(457 days)
Not Found
No
The summary describes a standard immunoassay system with a fluorescence analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on analytical validation metrics typical for IVD assays, not AI/ML model performance.
No.
This device is an in vitro diagnostic immunoassay system used to measure Vitamin D levels in human samples, which aids in diagnosis rather than directly treating a condition.
Yes
The device is an "enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma." This explicitly states its diagnostic purpose.
No
The device description clearly outlines physical components including a test cartridge, an ID chip, and an analyzer, which are hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ALFIS Vitamin D test is "intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma." It also states that the ALFIS-3 Analyzer is "for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens."
- Device Description: The description details the components of the test cartridge and the analyzer, which are designed to perform a diagnostic test on biological samples.
- Performance Studies: The document includes detailed descriptions and results of performance studies (Limit of Blank, Limit of Detection, Linearity, Analytical Specificity, Repeatability, Reproducibility, Matrix Comparison, Reference Interval, Method Comparison) which are standard evaluations for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a "Predicate Device(s)" (K210901; Elecsys Vitamin D Total III with cobas e 601 analzyer) is a strong indicator that this device is being submitted for regulatory review as an IVD, often in comparison to a previously cleared IVD.
All of these elements clearly indicate that the ALFIS Vitamin D test system is designed and intended for use in diagnosing or aiding in the diagnosis of a condition (Vitamin D sufficiency) by testing samples taken from the human body in vitro (outside the body).
N/A
Intended Use / Indications for Use
ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma.
ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults.
ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.
Product codes (comma separated list FDA assigned to the subject device)
MRG, KHO
Device Description
ALFIS Vitamin D Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'magnetic bead', 'antibody-alkaline phosphatase-conjugator (Ab-ALP)', 'sample diluent', 'diethanolamine (DEA)', '4-Methylumbelliferyl phosphate (MUP)', 'washing buffer'; all of which are integral components of ALFIS Vitamin D test.
ALFIS Vitamin D test cartridge is an elongated structure having 150.8 mm length, 17 mm width and 16 mm height.
'ALFIS Vitamin D Test ID Chip' is a flat, rectangular device with its main body measuring 23 mm x 27 mm. Half of the portion along the breadth of the main body is 5 mm thick while remaining half is 3 mm in thickness. Another rectangular portion measuring 12 mm x 10 mm x 2 mm protrudes out from the breadth of apical side of the 3 mm-thick portion of the main body.
ALFIS Vitamin D Test ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ALFIS Vitamin D Test ID Chip' is an integral component of ALFIS Vitamin D test system. Before initiating the test run for testing a clinical sample or calibrator/control using ALFIS Vitamin D Test Cartridge belonging to a new lot for the first time, the operator needs to mandatorily insert the lot-specific ALFIS Vitamin D Test ID Chip into the 'ID Chip Port' of the ALFIS-3 analyzer.
For performing ALFIS Vitamin D test on a clinical sample or an ALFIS Vitamin D Control, ALFIS Vitamin D test cartridge needs to be used in conjunction with the ALFIS-3 analyzer. ALFIS-3 analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 422 mm (L) x 270 mm (W) x 292 mm (H). ALFIS-3 weighs 13.0 kg. ALFIS-3 analyzer is a fluorometer instrument of closed-system analyzer type. The operator does not have access to those configuration parameters that could affect the assay process, test analysis or result calculation or any other parameter that could affect test result outcome. These and other operational parameters can only be configured by the 'System Administrator' through software and/or firmware upgrade and modification of operational settings in consultation with the manufacturer or an authorized service provider. With a simple computerized touchscreen user interface, the analyzer enables the operator to initiate the test run which is completed automatically and terminates with display of test result or an error message alert (in case of any procedural error and/or system malfunction).
