(127 days)
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No
The device description details a standard enzyme immunoassay process for measuring vitamin D levels, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) tool designed to measure vitamin D levels, which aids in determining vitamin D sufficiency. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only..." and "...is intended as an aid in the determination of Vitamin D sufficiency." These phrases clearly indicate that the device is used for diagnostic purposes.
No
The device description details a chemical immunoassay process involving reagents, magnetic beads, and a fluorogenic substrate, which are physical components, not software. The device is an in vitro diagnostic test kit used on a TOSOH AIA System Analyzer, which is a hardware instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only" and "The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency." It also states the calibrator and control sets are for "In Vitro Diagnostic Use Only". This is the most direct and definitive indicator.
- Device Description: The description details a laboratory test performed on human serum or plasma samples to measure a specific analyte (25-OH vitamin D). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document describes various performance studies (Precision, Linearity, Correlation, Matrix Comparison, Cross Reactivity, Interference, Limit of Detection and Quantification) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (K983617 DiaSorin Inc. 25-Hydroxyvitamin D 1261 RIA Kit) is common for IVD submissions to regulatory bodies, indicating a comparison to an already approved IVD.
All of these points strongly support the conclusion that this device is an In Vitro Diagnostic.
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 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.
The AIA-PACK 25-OH Vitamin D Control Set is.intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK 25-OH Vitamin D assay.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JIT, JJX
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. 25-0H vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzyme-labeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-0H vitamin D competes with 25-0H 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, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-OH 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 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
AIA-PACK 25-OH Vitamin D Control Set, 025434
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Precision:
The precision for ST AIA-PACK 25-OH Vitamin D was determined based on guidance from CLSI Protocol EP5-A2.
Within- run precision was assessed by assaying three levels of pooled and spiked Na heparinized plasma, EDTA plasma and serum specimens with each lot number and instrument. 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 for each specimen/reagent/ instrument combination. This equaled a total of 40 runs and 80 determinants for each data set. There were three (3) data sets at each level for each specimen type.
Linearity:
The linearity for ST AIA-PACK 25-OH Vitamin D was determined, based on guidance from CLSI protocol EP6-A. The linearity was measured on the AIA-2000 instrument and has been demonstrated to be linear from 4 ng/mL to 150 ng/mL.
Correlation:
Method Comparison: A total of 156 unaltered serum specimens were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay on the AIA-2000 analyzer and the 25-Hydroxyvitamin D 1251 RIA Kit (Diasorin).
The regression analysis for the correlation between the alternate method (x) and the ST AIA-PACK 25-OH Vitamin D (y) is as follows:
Deming: Slope: 0.934 (0.884 to 0.984), Intercept: 2.53 (0.75 to 4.31)
Regular: Slope: 0.885 (0.836 to 0.935), Intercept: 3.97 (2.21 to 5.73)
Corr Coef (R): 0.944
Result Ranges: Diasorin 4.4 to 103.0 ng/mL, Tosoh 6.2 to 103.2 ng/mL
Matrix Comparison:
Correlation between serum (x) and Na heparinized plasma (y) using 115 unaltered specimens.
Deming: Slope: 0.993 (0.974 to 1.012), Intercept: -0.390 (-1.13 to 0.36)
Regular: Slope: 0.988 (0.978 to 1.007), Intercept: -0.20 (-0.94 to 0.55)
Corr Coef (R): 0.995
Result Ranges: Na Heparin 11.3 to 112.8 ng/mL, Serum 11.0 - 111.1 ng/mL
Correlation between serum (x) and EDTA Plasma (y) using 115 unaltered specimens.
Deming: Slope: 1.041 (1.020 to 1.062), Intercept: 0.091 (0.09 to 1.73)
Regular: Slope: 1.034 (1.013 to 1.056), Intercept: 1.14 (0.032 to 1.96)
Corr Coef (R): 0.994
Result Ranges: EDTA 11.6 to 111.9 ng/mL, Serum 11.0 - 111.1 ng/mL
Cross Reactivity:
Tested cross reactants by spiking known quantities in serum specimen.
