(189 days)
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.
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.
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.
The Qualigen FastPack® Vitamin D Immunoassay is an in-vitro diagnostic device intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma, to be used as an aid in the assessment of vitamin D sufficiency in adults. The device demonstrated substantial equivalence to the LIAISON® 25 OH Vitamin D TOTAL Assay (K112725). The following information details its acceptance criteria and supporting studies.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly derived from the comparative performance against the predicate device (DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay) and established clinical laboratory guidelines for precision, linearity, limits of detection/quantitation, cross-reactivity, and interference. While explicit acceptance criteria values are not provided in all sections, the reported performance is presented to demonstrate that the device functions comparably or within reasonable assay limits.
| Performance Metric | Acceptance Criteria (Implicitly from Predicate / Guidelines) | Reported Device Performance (FastPack® Vitamin D Immunoassay) |
|---|---|---|
| Precision | Within-Run: ≤ 15.1% (Predicate: ≤ 7.7%) | |
| Sample 1 | N/A | 10.2% CV (Analyzer 1, Lot 1); 15.1% CV (Analyzer 2, Lot 2) |
| Sample 2 | N/A | 10.7% CV (Analyzer 1, Lot 1); 11.2% CV (Analyzer 2, Lot 2) |
| Sample 3 | N/A | 8.5% CV (Analyzer 1, Lot 1); 7.5% CV (Analyzer 2, Lot 2) |
| Sample 4 | N/A | 4.8% CV (Analyzer 1, Lot 1); 4.1% CV (Analyzer 2, Lot 2) |
| Total Precision (Inter-assay) | ≤ 15.1% (Predicate: ≤ 12.6%) | |
| Sample 1 | N/A | 13.4% CV (Analyzer 1, Lot 1); 15.1% CV (Analyzer 2, Lot 2) |
| Sample 2 | N/A | 12.1% CV (Analyzer 1, Lot 1); 12.7% CV (Analyzer 2, Lot 2) |
| Sample 3 | N/A | 9.5% CV (Analyzer 1, Lot 1); 7.9% CV (Analyzer 2, Lot 2) |
| Sample 4 | N/A | 6.1% CV (Analyzer 1, Lot 1); 4.7% CV (Analyzer 2, Lot 2) |
| Limit of Blank (LOB) | N/A | 2.3 ng/mL |
| Limit of Detection (LOD) | N/A | 6.2 ng/mL |
| Limit of Quantitation (LOQ) | N/A | 12.9 ng/mL |
| Linearity Range | Predicate: LOQ (4.0 ng/mL) to 150 ng/mL | LOQ (12.9 ng/mL) to 150.0 ng/mL |
| Cross-reactivity | <10% for non-25OH-D metabolites | |
| 25 (OH) Vitamin D2 | ~100% (Predicate: ~100%) | 93.0% |
| 25 (OH) Vitamin D3 | ~100% (Predicate: ~100%) | 106.0% |
| 1,25-(OH)2-Vitamin D2 | <10% (Predicate: <10%) | 4.0% |
| 1,25-(OH)2-Vitamin D3 | <10% (Predicate: <10%) | 9.8% |
| Vitamin D2 | <10% (Predicate: <10%) | 2.0% |
| Vitamin D3 | <10% (Predicate: <10%) | 1.9% |
| 3-epi-25(OH) Vitamin D3 | <10% (Predicate: <10%) | 7.8% |
| Non-interference (at stated concentrations) | No significant interference | Confirmed for Bilirubin (40 mg/dL), Biotin (1000 ng/mL), Cholesterol (500 mg/dL), Total Protein (10.7 g/dL), Hemoglobin (500 mg/dL), Lipids (250 mg/dL) |
| Serum/Plasma Equivalence | Strong correlation (R>0.9) and acceptable bias | Serum vs. EDTA Plasma: R=0.979, Slope=0.993, y-int=-6.3; Serum vs. Lithium-Heparin Plasma: R=0.971, Slope=0.970, y-int=-0.7 |
| Method Comparison (vs. Predicate) | Correlation coefficient (R) > 0.9, Slope close to 1, small y-intercept | N=137; R = 0.92 (0.90-0.94 CI), Slope = 0.97 (0.88-1.06 CI), y-intercept = -4.6 (-8.9 to -0.25 CI) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study: 4 samples tested in duplicate on two analyzers, with two reagent lots, over 20 days. This resulted in 160 replicate determinations for each sample (80 replicates per lot/analyzer).
