(259 days)
No
The summary describes a standard immunoassay system and reagents for measuring vitamin D. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical and instrumental aspects of the assay.
No
This device is for in vitro diagnostic use, specifically for quantitative measurement of vitamin D levels, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" for both the reagent pack and calibrators, and describes their use in the "quantitative measurement of total 25-OH vitamin D in human serum" for "assessment of Vitamin D sufficiency," and that "Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management." These phrases clearly indicate a diagnostic purpose.
No
The device description explicitly states that the test system comprises reagent packs, calibrators, and instrumentation (VITROS ECi/ECiQ, 3600, and 5600 systems), which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only". This is the most direct indicator.
- Nature of the Test: The device is designed for the "quantitative measurement of total 25-OH vitamin D in human serum". This involves analyzing a biological sample (serum) outside of the body (in vitro) to provide diagnostic information.
- Clinical Use: The results are intended to be "used in the assessment of Vitamin D sufficiency" and "may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management." This indicates the results are used for clinical decision-making, a key characteristic of IVDs.
- Components: The system includes reagents and calibrators specifically designed for performing the test on human serum, which are typical components of IVD kits.
- Regulatory Information: The mention of 510(k) pre-market notifications (K numbers) for the associated systems and predicate device indicates that these products have gone through the regulatory process for medical devices, specifically IVDs in this context.
N/A
Intended Use / Indications for Use
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack: For in vitro diagnostic use only For the quantitative measurement of total 25-0H vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management. VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators: For in vitro diagnostic use only. For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.
Product codes
MRG, JIT
Device Description
The reagent pack consists of: - wells coated with antibody against 25-OH Vitamin D . - conjugate reagent consisting of HRP-25-OH VitD, buffer and 0.5% Proclin 950 . - dissociation reagent consisting of EDTA buffer, surfactant and 0.5% Proclin 950 . The Calibrators consist of: 1 set of VITROS 25-0H Vitamin D Total Calibrators 1 and 2 (liquid, 25-OH Vitamin D in human serum with antimicrobial agent. 2.0 mL); nominal values 28 and 120 ng/mL (70 and 300 nmol/L). The VITROS Immunodiagnostic Products Vitamin D test system comprises three main elements: - 1. The VITROS Immunodiagnostic range of products. In this case the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators are required to perform a VITROS Vitamin D test. - The VITROS Immunodiagnostic and Integrated Systems: Instrumentation, which 2. provides automated use of the immunoassay kits. The VITROS ECi/ECiQ Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). This product was updated to the VITROS ECiQ Immunodiagnostic System by addition of a flat panel monitor with an accompanying articulating arm, cosmetic changes to the instrument cabinetry, and with FDA notification in January of 2004. The VITROS 3600 Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K083173). The VITROS 5600 Integrated System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Integrated System was cleared for market by a separate 510(k) pre-market notification (K081543). - 3. Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). The VITROS Immunodiagnostic and Integrated Systems and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
9.1 Precision
Precision was evaluated consistent with NCCLS document EP5. Two replicates each of three patient samples and one commercial control sample were tested on two separate occasions per day on at least 20 different days. The experiment was performed using three reagent lots on two different systems. The data presented are a representation of the product performance.
9.2 Linearity
The method was based on CLSI EP6-A ("Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical approach; Approved Guideline"). Two lots of VITROS 25-OH Vitamin D Total Assay (tVitD) were tested using three VITROS Systems (one VITROS ECi/ECiO Immunodiagnostic System, one VITROS 3600 Immunodiagnostic System, and one VITROS 5600 Integrated System). Two pools of VITROS 25-OH Vitamin D Total Assay samples were prepared with patient samples and were selected near the extremes of the calibration range. The low pool had an estimated concentration of 6.73 ng/mL. The high pool had an estimated concentration of 175 ng/mL. The low and high concentration pools were sequentially mixed to give 7 further pools of intermediate concentrations. All results from both Master Lot 1 and 2 and all three VITROS Systems supported a measuring range of 12.8 to 126 ng/mL. Analysis by weighted linear regression indicated that the assay results across the entire claimed range (12.8 to 126 ng/mL) are best fitted by a third order polynomial regression. In all cases, the third order polynomial regression had non-linear significant terms and/or was the best fit for the assay results. The linear regression fitted results deviate less than 15% from the third order polynomial regression. The assay is therefore linear over the entire range from 12.8 to 126 ng/mL.