'ALFIS Vitamin D Calibrators' needs to be tested by user laboratories for periodic calibration of ALFIS Vitamin D test system. Considering the reportable range of ALFIS Vitamin D test (6-100 ng/mL), the sponsor provides ALFIS Vitamin D Calibrators with following approximate assigned 25-OH Vitamin D levels:
- ALFIS Vitamin D Calibrator Level 1: 10 ng/mL
- ALFIS Vitamin D Calibrator Level 2: 40 ng/mL
The sponsor would market a set of 'ALFIS Vitamin D Calibrator Level 1 and Level 2' separately from the ALFIS Vitamin D test product on demand by the user laboratories.
'ALFIS Vitamin D Controls' needs to be tested by user laboratories periodically for monitoring the performance of ALFIS Vitamin D test system. Considering the reportable range (6 - 100 ng/mL) of ALFIS Vitamin D and usual adult reference intervals of 25(OH)D IVD tests, the sponsor provides ALFIS Vitamin D Controls with following approximate assigned 25-OH Vitamin D levels:
- ALFIS Vitamin D Control Level 1: 15 ng/mL (Acceptable Range: 13.5 ~ 16.5 ng/mL)
- ALFIS Vitamin D Control Level 2: 35 ng/mL (Acceptable Range: 31.5~38.5 ng/mL)
The sponsor would market a set of 'ALFIS Vitamin D Control Level 1 and Level 2' separately from the ALFIS Vitamin D test product on demand by the user laboratories.
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
clinical laboratories
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
Reference Interval Study: Serum samples collected from 299 apparently healthy adults in the United States, comprising 149 and 150 samples respectively from two external clinical samples repositories. Criteria for sample sets: Age (adults): 21~70 years of age; Approximately 20% central, 20% northern, 60% southern State residents; Approximately 50% male, 50% female; At least 30% collected from African American and 30% from Caucasian; Approximately 50% collected during fall, 25% during winter and 25% during summer; Individuals not taking vitamin D supplements (30% reported taking multivitamins with Vitamin D dosage
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 22, 2023
Immunostics Inc. % Parag Bhurchandi Principal Research Scientist (Regulatory Affairs) Boditech Med Inc. 43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do 24398 Korea. South
Re: K221817
Trade/Device Name: ALFIS Vitamin D, ALFIS-3 Analyzer Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Code: MRG, KHO Dated: March 24, 2023 Received: March 27, 2023
Dear Parag Bhurchandi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221817
Device Name
ALFIS Vitamin D. ALFIS-3 Analyzer
Indications for Use (Describe)
ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma.
ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults.
ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
Device Type/Common Name: Radioimmunoassay, Vitamin D Test System
| Trade/Proprietary Name | : ALFIS Vitamin D
ALFIS-3 Analyzer |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Submission | : Traditional 510(k) |
| Basis for Submission | : Traditional 510(k) Submission for a New Device |
| Submitter/Applicant/Sponsor | : Immunostics Inc.
38 Industrial Way E,
Eatontown, New Jersey, 07724,
United States
Phone No.: 732-918-0770
Fax No.: 732-918-0618
Website: www.immunostics.com |
| Applicant Contact Person | : Dr. Young Mi Kim
Director (RA & QA)
Phone No.: 732-918-0770
Fax No.: 732-918-0618
E-mail: ymkim@immunostics.com |
| Official correspondent | : Dr. Parag Bhurchandi
Principal Research Scientist (Regulatory Affairs)
Boditech Med. Inc.
43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gangwon-do 24398,
Republic of Korea (South Korea)
Phone No.: +82 33 243 1435
Fax No.: +82 33 243 9373
E-mail: parag@boditech.co.kr |
| Classification Regulation | : 21CFR § 862.1825 Vitamin D test system |
| Class | : II (for ALFIS Vitamin D Test Cartridges)
I (for ALFIS-3 Analyzer) |
| Panel | : Clinical Chemistry |
| Product Code | : MRG; Vitamin D Test System |
4
KHO; Fluorometer for Clinical Use
| Predicate Device | : Elecsys Vitamin D Total III |
|---|---|
| with cobas e 601 analzyer | |
| Roche Diagnostics GMBH | |
| Sandhofer Strasse 116 | |
| Mannheim Baden-Wurttenberg, | |
| DE D-68305 |
Predicate Device 'K' Number : K210901
Predicate Device Product Code: MRG, Vitamin D Test System
Intended use of ALFIS Vitamin D:
ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma.