25-OH Vitamin D2 (30 ng/mL): 101.1 mol%
25-OH Vitamin D3 (158.2 ng/mL): 99.2 mol%
3-epi 25-OH Vitamin D2 (30 ng/mL): 131.3 mol%
3-epi 25-OH Vitamin D3 (30 ng/mL): 107.7 mol%
24,25-(OH)2 Vitamin D2 (100 ng/mL): 5.2 mol%
24,25-(OH)2 Vitamin D3 (100 ng/mL): 18.1 mol%
Vitamin D2 (1000 ng/mL): 0.5 mol%
Vitamin D3 (1000 ng/mL): /= 100 % for both 25-OH Vitamin D2 and 3epi- 25-OH Vitamin D3 at 30 ng/mL. The ST AIA-PACK 25-OH Vitamin D recovers approximately 100 % for 25-OH Vitamin D3 at - 158.2 ng/mL. The ST AIA-PACK 25-OH Vitamin D had a cross reactivity of 5.2% at 100 ng/mL of 24,25-Dihydroxyvitamin-D2. The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with 24, 25-(OH)2 Vitamin D3 at 100 ng/mL. The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with Vitamin D3 and Vitamin D2 at 1000 ng/mL. The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with 1, 25-(OH)2 Vitamin D3, 1, 25-(OH)2 Vitamin D2 and Paricalcitol at 2.0 ng/mL.
Reference Ranges:
Number of Samples (n) 233
Reference Interval 10.8 - 54.75 ng/mL
The central 95% of the reference range was used to determine the reference interval.
Interference:
Interference is defined, for the purposes of this study, with recovery outside of 100 +/- 10% of the known concentration of the specimen after the following substances are added to human specimens. Three studies were conducted using EDTA plasma, Na heparinized plasma and serum.
- Added hemoglobin (up to 11.4 mg/dL) does not interfere with the assay.
- Conjugated bilirubin (up to 18.4 mg/dL) and free bilirubin (up to 16.8 mg/dL) does not interfere with the assay.
- Lipemia, as indicated by triglyceride concentration (up to 357 mg/dL), does not interfere with the assay.
- Protein, as indicated by human albumin concentration (up to 8.5 g/dL), does not interfere with the assay.
- Ascorbic acid (up to 20 mg/dL) does not interfere with the assay.
- EDTA.2K (up to 10 mg/mL) does not interfere with the assay.
- Sodium Heparin (up to 100 U/mL) does not interfere with the assay.
- Rheumatoid factor (up to 500 IU/mL) does not interfere with the assay.
Limit of Detection and Limit of Quantification:
The LoB and LoQ of the ST AIA-PACK 25-OH Vitamin D was determined based on CLSI 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 10 measurements of 6 low level samples. The sample range was chosen to be between LoB and 4xLoB and 3 lots of reagents were utilized. The LoD was determined to be 2.6 ng/mL.
The LoQ was determined by 10 measurements of 18 low level samples and the CV% for each sample was calculated. The samples were selected to be in the range of LoB to 4xLoB. A precision profile was plotted for concentration vs. the CV%. The functional sensitivity at 20% CV was calculated and determined as the LoQ. The LoQ was determined to be 2.9 ng/mL.
The reportable range for the assay is 4.0 - 120 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K983617 DiaSorin Inc. 25-Hydroxyvitamin D 1261 RIA Kit
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
r
. /= 100 % for both 25-OH Vitamin D2 and 3epi- 25-OH Vitamin D3 at 30 ng/mL.
The ST AIA-PACK 25-OH Vitamin D recovers approximately 100 % for 25-OH Vitamin D3 at - 158.2 ng/mL.
The ST AIA-PACK 25-OH Vitamin D had a cross reactivity of 5.2% at 100 ng/mL of 24,25-Dihydroxyvitamin-D2.