9.3 Limit of Detection
The Limit of Detection (LoD) for VITROS 25-OH Vitamin D Total Assay is 8.64 ng/mL (21.6 nmol/L), determined consistent with CSLI document EP17 and with proportions of false positives (α) less than 5% and false negatives (β) less than 5%; based on 700 determinations, with 1 blank and 6 low-level samples. The Limit of Blank (LoB) is 4.34ng/mL (10.9 nmol/L). The Limit of Quantitation (LoO) is 12.8 ng/mL (32.0 nmol/L) as determined by the lowest concentration at which precision design requirements are still met and within the linear range of the assay. At 12.8ng/mL (32.0 nmol/L), the observed imprecision (%CV) is 10% bias at the test concentrations. The VITROS 25-OH Vitamin D Total test was evaluated for interference consistent with CLSI document EP7 A2. Of the compounds tested, none was found to cause a bias of >10% with the test at the concentrations indicated at 25-OH Vitamin D concentrations of 30-80 ng/mL(75-200nmol/L).
Method Comparison
The method was consistent with CSLI document EP9-A2-IR ("Method Comparison and Bias Estimation Using Patient Samples"; Approved Guideline -Second Edition) Interim Review. A minimum of 117 human serum samples were assayed using the VITROS® Immunodiagnostic Products 25-OH Vitamin D Total assay on the VITROS Systems and the IDS-iSYS® 25-Hydroxy Vitamin D assay on the IDS-iSYS System All human serum samples were run in singleton on all systems. The highest sample (Sample ID: R204553) was approximately 95% of the top of the measuring range of the VITROS 25-OH Vitamin D Total Assay (i.e. 120 ng/mL). Seven (7) -spiked and one pooled sample were used for this test. Passing & Bablok Regression was performed for all comparisons. In each case, the VITROS 25-OH Vitamin D Total assay results were plotted as the "y" variable and those from the IDS-iSYS assay as the "x" variable. For the quantitative comparison, only those data within the measuring range of the compared IDS-iSYS and VITROS assays were analyzed. The measuring range for the VITROS 25-OH Vitamin D Total is 12.8 - 126 ng/mL. The IDS-iSYS measuring range is 6-126 ng/mL. Fourteen (14) samples were below the VITROS 25-OH Vitamin D Total assay's measuring range on the 3600 Integrated system and fifteen (15) samples were below the VITROS 25-OH Vitamin D Total assay's measuring range on the 5600 Integrated system and the ECi/ECiQ Immunodiagnostic system. The parameters of the Passing & Bablok Regressions were used to state the equations for the product claim for testing with the VITROS ECi/ECiQ Immunodiagnostic System, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. The comparisons of VITROS to IDS-iSYS are as follows: VITROS 5600 Integrated System 25-OH Vitamin D Total = 0.99 x IDS-iSYS -5.12 ng/mL, n = 102, r = 0.92. The 95%CI for the slope is 0.86 to 1.12 and for the Intercept is -10.2 to -0.53. VITROS 3600 Immunodiagnostic System 25-OH Vitamin D Total = 1.08 x IDSiSYS -7.87 ng/mL, n = 103, r = 0.93. The 95%CI for the slope is 0.96 to 1.22 and for the Intercept is -12.4 to -2.95. VITROS ECi/ECiQ Immunodiagnostic System 25-OH Vitamin D Total = 0.96 x IDS-iSYS -9.07 ng/mL, n = 102, r = 0.94. The 95%CI for the slope is 0.86 to 1.09 and for the Intercept is -14.2 to -4.69.
Q Matrix Comparison
Only serum can be used.
9.7 Reference Range
A study was conducted using 399 apparently healthy adults between the ages of 21-79. Samples came from individuals who live in the North, South and Central regions of the United States and were collected in both summer and winter. These samples were tested using the VITROS 25-OH Vitamin D Total assay and the observed values are summarized below: Median 25 OH Vitamin D 33.4 (ng/mL) 83.5(nmol/L), Observed Range 2.5th to 97.5th Percentile 14.7 to 68.3 (ng/mL) 36.8 – 171 (nmol/L).
9.8 Stability
The VITROS 25-OH Vitamin D Total assay is currently under a stability protocol to evaluate the maximum unopened reagent and calibrator dating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IDS-iSYS® 25-Hydroxy Vitamin D Assay (K091849)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
The assigned 510(k) number is
ber is K121608
FEB 1 5 2013
Submitter Name, Address, Contact 1.
