(147 days)
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No
The description details a standard immunoassay based on CLEIA technology, which is a chemical and enzymatic process, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic assay used for the quantitative determination of 25-hydroxyvitamin D in human samples, serving as an aid in assessing vitamin D sufficiency. It does not provide any treatment or therapy to a patient.
Yes
Explanation: The device is an "in vitro diagnostic device" for the "quantitative determination of 25-hydroxyvitamin D" in human samples and is "to be used as an aid in the assessment of vitamin D sufficiency," which directly aligns with the definition of a diagnostic device used to provide information for diagnosis or assessment of a medical condition.
No
The device is an in vitro diagnostic assay system that includes immunoassay reagents and is used on a specific hardware system (LUMIPULSE G System). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "Lumipulse G 25-0H Vitamin D For in vitro diagnostic use."
- "Lumipulse G 25-0H Vitamin D Calibrators are for in vitro diagnostic use..."
This clearly indicates that the device is intended for use in vitro (outside of a living organism) to diagnose or aid in the diagnosis of a condition, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
Lumipulse G 25-OH Vitamin D For in vitro diagnostic use.
Lumipulse G 25-OH Vitamin D is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) and other hydroxylated vitamin D metabolites in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.
Lumipulse G 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.
Lumipulse G 25-OH Vitamin D Calibrators Lumipulse G 25-OH Vitamin D Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G 25-OH Vitamin D on the LUMIPULSE G System.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JIT
Device Description
Lumipulse G 25-OH Vitamin D is an assay system, including a set of immunoassay reagents, for the quantitative measurement of 25-OH Vitamin D in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. 25-OH Vitamin D Calibrator or specimen is initially auto-diluted with Specimen Diluent 1 in the system. 25-OH vitamin D in specimens is separated from vitamin D binding protein by the extraction agent and specifically bound to anti-25-OH vitamin D monoclonal antibody (sheep) on the particles, and antigen-antibody immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP: calf)-labeled anti-(25-OH vitamin D/anti- 25-OH vitamin D monoclonal antibody immunocomplexes) recombinant chicken monoclonal antibody specifically binds to 25-OH vitamin D immunocomplexes on the particles, and additional immunocomplexes are formed The particles are washed and rinsed to remove unbound materials. Substrate Solution is added and mixed with the particles. AMPPD contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of dephosphorylated AMPPD. The luminescent signal reflects the amount of 25-OH vitamin D.
Lumipulse G 25-OH Vitamin D is an assay system, including a set of immunoassay reagents, for the quantitative measurement of 25-OH Vitamin D in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
The expected values section describes a study population of apparently healthy adults ranging in age from 18 to 74 years.
Intended User / Care Setting
Not Found
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)
-
Analytical performance:
a. Precision/Reproducibility:
- Lumipulse G 25-OH Vitamin D is ≤ 10% total (within-laboratory) CV (coefficient of variation).
- Demonstrated precision ≤ 5.2% (total %CV) in a study run according to the Clinical and Laboratory Standards Institute (CLSI) guideline EP5-A3.
- Study involved five human serum-based samples (specimen pools), and three controls assayed in replicates of two at two separate times of the day for 20 days (for each sample) using one LUMIPULSE G1200 System.b. Linearity/assay reportable range:
- Demonstrated linearity in a study consistent with the guidelines in the CLSI Guideline EP6-A.
- Two human serum specimen pools and two K2EDTA plasma specimen pools with high 25-Hydroxyvitamin D2 and 25-Hydroxyvtiamin D3 levels were diluted with one human serum specimen pool and one dipotassium EDTA plasma specimen pool with low 25-Hydroxyvitamin D2 and 25-Hydroxyvtiamin D3 levels throughout the range of the assay.
- Linearity found in the range of 6.9 to 150.0 ng/mL for serum and plasma.
- Correlated with expected concentrations according to the linear regression formulas:
- Serum: y= 1.0382 (x) + 1.251; R-squared: 0.9978
- Plasma: y= 1.0151 (x) + 6.7669; R-squared: 0.9936
- Verified to detect 25-OH vitamin D2 and vitamin D3 in equal parts to the true molar concentration. Recovery ranging from 101% to 103% for varying ratios.
- Recovers known concentrations of supplemental equimolar 25-OH vitamin D2 and 25-OH vitamin D3. Recovery ranging from 92% to 106%.
- No high dose hook effect observed for samples containing up to 3,000 ng/mL of 25-Hydroxyvitamin D2 and 25-Hydroxyvitamin D3.d. Detection limit:
- The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) of Lumipulse G 25-OH Vitamin D on the LUMIPULSE G1200 is ≤ 4.0 ng/mL.
- LoB was 0.0 ng/mL.
- LoD was 0.28 ng/mL, determined consistent with CLSI guideline EP17-A2 (Seven low-level specimens tested over 3 days using two LUMIPULSE G1200 Systems and two Lumipulse G 25-OH Vitamin D lots giving 120 determinations for each panel).