The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with 24, 25-(OH)2 Vitamin D3 at 100 ng/mL.
The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with Vitamin D3 and Vitamin D2 at 1000 ng/mL.
The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with 1, 25-(OH)2 Vitamin D3, 1, 25-(OH)2 Vitamin D2 and Paricalcitol at 2.0 ng/mL.
Reference Ranges
Number of Samples (n) 233 Reference Interval 10.8 - 54.75 ng/mL
The central 95% of the reference range was used to determine the reference interval.
Interference
Interference is defined, for the purposes of this study, with recovery outside of 100 +/- 10% of the known concentration of the specimen after the following substances are added to human specimens. Three studies were conducted using EDTA plasma, Na heparinized plasma and serum.´
- Added hemoglobin (up to 11.4 mg/dL) does not interfere with the assay. .
- Conjugated bilirubin (up to 18.4 mg/dL) and free bilirubin (up to 16.8 mg/dL) does not . interfere with the assay.
- Lipemia, as indicated by triglyceride concentration (up to 357 mg/dL), does not interfere . with the assay.
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- Protein, as indicated by human albumin concentration (up to 8.5 g/dL), does not interfere . with the assay.
- Ascorbic acid (up to 20 mg/dL) does not interfere with the assay. .
- EDTA.2K (up to 10 mg/mL) does not interfere with the assay. .
- Sodium Heparin (up to 100 U/mL) does not interfere with the assay. .
- Rheumatoid factor (up to 500 IU/mL) does not interfere with the assay. .
Limit of Detection and Limit of Quantification
The LoB and LoQ of the ST AIA-PACK 25-OH Vitamin D was determined based on CLSI 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 10 measurements of 6 low level samples. The sample range was chosen to be between LoB and 4xLoB and 3 lots of reagents were utilized. The LoD was determined to be 2.6 ng/mL.
The LoQ was determined by 10 measurements of 18 low level samples and the CV% for each sample was calculated. The samples were selected to be in the range of LoB to 4xLoB. A precision profile was plotted for concentration vs. the CV%. The functional sensitivity at 20% CV was calculated and determined as the LoQ. The LoQ was determined to be 2.9 ng/mL.
The reportable range for the assay is 4.0 - 120 ng/mL.
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 |
| C28-A3 | 7-202 | 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-A2 | 7-92 | 03/08/2004 | Method Comparison and Bias Estimation
Using Patient Samples; Approved Guideline-
Second Edition |
| EP21-A | 7-174 | 03/18/2009 | Estimation of Total Analytical Error for |
ST AIA-PACK 25-OH Vitamin D
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A & R. HE MENSE & BE
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Canadian
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CONCOLOGICAL
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ST AIA-PACK 25-OH Vitamin D
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100 million in the state
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Conclusion:
ﻢ
t.
ﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﻓﻲ
The Tosoh Bioscience, Inc. ST AIA-PACK 25-OH Vitamin D is substantially equivalent to the DiaSorin Inc. (k)983617-Hydroxyvitamin D 1251 RIA Kit 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
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol resembling an abstract human figure or a caduceus, rendered in a simple, flowing line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Tosoh Bioscience, Inc c/o Robert L. Wick 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080
Re: K123131
Trade/Device Name: ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system
Regulatory Class: II
Product Code: MRG, JIT, JJX
Dated: January 08, 2013
Received: January 09, 2013
Dear Mr. 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 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.
14
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/CDRHOffices/ucm115809.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
15
Indications for Use
510(k) Number (if known): K123131
Device Name:
ST AIA-PACK 25-OH Vitamin D
ST AIA-PACK 25-OH Vitamin D Calibrator Set
AIA-PACK 25-OH Vitamin D Control Set
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.
The AIA-PACK 25-OH Vitamin D Control Set is intended for in vitro diagnostic use only for performing quality control procedures with the ST AIA-PACK 25-OH Vitamin D 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)
Yung W.Chan -S
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K123131 510(k)
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