(127 days)
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No
The device description details a direct competitive colorimetric immunoassay based on enzyme activity and absorbance measurements. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis relies on standard biochemical principles and calibration curves.
No
This device is an in vitro diagnostic assay used for the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to assess vitamin D sufficiency, not for treating or preventing a disease.
Yes
The device quantitatively determines 25-hydroxyvitamin D (25-OH-D) levels in human serum and plasma, which is for "assessment of vitamin D sufficiency." This measurement provides information used to diagnose vitamin D deficiency or sufficiency. The device is also explicitly stated for "in vitro diagnostic use only."
No
The device is an in vitro diagnostic assay kit that utilizes chemical reactions and is intended for use on automated chemistry analyzers, indicating it is a hardware-dependent system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use only" for both the assay and the control set. It also describes the intended use as "quantitative determination of 25hydroxywiamin D (25-OH-D) in human serum and plasma on automated chemistry analyzer" for "assessment of vitamin D sufficiency," which are all characteristics of an IVD.
- Device Description: The description details a laboratory assay that analyzes biological samples (serum and plasma) to measure a specific analyte (25-OH vitamin D). This is the core function of an IVD.
- Intended User/Care Setting: The intended user is "clinical laboratories," which is a typical setting for the use of IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JJX
Device Description
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 beta-galactosidase 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.
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
The age of all individuals was within the 21-80 years old range.
Intended User / Care Setting
Intended for use in clinical laboratories.
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)
Precision Study:
- Study Type: Evaluated according to CLSI EP5-A guideline.
- Sample Size: 11 precision levels: Two serum controls (23.1 ng/mL and 45.7 ng/mL) and nine serum samples distributed across the dynamic range. 80 data points obtained per specimen.
- Key Results:
- Control #1: Mean 23.1 ng/mL, total SD 1.68 ng/mL, total CV 7.3%.
- Control #2: Mean 45.7 ng/mL, total SD 2.12 ng/mL, total CV 4.6%.
- Samples #1-9: Total CVs ranged from 2.9% to 6.4%.
- Very low Sample #1: Mean 9.4 ng/mL, total SD 1.31 ng/mL, total CV 14.0%.
- Very low Sample #2: Mean 11.2 ng/mL, total SD 1.55 ng/mL, total CV 13.9%.
Linearity/Reportable Range:
- Study Type: Based on CLSI protocol EP6-A.
- Sample Size: Eleven levels of linearity, prepared by diluting a high serum sample (147.8 ng/mL) with Vitamin D-depleted serum (0 ng/mL).
- Key Results: Assay was found to be linear between 7.6 ng/mL and 147.8 ng/mL.
LoB/LoD/LoQ:
- Study Type: Determined according to CLSI EP17-A.
- Key Results: LoB = 2.0 ng/mL, LoD = 3.5 ng/mL, LoQ = 7.6 ng/mL.
Interference Study:
- Study Type: According to CLSI EP7-A2 protocol.
- Key Results: Less than 10% deviation from various substances at specified concentrations (e.g., Conjugated Bilirubin 40 mg/dL, Hemoglobin 100 mg/dL, Triglycerides 750 mg/dL).
Cross Reactivity:
- Study Type: Determined by adding Vitamin D metabolites to serum pool samples.
- Key Results:
- 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%
- No significant cross-reactivity (4.1%) for Paricalcitol up to 25ng/mL.
Method Comparison:
- Study Type: Comparison with predicate method.
- Sample Size: 98 unaltered serum samples.
- Key Results:
- Deming Regression Analysis: 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
Matrix Comparison:
- Study Type: Evaluate effect of anticoagulants.
- Sample Size: 66 matched sets of serum, K3-EDTA plasma, and Li-Heparin plasma.
- Key Results:
- Li-Heparin plasma versus Serum: y = 0.9657 x - 0.6596 and R2 = 0.9736.
- K3-EDTA plasma versus Serum: y = 0.9948x - 0.7057 and R2 = 0.9866.
Reference Range Study:
- Sample Size: 157 apparently healthy individuals from the US.
- Key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy, precision, linearity, limits of detection/quantitation, interference, and cross-reactivity are reported instead)
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.
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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).
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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.
0
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 Court |
| Poway, CA 92064 | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Director, Technical Operations | |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Email: abhijit.datta@diazyme.com | |
| Phone: 858-455-4762 | |
| Fax: 858-455-2120 | |
| Date the Summary was Prepared: | November 04, 2013 |
| Name of the Device | Diazyme 25-OH Vitamin D Assay Kit |
| Diazyme 25-OH Vitamin D Control Set | |
| Trade Name: | Diazyme 25-OH Vitamin D Assay |
| Diazyme 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 System |
| JJX – Single (specified) Analyte Controls (Assayed and | |
| Unassayed) | |
| Panel: | Chemistry (75) |
| Submission Type | 510k |
1
| Regulation Number | 21 CFR 862.1825 - Vitamin D Test System
21 CFR 862.1660 - Quality Control material (Assayed
and Un-assayed) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II (Assay)
I (Control) |
| Predicate Device: | The Diazyme 25-OH Vitamin D Assay Kit and Control
Set is substantially equivalent to the currently marketed
LIAISON® 25-OH Vitamin D TOTAL Assay
(K112725, K071480). |
| Manufacturing Address | Diazyme Laboratories
12889 Gregg Court
Poway, CA 92064
USA |
| 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.
2
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 D | |
| quantification 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 against | |
| 25-OH Vitamin D, protein, phosphate buffer, Dilution buffer: | |
| Sheep Antibody against 25-OH Vitamin D, pro- | |
| teins, phosphate buffer, Assay Buffer: | |
| Buffer with 10% ethanol, surfactants and preserva- | |
| tives. | Reagent R1: |
| Proprietary dissociation solution with surfactants | |
| and preservatives. | |
| Conjugate: | |
| 25-OH Vitamin D conjugated to an isoluminol | |
| derivative, 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 |