(264 days)
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No
The description details a standard enzyme immunoassay and calculation based on a standard curve, with no mention of AI or ML techniques.
No.
This device is an in vitro diagnostic (IVD) intended for the quantitative measurement of total 25-hydroxyvitamin D, which aids in determining vitamin D sufficiency. It does not provide treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D)... The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency." This directly indicates its purpose as a diagnostic device.
No
The device is an in vitro diagnostic assay kit, which includes reagents and calibrators, and is intended for use on a specific hardware analyzer system (TOSOH AIA System Analyzers). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states "ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only".
- Purpose: It is used for the quantitative measurement of a substance (total 25-hydroxyvitamin D) in human biological samples (serum, plasma).
- Clinical Aid: The intended use also states it is "intended as an aid in the determination of Vitamin D sufficiency," indicating its role in providing information for clinical assessment.
- Device Description: The description details a laboratory assay method (enzyme immunoassay) performed on a specific analyzer (TOSOH AIA System Analyzers), which is characteristic of IVD devices.
- Calibrator Set: The inclusion and description of a calibrator set for "in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay" further confirms its IVD nature.
N/A
Intended Use / Indications for Use
ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na-heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.
The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.
Product codes
MRG, JIT
Device Description
The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK 25-OH Vitamin D test cup. Sample pretreatment reagents (containing sodium hydroxide) disassociate 25-OH vitamin D from its binding proteins in the test sample. 25-OH vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzymelabeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-OH vitamin D competes with 25-OH vitamin D for binding to the antibody on magnetic beads in the reaction mixture.
After the second incubation, the magnetic beads are washed to remove the unbound enzymelabeled 25-OH vitamin D and are then incubated with a fluorogenic substrate, 4- methylumbellifery phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-0H vitamin D concentration in the test sample. A standard curve is constructed, and unknown 25-OH vitamin D concentrations are calculated using this curve.
The ST AIA-PACK 25-OH Vitamin D Calibrator Set contains human sera with assigned levels of 25-OH Vitamin D. The calibrator set consists of six calibrators with assigned concentrations of approximately 0, 8, 17, 33, 66 and 135 ng/mL. Each level contains the assigned concentration of the 25-OH vitamin D (described on each vial) with sodium azide as a preservative.
Mentions image processing
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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
Precision was assessed by assaying three levels of unaltered serum specimens (Serum-B and Serum-C) and three spiked serum specimens (Serum-E and Serum-F) on two analyzers and two lots of reagents. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days. This equaled a total of 40 runs and 80 determinants per lot. In addition, all of the data were combined to assess the within run, between run, between lot and total precision.
The linearity for ST AIA-PACK 25-OH Vitamin D Calibrator was determined, based on the CLSI protocol entitled: Evaluation of the Linearity of Qualitative Measurement Methods; Approved Guidelines (EP6-A). The linearity was measured on the AIA-2000 instrument and has been demonstrated to be linear from 4.0 ng/mL to 120 ng/mL.
The methods comparison study was conducted with reference to the CLSI protocol entitled: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (EP9-A2). A total of 111 serum specimens in the range of 5.0 -114 ng/mL, as value assigned by the Ghent University ID-LC-MS/MS reference measurement procedure (RMP), were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay to assess the ST-AIA-PACK 25-OH Vitamin D Assay traceability to the RMP. To demonstrate the bias between the standardized assay (candidate) as compared to the original assay (predicate), one hundred eighty-one (181) unaltered serum specimens were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay on the AIA-2000 analyzer using calibrations from ST AIA-PACK 25-OH Vitamin D Calibrator (predicate and candidate) and comparing the results.
A reference range study was conducted based on guidance from Clinical and Laboratory Standards Institute (CLSI) Protocol C28-A3. To determine the reference range for the ST-AIA-PACK 25-OH Vitamin D Assay, a total of 252 serum samples, from 111 females and 141 males, ages 21 to 86 years, were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay on the AIA-2000 analyzer. The specimens were obtained from apparently healthy individuals with normal PTH, TSH, calcium, magnesium and phosphorus levels. The samples were collected in Maryland, Pennsylvania, Wisconsin and Southern California in March, May, June, and July respectively.
