(189 days)
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No
The summary describes a standard immunoassay and analyzer with no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is an immunoassay intended for quantitative determination of vitamin D metabolites, used as an aid in assessing vitamin D sufficiency. It is a diagnostic tool, not a therapeutic device.
Yes
The FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D, which is used as an aid in assessing vitamin D sufficiency. This measurement provides information that helps in the diagnosis or assessment of a medical condition.
No
The device description clearly outlines a complex immunoassay process involving chemical reactions, reagents, and a physical analyzer (FastPack® Analyzer) to measure luminescence. This is a hardware-based system with associated reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the FastPack® Vitamin D Immunoassay is intended for the quantitative determination of substances (total 25-hydroxyvitamin D and other hydroxylated metabolites) in human specimens (serum and plasma). It also states it is to be used as an aid in the assessment of vitamin D sufficiency in adults. This aligns directly with the definition of an in vitro diagnostic product, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details a laboratory test method (competitive immunoassay) performed on human samples using reagents and an analyzer.
- Performance Studies: The document includes performance studies (Precision, Limits of blank, detection, and quantitation, Linearity, Cross-reactivity, Interferences, Serum and plasma equivalence, Expected Values/Reference Intervals, Method Comparison) which are typical for the validation of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K112725) indicates a comparison to a previously cleared IVD device, which is a common regulatory pathway for new IVDs.
All these elements strongly indicate that the FastPack® Vitamin D Immunoassay and its associated components (Calibrator Kit, Control Kit, Method Verification Kit, and Analyzer) are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer.
The FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
FastPack® Vitamin D Control Kit is used for quality control of the FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
FastPack® Vitamin D Method Verification Kit is used in the quantitative verification of calibration and assay range of the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JIT, JJX
Device Description
The FastPack® Vitamin D Immunoassay employs a competitive immunoassay principle. Endogenous Vitamin D in a patient sample, calibrator, control, or verifier is mixed with pretreatment buffer then added into a FastPack® reagent pack. In the reagent pack, the pre-treated Vitamin D sample binds with a monoclonal (mouse) anti-Vitamin D antibody covalently linked to alkaline phosphatase (ALP). After incubation, a conjugate of Vitamin D-Biotin linked to streptavidin coated paramagnetic particles is added. Monoclonal anti-Vitamin D antibody-ALP conjugate not reacted with Vitamin D in the sample will bind to unoccupied binding sites of the Vitamin D-biotin conjugate bound to the streptavidin paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-Vitamin D monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N.Ndimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are inversely proportional to the concentration of Vitamin D in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.
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
Adults (21-90 years of age for reference interval study)
Intended User / Care Setting
Professional use
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: Precision evaluation following CLSI EP5-A2 guidance.
- Sample Size: 160 replicate determinations of each sample (80 replicates per lot/analyzer) for four samples.
- Key Results:
- Sample 1 (Average 27.3 ng/mL) on Analyzer 1, Reagent Lot 1: Total %CV = 13.4
- Sample 2 (Average 31.1 ng/mL) on Analyzer 1, Reagent Lot 1: Total %CV = 12.1
- Sample 3 (Average 45.5 ng/mL) on Analyzer 1, Reagent Lot 1: Total %CV = 9.5
- Sample 4 (Average 84.9 ng/mL) on Analyzer 1, Reagent Lot 1: Total %CV = 6.1
- Sample 1 (Average 25.9 ng/mL) on Analyzer 2, Reagent Lot 2: Total %CV = 15.1
- Sample 2 (Average 32.7 ng/mL) on Analyzer 2, Reagent Lot 2: Total %CV = 12.7
- Sample 3 (Average 46.1 ng/mL) on Analyzer 2, Reagent Lot 2: Total %CV = 7.9
- Sample 4 (Average 76.4 ng/mL) on Analyzer 2, Reagent Lot 2: Total %CV = 4.7
Limits of Blank, Detection, and Quantitation:
- Study Type: Determined according to CLSI EP17-A.
- Key Results:
- LOB = 2.3 ng/mL
- LOD = 6.2 ng/mL
- LOQ = 12.9 ng/mL
Linearity Study:
- Study Type: Linearity determined following CLSI EP6-A.
- Key Results: Linearity range found to extend from LOQ (12.9 ng/mL) to 150.0 ng/mL.
Cross-reactivity Study:
- Study Type: Tested with potential cross-reacting compounds.
- Key Results: % Cross-Reactivity: Vitamin D2 (2.0), Vitamin D3 (1.9), 1,25-(OH)2-Vitamin D2 (4.0), 1,25-(OH)2-Vitamin D3 (9.8), 3-epi-25(OH) Vitamin D3 (7.8), 25 (OH) Vitamin D2 (93.0), 25 (OH) Vitamin D3 (106.0), Paricalcitol (-1.2), 24, 25 (OH)2 Vitamin D2 (-0.9), 24, 25 (OH)2 Vitamin D3 (117.4).
Interferences Study:
- Study Type: Tested for interference from common blood substances.
- Key Results: No interference found at noted concentrations for Bilirubin, Biotin, Cholesterol, Total Protein, Hemoglobin, and Lipids.
Serum and plasma equivalence Study:
- Study Type: Comparison of measurements in serum, EDTA plasma, and lithium-heparin plasma.
- Sample Size: 32 volunteers.
- Key Results: Indicated equivalence between the three matrices.
- Serum vs EDTA plasma: Slope = 0.993, y-intercept = -6.3, R = 0.979.
- Serum vs lithium-heparin plasma: Slope = 0.970, y-intercept = -0.7, R = 0.971.
Expected Values/Reference Intervals Study:
- Study Type: Determination of a reference interval.
- Sample Size: 367 subjects.