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester. New York 14626-5101 (585) 453-4041 Contact Person: Marlene Hanna
2. Preparation Date
510(k) prepared: January 23, 2013
3. · Device Name
Trade or Proprietary Names:
VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Calibrators
4. Regulatory information
a. Regulatory Section 21 CFR 862.1825 Vitamin D Test System 21 CFR 862.1150 Calibrators
b. Classification Class II
c. Product Code MRG JIT
d. Panel Chemistry (75)
1
5. Intended Use
a. Intended Use(s):
See Indications for Use
b. Indications for Use
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack:
For in vitro diagnostic use only
For the quantitative measurement of total 25-0H vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.
Device Description: 6.
The reagent pack consists of:
- wells coated with antibody against 25-OH Vitamin D .
- conjugate reagent consisting of HRP-25-OH VitD, buffer and 0.5% Proclin 950 .
- dissociation reagent consisting of EDTA buffer, surfactant and 0.5% Proclin 950 .
The Calibrators consist of:
1 set of VITROS 25-0H Vitamin D Total Calibrators 1 and 2 (liquid, 25-OH Vitamin D in human serum with antimicrobial agent. 2.0 mL); nominal values 28 and 120 ng/mL (70 and 300 nmol/L)
2
7. Device Description
The VITROS Immunodiagnostic Products Vitamin D test system comprises three main elements:
-
- The VITROS Immunodiagnostic range of products. In this case the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators are required to perform a VITROS Vitamin D test.
- The VITROS Immunodiagnostic and Integrated Systems: Instrumentation, which 2. provides automated use of the immunoassay kits.
The VITROS ECi/ECiQ Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). This product was updated to the VITROS ECiQ Immunodiagnostic System by addition of a flat panel monitor with an accompanying articulating arm, cosmetic changes to the instrument cabinetry, and with FDA notification in January of 2004.
The VITROS 3600 Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K083173).
The VITROS 5600 Integrated System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Integrated System was cleared for market by a separate 510(k) pre-market notification (K081543).
-
- Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS Immunodiagnostic and Integrated Systems and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
- Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Substantial Equivalence Information 8.
a. Predicate Device name(s) IDS-iSYS® 25-Hydroxy Vitamin D Assay
3
b. Predicate 510(k) number(s) (K091849)
c. Comparison with predicate:
The VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and Calibrators are substantially equivalent to IDS-iSYS® 25-Hydroxy Vitamin D Assay (K091849).
Table 1 and 2 below present the similarities and differences between the predicate and new device.
| Table 1 Comparison of the VITROS® and IDS-iSYS® Vitamin D assays | |
|---|---|
| -- | ------------------------------------------------------------------ |
| Similarities | ||
|---|---|---|
| Item | New Device | Predicate (K091849) |
| Intended use and | ||
| indications for use | Same | Quantitative determination of 25- |
| Hydroxyvitamin D to be used in the | ||
| assessment of Vitamin D | ||
| sufficiency. | ||
| Fundamental | ||
| Scientific Technology | Same | Immunoassay, solid phase antibody |
| capture | ||
| Basic Principle | Same | Direct competitive assay |
| Detection | Same | Light signal measurement |
| Instrumentation | Same | Automated instrumentation |
| Sample Type | Same | Serum |
| Differences | ||
|---|---|---|
| Item | New Device | Predicate (K091849) |
| Antibody | Anti-25 OH D Sheep | |
| Monoclonal IgG | Anti-25 OH D Sheep | |
| Polyclonal IgG | ||
| Measuring Range | 12.8- 126 ng/mL | 6-126 ng/mL |
4
| Similarities | |||||
|---|---|---|---|---|---|
| Item | New Device | Predicate (K091849) | |||
| Intended use and | |||||
| indications for use | For use in the | ||||
| calibration of the | |||||
| VITROS Systems for | |||||
| the quantitative | |||||
| measurement of total | |||||
| 25-OH vitamin D in | |||||
| human serum. | For use in the calibration of the IDS | ||||
| iSYS System for the quantitative | |||||
| measurement of total 25-OH | |||||
| vitamin D in human serum. | |||||
| Format | Same | Liquid Ready-to-Use | |||
| Calibrator Levels | Same | Two | |||
| Storage | Same | Refrigerated |
Table 2 Comparison of the VITROS® and IDS-iSYS® Vitamin D Calibrators
| Differences | ||
|---|---|---|
| Item | New Device | Predicate (K091849) |
| Calibrator Matrix | Human serum and | |
| antimicrobial | Horse Serum in a buffer matrix | |
| and sodium azide |
9 Performance Testing
9.1 Precision
Precision was evaluated consistent with NCCLS document EP5. Two replicates each of three patient samples and one commercial control sample were tested on two separate occasions per day on at least 20 different days. The experiment was performed using three reagent lots on two different systems. The data presented are a representation of the product performance.
