(227 days)
Not Found
No
The summary describes a standard immunoassay for measuring vitamin D levels and does not mention any AI or ML components in the device description or performance studies.
No.
The device is for in vitro diagnostic use to quantitatively determine total 25 (OH) vitamin D in human serum and plasma, which aids in the determination of vitamin D sufficiency. It is an assay used for diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma." It also notes that it is "intended as an aid in the determination of vitamin D sufficiency," which is a diagnostic purpose.
No
The device description clearly outlines a competitive immunoassay using physical components like paramagnetic particles and acridium ester, which are hardware components of an in vitro diagnostic system.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The ADVIA Centaur Vitamin D Total (VitD) assay is for the in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma..."
- "The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay."
- "The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay..."
- "The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay."
These statements clearly indicate that the device and its associated components are intended for use in diagnostic procedures performed outside of the living body (in vitro).
N/A
Intended Use / Indications for Use
The ADVIA Centaur Vitamin D Total (VitD) assay is for the in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay.
The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay on the ADVIA Centaur systems.
The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JIT, JJX
Device Description
The ADVIA Centaur Vitamin D Total assay is a one-pass 18 minute competitive immunoassay that uses an anti-fluorescein labeled (FITC) monoclonal antibody covalently bound to paramagnetic particles (PMP), one monoclonal antibody labeled with acridium ester (AE), and a Vitamin D analog labeled with fluorescein. An inverse relationship exists between the amount of Vitamin D present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence for the ADVIA Centaur Vitamin D Total assay was demonstrated by testing several method performance characteristics including Analytical Sensitivity, linearity, imprecision, method comparison, interfering substances, and specificity. The following tables summarize the analytical sensitivity, linearity, precision (total), interfering substances, specificity, serum / plasma equivalency and method comparison results. All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Centaur Vitamin D Total assay (including the calibrators and controls) are substantially equivalent to the IDS 25-Hydroxy Vitamin D EIA that is currently marketed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity
LoB = 1.60 ng/mL LoD = 3.2 ng/mL LoQ = 4.2 ng/mL
Imprecision
ADVIA Centaur Vitamin D Total Assay
- Level (ng/mL): 11.7, Total CV (%): 11.1, n = 160
- Level (ng/mL): 18.0, Total CV (%): 9.6, n = 160
- Level (ng/mL): 32.4, Total CV (%): 9.8, n = 160
- Level (ng/mL): 49.9, Total CV (%): 8.2, n = 160
- Level (ng/mL): 55.8, Total CV (%): 7.8, n = 160
- Level (ng/mL): 132.1, Total CV (%): 4.8, n = 160
IDS 25-Hydroxy Vitamin D EIA
- Level (ng/mL): 40.3, Inter assay CV (%): 4.6, n = 11
- Level (ng/mL): 72.0, Inter assay CV (%): 6.4, n = 11
- Level (ng/mL): 132.0, Inter assay CV (%): 8.7, n = 11
Specificity
The ADVIA Centaur VitD Total assay shows high specificity for 25(OH) vitamin D2 and 25(OH) vitamin D3.