Indications for use of ALFIS Vitamin D:
ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults.
Intended use/indication for use of ALFIS-3 Analyzer:
ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.
Description of ALFIS Vitamin D Test Cartridges:
ALFIS Vitamin D Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'magnetic bead', 'antibody-alkaline phosphatase-conjugator (Ab-ALP)', 'sample diluent', 'diethanolamine (DEA)', '4-Methylumbelliferyl phosphate (MUP)', 'washing buffer'; all of which are integral components of ALFIS Vitamin D test.
ALFIS Vitamin D test cartridge is an elongated structure having 150.8 mm length, 17 mm width and 16 mm height.
Description of ALFIS Vitamin D Test ID Chip:
'ALFIS Vitamin D Test ID Chip' is a flat, rectangular device with its main body measuring 23 mm × 27 mm. Half of the portion along the breadth of the main body is 5 mm thick while remaining half is 3 mm in thickness.
5
Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the breadth of apical side of the 3 mm-thick portion of the main body.
ALFIS Vitamin D Test ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ALFIS Vitamin D Test ID Chip' is an integral component of ALFIS Vitamin D test system.
Before initiating the test run for testing a clinical sample or calibrator/control using ALFIS Vitamin D Test Cartridge belonging to a new lot for the first time, the operator needs to mandatorily insert the lot-specific ALFIS Vitamin D Test ID Chip into the 'ID Chip Port' of the ALFIS-3 analyzer.
Description of ALFIS-3 Analyzer:
For performing ALFIS Vitamin D test on a clinical sample or an ALFIS Vitamin D Control, ALFIS Vitamin D test cartridge needs to be used in conjunction with the ALFIS-3 analyzer.
ALFIS-3 analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 422 mm (L) x 270 mm (W) x 292 mm (H). ALFIS-3 weighs 13.0 kg.
ALFIS-3 analyzer is a fluorometer instrument of closed-system analyzer type. The operator does not have access to those configuration parameters that could affect the assay process, test analysis or result calculation or any other parameter that could affect test result outcome. These and other operational parameters can only be configured by the 'System Administrator' through software and/or firmware upgrade and modification of operational settings in consultation with the manufacturer or an authorized service provider.
With a simple computerized touchscreen user interface, the analyzer enables the operator to initiate the test run which is completed automatically and terminates with display of test result or an error message alert (in case of any procedural error and/or system malfunction).
Description of ALFIS Vitamin D Calibrators:
'ALFIS Vitamin D Calibrators' needs to be tested by user laboratories for periodic calibration of ALFIS Vitamin D test system.
Considering the reportable range of ALFIS Vitamin D test (6-100 ng/mL), the sponsor provides ALFIS Vitamin D Calibrators with following approximate assigned 25-OH Vitamin D levels:
| No. | ALFIS Vitamin D Calibrator | Approximate Assigned
/Target 25(OH)D Level |
|-----|------------------------------------|-----------------------------------------------|
| 1 | ALFIS Vitamin D Calibrator Level 1 | 10 ng/mL |
| 2 | ALFIS Vitamin D Calibrator Level 2 | 40 ng/mL |
Analyte levels of ALFIS Vitamin D Calibrators
The sponsor would market a set of 'ALFIS Vitamin D Calibrator Level 1 and Level 2' separately from the ALFIS Vitamin D test product on demand by the user laboratories.
6
Description of ALFIS Vitamin D Controls:
'ALFIS Vitamin D Controls' needs to be tested by user laboratories periodically for monitoring the performance of ALFIS Vitamin D test system.