- LoQ was 3.33 ng/mL (analyte level at which the CV is 10%).e. Analytical specificity:
- Demonstrated average interference of ≤ 10% (for each compound) for various endogenous and therapeutic interferences consistent with CLSI guideline EP7-A2.
- Cross-reactivity: Evaluated for cross-reactivity with other substances structurally similar to 25(OH) Vitamin D consistent with CLSI Protocol EP7-A2. Percent cross-reactivity reported for various compounds (e.g., 3-epi-25(OH) vitamin D3: 2%, 1,25(OH)2 vitamin D2: 143% at 10 ng/mL, 1,25(OH)2 vitamin D3: 39% at 100 ng/mL, Vitamin D3/D2: 0%). -
Comparison studies:
a. Method Comparison Liaison® 25 OH Vitamin D TOTAL:
- Performed using specimens consistent with CLSI guideline EP9-A3.
- Weighted Deming regression used.
- Sample size: 137
- Range of samples: 4.0 to 107.3 ng/mL (Lumipulse G 25-OH Vitamin D), 5.45 to 91.5 ng/mL (Liaison® 25 OH Vitamin D TOTAL).
- Correlation Coefficient (r): 0.9476
- Intercept (95% CI): -3.073 (-4.357 – -1.790)
- Slope (95% CI): 1.09 (1.04 – 1.13)
- Average Bias: 0.423 ng/mLb. Method Comparison – ID- HPLC-MS/MS:
- An additional method comparison study to evaluate accuracy consistent with CLSI guideline EP9-A3.
- Weighted Deming regression used to compare Lumipulse G 25-OH Vitamin D to CDC reference method (ID- HPLC-MS/MS).
- Sample size: 117
- Range of samples: 7.2 to 149.0 ng/mL (Lumipulse G 25-OH Vitamin D), 8.65 to 153 ng/mL (ID- HPLC-MS/MS).
- Correlation Coefficient (r): 0.9986
- Intercept (95% CI): -2.788 (-3.225 – -2.351)
- Slope (95% CI): 0.97 (0.96 – 0.99)
- Average Bias: -3.826 ng/mLc. Matrix Comparison:
- Evaluated for matrix differences by performing a study using fifty (50) matched sets of serum (red top and serum separator tubes (SST)) and plasma (sodium heparin, lithium heparin, K2EDTA) samples.
- Results demonstrated equivalency between matrices.
- Regression Equations and Correlation Coefficients:
- SST versus Red Top: y= 1.0076(x) – 0.2178; r=0.9981
- K₂EDTA versus Red Top: y= 0.9673(x) + 0.0008; r=0.9982
- Lithium Heparin versus Red Top: y= 1.019(x) – 0.5969; r=0.9964
- Sodium Heparin versus Red Top: y= 1.0103(x) – 0.4566; r=0.9983 -
Clinical studies:
- Clinical sensitivity: Not applicable
- Clinical specificity: Not applicable
- Other clinical supportive data: Not applicable
-
Clinical cut-off: See Expected Values below.
-
Expected values/Reference range:
- Results from a total of 322 samples were used to determine the distribution of Lumipulse G 25-OH Vitamin D results in apparently healthy adults.
- Observed range of 25(OH) vitamin D concentrations (according to CLSI Protocol EP28-A3c): n=287, Mean Conc. 22.9 ng/mL, Median Conc. 22.2 ng/mL, Observed Range (2.5th to 97.5th percentile) 7.6 to 47.6 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not applicable (quantitative assay, not qualitative). Precision and linearity are reported.
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.
K071480 DIASORIN. INC. LIAISON® 25 OH Vitamin D TOTAL Assay
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN MANAGER, REGULATORY AFFAIRS 201 GREAT VALLEY PARKWAY MALVERN, PA 19355
Re: K153361
Trade/Device Name: Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JIT Dated: March 17, 2016 Received: March 18, 2016
Dear Stacey Dolan:
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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. 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 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.
Sincerely vours.
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) K153361
Device Name Lumipulse G 25-0H Vitamin D Lumipulse G 25-0H Vitamin D Calibrators
Indications for Use (Describe) Lumipulse G 25-0H Vitamin D For in vitro diagnostic use.
Lumipulse G 25-0H Vitamin D is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of 25-hydroxyvitamin D (25-0H vitamin D) and other hydroxylated vitamin D metabolites in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.
Lumipulse G 25-0H Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.
