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510(k) Data Aggregation
(59 days)
Vitamin D 200M Assay for the Topaz System
The Vitamin D 200M Assay for the Topaz System is intended for in vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) through the measurement of 25-hydroxyvitamin D3 (25-OH-D3) and 25-hydroxyvitamin D2 (25-OH-D2) in human serum using LC-MS/MS technology by a trained laboratory professional in a clinical laboratory. The Assay is intended for use with the Topaz System. The Vitamin D 200M Assay for the Topaz System is intended to be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population in the assessment of vitamin D sufficiency.
The Vitamin D 200M Assay for the Topaz System employs LC-MS/MS technology (Topaz System) in conjunction with reagents and sample preparation components to extract, separate by chromatography, detect, and quantify total Vitamin in human serum.
The Topaz System is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) system intended to for use in a clinical laboratory environment to identify inorganic or organic compounds in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.
Each assay kit contains enough material for 1000 tests, and includes reagents, sample extraction and purification components, calibrators, controls and the Vitamin D 200M Assay specific file which contains all necessary parameters to process the assay.
This document describes the process by which a medical device, the Vitamin D 200M Assay for the Topaz System, received automatic Class III designation. The device is intended for quantitative determination of total 25-hydroxyvitamin D (25-OH-D) to assist clinicians in assessing vitamin D sufficiency.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the special controls defined in 21 CFR 862.1840 for Total 25-hydroxyvitamin D Mass Spectrometry Test Systems. The reported device performance is extracted from the "Performance Characteristics" section of the document.
| Acceptance Criteria (from 21 CFR 862.1840 Special Controls) | Reported Device Performance |
|---|---|
| (1) The device must have initial and annual standardization verification by a certifying vitamin D standardization organization deemed acceptable by FDA. | Traceability: The assigned 25-hydroxyvitamin D of the Vitamin D 200M Assay for the Topaz System is certified with the CDC Vitamin D Standardization-Certification Program (VDSCP). (Source: CDC website link provided, last accessed May 18, 2017). |
| (2) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of performance testing conducted to evaluate precision, accuracy, linearity, interference, including the following: | Detailed descriptions are provided in the "L. Performance Characteristics" section and other sections of the document. |
| (i) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard. | Reproducibility/Precision: Data was analyzed according to the multi-site evaluation study outlined in CLSI EP05-A3 guideline. The study was performed at three sites. Five serum samples were assayed on five calendar days, with one run per day and five replicates per sample. The analyte concentrations of the samples approximated both low and high levels, as well as medical decision points. The sixth sample was a native patient sample (unmodified). |
| Sample | Mean (ng/mL) | Repeatability SD | Repeatability %CV | Within-Laboratory SD | Within-Laboratory %CV | Reproducibility SD | Reproducibility %CV |
|---|---|---|---|---|---|---|---|
| 1 | 14.9 | 0.57 | 3.8% | 1.05 | 7.0% | 1.10 | 7.3% |
| 2 | 13.7 | 0.65 | 4.7% | 0.80 | 5.8% | 0.80 | 5.8% |
| 3 | 31.0 | 1.28 | 4.1% | 2.03 | 6.5% | 2.03 | 6.5% |
| 4 | 67.5 | 3.58 | 5.3% | 3.99 | 5.9% | 5.85 | 8.7% |
| 5 | 100 | 6.37 | 6.3% | 6.46 | 6.4% | 10.4 | 10.4% |
| Native Patient Sample | 28.4 | 1.44 | 5.1% | 2.04 | 7.2% | 2.10 | 7.4% |
| (ii) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device. | Method comparison with reference method: The sponsor performed an accuracy study to the CDC Vitamin D Standardization-Certification Program (VDSCP). The sample set contained 118 unique natural patient serum samples which were purchased and value assigned by CDC with total 25-OH-vitamin D concentrations ranging from 5.6 ng/mL to 133 ng/mL. Twelve specimens were contrived (10.2%). The comparison data was analyzed to find the Pearson correlation coefficient and an estimate of the bias using the slope of the line from the Passing-Bablok fit. |
| Passing-Bablok regression results | |
|---|---|
| n | 118 |
| Slope | 1.008 |
| Intercept | -0.3949 |
| Correlation Coefficient | 0.991 |
| Range (ng/mL) | 5.6 – 133 ng/mL |
| (iii) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26-Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25-dihydroxyvitamin-D3 must be described in the 21 CFR 809.10(b)(7) compliant labeling of the device. | Analytical specificity: The design of the analytical specificity study was based on CLSI EP07-A2 guideline. A total of 79 potential interferents, at high and low concentrations, were spiked into samples with high and low concentrations of analyte (~37 ng/mL and ~11 ng/mL). Each of the four concentration combinations was tested in triplicate: low analyte/low interferent, low analyte/high interferent, high analyte/low interferent, and high analyte/high interferent, and was compared to control samples spiked with solvent instead of interferent. None of the potential endogenous and exogenous interfering substances or collection tubes tested in this study was found to cause interference with the analyte of interest greater than a 10% difference between the test and control samples. A comprehensive table listing substances and their highest concentration tested without significant interference is provided in the document. This list includes the specific vitamin D analogs and metabolites mentioned in the acceptance criteria. |
| (3) The 21 CFR 809.10(b) compliant labeling must be supported by a reference range study representative of the performance of the device. The study must be conducted using samples collected from apparently healthy male and female adults at least 21 years of age and older from at least 3 distinct climatic regions within the United States of America in different weather seasons. The ethnic, racial, and gender background of this study population must be representative of the US population demographics. | Expected Values: A reference range study was conducted with reference to the CLSI EP28-A3 guideline. A total of 404 serum samples from apparently healthy male and female adults 21 years of age and older from 3 different geographic regions were analyzed. The inner 95% Reference interval of 25(OH) vitamin D concentrations found in this population was 8.6 to 49 ng/mL. (Note: The document states "3 different geographic regions" which addresses the "distinct climatic regions" without explicitly stating "United States of America" or "different weather seasons". It also does not explicitly detail the "ethnic, racial, and gender background" as being "representative of the US population demographics" within this specific section, though it is a general requirement for such studies). |
| (4) The results of the device as provided in the 21 CFR 809.10(b) compliant labeling and any test report generated must be reported as only total 25-hydroxyvitamin D. | Indications For Use: The assay is intended for in vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) through the measurement of 25-hydroxyvitamin D3 (25-OH-D3) and 25-hydroxyvitamin D2 (25-OH-D2). Test Principle: "Total Vitamin D concentrations is calculated as a total of the concentrations of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2." This directly supports reporting only total 25-hydroxyvitamin D. |
| Linearity/Assay Reportable Range: | A linearity study was performed according to CLSI EP06-A to assess the linearity of the Vitamin D 200M Assay across the assay measuring range (4 to 140 ng/mL). The results of the linear regression analyses were: y = 0.9974x + 1.1737 R2 = 0.9984. The linearity study data support the claimed measuring range of 4.0 to 140 ng/mL. |
| Detection Limit: | The lower limit of the measuring interval (LLMI) for this assay was determined to be 2.9 ng/mL for total 25-OH-Vitamin D. This was determined as the lowest concentration of analyte that achieved both the bias and precision goals ( |
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