- Compound: 1, 25 (OH)2 Vitamin D2, Concentration (ng/mL): 100, Cross-Reactivity (%): 4.0
- Compound: 1, 25 (OH)2 Vitamin D3, Concentration (ng/mL): 100, Cross-Reactivity (%): 1.0
- Compound: 25 OH Vitamin D2, Concentration (ng/mL): 30, Cross-Reactivity (%): 104.5
- Compound: 25 OH Vitamin D3, Concentration (ng/mL): 30, Cross-Reactivity (%): 100.7
- Compound: Paricalcitol, Concentration (ng/mL): 24, Cross-Reactivity (%): 0.1
- Compound: 3-epi-25-OH Vitamin D3, Concentration (ng/mL): 100, Cross-Reactivity (%): 1.1
- Compound: Vitamin D2, Concentration (ng/mL): 1000, Cross-Reactivity (%): 0.5
- Compound: Vitamin D3, Concentration (ng/mL): 1000, Cross-Reactivity (%): 0.3
Interfering Substances
- Specimens That Are hemolyzed Demonstrate ≤ 10% Change in Results Up To 155 mg/dL of hemoglobin
- Specimens That Are lipemic Demonstrate ≤ 10% Change in Results Up To 540 mg/dL of triglycerides
- Specimens That Are icteric Demonstrate ≤ 10% Change in Results Up To 40 mg/dL of conjugated bilirubin
- Specimens That Are icteric Demonstrate ≤ 10% Change in Results Up To 40 mg/dL of unconjugated bilirubin
- Specimens That Contain cholesterol Demonstrate ≤ 10% Change in Results Up To 350 mg/dL
- Specimens That Contain uric acid Demonstrate ≤ 10% Change in Results Up To 20 mg/dL
- Specimens That Contain human immunoglobulin Demonstrate ≤ 10% Change in Results Up To 12 g/dL
Correlation (y =ADVIA Centaur Vitamin D assay vs. x = IDS 25-OH Vitamin D EIA assay comparison method/system)
- X Axis: IDS, Y Axis: Centaur VitD, n: 195, r: .960, Slope: 1.0, Y-int: +2.22
Serum / Plasma (lithium heparin and EDTA)
Linear regression analysis was performed using the following:
- serum (x) vs. SST (y1)
- serum (x) vs. EDTA (y2)
- serum (x) vs. lithium heparin (y3)
- serum (x) vs. sodium heparin (y4)
No significant differences between tube types were observed. The following results were obtained:
- Tube Types: Serum vs. SST, N: 231, Range (ng/mL): 11.9 - 136.9, Slope: 1.01, Intercept: -0.33, R: 0.994
- Tube Types: Serum vs. EDTA, N: 231, Range (ng/mL): 11.9 - 136.9, Slope: 1.09, Intercept: -0.17, R: 0.993
- Tube Types: Serum vs. Lithium Heparin, N: 231, Range (ng/mL): 11.9 - 136.9, Slope: 1.04, Intercept: 0.18, R: 0.992
- Tube Types: Serum vs. Sodium Heparin, N: 231, Range (ng/mL): 11.9 - 136.9, Slope: 1.04, Intercept: 0.90, R: 0.992
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 4 2011
510(k) Summary
| Submitter information | |
|---|---|
| Contact person: | Neil Parker |
| Senior Regulatory Affairs Specialist | |
| Address: | Siemens Healthcare Diagnostics |
| 511 Benedict Avenue | |
| Tarrytown, NY 10591 | |
| Phone: | 914-524-2477 |
| 914-524-2500 (fax) |
Date summary prepared: February 28, 2011
Device Trade or Proprietary Names:
ADVIA Centaur Vitamin D Total Assay
ADVIA Centaur Vitamin D Total calibrators
ADVIA Centaur Vitamin D Total QC
ADVIA Centaur Vitamin D Total Master Curve Material
Device Common/Usual Name or Classification Name:
Vitamin D Test System Calibrator Quality Control Material (Assayed and Unassayed)
Classification Number / Class:
21 CFR 862.1825 - Vitamin D Test System - Class II 21 CFR 862.1150 - Calibrator - Class II 21 CFR 862.1660 - Quality Control Material (Assayed and Unassayed) - Class I
Siemens Healthcare Diagnostics ADVIA Centaur Vitamin D Total assay 510(k) Summary
1
Product code:
MRG - Vitamin D Test system JIT - Calibrator, Secondary JJX - single (specified) Analyte Controls (Assayed and Unassayed)
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: __
Assay Predicate Device (including calibrators and controls):
| Predicate Device | |
|---|---|
| Device Name | IDS 25-Hydroxy Vitamin D EIA |
| Common name | Vitamin D Test System |
| 510(k) Number | K021163 |
| Manufacturer | Immunodiagnostic Systems Ltd (IDS Ltd) |
Master Curve Material Predicate Device
| Predicate Device | ||
|---|---|---|
| Device Name | The VALIDATE Thyroid Calibration Verification Test | |
| Set | ||
| Common name | single (specified) Analyte Controls (Assayed | |
| and Unassayed) | ||
| 510(k) Number | K062501 | |
| Manufacturer | Maine Standards Company |
Device Description:
The ADVIA Centaur Vitamin D Total assay is a one-pass 18 minute competitive immunoassay that uses an anti-fluorescein labeled (FITC) monoclonal antibody covalently bound to paramagnetic particles (PMP), one monoclonal antibody labeled with acridium ester (AE), and a Vitamin D analog labeled with fluorescein. An inverse relationship exists between the amount of Vitamin D present in the patient sample and the amount of relative light units (RLUs) detected by the system.