- Data Source: Acquired from 4 different sources representing 5 different geographic regions of the United States.
- Key Results: Reference interval of 13.7 - 57.3 ng/mL based on the non-parametric 2.5th - 97.5th percentiles. Mean: 27.6 ng/mL, Median: 24.2 ng/mL.
Method Comparison Study:
- Study Type: Comparison with the predicate method.
- Sample Size: 137 samples.
- Key Results: FastPack® Vitamin D Immunoassay correlated well with the predicate method with correlation coefficient (R) of 0.92, slope = 0.97, and y-intercept = - 4.6 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LOB, LOD, LOQ, %CV, Slope, y-intercept, R (correlation coefficient), % Cross-Reactivity, % Bias, Mean, Median, Percentiles.
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
JUL 0 3 2013
This 510(k) Summary information is submitted in accordance with the requirements of 21 CFR § 807.92.
510(k) Number: K123983
Submitter:
Qualigen, Inc. 2042 Corte Del Nogal, Suite B Carlsbad, CA 92009
| Telephone: | (760) 918-9165 |
|---|---|
| Facsimile: | (760) 918-9127 |
Date Prepared:
June 27, 2013
Contact Person:
Mr. Michael Poirier Senior Vice President, Chief Technical Officer, Chief Scientific Officer Telephone: (760) 918-9165 x227 (760) 918-9127 Facsimile: Email: mpoirier@qualigeninc.com
Device Identification
| Trade Names: | FastPack® Vitamin D Immunoassay |
|---|---|
| FastPack® Vitamin D Calibrator Kit | |
| FastPack® Vitamin D Control Kit | |
| FastPack® Vitamin D Method Verification Kit |
- Common Names: Vitamin D Assay Vitamin D Calibrator Vitamin D Controls Vitamin D Verifiers
Classification names: System, Test, Vitamin D Calibrator Quality control material (assayed and unassayed)
Revised 510(k) Summary of Safety and Effectiveness
1
Classifications:
Class II (assay) Class II (calibrators) Class I. reserved (controls) Class I. reserved (verifiers)
Panel:
Chemistry (75)
Product Codes:
MRG - Vitamin D test system JIT - Calibrator, Secondary JJX - Single (specified) Analyte Controls (Assayed and Unassayed)
Regulation Numbers: 21 CFR § 862.1825 - Vitamin D test system 21 CFR § 862.1150 - Calibrator 21 CFR & 862.1660 - Quality control material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed
LIAISON® 25 OH Vitamin D TOTAL Assay DiaSorin Inc. 1951 Northwestern Avenue PO Box 285 Stillwater, MN 55082-0285 K112725
Device Description
The FastPack® Vitamin D Immunoassay employs a competitive immunoassay principle. Endogenous Vitamin D in a patient sample, calibrator, control, or verifier is mixed with pretreatment buffer then added into a FastPack® reagent pack. In the reagent pack, the pre-treated Vitamin D sample binds with a monoclonal (mouse) anti-Vitamin D antibody covalently linked to alkaline phosphatase (ALP). After incubation, a conjugate of Vitamin D-Biotin linked to streptavidin coated paramagnetic particles is added. Monoclonal anti-Vitamin D antibody-ALP conjugate not reacted with Vitamin D in the sample will bind to unoccupied binding sites of the Vitamin D-biotin conjugate bound to the streptavidin paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-Vitamin D monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N.Ndimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to
2
indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are inversely proportional to the concentration of Vitamin D in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.
Intended Use
FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer.
The FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
FastPack® Vitamin D Control Kit is used for quality control of the FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
FastPack® Vitamin D Method Verification Kit is used in the quantitative verification of calibration and assay range of the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
3
Comparison of new device to predicate devices
Similarities between FastPack® and LIAISON® Vitamin D Assays
| CHARACTERISTIC | Qualigen FastPack® Vitamin D Immunoassay | DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay (K112725) |
|---|---|---|
| Intended Use/ Indications for Use | for the in-vitro quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Assay is intended for use with the FastPack® Analyzer. | for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population. |
| Sample Type | Serum or plasma (lithium-
heparin or EDTA) | Serum only |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Preparation | Standard processing for serum
or plasma | Standard processing for
serum |
| Assay principle | Chemiluminescence | Chemiluminescence |
| Approximate run time | 10 minutes | 20 minutes |
| Interpretation of
Results | Standard Curve | Standard Curve |
| Reagent Storage
Temperature | 2-8 °C | 2-8 °C |
| Methodology | The FastPack® Vitamin D
Immunoassay is a direct
competitive chemiluminescence
immunoassay employing
paramagnetic particles. | The DiaSorin LIAISON 25
OH Vitamin D TOTAL
Assay is a direct competitive
chemiluminescence
immunoassay employing
paramagnetic particles. |
| Testing Environment | Professional use | Professional use |
| Precision | Within-run: ≤ 15.1
Between-run: ≤ 4.9%
Total: ≤ 15.1 | Within-run: ≤ 7.7%
Between-run: ≤ 3.2%
Total: ≤ 12.6% |
| Linearity | Assay linear from LOQ (12.9
ng/mL) to 150 ng/mL | Assay linear from LOQ (4.0
ng/mL) to 150 ng/mL |
| Interfering Substances | No interference from high
levels of bilirubin, hemoglobin | No interference from high
levels of bilirubin |
Revised 510(k) Summary of Safety and Effectiveness
4
| | cholesterol, lipids, total protein,
and biotin | hemoglobin, triglycerides,
uric acid, IgG, albumin, and
cholesterol |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cross-reactivity | ~100% cross-reactivity with
25-OH D2, 25-OH D3, and
24,25-(OH)2-Vitamin D3;