Lumipulse G 25-0H Vitamin D Calibrators Lumipulse G 25-0H Vitamin D Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G 25-0H Vitamin D on the LUMIPULSE G System.
| 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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Section 5 510(k) SUMMARY
Lumipulse G 25-OH Vitamin D K153361
Date: April 13, 2016
- Submitter: Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
- Contact Person: Stacey Dolan Manager, Requlatory Affairs Phone: (610) 240-3843 Fax: (610) 240-3803 Email: dolans@fdi.com
- Device Name: Lumipulse G 25-OH Vitamin D Classification: Class II MRG 75, Clinical Chemistry 21 CFR § 862.1825
- Device Name: Lumipulse G 25-OH Vitamin D Calibrators Classification: Class II JIT 75. Clinical Chemistry 21 CFR § 862.1150
- Predicate Device: K071480 DIASORIN. INC. LIAISON® 25 OH Vitamin D TOTAL Assay
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:
Lumipulse G 25-OH Vitamin D is an assay system, including a set of immunoassay reagents, for the quantitative measurement of 25-OH Vitamin D in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. 25-OH Vitamin D Calibrator or specimen is initially auto-diluted with Specimen Diluent 1 in the system. 25-OH vitamin D in specimens is separated from vitamin D binding protein by the extraction agent and specifically bound to anti-25-OH vitamin D monoclonal antibody (sheep) on the particles, and antigen-antibody immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP: calf)-labeled anti-(25-OH vitamin D/anti- 25-OH vitamin D monoclonal antibody immunocomplexes) recombinant chicken monoclonal antibody specifically binds to 25-OH vitamin D immunocomplexes on the particles,
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and additional immunocomplexes are formed The particles are washed and rinsed to remove unbound materials. Substrate Solution is added and mixed with the particles. AMPPD contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of dephosphorylated AMPPD. The luminescent signal reflects the amount of 25-OH vitamin D.
Lumipulse G 25-OH Vitamin D is an assay system, including a set of immunoassay reagents, for the quantitative measurement of 25-OH Vitamin D in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.
Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges |REF|235089
The Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following:
1)Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-25-OH vitamin D monoclonal antibody (sheep)-coated particles, protein stabilizers (bovine and sheep) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 ℃ or lower. Preservative: sodium azide.
2)Enzyme-Labeled Antibody Solution
(Liquid. 320 uL/Immunoreaction Cartridge)
Contains 3 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-(25-0H vitamin D / anti-25-OH vitamin D monoclonal antibody immunocomplexes) recombinant chicken monoclonal antibody, protein stabilizers (bovine and calf) and chemical stabilizers in 0.15 M sodium chloride/MES buffer. Preservative: sodium azide.
Lumipulse G 25-OH Vitamin D Calibrators CAL 235096, Liquid 1x6 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 6. The calibrator kit is packaged separately.
CAL 1 0 ng/mL (0 nmol/L) 25-OH Vitamin D calibrator (1 x 1.5 mL) CAL 2 10 ng/mL (25 nmol/L) 25-OH Vitamin D calibrator (1 x 1.5 mL) CAL 3 20 ng/mL (50 nmol/L) 25-OH Vitamin D calibrator (1 x 1.5 mL) CAL 4 50 ng/mL (125 nmol/L) 25-OH Vitamin D calibrator (1 x 1.5 mL) CAL 5 100 ng/mL (250 nmol/L) 25-OH Vitamin D calibrator (1 x 1.5 mL) CAL 6 150 ng/mL (375 nmol/L) 25-OH Vitamin D calibrator (1 × 1.5 mL) Contains calcifediol in 0.1 M sodium chloride in HEPES buffer with protein stabilizer (bovine). Preservative: sodium azide
Device Intended Use:
Lumipulse G 25-OH Vitamin D For in vitro diagnostic use.
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Lumipulse G 25-OH Vitamin D is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) and other hydroxylated vitamin D metabolites in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.
Lumipulse G 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions.
Lumipulse G 25-OH Vitamin D Calibrators
Lumipulse G 25-OH Vitamin D Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G 25-OH Vitamin D on the LUMIPULSE G System.