2
Statements of Intended Use:
The ADVIA Centaur Vitamin D Total (VitD) assay is for the in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay.
The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay on the ADVIA Centaur systems.
The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
3
Comparisons to the Predicate Devices: Assay Similarities
| Items | ADVIA Centaur Vitamin D Total
assay | IDS 25-OH Vitamin D EIA
assay (Predicate Device)
K021163 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarity | | |
| Intended Use/Indication for
use | For the in vitro diagnostic use in
the quantitative determination of
total 25 (OH) vitamin D in human
serum and plasma (EDTA,
lithium-heparin, sodium-heparin)
using the ADVIA Centaur XP
system. The ADVIA Centaur VitD
assay is intended as an aid in the
determination of vitamin D
sufficiency. | Similar
The IDS 25-OH Vitamin D EIA
kit is an enzymeimmunoassay
intended for the quantitative
determination of 25-
Hydroxyvitamin D and other
hydroxylated metabolites in
human serum and plasma.
Results are to be used in
conjunction with other clinical
and laboratory data to assist
the clinician in the assessment
of vitamin D sufficiency in
adult populations. |
| Sample Type | Serum and Plasma | same |
| Reagent storage temperature | 2-8°C | same |
| Interpretation of results | Standard curve | same |
| Expected Values | Deficiency 100ng/mL | Same |
| | Ranges established for
apparently healthy adults not on
supplements:
10.6 ng/mL to 43.4 ng/mL
n = 542 | Ranges established adults
19.1 ng/mL to 57.6 ng/mL
n = 36 |
Assay Differences
| Items | ADVIA Centaur Vitamin D Total
assay | IDS 25-OH Vitamin D EIA
assay (Predicate Device)
K021163 |
|------------------------|----------------------------------------|-----------------------------------------------------------------|
| Differences | | |
| Platform | ADVIA Centaur XP | ELISA plate read on a plate
reader |
| Assay principle | Chemiluminescence | ELISA |
| Assay procedure | Automated | Manual |
| Approximate Assay time | 18 minute | 3.5 hours |
| Assay Range | 4.2 to 150 ng/mL | 5.9 to 120 ng/mL |
| Traceability | Traceable to LC-MS/MS | Standardized using UV
quantification of 25-(OH)
vitamin D |
Siemens Healthcare Diagnostics
ADVIA Centaur Vitamin D Total assay
510(k) Summary
4
Calibrator Similarities
| Items | ADVIA Centaur Vitamin D Total
assay calibrators | IDS 25-OH Vitamin D EIA
assay calibrators (Predicate
Device) K021163 |
|------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Similarity | | |
| Intended Use/Indication for
use | For in vitro diagnostic use in
calibrating ADVIA Centaur®
systems Vitamin D Total (VitD)
assay. | Similar |
| Antigen used in calibrators | 25-(OH) vitamin D3 | same |
| Storage temperature | 2-8°C | same. |
Calibrator Differences
| Items | ADVIA Centaur Vitamin D Total
assay | IDS 25-OH Vitamin D EIA
assay calibrators (Predicate
Device) K021163 |
|-----------------------|----------------------------------------|----------------------------------------------------------------------------|
| Differences | | |
| Number of calibrators | 2 | 6 |
| Matrix | Lyophilized human plasma | Lyophilized human serum |
5
QC Similarities
| Items | ADVIA Centaur Vitamin D Total
assay controls | IDS 25-OH Vitamin D EIA
assay controls (Predicate
Device) K021163 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Similarity | | |
| Intended Use/Indication for
use | For in vitro diagnostic use to
monitor the precision and
accuracy of the ADVIA Centaur®
VitD assay on the ADVIA
Centaur systems. | Similar |