- LOB/LOD/LOQ Determination: Specific sample size not explicitly stated but conducted according to CLSI EP17-A.
- Linearity Study: A high patient sample was intermixed with a low sample to generate 9 concentration levels, each tested in duplicate. Specific number of patient samples not explicitly stated.
- Cross-reactivity Study: Two samples (low and high Vitamin D concentrations) were tested with and without added potential cross-reacting compounds. Specific number of samples per compound not explicitly stated.
- Interference Study: Specific number of samples not explicitly stated; substances were tested at noted concentrations.
- Serum and Plasma Equivalence: 32 volunteers provided blood samples (serum, EDTA plasma, lithium-heparin plasma).
- Expected Values/Reference Intervals: 367 subjects.
- Method Comparison: 137 human serum samples.
Data Provenance:
The document does not explicitly state the country of origin for all samples. However, for the "Expected Values/Reference Intervals" study, serum samples from 367 subjects were acquired from 4 different sources representing 5 different geographic regions of the United States. This suggests at least a portion of the clinical data is from the US. The studies are prospective in nature, designed specifically to evaluate the device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not describe the use of human experts to establish "ground truth" for the test sets in the traditional sense of diagnostic image interpretation. This device is a quantitative immunoassay. The "ground truth" for method comparison and equivalence studies is established by comparison to a legally marketed predicate device (LIAISON® 25 OH Vitamin D TOTAL Assay) or by highly controlled analytical methods (e.g., for linearity, LOB/LOD/LOQ, cross-reactivity, interference). Therefore, the concept of "experts" and their qualifications for establishing ground truth as in imaging studies is not directly applicable here. The accuracy of measurements on the predicate device or the analytical standards used would serve as the reference.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative immunoassay, the "adjudication method" in the context of expert consensus (e.g., 2+1, 3+1) is not relevant. The results are quantitative values derived from the immunoassay and compared against analytical standards, reference methods, or statistical criteria.
5. 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 device is a laboratory immunoassay for quantitative measurement of Vitamin D, not an AI-based diagnostic imaging or interpretive tool requiring human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The performance studies described are inherently "standalone" in the context of the device's function. The FastPack® Vitamin D Immunoassay, run on the FastPack® Analyzer, provides a quantitative result. The studies assess the analytical performance of this automated system directly (e.g., precision, linearity, limits, interference, method comparison with a predicate device), without human interpretive input affecting the direct measurement output. The human involvement would be in operating the instrument and interpreting the resulting quantitative value in a clinical context, which is outside the scope of the device's standalone analytical performance.
7. The Type of Ground Truth Used
The ground truth used for various studies includes:
- Predicate Device Measurements: For the method comparison study, results from the LIAISON® 25 OH Vitamin D TOTAL Assay (K112725) were used as the reference "ground truth" for comparison.
- Reference Standards/Known Concentrations: For linearity, LOB/LOD/LOQ, cross-reactivity, and interference studies, the "ground truth" is established by using samples with known, carefully prepared, or spiked concentrations of analytes and interfering substances.
- Paired Sample Measurements: For serum/plasma equivalence, the "ground truth" is the quantitative value obtained from one matrix (e.g., serum) against which measurements from another matrix (e.g., plasma) are compared.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional immunoassay, not an AI/machine learning model that typically requires a "training set." The development of the assay involves chemical and biological optimization, not algorithm training on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set (in the AI/ML sense) was used for this traditional immunoassay device.