Considering the reportable range (6 - 100 ng/mL) of ALFIS Vitamin D and usual adult reference intervals of 25(OH)D IVD tests, the sponsor provides ALFIS Vitamin D Controls with following approximate assigned 25-OH Vitamin D levels:
| No. | ALFIS Vitamin D
Control | Approximate Assigned
/Target 25(OH)D
Level | Acceptable
Range |
|-----|------------------------------------|--------------------------------------------------|---------------------|
| 1 | ALFIS Vitamin D
Control Level 1 | 15 ng/mL | 13.5 ~ 16.5 ng/mL |
| 2 | ALFIS Vitamin D
Control Level 2 | 35 ng/mL | 31.5~38.5 ng/mL |
Analyte levels and reference ranges of ALFIS Vitamin D Controls
The sponsor would market a set of 'ALFIS Vitamin D Control Level 1 and Level 2' separately from the ALFIS Vitamin D test product on demand by the user laboratories.
Similarities between ALFIS Vitamin D (with ALFIS-3 analyzer) and the predicate device Elecsys Vitamin D Total III:
Following table shows the similarities between ALFIS Vitamin D (with ALFIS-3 analyzer) and the predicate device Elecsys Vitamin D Total III
| Table 5.1: Similarities between ALFIS Vitamin D (with ALFIS-3 analyzer)
| and the predicate device Elecsys Vitamin D Total III | |||
|---|---|---|---|
| No. | Comparison Parameter | Candidate Device/Test | |
| ALFIS Vitamin D | |||
| (with ALFIS-3 Analyzer) | Elecsys Vitamin D | ||
| Total III | |||
| 1 | Nature of the test | Quantitative in vitro diagnostic | |
| test system for total 25- | |||
| hydroxyvitamin D | Same | ||
| 2 | Indications for use(s) | As an aid in the assessment of | |
| Vitamin D sufficiency in adults | Same | ||
| 3 | Intended use sites | Clinical laboratories | Same |
| 4 | Sample type | Serum or plasma | Same |
| 5 | Result unit | ng/mL | Same |
| No. | Comparison | ||
| Parameter | Candidate Device/Test | ||
| ALFIS Vitamin D | |||
| (with ALFIS-3) | Predicate Device/Test | ||
| Elecsys Vitamin D Total III | |||
| Table 5.2: Differences between ALFIS Vitamin D (with ALFIS-3) and the predicate device Elecsys Vitamin D Total III | |||
| 1 | Detection | ||
| protocol | Enzyme-linked fluorescence assay | Electrochemiluminescence | |
| 2 | Measuring | ||
| range | 6-100 ng/mL | 6-125 ng/mL | |
| 6-240 ng/mL (after dilution) | |||
| 3 | Associated | ||
| instrument | ALFIS-3 Analyzer | Cobas e analyzers | |
| 4 | Test format | Self-contained, unitized, ready-to- | |
| use, disposable cartridge to be used | |||
| in conjunction with ALFIS-3 | |||
| analyser | A kit for multiple use with three | ||
| ready to use liquid assay reagents | |||
| and two pretreatment reagents; | |||
| capable of testing up to 43 samples | |||
| at a time | |||
| 5 | Turnaround | ||
| time | Total turnaround time = 36 minutes | Total duration of assay = 27 | |
| minutes | |||
| 6 | Sample volume | ||
| required per test | 100 μL | 20 μL | |
| 7 | Sample volume | ||
| utilized per test | 40 μL | 20 μL | |
| 8 | Limit of | ||
| Quantitation | |||
| /Functional | |||
| Sensitivity | 6.0 ng/mL | ||
| (with imprecision of CV ≤ 20%) | 6.0 ng/mL | ||
| (with imprecision of CV ≤ 20%) | |||
| 9 | Calibration | Lot-specific master calibration | |
| curve/equation is encoded in the | |||
| 'Lot-specific ALFIS Vitamin D Test | |||
| ID Chip' which needs to be inserted | |||
| in the 'ID Chip Port' of ALFIS-3 | |||
| analyzer prior to using that ALFIS | |||
| Vitamin D test cartridge lot for the | |||
| first time. | |||
| User-level periodic calibration to | |||
| modify the pre-defined master | |||
| calibration curve (encoded in the ID | |||
| chip) needs to be performed by | Every Elecsys reagent set has a | ||
| barcoded label containing specific | |||
| information for calibration of the | |||
| particular reagent lot. | |||
| The predefined master curve is | |||
| adapted to the analyzer using the | |||
| relevant calibrators. |
7
Differences between ALFIS Vitamin D (with ALFIS-3 Analyzer) and the predicate device Elecsys Vitamin D Total III.