Key Metrics
Precision:
Within-run precision: 1.3 - 3.9%
Between run precision: 1.5 - 3.1%
Between day precision: 2.2 - 4.1%
Total precision: 2.6 - 4.9%
Between lot precision: 1.1 - 3.1%
Linearity: 4.0 ng/mL to 120 ng/mL.
Method Comparison (Weighted Deming regression between RMP and ST AIA-PACK 25-OH Vitamin D Assay):
Slope: 0.98 (0.92 - 1.05)
Intercept: -0.48 (-1.89 - 0.92)
Standard Error Estimate: 0.708
Corr Coef (R): 0.965
Bias: -0.23 (-0.71%)
Method Comparison (Deming regression between Predicate calibrator and Candidate calibrator):
Slope: 0.808 (0.801 to 0.816)
Intercept: 0.26 (-0.15 to 0.67)
Standard Error Estimate: 1.17
Corr Coef (R): 0.9979
Bias: -8.90 (-20.25%)
Reference Range: 12.3 – 60.0 ng/mL (for adult population)
Limit of Detection (LoD): 3.2 ng/mL
Limit of Quantification (LoQ) / Functional sensitivity: 3.3 ng/mL at 20% CV.
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a pair of wings.
October 26,2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TOSOH BIOSCIENCE, INC. ROBERT WICK REGULATORY SPECIALIST 6000 SHORELINE COURT, SUITE 101 SOUTH SAN FRANCISCO CA 94080
Re: K150270
Trade/Device Name: ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JIT Dated: September 10, 2015 Received: September 14, 2015
Dear Robert Wick:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150270
Device Name
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set
Indications for Use (Describe)
ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na-heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.
The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary
ST AIA-PACK 25-OH Vitamin D K150270
| Date: | October 22, 2015 |
|---|---|
| Submitter: | Tosoh Bioscience, Inc |
| 3600 Gantz Road | |
| Grove City, OH 43123 | |
| Contact Person: | Robert L. Wick |
| Regulatory Specialist | |
| 6000 Shoreline Ct., Ste. 101 | |
| South San Francisco, CA 94080 | |
| Phone: 650-636-8117 | |
| Fax: | |
| 650-636-8121 | |
| Email: Robert.Wick@Tosoh.com | |
| Device Name: | |
| Classification: | ST AIA-PACK 25-OH Vitamin D |
| Class II | |
| MRG | |
| Clinical Chemistry | |
| 21 CFR 862.1825 | |
| Device Name: | |
| Classification | ST AIA-PACK 25-OH Vitamin D Calibrator Set |
| Class II | |
| JIT | |
| ClinicalChemistry | |
| 21 CFR 862.1150 | |
| Predicate Device: | K123131 |
| Tosoh Bioscience, Inc. | |
| ST AIA-PACK 25-OH Vitamin D Assay | |
| ST AIA-PACK 25-OH Vitamin D Calibrator Set |
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.
Device Description:
The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK 25-OH Vitamin D test cup. Sample pretreatment reagents (containing sodium hydroxide) disassociate 25-OH vitamin D from its binding proteins in the test sample. 25-OH vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzymelabeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-OH vitamin D competes with 25-OH vitamin D for binding to the antibody on magnetic beads in the reaction mixture.
After the second incubation, the magnetic beads are washed to remove the unbound enzymelabeled 25-OH vitamin D and are then incubated with a fluorogenic substrate, 4- methylumbellifery phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-0H vitamin D concentration in the test sample. A standard curve is
ST AIA-PACK 25-OH Vitamin D
4
Tosoh Bioscience, Inc. constructed, and unknown 25-OH vitamin D concentrations are calculated using this curve.
The ST AIA-PACK 25-OH Vitamin D Calibrator Set contains human sera with assigned levels of 25-OH Vitamin D. The calibrator set consists of six calibrators with assigned concentrations of approximately 0, 8, 17, 33, 66 and 135 ng/mL. Each level contains the assigned concentration of the 25-OH vitamin D (described on each vial) with sodium azide as a preservative.
The following products are required to use the ST AIA-PACK 25-OH Vitamin D P/N 025234: ST
| AIA-PACK 25-OH Vitamin D Calibrator Set | 025334 |
|---|---|
| ST AIA-PACK 25-OH Vitamin D Pretreatment Set | 025734 |
Device Intended Use:
ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na heparinized or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.