Device Indications for Use:
Same as Intended Use
Substantial Equivalence:
Comparison between the Lumipulse G 25-OH Vitamin D Assay and LIAISON® 25 OH Vitamin D TOTAL Assay
| Similarities and Differences | ||
|---|---|---|
| Parameter | Lumipulse G | |
| 25-OH Vitamin D | ||
| (Proposed Device) | LIAISON® 25 OH Vitamin | |
| D TOTAL Assay | ||
| (Predicate Device) | ||
| K071480 | ||
| Device Type | ||
| Classification | In vitro diagnostic | |
| Class II | Same | |
| Regulation Number | 21CFR § 862.1825 Vitamin D test | |
| system. | Same | |
| Principle of Operation | Automated Quantitative | |
| Chemiluminscent Immunoassay | Same | |
| Specimen Collection Method | Routine Phlebotomy Techniques | Same |
| Assay Range | 6.9 – 150 ng/mL | 4.0 – 150 ng/mL |
| Intended Use | Lumipulse G 25-OH Vitamin D is a | |
| Chemiluminescent Enzyme | ||
| Immunoassay (CLEIA) for the | ||
| quantitative determination of 25- | ||
| hydroxyvitamin D (25-OH vitamin | ||
| D) and other hydroxylated vitamin | ||
| D metabolites in human serum and | ||
| plasma (sodium heparin, lithium | ||
| heparin, or dipotassium EDTA) on | ||
| the LUMIPULSE G System. | ||
| Lumipulse G 25-OH Vitamin D is to | ||
| be used as an aid in the | ||
| assessment of vitamin D | ||
| sufficiency. | The LIAISON 25 OH | |
| Vitamin D TOTAL Assay | ||
| uses chemiluminescent | ||
| immunoassay (CLIA) | ||
| technology for the | ||
| quantitative determination | ||
| of 25-hydroxyvitamin D and | ||
| other hydroxylated vitamin | ||
| D metabolites in human | ||
| serum, EDTA-plasma or | ||
| lithium heparin plasma to | ||
| be used in the assessment | ||
| of vitamin D sufficiency. |
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| Similarities and Differences | ||
|---|---|---|
| Parameter | Lumipulse G | |
| 25-OH Vitamin D | ||
| (Proposed Device) | LIAISON® 25 OH Vitamin | |
| D TOTAL Assay | ||
| (Predicate Device) | ||
| K071480 | ||
| Assay results should be used in | ||
| conjunction with other clinical or | ||
| laboratory data to assist the | ||
| clinician in making individual patient | ||
| management decisions. | used in conjunction with | |
| other clinical or laboratory | ||
| data to assist the clinician | ||
| in making individual patient | ||
| management decisions in | ||
| an adult population. | ||
| Instrument System | LUMIPULSE G System | LIAISON |
| Assay Type | Direct sandwich | |
| immunoassay based on | ||
| chemiluminescent | ||
| technology | Competitive | |
| immunoassay based on | ||
| chemiluminescent | ||
| technology | ||
| Sample Volume | Sample Volume: | |
| 20 μL | ||
| Minimum Volume: | ||
| 120 μL for sample cups and 270 μL | ||
| for sample tubes | Sample Volume: | |
| 25 μL | ||
| Minimum Volume: | ||
| 250 μL | ||
| Type of Specimen | Human serum or plasma (sodium | |
| heparin, lithium heparin, or | ||
| dipotassium EDTA) | Human serum or plasma | |
| (lithium heparin or | ||
| dipotassium EDTA) | ||
| Analyte Detected | 25-OH vitamin D and other | |
| hydroxylated vitamin D metabolites | Same |
Calibrator Set
| Similarities and Differences | ||
|---|---|---|
| Parameter | Lumipulse G | |
| 25-OH Vitamin D | ||
| (Proposed Device) | LIAISON® 25 OH Vitamin | |
| D TOTAL Assay | ||
| (Predicate Device) | ||
| K071480 | ||
| Number of Calibrators | 6 calibrators, 1.5 mL each | 2 calibrators, 1.0 mL each |
| Standardization/Traceability | The calibrators for use with | |
| Lumipulse G 25-OH Vitamin D are | ||
| prepared gravimetrically and are | ||
| traceable to internal reference | ||
| calibrator concentrations | ||
| determined by UV | ||
| spectrophotometric analysis and | ||
| verified by Reference Method | ||
| Procedure (University of Ghent). | Calibrators are traceable to | |
| concentrations determined | ||
| by UV spectrophotometric | ||
| analysis. | ||
| Calibration Curve | Full Calibration Curve | Master Calibration Curve |
| Matrix | HEPES buffer with protein stabilizer | |
| (bovine) | Human serum and BSA |
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Performance Characteristics
Data were generated using the LUMIPULSE G1200 System.
1. Analytical performance:
- a. Precision/Reproducibility:
Lumipulse G 25-OH Vitamin D is ≤ 10% total (within-laboratory) CV (coefficient of variation). Lumipulse G 25-OH Vitamin D demonstrated precision ≤ 5.2% (total %CV) in a study run according to the Clinical and Laboratory Standards Institute (CLSI) guideline EP5-A3. Five human serum-based samples (specimen pools), and three controls were assayed in replicates of two at two separate times of the day for 20 for each sample) using one LUMIPULSE G1200 System. Data from this study are presented below.