Following table shows the differences between ALFIS Vitamin D (with ALFIS-3 Analyzer) and the predicate device Elecsys Vitamin D Total III.
8
| testing ALFIS Vitamin D Calibrators | |
|---|---|
| Level 1 and 2 with the ALFIS | |
| Vitamin D test system. |
Summary of Performance Evaluation Studies:
1) Limit of Blank:
- Limit of Blank (LoB) of ALFIS Vitamin D test has been evaluated as per CLSI EP -17-A2.
- -6 replicates of 4 blank (25-hydroxyvitamin D-depleted) serum samples were tested with 3 lots of test cartridges on 3 ALFIS-3 analyzers (1 lot/analyzer) for 3 successive days; thus testing 72 blank replicates per lot/analyzer pair.
- -Limit of Blank (LoB) was calculated by non-parametric analysis of the data.
- -Limit of Blank of ALFIS Vitamin D test is 1.82 ng/mL.
2) Limit of Detection:
- -Limit of Detection (LoD) of ALFIS Vitamin D test has been evaluated as per CLSI EP 17-A2.
- 5 replicates each of 4 low 25-hydroxyvitamin D-spiked serum samples were tested with 3 lots of test cartridges on 3 respective analyzers (1 lot/analyzer) for 3 successive days; thus testing 15 replicates per lot/analyzer pair and total 45 replicates per sample.
- Limit of Detection (LoD) was calculated by parametric analysis of the data. -
- -Limit of Detection of ALFIS Vitamin D test is 3.76 ng/mL.
3) Limit of Quantitation:
- Limit of Quantitation (LoQ) of ALFIS Vitamin D has been evaluated as per CLSI EP -17-A2.
- 4 replicates of each of the 5 low 25-hydroxyvitamin D serum samples were tested with 3 lots of test cartridges on 3 respective analyzers (1 lot/analyzer) for 3 successive days; thus testing 12 replicates per lot/analyzer pair and total 36 replicates per sample.
- -Limit of Quantitation (LoQ) was calculated by considering accuracy goal of interassay CV ≤ 20%.
- -Limit of Quantitation of ALFIS Vitamin D test is 6.0 ng/mL
4) Linearity and Reportable Range:
- For evaluating linearity and measuring/reportable range of ALFIS Vitamin D test, a series of 19 25-hydroxyvitamin D-spiked serum samples spanning the concentration
9
range of 1.3 ng/mL - 130 ng/mL was tested in triplicate with the one lot of ALFIS Vitamin D test cartridges on one ALFIS-3 analyzer on the same day.
- Mean of the triplicate test results of each sample was plotted against its expected TSH concentration calculated mathematically.
-
- ALFIS Vitamin D test showed linearity over the entire claimed measuring/reportable range of 6-100 ng/mL with following linear regression equations.
y = 1.0708x - 0.0757, R2= 0.9998
5) Susceptibility to High-dose Hook Effect:
- For evaluating susceptibility to high dose hook (prozone) effect, a series of spiked samples having approximate 25-hydroxyvitamin D concentrations 12.5 ng/mL, 25 ng/mL, 50 ng/mL, 75 ng/mL, 100 ng/mL, 150 ng/mL, 200 ng/mL, 500 ng/mL, 750, and 1000 ng/mL were tested in triplicate with one lot of test cartridges using one analyzer on the same day by the same operator.
- -No hook/prozone effect was observed up to 25-hydroxyvitamin D concentration of 1000 ng/mL.
6) Analytical specificity:
- 트 Analytical specificity of ALFIS Vitamin D has been evaluated as per CLSI EP07, 3rd edition.
Interference from endogenous and exogenous substances:
- Susceptibility of ALFIS Vitamin D test to interference from various endogenous . and exogenous substances has been evaluated.