5
| System | Mean [25-OH Vitamin D Total] Conc. | Within-run* | Within-calibration** | Within-lab*** | No. Observ. | No. Days | |||
|---|---|---|---|---|---|---|---|---|---|
| SD | CV (%) | SD | CV (%) | SD | CV (%) | ||||
| ECI/ECIQ | 22.5 | 1.66 | 7.4 | 3.14 | 14.0 | 3.43 | 15.3 | 80 | 20 |
| ECI/ECIQ System 1 Lot 1 | 31.1 | 2.25 | 7.2 | 3.86 | 12.4 | 4.13 | 13.3 | 80 | 20 |
| 70.0† | 3.86 | 5.5 | 5.86 | 8.4 | 6.24 | 8.9 | 80 | 20 | |
| 121 | 4.1 | 3.4 | 6.1 | 5.1 | 6.7 | 5.5 | 80 | 20 | |
| ECI/ECIQ System 2 Lot 2 | 20.7 | 2.46 | 12.0 | 3.32 | 16.2 | 3.43 | 16.4 | 80 | 20 |
| 28.1 | 3.06 | 11.0 | 3.34 | 12.0 | 3.43 | 12.1 | 80 | 20 | |
| 65.0+ | 5.20 | 8.1 | 5.66 | 8.8 | 5.94 | 9.1 | 80 | 20 | |
| 108 | 4.1 | 3.8 | 5.5 | 5.2 | 5.9 | 5.4 | 80 | 20 | |
| 3600 System 1 Lot 1 | 22.9 | 2.26 | 10.5 | 2.90 | 13.5 | 4.04 | 16.5 | 80 | 20 |
| 31.6 | 2.66 | 8.9 | 3.36 | 11.2 | 4.65 | 14.0 | 80 | 20 | |
| 72.2+ | 4.30 | 6.1 | 5.73 | 8.1 | 6.80 | 9.2 | 80 | 20 | |
| 123 | 4.8 | 3.9 | 6.5 | 5.3 | 7.4 | 6.0 | 80 | 20 | |
| 3600 System 1 Lot 3 | 21.0 | 3.22 | 15.3 | 3.29 | 15.6 | 3.32 | 15.8 | 80 | 20 |
| 29.5 | 3.35 | 11.3 | 3.43 | 11.6 | 3.62 | 12.3 | 80 | 20 | |
| 71.1+ | 5.93 | 8.3 | 6.07 | 8.5 | 5.92 | 8.4 | 80 | 20 | |
| 120 | 5.8 | 4.7 | 5.9 | 4.9 | 5.8 | 4.8 | 80 | 20 | |
| 5600 System 1 Lot 2 | 23.5 | 2.43 | 10.1 | 2.95 | 12.2 | 2.93 | 12.8 | 80 | 20 |
| 31.9 | 2.52 | 7.7 | 3.22 | 9.9 | 3.13 | 10.1 | 80 | 20 | |
| 69.4+ | 3.75 | 5.3 | 4.82 | 6.8 | 4.39 | 6.5 | 80 | 20 | |
| 117 | 6.1 | 5.1 | 6.5 | 5.4 | 6.4 | 5.6 | 80 | 20 | |
| Units = [nmol/L] | |||||||||
| System | Mean [25-OH | ||||||||
| Vitamin D Total] | |||||||||
| Conc. | Within-run* | Within-calibration** | Within-lab*** | No. | |||||
| Observ. | No. | ||||||||
| Days | |||||||||
| 56.3 | 4.15 | 7.4 | 7.85 | 14.0 | 8.58 | 15.3 | 80 | 20 | |
| ECI/ECIQ | 77.8 | 5.63 | 7.2 | 9.65 | 12.4 | 10.30 | 13.3 | 80 | 20 |
| System 1 | |||||||||
| Lot 1 | 175+ | 9.7 | 5.5 | 14.7 | 8.4 | 15.6 | 8.9 | 80 | 20 |
| 303 | 10.3 | 3.4 | 15.3 | 5.1 | 16.8 | 5.5 | 80 | 20 | |
| 51.8 | 6.15 | 12.0 | 8.30 | 16.2 | 8.58 | 16.4 | 80 | 20 | |
| ECI/ECIQ | 70.3 | 7.65 | 11.0 | 8.35 | 12.0 | 8.58 | 12.1 | 80 | 20 |
| System 2 | |||||||||
| Lot 2 | 163+ | 13.0 | 8.1 | 14.2 | 8.8 | 14.9 | 9.1 | 80 | 20 |
| 270 | 10.3 | 3.8 | 13.8 | 5.2 | 14.8 | 5.4 | 80 | 20 | |
| 57.3 | 5.65 | 10.5 | 7.25 | 13.5 | 10.10 | 16.5 | 80 | 20 | |
| 3600 | 79.0 | 6.65 | 8.9 | 8.40 | 11.2 | 11.60 | 14.0 | 80 | 20 |
| System 1 | |||||||||
| Lot 1 | 181+ | 10.8 | 6.1 | 14.3 | 8.1 | 17.0 | 9.2 | 80 | 20 |
| 308 | 12.0 | 3.9 | 16.3 | 5.3 | 18.5 | 6.0 | 80 | 20 | |
| 52.5 | 8.05 | 15.3 | 8.23 | 15.6 | 8.30 | 15.8 | 80 | 20 | |
| 3600 | 73.8 | 8.38 | 11.3 | 8.58 | 11.6 | 9.05 | 12.3 | 80 | 20 |