Calibrators:
The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.
Device Indications for Use:
Same as Intended Use
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK 25-OH Vitamin D (standardized) and Tosoh AIA-PACK 25- OH Vitamin D Assay (unstandardized)
Similarities and Differences
| Parameter | ST AIA-PACK 25-OH Vitamin
D Test Cups (modified calibrator) | ST AIA-PACK 25-OH Vitamin
D Test Cups K123131 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended use | ST AIA-PACK 25-OH Vitamin D is designed for in vitro
diagnostic use only for the
quantitative measurement of
total 25-hydroxyvitamin D (25-
OH vitamin D) in human
serum, Na heparinized or
EDTA plasma on TOSOH AIA
System Analyzers. The Tosoh
ST AIA-PACK 25-OH Vitamin
D is intended as an aid in the
determination of Vitamin D
sufficiency. | Same |
| Indications for Use | Same as Intended Use. | Same |
| Sample type | EDTA plasma, Na heparinized
plasma or serum | Same |
| Assay Range | 4.0 ng/mL - 120.0 ng/mL | Same |
| Assay Technology | Fluorescent Immunoassay | Same |
| Incubation Time | 10 minute cycle | Same |
| Reference range | 12.3 ng/mL to 60.0 ng/mL | 10.8 to 54.75 ng/mL |
5
| Parameter | ST AIA-PACK 25-OH Vitamin
D Calibrator Set | ST AIA-PACK 25-OH Vitamin
D Calibrator Set K123131 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended use | The ST AIA-PACK 25-OH
Vitamin D Calibrator Set is
intended for IN VITRO
DIAGNOSTIC USE ONLY for
the calibration of the ST AIA-
PACK 25-OH Vitamin D assay. | Same |
| Matrix | Human serum | Same |
| Number of Calibrators | 6 | Same |
| Format | Lyophilized | Same |
| Standardization/Traceability | Traceable to the ID-LC/MS/MS
25 (OH) vitamin D reference
measurement procedure
(University of Ghent) via patient
sample correlation. | Traceable to an Internal
reference standard |
| Concentration 25-OH vit D | Approximately 0-135 ng/mL (0,
8, 17, 33, 66, 135 ng/mL) | Approximately 0-165 ng/mL (0,
10, 20, 40, 80, 165 ng/mL) |
Calibrator Set പ വിഷ Similarities
PERFORMANCE CHARACTERISTICS
Precision
Precision was assessed by assaying three levels of unaltered serum specimens (Serum-B and Serum-C) and three spiked serum specimens (Serum-E and Serum-F) on two analyzers and two lots of reagents. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days. This equaled a total of 40 runs and 80 determinants per lot. In addition, all of the data were combined to assess the within run, between run, between lot and total precision. The following results were obtained when testing for precision:
| Within-run precision | 1.3 - 3.9% |
|---|---|
| Between run precision | 1.5 - 3.1% |
| Between day precision | 2.2 - 4.1% |
| Total precision | 2.6 - 4.9% |
| Between lot precision | 1.1 - 3.1% |
Combined Lot Summary Table
| Sample | Serum A | Serum B | Serum C | Serum D | Serum E | Serum F | |
|---|---|---|---|---|---|---|---|
| Mean Conc. | |||||||
| ng/mL | 16.9 | 20.9 | 24.7 | 55.2 | 74.6 | 95.3 | |
| Within | |||||||
| Run | SD | 0.62 | 0.82 | 0.77 | 1.28 | 1.55 | 1.24 |
| %CV | 3.7 | 3.9 | 3.1 | 2.3 | 2.1 | 1.3 |
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Tosoh Bioscience. Inc
| Between
| Run | SD | 0.53 | 0.65 | 0.52 | 1.07 | 1.26 | 1.40 |
|---|---|---|---|---|---|---|---|
| %CV | 3.1 | 3.1 | 2.1 | 1.9 | 1.7 | 1.5 | |
| Between | |||||||
| Day | SD | 0.64 | 0.68 | 1.02 | 1.48 | 1.88 | 2.07 |
| %CV | 3.8 | 3.3 | 4.1 | 2.7 | 2.5 | 2.2 | |
| Between | |||||||
| Lot | SD | 0.53 | 0.36 | 0.76 | 1.16 | 1.57 | 1.03 |
| %CV | 3.1 | 1.7 | 3.1 | 2.1 | 2.1 | 1.1 | |
| Total | SD | 0.82 | 0.96 | 1.19 | 1.81 | 2.28 | 2.43 |
| %CV | 4.9 | 4.6 | 4.8 | 3.3 | 3.1 | 2.6 |
The precision equals or exceeds the precision obtained with the predicate calibrator traceability for (k)123131.