{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 serumor plasma | Standard processing forserum |
| Assay principle | Chemiluminescence | Chemiluminescence |
| Approximate run time | 10 minutes | 20 minutes |
| Interpretation ofResults | Standard Curve | Standard Curve |
| Reagent StorageTemperature | 2-8 °C | 2-8 °C |
| Methodology | The FastPack® Vitamin DImmunoassay is a directcompetitive chemiluminescenceimmunoassay employingparamagnetic particles. | The DiaSorin LIAISON 25OH Vitamin D TOTALAssay is a direct competitivechemiluminescenceimmunoassay employingparamagnetic particles. |
| Testing Environment | Professional use | Professional use |
| Precision | Within-run: ≤ 15.1Between-run: ≤ 4.9%Total: ≤ 15.1 | Within-run: ≤ 7.7%Between-run: ≤ 3.2%Total: ≤ 12.6% |
| Linearity | Assay linear from LOQ (12.9ng/mL) to 150 ng/mL | Assay linear from LOQ (4.0ng/mL) to 150 ng/mL |
| Interfering Substances | No interference from highlevels of bilirubin, hemoglobin | No interference from highlevels of bilirubin |
Revised 510(k) Summary of Safety and Effectiveness
{4}------------------------------------------------
| cholesterol, lipids, total protein,and biotin | hemoglobin, triglycerides,uric acid, IgG, albumin, andcholesterol | |
|---|---|---|
| Cross-reactivity | ~100% cross-reactivity with25-OH D2, 25-OH D3, and24,25-(OH)2-Vitamin D3;<10% cross-reactivity withVitamin D2, Vitamin D3, 1,25-(OH)2-Vitamin D2, 1,25-(OH)2-Vitamin D3, 3-epi-25(OH) Vitamin D3, 24,25-(OH)2-Vitamin D2, andParicalcitol | ~100% cross-reactivity with25 OH D2, 25 OH D3; <10%cross-reactivity with VitaminD2, Vitamin D3, 3-epi-25OHVitamin D3, 1,25-(OH)2-Vitamin D2, and 1,25-(OH)2-Vitamin D3 |
| Comparative TestingvsEstablished Methods | N = 137Range of observations:18.6 to 132.6 ng/mLDeming regression toLIAISON:Slope (95% CI): 0.97 (0.88-1.06)y (95% CI): -4.6 (-8.9 to -0.25)R (95% CI) = 0.92 (0.90-0.94)Svlx = 10.3 | N = 587Range of observations:4.0 to 150.0 ng/mLLinear regression toradioimmunoassay:Slope (95% CI): 1.047 (1.02-1.07)Y (95% CI): 2.41 (1.43-3.40)R = 0.936 |
Differences between FastPack® and LIAISON® Vitamin D Assays
| CHARACTERISTIC | Qualigen FastPack®Vitamin D Immunoassay | DiaSorin LIAISON®25 OH Vitamin DTOTAL Assay(K112725) |
|---|---|---|
| Platform | FastPack® Analyzer | LIAISON® Analyzer |
| Assay procedure | Automated | Automated |
| Traceability | Internal standards (9 levels) assignedbased on patient correlation withLIAISON® 25 OH Vitamin DTOTAL Assay. | Standardized using UVquantification of 25-(OH) Vitamin D |
.