| Antigen used in controls | 25-(OH) vitamin D3 | same |
| Number of Levels | 2 | same |
| Storage temperature | 2-8°C | same |
QC Differences
| Items | ADVIA Centaur Vitamin D Total
assay controls | IDS 25-OH Vitamin D EIA
assay controls (Predicate
Device) K021163 |
|-------------|-------------------------------------------------|-------------------------------------------------------------------------|
| Differences | | |
| | | |
| Matrix | Lyophilized human plasma | Lyophilized human serum |
· :
6
MCM Similarities
| Items | ADVIA Centaur Vitamin D Total
assay MCMs | Maine Standards Company
VALIDATE Thyroid Calibration
Verification Test Set
(K062501) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarity | | |
| Intended Use/Indication for
use | The ADVIA Centaur® Vitamin D
Total (VitD) Master Curve
Material is for in vitro diagnostic
use in the verification of
calibration and reportable range
of the ADVIA Centaur VitD
assay. | The VALIDATE Thyroid
Calibration Verification Test
Set solutions are for in vitro
diagnostic use in the
uantitative determination of
linearity, calibration verification
and verification of reportable
range in automated, semi-
automated and manual
chemistry systems. |
| Number of Levels | 5 | Same |
MCM Differences
| Items | ADVIA Centaur Vitamin D Total assay MCMs | Maine Standards Company
VALIDATE Thyroid
Calibration
Verification Test Set
(K062501) |
|-------------|------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Differences | | |
| Matrix | Human plasma | Human Serum |
| Form | Lyophilized | liquid |
| Analyte | 25 (OH) vitamin D | Triiodothyronine (T3),
Thyroxine (T4), human
Thyroid Stimulating Hormone
(TSH), and Cortisol. |
Performance:
Substantial equivalence for the ADVIA Centaur Vitamin D Total assay was demonstrated by testing several method performance characteristics including Analytical Sensitivity, linearity, imprecision, method comparison, interfering substances, and specificity. The following tables summarize the analytical sensitivity, linearity, precision (total), interfering substances, specificity, serum / plasma equivalency and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Centaur Vitamin D Total assay (including the
7
calibrators and controls) are substantially equivalent to the IDS 25-Hydroxy Vitamin D EIA that is currently marketed.
Analytical Sensitivity
LoB = 1.60 ng/mL LoD = 3.2 ng/mL LoQ = 4.2 ng/mL
Imprecision
| ADVIA Centaur Vitamin D
| Total Assay | IDS 25-Hydroxy Vitamin D EIA | ||
|---|---|---|---|
| Level (ng/mL) | Total CV (%) | ||
| n = 160 | Level (ng/mL) | Inter assay CV (%) | |
| n = 11 | |||
| 11.7 | 11.1 | ||
| 18.0 | 9.6 | ||
| 32.4 | 9.8 | 40.3 | 4.6 |
| 49.9 | 8.2 | ||
| 55.8 | 7.8 | 72.0 | 6.4 |
| 132.1 | 4.8 | 132.0 | 8.7 |
Specificity
The ADVIA Centaur VitD Total assay shows high specificity for 25(OH) vitamin D2 and 25(OH) vitamin D3. The following compounds were tested with total 25(OH) vitamin D concentrations of 35 and 115 ng/mL. Percent change is calculated as: Percent cross-reactivity = (corrected assay value / amount of compound spiked) x 100
8
| Compound | Concentration (ng/mL) | Cross-Reactivity (%) |
|---|---|---|
| 1, 25 (OH)2 Vitamin D2 | 100 | 4.0 |
| 1, 25 (OH)2 Vitamin D3 | 100 | 1.0 |
| 25 OH Vitamin D2 | 30 | 104.5 |
| 25 OH Vitamin D3 | 30 | 100.7 |
| Paricalcitol | 24 | 0.1 |
| 3-epi-25-OH Vitamin D3 | 100 | 1.1 |
| Vitamin D2 | 1000 | 0.5 |
| Vitamin D3 | 1000 | 0.3 |
Interfering Substances
Interfering substances were tested as described in CLSI Document EP7-A2 using the ADVIA Centaur VitD assay.