Linearity:
The linearity for ST AIA-PACK 25-OH Vitamin D Calibrator was determined, based on the CLSI protocol entitled: Evaluation of the Linearity of Qualitative Measurement Methods; Approved Guidelines (EP6-A). The linearity was measured on the AIA-2000 instrument and has been demonstrated to be linear from 4.0 ng/mL to 120 ng/mL.
There is no change in linearity from K123131.
Standardization and Traceability
This assay is traceable to the isotope dilution-liquid chromatography/tandem mass spectrometry (ID-LC-/MS/MS) 25-OH Vitamin D Reference Method Procedure (RMP) that is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 2972.
The Tosoh ST-AIA PACK 25 OH Vitamin D assay was originally cleared under 510(k)123131. Tosoh modified the assay by standardizing the cleared Vitamin D assay in accordance with the Vitamin D Standardization and Certification Program (VDSCP).
Please refer to http://ods.od.nih.gov/Research/Vitamin D.aspx for more information on this program.
In accordance with the recommendations of the program, the traceability of the Tosoh ST-AIA PACK 25-OH Vitamin D Calibrator Set was verified by completing a method comparison and bias estimation using the University of Ghent's ID-LC/MS/MS 25-OH vitamin D Reference Measurement Procedure (RMP).
The relationship between the Tosoh ST-AIA PACK 25-OH Vitamin D assay and the ID-LC/MS/MS 25-OH Vitamin D RMP is described below in the method comparison section.
Value Assignment
The values of the primary reference materials were adjusted with correlation study results with the ID-LC-MS/MS method. The values were verified by comparing measured results with those obtained with ID-LC-MS/MS for patient samples at the University of Ghent, in Ghent, Belgium.
The values of the secondary reference material were assigned using the primary reference
ST AIA-PACK 25-OH Vitamin D
7
materials as calibrators. The values were verified by comparing measured results with those obtained with the previous lot for patient samples.
The commercial calibrator values were assigned with the secondary reference materials as calibrators. The values were verified by comparing measured results with those obtained with the previous lot for control materials.
Correlation
Method Comparison
The methods comparison study was conducted with reference to the CLSI protocol entitled: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (EP9-A2)
A total of 111 serum specimens in the range of 5.0 -114 ng/mL, as value assigned by the Ghent University ID-LC-MS/MS reference measurement procedure (RMP), were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay to assess the ST-AIA-PACK 25-OH Vitamin D Assay traceability to the RMP.
The Weighted Deming regression analysis between the RMP method and the ST AIA-PACK 25-OH Vitamin D Assay is listed below:
| Weighted Deming * | |
|---|---|
| Slope: | 0.98 (0.92 - 1.05) |
| Intercept: | -0.48 (-1.89 - 0.92) |
| Standard Error Estimate | 0.708 |
| Corr Coef (R): | 0.965 |
| Bias: | -0.23 (-0.71%) |
| Points (Plotted/Total): | 111/111 |
| Result Ranges: | ST AIA-PACK 25-OH Vitamin D 4.7 to 120 ng/mL |
| ID-LC-MS/MS (Ghent University) 5.0 to 114 ng/mL |
*95% Confidence Intervals are shown in parentheses
To demonstrate the bias between the standardized assay (candidate) as compared to the original assay (predicate), one hundred eighty-one (181) unaltered serum specimens were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay on the AIA-2000 analyzer using calibrations from ST AIA-PACK 25-OH Vitamin D Calibrator (predicate and candidate) and comparing the results. The results are listed below:
| Deming * | Regular * | |
|---|---|---|
| Slope | 0.808 (0.801 to 0.816) | 0.807 (0.7999 to 0.815) |
| Intercept | 0.26 (-0.15 to 0.67) | 0.33 (-0.08 to 0.73) |
| Standard Error Estimate | 1.17 | 1.17 |
| Corr Coef ® | 0.9979 | |
| Bias | -8.90 (-20.25%) | |
| Points (Plotted/Total) | 181/181 | |
| Result Ranges | Predicate calibrator 11.4 to111.8 ng/mL | |
| Candidate calibrator 9.4 to 92.3 ng/mL |
*95% Confidence Intervals are shown in parentheses
Matrix Comparison
See K123131
8
Cross Reactivity
See K123131
Reference Ranges
A reference range study was conducted based on guidance from Clinical and Laboratory Standards Institute (CLSI) Protocol C28-A3.