| System 1 | |||||||||
| Lot 3 | 178+ | 14.8 | 8.3 | 15.2 | 8.5 | 14.8 | 8.4 | 80 | 20 |
| 300 | 14.5 | 4.7 | 14.8 | 4.9 | 14.5 | 4.8 | 80 | 20 | |
| 5600 | 58.8 | 6.08 | 10.1 | 7.38 | 12.2 | 7.33 | 12.8 | 80 | 20 |
| System 1 | 79.8 | 6.30 | 7.7 | 8.05 | 9.9 | 7.83 | 10.1 | 80 | 20 |
| Lot 2 | 174+ | 9.4 | 5.3 | 12.1 | 6.8 | 11.0 | 6.5 | 80 | 20 |
| 293 | 15.3 | 5.1 | 16.3 | 5.4 | 16.0 | 5.6 | 80 | 20 |
VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System
Within-run (repeatability). Between Duplicate precision averaged over all runs *
** Within-calibration. Total precision with weighted components of within-run, between-run and between-day variation *** Within-lab. A measure of the effect of recalibration on total precision, calculated within reagent lot, using data from at least 4 calibrations
† This sample is a commercial quality control fluid. The other samples are human serum samples
6
Within-run (repeatability). Between Duplicate precision averaged over all runs
Within-calibration. Total precision with weighted components of within-run, between-run and between-day variation ** ** Within-lab. A measure of the effect of recalibration on total precision, calculated within reagent lot, using data from at least 4 calibrations
† This sample is a commercial quality control fluid. The other samples are human serum samples
9.2 Linearity
The method was based on CLSI EP6-A ("Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical approach; Approved Guideline"). Two lots of VITROS 25-OH Vitamin D Total Assay (tVitD) were
7
tested using three VITROS Systems (one VITROS ECi/ECiO Immunodiagnostic System, one VITROS 3600 Immunodiagnostic System, and one VITROS 5600 Integrated System). Two pools of VITROS 25-OH Vitamin D Total Assay samples were prepared with patient samples and were selected near the extremes of the calibration range. The low pool had an estimated concentration of 6.73 ng/mL. The high pool had an estimated concentration of 175 ng/mL. The low and . high concentration pools were sequentially mixed to give 7 further pools of intermediate concentrations.
All results from both Master Lot 1 and 2 and all three VITROS Systems supported a measuring range of 12.8 to 126 ng/mL. Analysis by weighted linear regression indicated that the assay results across the entire claimed range (12.8 to 126 ng/mL) are best fitted by a third order polynomial regression. In all cases, the third order polynomial regression had non-linear significant terms and/or was the best fit for the assay results. The linear regression fitted results deviate less than 15% from the third order polynomial regression. The assay is therefore linear over the entire range from 12.8 to 126 ng/mL.