| Specimens That Are | Demonstrate ≤ 10% Change in Results Up To |
|---|---|
| hemolyzed | 155 mg/dL of hemoglobin |
| lipemic | 540 mg/dL of triglycerides |
| icteric | 40 mg/dL of conjugated bilirubin |
| icteric | 40 mg/dL of unconjugated bilirubin |
| Specimens That Contain | Demonstrate ≤ 10% Change in Results Up To |
| cholesterol | 350 mg/dL |
| uric acid | 20 mg/dL |
| human immunoglobulin | 12 g/dL |
Correlation
(y =ADVIA Centaur Vitamin D assay vs. x = IDS 25-OH Vitamin D EIA assay comparison method/system)
| IDS vs Centaur | |||||
|---|---|---|---|---|---|
| X Axis | Y Axis | n | r | Slope | Y-int |
| IDS | Centaur VitD | 195 | .960 | 1.0 | +2.22 |
9
Serum / Plasma (lithium heparin and EDTA)
The ADVIA Centaur VITD assay was evaluated using different sample matrices and tube collection types. A matrix study was performed using matched specimens drawn in different tube types,including serum red top, SST, EDTA, lithium heparin, and sodium heparin. Vitamin D values ranged from 11.9 to 136.9 ng/mL (29.8 to 342.3 nmol/L). Linear regression analysis was performed using the following:
- · serum (x) vs. SST (y1)
- · serum (x) vs. EDTA (y2)
- · serum (x) vs. lithium heparin (y3)
- · serum (x) vs. sodium heparin (y4)
No significant differences between tube types was observed. The following results were obtained:
| Tube Types | N | Range
(ng/mL) | Slope | Intercept | R |
|---------------------------|-----|------------------|-------|-----------|-------|
| Serum vs. SST | 231 | 11.9 - 136.9 | 1.01 | -0.33 | 0.994 |
| Serum vs. EDTA | 231 | 11.9 - 136.9 | 1.09 | -0.17 | 0.993 |
| Serum vs. Lithium Heparin | 231 | 11.9 - 136.9 | 1.04 | 0.18 | 0.992 |
| Serum vs. Sodium Heparin | 231 | 11.9 - 136.9 | 1.04 | 0.90 | 0.992 |
Conclusions:
The Siemens Healthcare Diagnostics ADVIA Centaur Vitamin D Total assay (including calibrators and controls) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed IDS 25-Hydroxy Vitamin D EIA (K021163).
The Siemens Healthcare Diagnostics ADVIA Centaur Vitamin D Total assay MCMs are substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed VALIDATE Thyroid Calibration Verification Test Set (K062501).
10
Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Mr. Neil Parker 511 Benedict Avenue Tarrytown, New York 10509
OCT 1 4 2011
Re: K110586
Trade Name: ADVIA Centaur Vitamin D Total (VitD) Assay ADVIA Centaur Vitamin D Total (VitD) Calibrators ADVIA Centaur Vitamin D Total (VitD) QC ADVIA Centaur Vitamin D Total (VitD) Master Curve Material Regulation Number: 21 CFR §862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Codes: MRG, JIS, JIX Dated: September 15, 2011 Received: September 16, 2011
Dear Dr. Neil Parker,
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
11
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
12
Indication for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ADVIA Centaur Vitamin D Total Assay Indication for Use:
The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium-heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay.
The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay on the ADVIA Centaur systems.
The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
Prescription Use X_ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110586.
Page 1 of