To determine the reference range for the ST-AIA-PACK 25-OH Vitamin D Assay, a total of 252 serum samples, from 111 females and 141 males, ages 21 to 86 years, were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay on the AIA-2000 analyzer. The specimens were obtained from apparently healthy individuals with normal PTH, TSH, calcium, magnesium and phosphorus levels. The samples were collected in Maryland, Pennsylvania, Wisconsin and Southern California in March, May, June, and July respectively.
The reference range specimens had a normal distribution and the 95% confidence interval was defined as the ref. range interval.
Demographics
| Caucasian | 48% | non-Caucasian | 52% | |
|---|---|---|---|---|
| Female | 44% | Male | 56% | |
| Supplements | 26% | No Supplements | 56% | Not specified 18% |
There was no significant difference between values obtained for male and females. The following reference range was obtained for the adult population:
| Number of Samples (n) | 252 |
|---|---|
| Reference Interval | 12.3 – 60.0 ng/mL |
Interference
See K123131
Limit of Detection and Limit of Quantification
The LoB and LoD of the ST AIA-PACK 25-OH Vitamin D was determined based on the CLSI guideline entitled: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline EP17-A.
The LoB was determined by 60 measurements of 3 different blank specimens. The LoB was the value at the 95th percentile. In this case the LoB was determined to be 1.6 ng/mL.
The LoD was determined by 12 measurements of 5 low level sample range was chosen to be between LoB and 4xLoB and 3 lots of reagents were utilized. The LoD was determined to be 3.2 ng/mL.
The LoQ was determined by measuring a series of low Vitamin D samples that were prepared by diluting a specimen with known Vitamin C concentration at different dilution ratios. The prepared samples were assayed in replicates of eight 98) every day for five (5) days on one instrument for a total of 40 replicates per sample.
9
The mean, SD and %CV were established and plotted to calculate the functional sensitivity. The functional sensitivity is 3.3 ng/mL at 20% CV.
Standards:
| Number | FDA
Recognition
Number | Revision
Date | Title |
|---------|------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------|
| EP5-A2 | 7-110 | 10/31/2005 | Evaluation of Precision Performance of
Quantitative Measurement Methods;
Approved Guideline-Second Edition |
| EP6-A | 7-193 | 03/18/2009 | Evaluation of the Linearity of Quantitative
Measurement Procedures: a Statistical
Approach: Approved Guideline |
| EP28-A3 | 7-224 | 09/08/2009 | Defining, Establishing, and verifying
Reference Intervals in the Clinical Laboratory;
Approved Guideline - Third Edition |
| EP17-A | 7-194 | 03/18/2009 | Protocols for Determination of Limits of
Detection and Limits of Quantitation;
Approved Guideline |
| EP9-A3 | 7-92 | 03/08/2004 | Method Comparison and Bias Estimation
Using Patient Samples; Approved Guideline-
Second Edition |
Conclusion:
The Tosoh Bioscience, Inc. ST AIA-PACK 25-OH Vitamin D Assay and Calibrator Set is substantially equivalent to the Tosoh K123131- ST AIA-PACK 25-OH Vitamin D Assay and Calibrator Set for in vitro diagnostic use only for the quantitative measurement of total 25hydroxyvitamin D (25-OH Vitamin D) in human serum, Na heparinized or EDTA plasma on Tosoh AIA System Analyzers.