:
{5}------------------------------------------------
| CHARACTERISTIC | Qualigen FastPack®Vitamin D Calibrator Kit | DiaSorin LIAISON®25 OH Vitamin DTOTAL Assay(K112725) |
|---|---|---|
| Intended Use/Indicationfor Use | For in-vitro diagnostic use incalibrating FastPack® Vitamin DImmunoassay | Similar |
| Storage temperature | 2-8 °C | 2-8 °C in the dark |
| Matrix | Human serum-based matrixcontaining preservative andstabilizers | Human serum-basedmatrix containingpreservative |
Similarities between FastPack® and LIAISON® Vitamin D Calibrators
Differences between FastPack® and LIAISON® Vitamin D Calibrators
| CHARACTERISTIC | Qualigen FastPack®Vitamin D Calibrator Kit | DiaSorin LIAISON®25 OH Vitamin DTOTAL Assay(K112725) |
|---|---|---|
| Antigen used in calibrators | No antigen present | Antigen present |
| Number of calibrators | 1 | 2 |
| Open vial stability | 60 days | 4 weeks |
Similarities between FastPack® and LIAISON® Vitamin D Controls
| CHARACTERISTIC | Qualigen FastPack®Vitamin D Control Kit | DiaSorin LIAISON® 25 OHVitamin D TOTAL Assay(K112725) |
|---|---|---|
| Intended Use/Indicationfor Use | For in-vitro diagnostic use tomonitor the precision andaccuracy of the FastPack®Vitamin D Immunoassay onthe FastPack® Analyzer. | For use as assayed qualitycontrol samples to monitorthe accuracy and precision ofthe DiaSorin LIAISON® 25OH Vitamin D TOTALAssay. |
| Antigen used incontrols | 25-(OH) vitamin D | Same |
| Matrix | Human serum-based matrixcontaining preservative andstabilizers | Human serum-based matrixcontaining preservative |
| Number of levels | 2 | Same |
| Storage temperature | 2-8 °C | Same |
{6}------------------------------------------------
| CHARACTERISTIC | Qualigen FastPack®Vitamin D Control Kit | DiaSorin LIAISON® 25OH Vitamin D TOTALAssay (K112725) |
|---|---|---|
| Open vial stability | 30 days | No open vial stabilityclaimed |
es between EastPack® and IIAISON® Vitamin D Controls
Similarities between FastPack® and LIAISON® Vitamin D Verifiers
| CHARACTERISTIC | Qualigen FastPack®Vitamin D MethodVerification Kit | DiaSorin LIAISON® 25 OHVitamin D TOTAL Assay(K112725) |
|---|---|---|
| IntendedUse/Indication for Use | For in-vitro diagnostic useto monitor the precisionand accuracy of theFastPack® Vitamin DImmunoassay on theFastPack® Analyzer. | For use as assayed quality controlmaterials intended for in vitrodiagnostic use in the quantitativeverification of calibration andreportable range of the Liaison 25OH Vitamin D Total Assay whenperformed on the LiaisonAnalyzer. |
| Antigen used inVerifiers | 25-(OH) vitamin D | Same |
| Matrix | Human serum-basedmatrix containingpreservative andstabilizers | Human serum-based matrixcontaining preservative |
| Storage temperature | 2-8 °C | Same |
| Open vial stability | Single Use - NA | 4 weeks |
Differences between FastPack® and LIAISON® Vitamin D Verifiers
| CHARACTERISTIC | Qualigen FastPack®Vitamin D Method VerificationKit | DiaSorin LIAISON® 25OH Vitamin D TOTALAssay (K112725) |
|---|---|---|
| Number of levels | 3 | 4 |
Performance Summary
Precision
Precision was evaluated following the CLSI EP5-A2 guidance. Four samples with concentrations of ~25, ~30, ~45, and ~80 ng/mL were tested in duplicate determinations in each of two runs per day on each of two FastPack® Analyzers, each paired with an individual FastPack® Reagent lot over a period of 20 days to yield 160 replicate determinations of each sample (80 replicates per lot/analyzer). Within-run, between-run,
{7}------------------------------------------------