| | | | Within-Run | | Between Run
Within Day | | Between-Day | | Total |
|--------------------|-----------------|------|------------|------|---------------------------|------|-------------|------|-------|
| Sample | Mean
(ng/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Control
Level 1 | 10.3 | 0.23 | 2.2% | 0.24 | 2.3% | 0.32 | 3.1% | 0.46 | 4.5% |
| Control
Level 2 | 34.0 | 0.36 | 1.1% | 0.48 | 1.4% | 0.54 | 1.6% | 0.81 | 2.4% |
| Control
Level 3 | 70.6 | 0.68 | 1.0% | 0.72 | 1.0% | 1.07 | 1.5% | 1.46 | 2.1% |
| Panel 1 | 7.7 | 0.21 | 2.8% | 0.20 | 2.6% | 0.28 | 3.6% | 0.40 | 5.2% |
| Panel 2 | 20.7 | 0.33 | 1.6% | 0.24 | 1.2% | 0.32 | 1.6% | 0.52 | 2.5% |
| Panel 3 | 41.2 | 0.53 | 1.3% | 0.45 | 1.1% | 0.67 | 1.6% | 0.97 | 2.3% |
| Panel 4 | 61.0 | 0.57 | 0.9% | 0.05 | 0.1% | 0.77 | 1.3% | 0.96 | 1.6% |
| Panel 5 | 120.6 | 1.36 | 1.1% | 0.00 | 0.0% | 1.32 | 1.1% | 1.89 | 1.6% |
b. Linearity/assay reportable range:
Lumipulse G 25-OH Vitamin D demonstrated linearity in a study consistent with the guidelines in the CLSI Guideline EP6-A. Two human serum specimen pools and two K2EDTA plasma specimen pools with high 25-Hydroxyvitamin D2 and 25-Hydroxyvtiamin D3 levels were diluted with one human serum specimen pool and one dipotassium EDTA plasma specimen pool with low 25-Hydroxyvitamin D2 and 25-Hydroxyvtiamin D3 levels throughout the range of the assay. The linearity was found in the range of 6.9 to 150.0 ng/mL for serum and plasma. Lumipulse G 25-OH Vitamin D correlated with expected concentrations according to the linear regression formulas:
y= 1.0382 (x) + 1.251; R-squared: 0.9978 Serum: Plasma: y= 1.0151 (x) + 6.7669; R-squared: 0.9936
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Lumipulse G 25-OH Vitamin D has been verified to detect 25-OH vitamin D2 and vitamin D3 in equal parts to the true molar concentration. 25-0H vitamin D2 and 25-OH vitamin D3 were prepared in seven (7) different ratios targeting a final concentration of 50 ng/mL in a serum sample pool with a low endogenous 25-OH vitamin D level. The concentration of 25-OH vitamin D was determined using Lumipulse G 25-OH Vitamin D and the resulting percent recovery was calculated. Samples with varying amounts of 25-OH vitamin D2 and 25-OH vitamin D3 recover within 100 ± 10%, ranging from 101% to 103%. The data are summarized in the following table
| Ratio of vitamin
D2 to vitamin D3 | Expected Conc.
(ng/mL) | Mean Measured
Conc. (ng/mL)
(n=3) | % Recovery |
|--------------------------------------|---------------------------|-----------------------------------------|------------|
| 1to1 | 53.1 | 54.8 | 103 |
| 1to2 | 54.0 | 55.6 | 103 |
| 2to1 | 52.3 | 53.5 | 102 |
| 1to3 | 54.4 | 55.8 | 103 |
| 3to1 | 51.9 | 52.9 | 102 |
| 1to7 | 55.0 | 55.7 | 101 |
| 7to1 | 51.4 | 52.7 | 103 |
Lumipulse G 25-OH Vitamin D recovers known concentrations of supplemental equimolar 25-OH vitamin D2 and 25-OH vitamin D3. A study was performed where known concentrations of 25-OH vitamin D (25-OH vitamin D2 and 25-OH vitamin D3) were added to human serum and Ko EDTA plasma samples with low endogenous 25-OH vitamin D levels. The concentration of 25-0H vitamin D was determined using the Lumipulse G 25-OH Vitamin D and the resulting percent recovery was calculated. 25-OH vitamin D recovery is 100 ± 10%, ranging from 92% to 106%. The data are summarized in the following table.
| Sample | Mean Measured
Conc.
(ng/mL)
(n=3) | Expected Conc.
(ng/mL) | %
Recovery |
|---------|--------------------------------------------|---------------------------|---------------|
| Serum 1 | 29.5 | 31.0 | 95 |
| | 44.2 | 45.3 | 98 |
| | 57.7 | 57.9 | 100 |
| | 89.9 | 89.8 | 100 |
| | 112.9 | 112.4 | 100 |
| | 137.1 | 135.7 | 101 |
| Serum 2 | 23.9 | 24.1 | 99 |
| | 38.0 | 38.4 | 99 |
| | 50.6 | 51.0 | 99 |
| | 83.2 | 82.9 | 100 |
| | 105.0 | 105.5 | 100 |
| | 136.3 | 128.8 | 106 |
| Serum 3 | 29.3 | 29.0 | 101 |
| | 43.7 | 43.3 | 101 |
| | 56.1 | 55.9 | 100 |
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| Sample | Mean Measured
Conc.
(ng/mL)
(n=3) | Expected Conc.