- Performance of ALFIS Vitamin D test has not been found to be significantly 트 affected when the endogenous and exogenous substances were tested at specified highest concentrations as follows.
- . ALFIS Vitamin D test showed analyte recovery within the acceptable range of 90-110% in presence of specified concentrations of above endogenous and exogenous interferants thereby indicating insignificant interference.
| Potential endogenous interferent tested | Highest concentration tested at which no
significant interference was observed |
|-----------------------------------------|-----------------------------------------------------------------------------------|
| Albumin/Protein | 12,000 mg/dL |
| Conjugated Bilirubin | 40 mg/dL |
| Human hemoglobin | 1,000 mg/dL |
| Triglycerides | 2,000 mg/dL |
| HAMA | 800 ng/mL |
| Rheumatoid Factor | 200 IU/mL |
| Biotin | 3,500 ng/mL |
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| Potential exogenous interferent tested | Highest concentration tested at which no
significant interference was observed |
|----------------------------------------|-----------------------------------------------------------------------------------|
| Acetaminopen | 15.5 mg/dL |
| Acetylcysteine | 15 mg/dL |
| Acetylsalicylic acid | 3.0 mg/dL |
| Ampicillin-Na | 7.5 mg/dL |
| Cyclosporin | 180 µg/dL |
| Doxycycline | 1.8 mg/dL |
| Ibuprofen | 22 mg/dL |
| Itraconazole | 3.0 mg/dL |
| Levodopa | 750 µg/dL |
| Methyldopa | 2.25 mg/dL |
| Rifampicin | 4.8 mg/dL |
| Ascorbic acid | 5.25 mg/dL |
Cross-reactivity with structural analogs of 25-hydroxyvitamin D:
- . Cross-reactivity of ALFIS Vitamin D test system with various structural analogs of 25-hydroxyvitamin D has been evaluated.
- . The cross-reactivity was determined using the following formula:
% cross reactivity = [(mean recovery of test samples) - (mean recovery of control samples) / (concentration of cross reactant] × 100
- 트 Cross-reactivity of ALFIS Vitamin D test with various potential cross-reactants that were tested at specified highest concentration has been shown in the following table.
| Potential cross-reactant tested | Concentration of the
cross-reactant tested | Percent cross-reactivity
observed |
|---------------------------------|-----------------------------------------------|--------------------------------------|
| 25-hydroxyvitamin D3 | 50 ng/mL | 99.30 – 100.61 % |
| 25-hydroxyvitamin D2 | 50 ng/mL | 98.42 – 98.38 % |
| 3-epi-25-hydroxyvitamin D3 | 50 ng/mL | 20.24 – 22.18 % |
| 24,25-dihydroxyvitamin D3 | 50 ng/mL | 121.59 – 121.91 % |
| 1,25-dihydroxyvitamin D3 | 100 ng/mL | 0.81 – 0.27 % |
| 1,25-dihydroxyvitamin D2 | 100 ng/mL | 0.59 – 0.05 % |
| Vitamin D3 (Cholecalciferol) | 1000 ng/mL | 0.1 – 0.04 % |
| Vitamin D2 (Ergocalciferol) | 1000 ng/mL | 0.06 – 0.08 % |
7) In-house repeatability and reproducibility:
- In-house repeatability and reproducibility studies of ALFIS Vitamin D test system । were performed as per CLSI EP05-A3 guideline.
- For evaluating in-house repeatability of ALFIS Vitamin D, 3 spiked serum samples । having 25-hydroxyvitamin D concentrations 10, 30, 50 ng/mL were tested with 1 lot of ALFIS Vitamin D Cartridges and 1 ALFIS-3 Analyzer. Each sample was tested in duplicate daily for 20 successive days by the same operator.
- For evaluating in-house reproducibility of ALFIS Vitamin D, 3 spiked serum samples । having 25-hydroxyvitamin D concentrations 10, 30, 50 ng/mL were tested with 3
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cartridge lots and ALFIS-3 analyzer/operator pairs. Each sample was tested in quintuplicate daily for 5 successive days.
- In these in-house studies, ALFIS Vitamin D test system showed CV