(236 days)
No reference device K/DEN numbers were found in the text. The section for "Reference Device(s)" states "Not Found".
No
The device description details a standard electrochemiluminescence immunoassay and associated reagents and controls. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in-vitro diagnostic assay and associated reagents used to measure 25-hydroxyvitamin D levels, which aids in assessing vitamin D sufficiency. It is not used for treating or preventing diseases.
Yes
The intended use explicitly states: "The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults." This indicates the device provides information for making a clinical determination.
No
The device description clearly outlines a competitive protein binding assay using reagents, calibrators, and controls, intended for use on Elecsys and cobas e immunoassay analyzers. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the Elecsys Vitamin D assay is for the "quantitative determination of total 25-hydroxyvitamin D in human serum and plasma." This is a measurement performed in vitro (outside the body) on biological samples.
- Aid in Assessment: The assay is used as an "aid in the assessment of vitamin D sufficiency in adults." This indicates its use in a clinical context to provide information for diagnosis or assessment of a health condition.
- Device Description: The description details a laboratory-based assay using reagents, calibrators, and controls to measure an analyte in a biological sample. This is characteristic of an IVD.
- Components: The components listed (reagent, calibrator, control) are all typical components of an IVD system used for laboratory testing.
- Performance Studies: The inclusion of method comparison studies against other assays (LC-MS/MS and Abbott) and analytical sensitivity metrics (LoB, LoD, LoQ) are standard for demonstrating the performance of an IVD.
- Predicate Devices: The listing of predicate devices, which are also IVDs (assays, calibrators, controls), further confirms the classification of this device as an IVD.
In summary, the device is designed to perform a test on biological samples in vitro to provide information for clinical assessment, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
• Elecsys Vitamin D Reagent:
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers.
• Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 is used for quality control of the specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
MRG, JIT, JJY, JJX
Device Description
(1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code.
(2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. .
(3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes:
Assay Name:
Vitamin B12
Ferritin
Folate III
βCrossLaps/Serum (-CTx)
Osteocalcin
Parathyroid Hormone
Parathyroid Hormone Short Turnaround Time (PTH-STAT)
FDA Clearance Number for Reagents:
K060755
K971833
K082340
K993706
K051297
K070709
K070709
(4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum.
Note: The reagent, calibrator, and the quality control materials are all packaged separately.
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
Adults
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison (LC-MS/MS vs. Elecsys): Deming (n=290): Slope 1.03, Intercept -3.07, r 0.85
Method Comparison (Abbott vs. Elecsys): Deming (n=165): Slope 0.99, Intercept 1.20, r 0.91
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Blank (LoB) 2.00 ng/mL
Limit of Detection (LoD) 3.00 ng/mL
Limit of Quantitation (LoQ) 5.00 ng/mL
Precision (Elecsys 2010/ cobas e 411):
Within-run (will be labeled Repeatability) n=84, human sera
7.2% CV @ 6.2 ng/mL
5.1% CV @ 11.2 ng/mL
2.9% CV @ 23.2 ng/mL
2.4% CV @ 45.3ng/mL
1.6% CV @ 52.6 ng/mL
Total (will be labeled Intermediate)
10.3% CV @ 6.2 ng/mL
7.6% CV @ 11.2 ng/mL
5.3% CV @ 23.2 ng/mL
3.4% CV @ 45.3ng/mL
2.9% CV @ 52.6 ng/mL
Predicate Device(s)
K110619, K103221, K102157, K112528
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
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter Name, Address, Contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 521-2458 |
Contact Person: Michael Leuther, PhD, MBA
Date Prepared: July 18, 2012 |
| Device Name | Proprietary name: (1) Elecsys Vitamin D Assay
(2) Elecsys Vitamin D CalSet
(3) Elecsys PreciControl Varia 3
(4) Elecsys Vitamin D CalCheck 5
Common name: (1) Vitamin D Assay
(2) Vitamin D Calibrator
(3) Vitamin D Control
(4) Vitamin D CalCheck 5
Classification name: (1) System, Test, Vitamin D
(2) Calibrator, Secondary
(3) Multi-analyte controls, all kinds (Assayed and Unassayed)
(4) Single (specified) analyte controls (Assayed and Unassayed) |
.
· . :
1
510(k) Summary, Continued
Device Description
(1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code.
(2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. .
(3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes:
| Assay Name | FDA Clearance Number for
Reagents |
|---------------------------------------------------------|--------------------------------------|
| Vitamin B12 | K060755 |
| Ferritin | K971833 |
| Folate III | K082340 |
| βCrossLaps/Serum (-CTx) | K993706 |
| Osteocalcin | K051297 |
| Parathyroid Hormone | K070709 |
| Parathyroid Hormone Short
Turnaround Time (PTH-STAT) | K070709 |
(4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum.
Note: The reagent, calibrator, and the quality control materials are all packaged separately.