9.3 Limit of Detection
The Limit of Detection (LoD) for VITROS 25-OH Vitamin D Total Assay is 8.64 ng/mL (21.6 nmol/L), determined consistent with CSLI document EP17 and with proportions of false positives (α) less than 5% and false negatives (β) less than 5%; based on 700 determinations, with 1 blank and 6 low-level samples. The Limit of Blank (LoB) is 4.34ng/mL (10.9 nmol/L). The Limit of Quantitation (LoO) is 12.8 ng/mL (32.0 nmol/L) as determined by the lowest concentration at which precision design requirements are still met and within the linear range of the assay.
At 12.8ng/mL (32.0 nmol/L), the observed imprecision (%CV) is 10% bias at the test concentrations.
8
Specificity
Substances that do not Interfere
The VITROS 25-OH Vitamin D Total test was evaluated for interference consistent with CLSI document EP7 A2. Of the compounds tested, none was found to cause a bias of >10% with the test at the concentrations indicated at 25-OH Vitamin D concentrations of 30-80 ng/mL(75-200nmol/L).
| Compound | Concentration | Concentration |
|---|---|---|
| Acetaminophen | 1324µmol/L | 200µg/mL |
| Acetylsalicylic Acid | 3.62mmol/L | 65.16mg/dL |
| Bilirubin (unconjugated) | 513µmol/L | 30 mg/dL |
| Bilirubin (conjugated) | 356µmol/L | 30 mg/dL |
| Biotin | 61.35nmol/L | 1.5µg/dL |
| Hemoglobin (hemolysate) | 0.124mmol/L | 200 mg/dL |
| Ibuprofen | 0.576mmol/L | 12mg/dL |
| Triolein | 33.0mmol/L | 3000 mg/dL |
| Cholesterol | 7.91 mmol/L | 306 mg/dL |
| Total Protein | 108g/L | 10.8g/dL |
| Triglycerides | 5.69 mmol/L | 504 mg/dL |
The results of the potentially cross-reacting substances listed in the Table below show the % cross-reactivity in the VITROS 25-OH Vitamin D Total assay
| Compound | Concentration | Sample 25-OH Vitamin D
Concentration | | Mean 25-OH Vitamin D
Result of Cross-reactant
Pool | | % Cross-
reactivity |
|--------------------------------|---------------|-----------------------------------------|----------|----------------------------------------------------------|----------|------------------------|
| | | [ng/mL] | [nmol/L] | [ng/mL] | [nmol/L] | |
| Vitamin D₂
(Ergocalciferol) | 100ng/mL | 8.81 | 22.0 | 9.77 | 24.4 | 1.0 |
9
| Vitamin D3
| (Cholecalciferol) | 100ng/mL | 8.81 | 22.0 | 9.66 | 24.2 | 0.9 |
|---|---|---|---|---|---|---|
| 25-OH Vitamin D2 | 100ng/mL | 8.10 | 20.3 | 113 | 283 | 104.9 |
| 25-OH Vitamin D3 | 100ng/mL | 8.10 | 20.3 | 107 | 268 | 98.9 |
| 1,25 (OH)2 | ||||||
| Vitamin D2 | 0.2ng/mL* | 8.81 | 22.0 | 10.1 | 25.3 | >100 |
| 1,25 (OH)2 | ||||||
| Vitamin D2 | 0.2ng/mL* | 26.8 | 67.0 | 28.5 | 71.3 | >100 |
| 1,25 (OH)2 | ||||||
| Vitamin D3 | 0.2ng/mL* | 8.10 | 20.3 | 8.09 | 20.2 | -5.0 |
| 24,25 (OH)2 | ||||||
| Vitamin D2 | 10ng/mL** | 26.8 | 67.0 | 30.2 | 75.5 | 34.3 |
| 24,25 (OH)2 | ||||||
| Vitamin D3 | 10ng/mL** | 7.92 | 19.8 | 11.4 | 28.5 | 34.8 |
| 3-epi 25-OH | ||||||
| Vitamin D3 | 100ng/mL | 7.92 | 19.8 | 45.3 | 113 | 37.4 |
*Levels tested were 2x to 4x the typical endogenous levels of analyte. 0.2 ng/ml 1,25 (OH)2 Vitamin D₂ (4 x the upper limit of the reference interval) produced a bias in the measurement of just 1.7 ng/mL at a baseline 25-OH Vitamin D of 30 ng/mL.