and between-day components of variation were calculated as well as total imprecision using a fully nested 2-way random factor ANOVA model with runs nested within days. The tables below present the results by instrument/reagent combination:
| Within-Run | Between-Run | Between-Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Average | SD | % CV | SD | % CV | SD | % CV | SD | % CV | |
| Sample 1 | 27.3 | 2.8 | 10.2 | 1.3 | 4.9 | 1.9 | 7.1 | 3.7 | 13.4 |
| Sample 2 | 31.1 | 3.3 | 10.7 | 0.0 | 0.0 | 1.8 | 5.7 | 3.8 | 12.1 |
| Sample 3 | 45.5 | 3.9 | 8.5 | 0.0 | 0.0 | 2.0 | 4.3 | 4.3 | 9.5 |
| Sample 4 | 84.9 | 4.1 | 4.8 | 0.0 | 0.0 | 3.2 | 3.7 | 5.1 | 6.1 |
Analyzer 1, Reagent Lot 1
Analyzer 2, Reagent Lot 2
| Average | Within-Run | Between-Run | Between-Day | Total | |||||
|---|---|---|---|---|---|---|---|---|---|
| SD | % CV | SD | % CV | SD | % CV | SD | % CV | ||
| Sample 1 | 25.9 | 3.9 | 15.1 | 0.0 | 0.0 | 0.0 | 0.0 | 3.9 | 15.1 |
| Sample 2 | 32.7 | 3.7 | 11.2 | 0.0 | 0.0 | 2.0 | 6.0 | 4.2 | 12.7 |
| Sample 3 | 46.1 | 3.5 | 7.5 | 0.0 | 0.0 | 1.2 | 2.6 | 3.7 | 7.9 |
| Sample 4 | 76.4 | 3.2 | 4.1 | 0.0 | 0.0 | 1.7 | 2.3 | 3.6 | 4.7 |
Limits of blank, detection, and quantitation
The Limit of Blank (LOB), the Limit of Detection (LOD), and the Limit of Quantitation (LOQ) of the FastPack® Vitamin D Immunoassay were determined according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation. The following are the limits determined:
LOB = 2.3 ng/mL LOD = 6.2 ng/mL LOQ = 12.9 ng/mL
Linearity
Linearity was determined following CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approved Guideline. A high patient sample was intermixed with a low sample to generate 9 concentration levels each tested in duplicate determinations. Linear results were compared to 2nd and 3th order polynomial fits against a pre-specified allowable error of ± 5 ng/mL. The linearity range was found to extend from the LOQ (12.9 ng/mL) to 150.0 ng/mL.
{8}------------------------------------------------
Cross-reactivity
Two samples containing low and high concentrations of Vitamin D were tested without and with added concentrations of potential cross-reacting compounds including 1,25dihydroxy Vitamin D2; 1,25-dihydroxy Vitamin D3; Vitamin D2; 25hydroxy Vitamin D2; 25-hydroxy Vitamin D3; 24,25-dihydroxy Vitamin D2; 24,25dihydroxy Vitamin D; 3-epi-25-hydroxy Vitamin D3, and Paricalcitol. Maximum crossreactivity at the indicated cross-reactant concentration tested was determined for each compound.
| Compound | Concentration(ng/mL) | % Cross-Reactivity |
|---|---|---|
| Vitamin D2 | 500 | 2.0 |
| Vitamin D3 | 500 | 1.9 |
| 1,25-(OH)2-Vitamin D2 | 100 | 4.0 |
| 1,25-(OH)2-Vitamin D3 | 100 | 9.8 |
| 3-epi-25(OH) Vitamin D3 | 400 | 7.8 |
| 25 (OH) Vitamin D2 | 100 | 93.0 |
| 25 (OH) Vitamin D3 | 25 | 106.0 |
| Paricalcitol | 200 | -1.2 |
| 24, 25 (OH)2 Vitamin D2 | 40 | -0.9 |
| 24, 25 (OH)2 Vitamin D3 | 20 | 117.4 |
Interferences
The following substances normally present in blood were tested and found not to interfere in the FastPack® Vitamin D Immunoassay at the noted concentrations:
| Bilirubin | Tested to 40 mg/dL |
|---|---|
| Biotin | Tested to 1000 ng/mL |
| Cholesterol | Tested to 500 mg/dL |
| Total Protein | Tested to 10.7 g/dL |
| Hemoglobin | Tested to 500 mg/dL |
| Lipids | Tested to 250 mg/dL |
Serum and plasma equivalence
{9}------------------------------------------------
Blood collections were obtained from 32 volunteers and processed in parallel to serum EDTA plasma, and lithium-heparin plasma. Measurements in FastPack® Vitamin D Immunoassay were compared via Deming regression and indicated equivalence between the three matrices.