2
510(k) Summary, Continued
| Intended
Use/Indications
for Use | • Elecsys Vitamin D Reagent:
The Elecsys Vitamin D assay is intended for the quantitative
determination of total 25-hydroxyvitamin D in human serum and
plasma. The assay is to be used as an aid in the assessment of
vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on
Elecsys and cobas e immunoassay analyzers. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used for
calibrating the quantitative Elecsys Vitamin D assay on the Elecsys
and cobas e immunoassay analyzers. |
| | • Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 is
used for quality control of the specified Elecsys immunoassays on
the Elecsys and cobas e immunoassay analyzers. |
| | • Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck
5 is an assayed control for use in calibration verification and for use
in the verification of the assay range established by the Elecsys
Vitamin D reagent on the indicated Elecsys and cobas e
immunoassay analyzers. |
3
510(k) Summary, Continued
Substantial The Elecsys Vitamin D Test System is substantially equivalent to other -Equivalence devices legally marketed in the United States. (1) Elecsys Vitamin D Assay is equivalent to the Abbott Architect 25-OH Vitamin D assay (K110619). (2) Elecsys Vitamin D CalSet is equivalent to the standards contained in the Elecsys hGH CalSet (K103221) (Human Growth Hormone). (3) Elecsys PreciControl Varia 3 is equivalent to the controls contained in the PreciControl Multimarker (K102157). (4) The Elecsys Vitamin D CalCheck 5 is equivalent to the Elecsys T4 CalCheck 5 (K112528).
4
Premarket Notification, 510(k) for Elecsys Vitamin D Test System ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
| Substantial
Equivalence -
Comparison | The following table compares the Elecsys Vitamin D Test System with the
predicate device. The next three tables compare the Elecsys Vitamin D
CalSet, CalCheck 5, and PreciControl Varia 3 to their predicates. |
| -------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Comparison of Assays, Similarities and Differences Premarket Notification, 510(k) for Elecsys Vitamin D Test System
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect |
| 25-OH Vitamin D | ||
| (K110619) | ||
| General Assay Features | ||
| Intended | ||
| Use/ | ||
| Indications | ||
| for Use | The Vitamin D assay is intended for | |
| the quantitative determination of total | ||
| 25-hydroxyvitamin D in human serum | ||
| and plasma. This assay is to be used | ||
| as an aid in the assessment of vitamin | ||
| D sufficiency in adults. | ||
| The electrochemiluminescence | ||
| binding assay is intended for use on | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | The Abbott Architect 25-OH Vitamin | |
| D assay is a chemiluminescent | ||
| microparticle immunoassay (CMIA) | ||
| for the quantitative determination of | ||
| 25-hydroxyvitamin D (25-OH vitamin | ||
| D) in human serum or plasma. The | ||
| Architect 25-OH Vitamin D assay is to | ||
| be used as an aid in the assessment of | ||
| vitamin D sufficiency. | ||
| Assay | ||
| Protocol | Quantitative protein binding assay | Quantitative chemiluminescence |
| immunoassay | ||
| Detection | ||
| Protocol | Electrochemiluminescence | Chemiluminescence |
| Applications | 27 minute application | 36 minutes (time to first result) |
5
Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued .
| Assay Comparison | ||||
|---|---|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott | ||
| Architect 25-OH Vitamin D | ||||
| (K110619) | ||||
| General Assay Features | ||||
| Instrument | ||||
| Platform | Elecsys 2010 and cobas e 411 | Abbott Architect 25-OH Vitamin D | ||
| Sample | ||||
| Volume | 15 uL | 60 uL for first run, 10 uL for | ||
| additional runs | ||||
| Sample | ||||
| Type | Human serum and plasma treated with | |||
| K2-EDTA, K3-EDTA or lithium | ||||
| heparin. | Human serum, plasma treated with | |||
| lithium heparin, sodium heparin, | ||||
| potassium EDTA, or sodium citrate. | ||||
| Reagents | The Elecsys Vitamin D assay is a | |||
| competitive binding assay which | ||||
| includes vitamin D (25-OH) labeled | ||||
| with biotin, and a ruthenium labeled | ||||
| vitamin D binding protein, and | ||||
| streptavidin coated microparticles. | The Abbott Architect 25-OH Vitamin | |||
| D assay is a competitive one-step | ||||
| delayed immunometric assay which | ||||
| includes anti-vitamin D coated | ||||