(ng/mL) | %
Recovery |
|----------|--------------------------------------------|---------------------------|---------------|
| | 88.5 | 87.8 | 101 |
| | 113.1 | 110.4 | 102 |
| | 137.3 | 133.7 | 103 |
| | 26.7 | 26.5 | 101 |
| | 38.1 | 40.5 | 94 |
| | 52.1 | 56.0 | 93 |
| Plasma 1 | 83.3 | 86.0 | 97 |
| | 110.2 | 114.8 | 96 |
| | 137.9 | 143.4 | 96 |
| | 23.1 | 23.9 | 97 |
| | 34.9 | 37.9 | 92 |
| | 49.0 | 53.4 | 92 |
| Plasma 2 | 79.9 | 83.4 | 96 |
| | 106.9 | 112.2 | 95 |
| | 134.9 | 140.8 | 96 |
| | 20.7 | 21.8 | 95 |
| | 33.4 | 35.8 | 93 |
| | 48.3 | 51.3 | 94 |
| Plasma 3 | 77.2 | 81.3 | 95 |
| | 103.8 | 110.1 | 94 |
| | 130.5 | 138.7 | 94 |
High dose hook is a phenomenon whereby very high level specimens may read within the dynamic range of the assay. For Lumipulse G 25-OH Vitamin D, no high dose hook effect was observed for samples containing up to 3,000 ng/mL of 25-Hydroxyvitamin D2 and 25-Hydroxyvitamin D3.
C. Traceability, Stability, Expected values (controls, calibrators, or methods):
Lumipulse G 25-OH Vitamin D Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G 25-OH Vitamin D on the LUMIPULSE G System for the quantitative determination of 25-hydroxyvitamin D (25-OH Vitamin D) in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA).
6 Bottles (1.5 mL each) are supplied for the LUMIPULSE G 25-OH Vitamin D Calibrators. Preservative: Sodium azide. The calibrators are at the following concentrations:
| Calibrator | Concentration
(ng/mL) | Concentration
(nmol/L) |
|------------|--------------------------|---------------------------|
| CAL 1 | 0 | 0 |
| CAL 2 | 10 | 25 |
| CAL 3 | 20 | 50 |
| CAL 4 | 50 | 125 |
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| CAL 5 | 100 | 250 |
|---|---|---|
| CAL 6 | 150 | 375 |
The calibrators for use with Lumipulse G 25-OH Vitamin D are prepared gravimetrically and are traceable to internal reference calibrator concentrations determined by UV spectrophotometric analysis and verified by Reference Method Procedure (University of Ghent).
Shelf life
The shelf life for Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges and the Lumipulse G 25-OH Vitamin D Calibrators is 12 months at 2-10°C.
On board the LUMIPULSE G1200
The Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges are sealed unit dose stored at 2-10°C. To reduce risk for any misuse, the package insert states "The Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges can be stored (refrigerated unit) on-board the LUMIPULSE G System for a maximum of 30 days".
The package insert recommends calibrator curve storage on the LUMIPULSE G1200 for a maximum of 30 days.
Transport Conditions
Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges and the Lumipulse G 25-OH Vitamin D Calibrators are shipped at 2-10°C.
Materials will be shipped to the end user using an insulated container and a predetermined configuration of gel (cold and/or frozen) packs to maintain the product for up to 72 hours when stored at ambient temperature.
-
d. Detection limit:
The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) of Lumipulse G 25-OH Vitamin D on the LUMIPULSE G1200 is ≤ 4.0 ng/mL. -
- LoB and LoD
The LoB for Lumipulse G 25-OH Vitamin D was 0.0 ng/mL.
- LoB and LoD
The LoD for Lumipulse G 25-OH Vitamin D on the LUMIPULSE G1200 was 0.28 ng/mL, determined consistent with the CLSI guideline EP17-A2. Seven low-level specimens were tested over 3 days using two LUMIPULSE G1200 Systems and two Lumipulse G 25-OH Vitamin D lots giving 120 determinations for each panel.
-
- LoQ
The LOQ for Lumipulse G 25-OH Vitamin D on the LUMIPULSE G1200 was 3.33 ng/mL. determined consistent with the CLSI guideline EP17-A2. The LoQ is the analyte level at which the CV is 10%.