| Parameter | Result |
|---|---|
| N compared | 32 |
| Range of observations, ng/mL | Serum: 17.4 - 139.5Plasma: 14.9 - 134.1 |
| Absolute bias, ng/mL | -6.7 |
| % Bias | -11.1 |
| Regression results | |
| Slope | 0.993 |
| y-intercept | -6.3 |
| R | 0.979 |
| R2 | 0.959 |
Serum versus EDTA plasma
Serum versus lithium-heparin plasma
| Parameter | Result |
|---|---|
| N compared | 32 |
| Range of observations, ng/mL | Serum: 17.4 - 139.5Plasma: 18.1 - 133.3 |
| Absolute bias, ng/mL | -2.5 |
| % Bias | -4.1 |
| Deming regression results | |
| Slope | 0.970 |
| y-intercept | -0.7 |
| R | 0.971 |
| R2 | 0.943 |
Expected Values/Reference Intervals
To determine a reference interval, serum samples from 367 subjects were acquired from 4 different sources representing 5 different geographic regions of the United States. Sampling took place during the period of February - May 2013, representing a range of exposures to sunlight based on the geographic regions of sampling and to the transition of weather conditions from Winter to Spring to early Summer. Samples were acquired only from subjects in the range of 21-90 years of age, with no family or personal history of
{10}------------------------------------------------
parathyroid disease, thyroid disease, calcium regulatory disease; and no personal history of kidney disease, gastrointestinal disease, liver disease, seizures, chronic disease, or bariatric surgery. Additionally, subjects were not taking any medications that might interfere with Vitamin D absorption. Lastly, subjects were restricted to < 2000 IU/day of Vitamin D supplementation. The results indicated a reference interval of 13.7 - 57.3 ng/mL based on the non-parametric 2.5th - 97.5th percentiles.
| Observed values | |
|---|---|
| Mean | 27.6 ng/mL |
| Median | 24.2 ng/mL |
| 2.5th - 97.5th percentile | 13.7 - 57.3 ng/mL |
Method Comparison
Human serum samples were tested with the FastPack® Vitamin D Immunoassay and the obtained results were compared to the predicate method. A total of 137 samples ranging from 18.6 to 132.6 ng/mL were tested in both assays. The 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.
| Parameter | Result |
|---|---|
| Slope (95% CI) | 0.97 (0.88 - 1.06) |
| y-intercept (95% CI) | -4.6 (-8.9 to -0.25) |
| R (95% CI) | 0.92 (0.90 - 0.94) |
| Range of values | 18.6 - 132.6 ng/mL |
SUMMARY
The information provided in this pre-market notification indicates that the FastPack® Vitamin D Immunoassay is substantially equivalent to the stated predicate device. The information further indicates that the FastPack® Vitamin D Immunoassay is safe and effective for its stated intended use.
{11}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Qualigen, Inc. C/O Michael Poirier 2042 Corte Del Nogal, Suite B CARLSBAD CA 92009
Re: K123983
Trade/Device Name: FastPack® Vitamin D Immunoassay FastPack® Vitamin D Calibrator Kit Fastpack® Vitamin D Control Kit FastPack® Vitamin D Method Verification Kit
Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JIT, JJX Dated: May 31, 2013 Received: June 3, 2013
Dear Mr. Poirier:
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 (2 h 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.
{12}------------------------------------------------
Page 2-Mr. Poirier
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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
{13}------------------------------------------------
Indications for Use
510(k) Number (if known): K123983
Device Name: Device Name:
FastPack® Vitamin D Immunoassay FastPack® Vitamin D Calibrator Kit FastPack® Vitamin D Control Kit FastPack® Vitamin D Method Verification Kit
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.
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.
Over the Counter Use And/Or Prescription Use (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D)
(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)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K123983 510(k)
§ 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.