| microparticles, an assay diluent, and | ||||
| biotinylated vitamin D anti-biotin | ||||
| acridinium labeled conjugate. | ||||
| Calibrator | Elecsys Vitamin D CalSet, 2 levels | Architect 25-OH Vitamin D | ||
| Calibrators, 6 levels |
Comparison of Assays—Similarities and Differences, continued
6
Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued ·
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott |
| Architect 25-OH Vitamin D | ||
| (K110619) | ||
| Calibration | ||
| Interval | Calibration must be performed once | |
| per reagent lot using fresh reagent | ||
| (i.e. not more than 24 hours since the | ||
| reagent kit was registered on the | ||
| analyzer). Renewed calibration is | ||
| recommended as follows: | ||
| After 1 month (28 days) when | ||
| using the same reagent lot. After 7 days (when using the | ||
| same reagent kit on the | ||
| analyzer). As required: e.g. quality | ||
| control findings outside the | ||
| specified limits | Calibration must be performed: | |
| After 7 days When a control value is out of | ||
| range | ||
| Controls | Elecsys PreciControl Varia 3 | Architect 25-OH Vitamin D Controls |
7
Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott |
| Architect 25-OH Vitamin D | ||
| (K110619) | ||
| General assay features | ||
| Traceability / | ||
| Standardization | The Elecsys Vitamin D Assay has | |
| been standardized against LC-MS/MS | ||
| which in turn has been standardized to | ||
| the NIST standard. | Architect 25-OH Vitamin D is | |
| traceable to a manufacturer's | ||
| internal standard (Primary | ||
| Calibrator), which is anchored | ||
| against Absorbance at 264 nm. | ||
| Reagent | ||
| Stability | Unopened at 2-8 oC-up to stated | |
| expiration date | ||
| After opening at 2-8 oC—56 days | ||
| On the Elecsys 2010 and cobas e | ||
| 411—21 days | Unopened at 2-8 oC-up to stated | |
| expiration date. | ||
| After opening: on-board the | ||
| analyzer for 14 days |
8
System, Continued Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott |
| Architect 25-OH Vitamin D | ||
| (K110619) | ||
| Labeled Performance Characteristics | ||
| Measuring | ||
| Range | 5-60 ng/mL | 13-96 ng/mL |
| Precision | Elecsys 2010/ cobas e 411: | |
| Within-run (will be labeled Repeatability) | ||
| n=84, human sera | ||
| 7.2% CV @ 6.2 ng/mL | ||
| 5.1% CV @ 11.2 ng/mL | ||
| 2.9% CV @ 23.2 ng/mL | ||
| 2.4% CV @ 45.3ng/mL | ||
| 1.6% CV @ 52.6 ng/mL |
Total (will be labeled Intermediate)
10.3% CV @ 6.2 ng/mL
7.6% CV @ 11.2 ng/mL
5.3% CV @ 23.2 ng/mL
3.4% CV @ 45.3ng/mL
2.9% CV @ 52.6 ng/mL | Abbott Architect 25-OH Vitamin D
Within-run
n=80, human sera
3.1% CV @ 23.0 ng/mL
2.6% CV @ 42.5 ng/mL
1.4% CV @ 75.4 ng/mL
Total
4.0% CV @ 23.0 ng/mL
3.2% CV @ 42.5 ng/mL
2.7% CV @ 75.4 ng/mL |
9
:
Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||||
|---|---|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott | ||
| Architect 25-OH Vitamin D | ||||
| (K110619) | ||||
| Labeled Performance Characteristics | ||||
| Analytical | ||||
| Sensitivity | Limit of Blank (LoB) 2.00 ng/mL | |||
| Limit of Detection (LoD) 3.00 ng/mL | ||||
| Limit of Quantitation (LoQ) 5.00 | ||||
| ng/mL | Limit of Blank: 1.9 ng/mL | |||
| Limit of Detection: 3.1 ng/mLL | ||||
| Limit of Quantitation (LoQ) 8.0 | ||||
| ng/mL | ||||
| Analytical | ||||
| Specificity | Cross Reactant | |||
| 25-hydroxyvitamin D3 | ||||
| 25-hydroxyvitamin D2 | ||||
| 24,25-hydroxyvitamin D3 | ||||
| 1,25-hydroxyvitamin D3 | ||||
| 1,25-hydroxyvitamin D2 | ||||
| Vitamin D3 | ||||
| Vitamin D2 | ||||
| C3-epimer of 25- | ||||
| hydroxyvitamin D3 | Cross Reactant | |||
| Cross | ||||
| Reactivity | ||||
| (%) | ||||
| 100 | ||||
| 92 | ||||
| 149 | ||||
| not detected | ||||
| not detected | ||||
| not detected | ||||
| not detected | ||||
| 91 | Cross Reactant | |||
| 25-hydroxyvitamin D3 | ||||
| 25-hydroxyvitamin D2 | ||||
| 24,25-hydroxyvitamin D3 | ||||
| 1,25-hydroxyvitamin D3 | ||||
| 1,25-hydroxyvitamin D2 | ||||
| Vitamin D3 | ||||
| Vitamin D2 | ||||
| C3-epimer of 25- | ||||
| hydroxyvitamin D3 | Cross | |||
| Reactivity | ||||
| (%) | ||||
| 105 | ||||
| 82 | ||||
| 112 | ||||
| 12.6 | ||||
| Not tested | ||||
| 0.3 | ||||
| 0.1 | ||||
| 2.7 | ||||
| Hook Effect | There is no high-dose hook effect | |||
| since the Elecsys Vitamin D assay is a | ||||
| competitive assay | Unknown | |||
| Limitations | The assay is unaffected by: | |||
| • Hemoglobin |