vitamin D3 and the assay recovers both 25-OH Vitamin D2 and 25-OH Vitamin D3 similarly. Cross-reactivity with various Vitamin D metabolites is summarized in the table below:
| Compound | Concentration tested (ng/mL) | Cross-reactivity |
|---|---|---|
| 25-OH Vitamin D3 | 44.0 | 100% |
| 25-OH Vitamin D2 | 44.0 | 92.3% |
| Vitamin D3 | 44.0 | 1.0% |
| Vitamin D2 | 44.0 | 2.9% |
| 1,25-(OH)2 Vitamin D3 | 2.9 | 2.5% |
| 1,25-(OH)2 Vitamin D2 | 2.9 | -1.5% |
| 24R,25-(OH)2 Vitamin D3 | 41.0 | 5.1% |
| 3-epi-25-OH Vitamin D3 | 42.0 | 61.7% |
| 3-epi-25-OH Vitamin D2 | 42.0 | 55.1% |
% Cross-reactivity = (Corrected Assay Value /Concentration Spiked) 100
No significant cross-reactivity (4.1%) was found for Paricalcitol (Zemplar®) up to 25ng/mL.
Comparison Studies
Method Comparison
Human serum samples were tested with the Diazyme 25-OH Vitamin D Assay and the obtained results were compared to the predicate method. A total of 98 unaltered serum samples were used in this experiment. Using this study, we found that the Diazyme 25-OH Vitamin D Assay correlated with the predicate method with the following results:
| Deming Regression Analysis | 95% Confidence Interval |
|---|---|
| Slope | 1.005 (0.969 to 1.041) |
| Intercept | -0.21 (-2.15 to 1.73) |
| Correlation Coefficient | 0.984 (0.976 to 0.989) |
| Range | 9.5-140.9 |
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Matrix Comparison
To evaluate the effect of anticoagulants, the Diazyme 25-OH Vitamin D Assay was used to measure the 25-0H Vitamin D concentrations of matched sets of serum, K3-EDTA plasma and Li-Heparin plasma. The reported values for each sample and for each matrix were obtained from single measurements. The total number of matched sets tested was 66. In order to cover the claimed measuring range for each matrix, seven spiked patient samples were included in the study.
Linear regression of the "Li-Heparin plasma versus Serum" data yielded the following results: y = 0.9657 x - 0.6596 and R2 = 0.9736.
Linear regression of the "K3-EDTA plasma versus Serum" data vielded the following results: y = 0.9948x - 0.7057 and R2 = 0.9866.
Reference Range Study
To determine a reference range for the Diazyme 25-OH Vitamin D Assay, the 25-OH Vitamin D serum concentrations of a US population of 157 apparently healthy individuals were measured with the Diazyme method. The individual patient serum samples used in this study were obtained from certified commercial sources. Forty seven (47) samples from Pennsylvania (Northern U.S.) were collected from an FDA Licensed Donor Center with informed consent. Fifty six (56) samples from Tennessee (Central U.S.) and Fifty four (54) samples from Texas (Southern U.S.) were collected according to an IRB approved protocol.
All participating individuals met the following inclusion conditions:
- The age of all individuals was within the 21-80 years old range. .
- Individuals were from three different geographical locations: 47 from Pennsylvania . (Northern US), 56 from Tennessee (Central US) and 54 from Texas (Southern US).
- All samples were collected during the months of October and November (fall season). ●
- The studied population consisted of 72 light skin individuals (46%) and 85 dark skin in-. dividuals (54%).
- 155 individuals (98.7%) did not take any artificial Vitamin D supplements. Two individ-. uals (1.3%) did take some Vitamin D supplements but did not exceed the daily dose of 2000 IU.
- All 157 individuals did not have any family history of parathyroid or calcium regulatory . disease.
- . All 157 individuals did not have any history of kidney disease. GI disease, calcium-levels related disease, thyroid disease, parathyroid disease, calcium related disease, seizures, chronic disease or bariatric surgery.
- All 157 individuals were not currently taking any medications that are known to affect . absorption or catabolism of Vitamin D (including cholesterol absorption inhibitors such as Vytorin®, Inegy™ or Zetia; anticonvulsants such as Neurontin, Depakine® and Trileptal: glucocorticoids such as Cortisol, Prednisone and Dexamethasone; HAART (AIDS treatment) or antirejection medications.
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Analysis of the reference range study data vielded the following results:
- Lowest 25-OH Vitamin D concentration: 12.6 ng/mL. .
- Highest 25-OH Vitamin D concentration: 51.4 ng/mL. .
- . Median 25-OH Vitamin D concentration: 25.6 ng/mL
- . Observed range (2.5th to 97.5th percentile): 15.0 to 45.9 ng/mL.
Conclusion
The Diazyme 25-OH Vitamin D assay has a linear range of 7.6 - 147.8 ng/mL for serum samples. For samples with Vitamin D levels ranging from 23.1 ng/mL to 134.6 ng/mL; within-run CVs were 1.8 to 8.8% and total CVs were 2.1 to 8.8%. For 98 tested serum samples, Deming regression yielded a correlation coefficient between the Diazyme 25-OH Vitamin D assay and the Diasorin Liaison® 25-OH Vitamin D Total assay was 0.984, the slope was 1.005, and the v intercept was -0.21. Interference studies demonstrated that this assay was not significantly affected by triglycerides (up to 750 mg/dL), ascorbic acid (up to 176mg/dL), free bilirubin (up to 40 mg/dL), conjugated bilirubin (up to 40 mg/dL) and hemoglobin (up to 100 mg/dL).
The Diazyme 25-OH Vitamin D Assay and the Diazyme 25-OH Vitamin D Control data presented and provided is complete and supports the basis for substantial equivalence to the predicate device.
References
-
- Wacker M, Holick MF. Sunlight and Vitamin D: A global perspective for health. Dermatoendocrinol. 2013, 5, 51-108.
-
- National Osteoporosis Foundation. Prevention Vitamin D. http://www.nof.org/aboutosteoporosis/prevention/vitamind
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
DIAZYME LABORATORIES ABHIJIT DATTA DIRECTOR, TECHNICAL OPERATIONS 12889 GREGG COURT POWAY CA 92064
Re: K133410
Trade/Device Name: Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control Set Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Il Product Code: MRG, JJX Dated: February 10, 2014 Received: February 12, 2014
Dear Dr. Datta:
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 Parts 801 and 809); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/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 vours.
Courtney H. Lias -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133410
Device Name
Diazyme 25-0H Vitamin D Assay and Diazyme 25-0H Vitamin D Control set
Indications for Use (Describe)
The Diazyne 25-OH Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of 25hydroxywiamin D (25-OH-D) in human serum and plasma on automated chemistry analyzer. Measurement of 25-hydroxy wiamin D (25-OH-D) is for assessment of vitamin D sufficiency. For in vitro diagnostic use only.
The 25-0H Vitamin D Control Ser is intended for use as quality controls for Diazyne 25-0H Viamin D Assay Kit only. For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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.