- LoQ
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e. Analytical specificity:
The Lumipulse G 25-OH Vitamin D demonstrated an average interference of ≤ 10% (for each compound) in a study consistent with the guidelines in the CLSI guideline EP7-A2. Human serum specimens with 25-OH vitamin D concentrations of approximately 20, 40 and 100 ng/mL were supplemented with potentially interfering compounds. The following compounds were tested and found not to interfere with the test.
| Endogenous
Interferences | Test
Concentration |
|-----------------------------------------|-----------------------|
| Free Bilirubin (unconjugated) | 60 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Triglycerides (Intralipid 20% Emulsion) | 1000 mg/dL |
| Hemoglobin | 500 mg/dL |
| Total Protein (Human Serum Albumin) | 11 g/dL |
| Immunoglobulin G (IgG) | 5 g/dL |
| Biotin | 19.7 mg/dL |
| Uric Acid | 24 mg/dL |
| Cholesterol | 500 mg/dL |
| L-Ascorbic Acid | 3 mg/dL |
| Human Vitamin D Binding Protein | 0.200 mg/mL |
| Human Anti-Mouse Antibodies (HAMA) | 1,000 ng/mL |
| Rheumatoid Factor (RF) | 1.000 IU/mL |
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| Therapeutic drug | Test | |
|---|---|---|
| Interferences | Concentration | |
| Acetaminophen | 1455 µmol/L | |
| Acetylsalicylic acid | 3.65 mmol/L | |
| Alendronate | 350 mg/L | |
| Ampicillin | 344 µmol/L | |
| Ascorbic Acid | 375 µmol/L | |
| Caffeine | 309 µmol/L | |
| Chloramphenicol | 155 µmol/L | |
| Digoxin | 8.7 µmol/L | |
| EinsAlpha (Alfacalcidol) | 3633 µg/L | |
| Hydrochlorothiazide | 22.2 µmol/L | |
| Ibandronate | 52 mg/L | |
| Ibuprofen | 2486 µmol/L | |
| Indomethacin | 103 µmol/L | |
| Lidocaine | 57.9 µmol/L | |
| Lovastatin | 1932 µmol/L | |
| Metoprolol | 18.7 µmol/L | |
| Naproxen | 2247 µmol/L | |
| Pamidron | 90 mg/L | |
| Risedronate | 175 mg/L | |
| Theophylline | 243 µmol/L | |
| Warfarin | 37.5 µmol/L | |
| Zometa (Zoledronic Acid) | 4 mg/L |
Lumipulse G 25-OH Vitamin D on the LUMIPULSE G1200 System was evaluated for cross-reactivity of the assay with other substances that are similar in structure to 25(OH) Vitamin D in a study consistent with the guidelines in the CLSI Protocol EP7-A2. Human serum specimens with 25-OH vitamin D concentrations of approximately 20, 40 and 100 ng/mL were supplemented with potentially cross-reacting compounds. The compounds were tested at the concentrations listed below and found to have the following percent cross-reactivity.
| Substance | Test Concentration
(ng/mL) | % Cross-Reactivity |
|--------------------------------|-------------------------------|--------------------|
| 3-epi-25(OH) vitamin D3 | 100 | 2 |
| 3-epi-25(OH) vitamin D2 | 100 | 0 |
| 1,25(OH)2 vitamin D2 | 10 | 143 |
| 1,25(OH)2 vitamin D2 | 100 | 24 |
| 1,25(OH)2 vitamin D3 | 100 | 39 |
| 24,25(OH)2 vitamin D3 | 100 | 21 |
| Vitamin D3 (Cholecalciferol) | 20,000 | 0 |
| Vitamin D2 (Ergocalciferol) | 20,000 | 0 |
| 1αOH Vitamin D3 (alfacalcidol) | 8,000 | 0 |
| Paricalcitol (Zemplar) | 25 | -2 |
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-
f. Assay cut-off:
See Clinical Cutoff in 4. below. -
- Comparison studies:
- a. Method Comparison Liaison® 25 OH Vitamin D TOTAL
Lumipulse G 25-OH Vitamin D method comparison study was performed using specimens consistent with CLSI guideline EP9-A3. The weighted Deming regression method was used to compare Lumipulse G 25-OH Vitamin D to Liaison® 25 OH Vitamin D TOTAL. The data are summarized in the following table and presented graphically.
Range of samples: 4.0 to 107.3 ng/mL. (Lumipulse G 25-OH Vitamin D) 5.45 to 91.5 ng/mL (Liaison® 25 OH Vitamin D TOTAL)
| Lumipulse G 25-OH Vitamin D vs. Liaison® 25 OH Vitamin D TOTAL | |
|---|---|
| ---------------------------------------------------------------- | -- |
| n | Correlation
Coefficient
(r) | Intercept
(95% CI) | Slope
(95% CI) | Average Bias
(ng/mL) |
|-----|-----------------------------------|-----------------------|-------------------|-------------------------|
| 137 | 0.9476 | -3.073 | 1.09 | 0.423 |
| | | -4.357 –
-1.790 | 1.04 – 1.13 | |
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Image /page/14/Figure/2 description: The image is a scatter plot titled "Deming regression". The x-axis is labeled "LIAISON ng/mL" and ranges from 0 to 80. The y-axis is labeled "Lumipulse ng/mL" and ranges from 0 to 100. The plot shows a positive correlation between the two variables, with a regression line and confidence intervals displayed.
b. Method Comparison – ID- HPLC-MS/MS
To evaluate accuracy of Lumipulse G 25-OH Vitamin D, an additional method comparison study was performed using specimens consistent with CLSI guideline EP9-A3. The weighted Deming regression method was used to compare Lumipulse G 25-OH Vitamin D to reference Vitamin D values determined by the CDC reference method, a validated isotope dilution high performance liquid chromatography tandem mass spectrometry (ID- HPLC-MS/MS) 25-OH Vitamin D. The data are summarized in the following table and presented graphically.