**Levels tested were 2x to 4x the typical endogenous levels of analyte
તે જે રે Method Comparison
The method was consistent with CSLI document EP9-A2-IR ("Method Comparison and Bias Estimation Using Patient Samples"; Approved Guideline -Second Edition) Interim Review.
A minimum of 117 human serum samples were assayed using the VITROS® Immunodiagnostic Products 25-OH Vitamin D Total assay on the VITROS Systems and the IDS-iSYS® 25-Hydroxy Vitamin D assay on the IDS-iSYS System All human serum samples were run in singleton on all systems. The highest sample (Sample ID: R204553) was approximately 95% of the top of the measuring range of the VITROS 25-OH Vitamin D Total Assay (i.e. 120 ng/mL). Seven (7) -spiked and one pooled sample were used for this test.
Passing & Bablok Regression was performed for all comparisons. In each case, the VITROS 25-OH Vitamin D Total assay results were plotted as the "y"
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variable and those from the IDS-iSYS assay as the "x" variable. For the quantitative comparison, only those data within the measuring range of the compared IDS-iSYS and VITROS assays were analyzed. The measuring range for the VITROS 25-OH Vitamin D Total is 12.8 - 126 ng/mL. The IDS-iSYS measuring range is 6-126 ng/mL. Fourteen (14) samples were below the VITROS 25-OH Vitamin D Total assay's measuring range on the 3600 Integrated system and fifteen (15) samples were below the VITROS 25-OH Vitamin D Total assay's measuring range on the 5600 Integrated system and the ECi/ECiQ Immunodiagnostic system. The parameters of the Passing & Bablok Regressions were used to state the equations for the product claim for testing with the VITROS ECi/ECiQ Immunodiagnostic System, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
The comparisons of VITROS to IDS-iSYS are as follows:
VITROS 5600 Integrated System 25-OH Vitamin D Total = 0.99 x IDS-iSYS -5.12 ng/mL, n = 102, r = 0.92. The 95%CI for the slope is 0.86 to 1.12 and for the Intercept is -10.2 to -0.53.
VITROS 3600 Immunodiagnostic System 25-OH Vitamin D Total = 1.08 x IDSiSYS -7.87 ng/mL, n = 103, r = 0.93. The 95%CI for the slope is 0.96 to 1.22 and for the Intercept is -12.4 to -2.95.
VITROS ECi/ECiQ Immunodiagnostic System 25-OH Vitamin D Total = 0.96 x IDS-iSYS -9.07 ng/mL, n = 102, r = 0.94. The 95%CI for the slope is 0.86 to 1.09 and for the Intercept is -14.2 to -4.69.
તે 'Q Matrix Comparison
Only serum can be used.
9.7 Reference Range
A study was conducted using 399 apparently healthy adults between the ages of Samples came from individuals who live in the North, South and 21-79. Central regions of the United States and were collected in both summer and winter. These samples were tested using the VITROS 25-OH Vitamin D Total assay and the observed values are summarized below: f
| Observed Values | ||
|---|---|---|
| Median 25 OH Vitamin D | 33.4 (ng/mL) | 83.5(nmol/L) |
| Observed Range 2.5th to | ||
| 97.5th Percentile | 14.7 to 68.3 | |
| (ng/mL) | 36.8 – 171 | |
| (nmol/L) |
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9.8 Stability
The VITROS 25-OH Vitamin D Total assay is currently under a stability protocol to evaluate the maximum unopened reagent and calibrator dating.
Conclusion 10.
The data presented provide a reasonable assurance that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and Calibrators are safe and effective for the stated intended uses and are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2013
Ortho-Clinical Diagnostics, Inc. c/o Eric Schaeffer 100 Indigo Creek Dr. Rochester, NY 14626-5101
Re: K121608
Trade/Device Name: VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Calibrators Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JIT Dated: January 18, 2013 Received: January 22, 2013
Dear Mr. Schaeffer:
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 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 (OS) 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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Page 2-Mr. Schaeffer
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/ucm 1 1 5809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours, Carol C. Benson 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
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Indications for Use Form
510(k) Number (if known):
Device Name: VITROS Immunodiagnostic Products 25-OH Vitamin D Total Assay Indications for Use:
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack:
For in vitro diagnostic use only
For the quantitative measurement of total 25-OH vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OlR)
Ruth A. Chester/A
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K121608