Range of samples: 7.2 to 149.0 ng/mL (Lumipulse G 25-OH Vitamin D) 8.65 to 153 ng/mL (ID- HPLC-MS/MS)
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| Lumipulse G 25-OH Vitamin D vs. ID- HPLC-MS/MS | ||||
|---|---|---|---|---|
| n | Correlation | |||
| Coefficient | ||||
| (r) | Intercept | |||
| (95% CI) | Slope | |||
| (95% CI) | Average Bias | |||
| (ng/mL) | ||||
| 117 | 0.9986 | -2.788 | 0.97 | -3.826 |
| -3.225 – | ||||
| -2.351 | 0.96 – 0.99 |
Image /page/15/Figure/3 description: The image is a scatter plot showing the correlation between Lumipulse and ID-HPLC-MS/MS 25-OH Vitamin D measurements. The x-axis represents ID-HPLC-MS/MS 25-OH Vitamin D in ng/mL, ranging from approximately 0 to 150. The y-axis represents Lumipulse in ng/mL, also ranging from approximately 0 to 140. A Deming regression line is plotted through the data points, along with dashed lines indicating the confidence interval.
Matrix Comparison ﻥ
Lumipulse G 25-OH Vitamin D on the LUMIPULSE G1200 System was evaluated for matrix differences by performing a study using fifty (50) matched sets of serum (red top and serum separator tubes (SST)) and plasma (sodium heparin, lithium heparin, K2EDTA) samples. The results demonstrated equivalency between matrices and are presented as regression equations in the following table:
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| Matrix Comparison | Sample
Range
(ng/mL) | Regression Equation and
Correlation Coefficient |
|--------------------------------|----------------------------|----------------------------------------------------|
| SST versus Red Top | 8.6 –
113.7 | $y= 1.0076(x) – 0.2178;$
$r=0.9981$ |
| K₂EDTA versus Red Top | 8.6 –
111.2 | $y= 0.9673(x) + 0.0008;$
$r=0.9982$ |
| Lithium Heparin versus Red Top | 8.8 –
119.2 | $y= 1.019(x) – 0.5969;$
$r=0.9964$ |
| Sodium Heparin versus Red Top | 8.8 –
116.3 | $y= 1.0103(x) – 0.4566;$
$r=0.9983$ |
3. Clinical studies:
-
a. Clinical sensitivity:
Not applicable -
b. Clinical specificity:
Not applicable -
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
See Expected Values below.
5. Expected values/Reference range:
It is recommended that each laboratory establish its own range, which may be unique to the population it serves depending upon geographical, patient, and environmental factors.
There is considerable discussion of the serum concentrations of 25-OH Vitamin D associated with deficiency, adequacy for bone health and optimal overall health. In the past, vitamin D deficiency was defined as serum 25-0H vitamin D below 10 ng/mL. The World Health Organization (WHO) defined vitamin D insufficiency as serum 25-OH vitamin D below 20 ng/mL. However, others recently started to define vitamin D deficiency as serum 25-OH vitamin D level below 20 ng/mL and vitamin D insufficiency as less than 30 ng/mL. A review of the available literature suggests the following recommendations for 25-0H vitamin D levels:
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| Level | Ranges according to World
Health Organization | Ranges according to
Endocrine Society Clinical
Practice Guideline |
|--------------------|--------------------------------------------------|-------------------------------------------------------------------------|
| Deficient | 100 ng/mL | >100 ng/mL |
Results from a total of 322 samples were used to determine the distribution of Lumipulse G 25-OH Vitamin D results in apparently healthy adults.
Excluded from the study were individuals who had history of current use of dietary supplements containing > 2,000 IU per day of Vitamin D, history of Vitamin D deficiency, any disease considered chronic, history of seizures, bariatric surgery, parathyroid and thyroid disease, were pregnant or lactating, had an active malignancy or were diagnosed with cancer other than basal/squamous cell skin cancer within 5 years, were receiving chemotherapy or radiation treatment, had a family history of parathyroid or calcium regulatory disease, were on medicines known to affect absorption or increase catabolism, or had abnormal serum levels for calcium PTH or TSH.
The subjects ranged in age from 18 to 74 years (median age of 36) and were representative of the overall US population in terms of sex (46.9% male and 53.1% female) and ethnicity/race (60.0% White, 7.5% Black, 19.3% Hispanic, 8.1% Asian/Pacific Islander and 5.3% Other). The majority of the population was