(165 days)
Not Found
No
The summary describes a standard immunoassay for measuring PTH levels and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative measurement of PTH in human serum and plasma for diagnostic purposes, not for treating a disease or condition.
Yes
The intended use explicitly states, "For in vitro diagnostic use. ... Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This indicates its purpose is to aid in diagnosing medical conditions.
No
The device description clearly outlines physical components (Immunoreaction Cartridges, Antibody-Coated Particle Solution, Enzyme-Labeled Antibody Solution) which are reagents used in a laboratory setting, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first line explicitly states "For in vitro diagnostic use." It also describes the device's purpose as measuring PTH in human serum and plasma for the "differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This clearly indicates its use in a diagnostic context outside of a living organism.
- Device Description: The description details the components of the "Immunoreaction Cartridges" which are used to perform the test on biological samples (serum and plasma).
- Intended User/Care Setting: The intended user is a "Clinical Laboratory," which is the typical setting for performing in vitro diagnostic tests.
- Performance Studies: The document details various analytical performance studies (Reproducibility, Linearity, Detection Limit, etc.) which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device(s): The mention of a "Predicate Device(s)" (K150879; LIAISON® 1-84 PTH Assay) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use. Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following:
-
- Antibody-Coated Particle Solution (Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300
-
- Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf )-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300
Lumipulse G whole PTH is an assay system, including a set of immunoassay reagents and calibrators, for the quantitative measurement of whole parathyroid hormone (whole PTH) in specimens based on Chemiluminescent Enzyme Immunoassay (CLEIA) technology by a one-step sandwich immunoassay method on the LUMIPULSE G System. In the first reaction, alkaline phosphatase (ALP: calf )-labelled anti-PTH polyclonal antibody (goat), PTH in specimens, and anti-PTH polyclonal antibody (goat) - coated ferrite particles specifically bind to form antibody immunocomplexes. The particles are washed and rinsed to remove unbound materials. The Substrate Solution is then added and mixed with the particles in the enzyme reaction. AMPPD* contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Finally, the Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of the dephosphorylated AMPPD. The Luminescent signal reflects the amount of whole РТН.
*AMPPD: 3-(2'-spiroadmantane)-4-methoxy-4-(3"-phosphoryloxy)phenyl-1,2-dioxetane disodium salt
- Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf )-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility/Precision:
- 20-Day Precision: Single site precision study using 7 native human serum samples, assayed in replicates of two at two separate times of the day for 20 days (n=80 for each sample). Demonstrated precision ≤4 % (total %CV).
- Lot-to-Lot Precision: Study used three lots of Lumipulse G whole PTH and Calibrators. 4 native human serum samples and 2 control levels were assayed in duplicate in two runs per day across 8 days (n=32 replicates per lot per lot combination). Demonstrated precision ≤4% (inter-lot %CV).
- Site-to-site Precision: Studies at internal laboratory and two additional sites. 5 native serum samples assayed in triplicate at two separate times of the day for five days. Two lots of reagents utilized. Demonstrated precision ≤ 6.7% (total %CV).
Linearity/Assay Reportable Range:
- Linearity: High and low sample pools created using patient serum samples. Linearity found in the range 1.4 pg/mL - 2190.3 pg/mL. Linear regression formula: y= - 0.36519+1.091572x; R2=0.9984. Measuring range 4.0 pg/mL - 1800.0 pg/mL.
Detection Limit:
- Limit of Blank (LoB): 0.0 pg/mL
- Limit of Detection (LoD): 0.295 pg/mL
- Limit of Quantitation (LoQ): 2.128 pg/mL (concentration with an interassay CV of 10%)
Analytical Specificity/Cross Reactivity:
- Evaluated for cross-reactivity with Calcitonin, Osteocalcin, C-Telopeptide (β-crosslaps), and various PTH fragments (7-84, 1-34, 39-84, 39-68, 44-68, 53-84, 13-34) on a panel of serum samples with naturally occurring whole PTH (n=4 panel members). No cross reactivity observed (
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.
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August 30, 2019
Fujirebio Diagnostics, Inc. Stacey Dolan Senior Manager, Regulatory Affairs 201 Great Valley Pkwy Malvern, PA 19355
Re: K190702
Trade/Device Name: Lumipulse G whole PTH Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: July 29, 2019 Received: July 30, 2019
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. 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.
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
1
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 medical devices and radiation-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,
Kellie Kelm, Ph.D., Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190702
Device Name Lumipulse G whole PTH
Indications for Use (Describe) For in vitro diagnostic use
Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia resulting from disorders of calcium metabolism.
| 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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Section 5 510(k) SUMMARY
A. GENERAL INFORMATION
Submission Date: August 20, 2019
510(k) Number: K190702
Submitter Information:
Submitted By:
Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
Contact Person: Stacey Dolan, RAC (US) Senior Manager, Regulatory Affairs Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 Office: (610)-240-3843
B. PURPOSE FOR SUBMISSION
To obtain a substantial equivalence determination for the Lumipulse G whole PTH
C. MEASURAND
Parathyroid Hormone
D. TYPE OF TEST
Quantitative, Chemiluminescent Immunoassay
E. APPLICANT
Fujirebio Diagnostics, Inc.
F. PROPRIETARY AND ESTABLISHED NAMES
Lumipulse® G whole PTH Lumipulse® G whole PTH Immunoreaction Cartridges
G. REGULATORY INFORMATION
Trade Name: Lumipulse G whole PTH
Lumipulse G whole PTH
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Classification: Class II Regulation: 21 CFR § 862.1545 Regulation Name: Parathyroid hormone test system Product Code: CEW - Radioimmunoassay, Parathyroid Hormone Panel: 75, Clinical Chemistry
H. INTENDED USE / INDICATIONS FOR USE
-
- Intended Use / Indications for use For in vitro diagnostic use.
Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
- Intended Use / Indications for use For in vitro diagnostic use.
-
- Special conditions for use statement(s): For prescription use only.
-
- Special instrument requirements: LUMIPULSE G System
-INDICATIONS FOR USE
Same as Intended Use.
J. DEVICE DESCRIPTION
Reagents
The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following:
-
- Antibody-Coated Particle Solution
(Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300
- Antibody-Coated Particle Solution
-
- Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300
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Image /page/5/Picture/1 description: The image is a logo for Fujirebio Diagnostics, Inc. The logo features a stylized graphic on the left, consisting of blue and white shapes. To the right of the graphic, the word "FUJIREBIO" is written in a bold, blue sans-serif font. Below "FUJIREBIO", the words "Diagnostics, Inc." are written in a smaller, thinner sans-serif font, also in blue.
K. SUBSTANTIAL EQUIVALENCE INFORMATION
-
- Predicate device name(s): LIAISON® 1-84 PTH Assay
-
- Predicate 510(k) number: K150879
-
- Comparison with predicate:
| | Lumipulse G whole PTH
(Proposed Device) | LIAISON® 1-84 PTH Assay (K150879)
(Predicate) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Intended
Use | Lumipulse G whole PTH is a
Chemiluminescent Enzyme
Immunoassay (CLEIA) for the
quantitative measurement of PTH
(1-84) in human serum and
plasma on the LUMIPULSE G
System. Measurements of
parathyroid hormone levels are
used in the differential diagnosis
of hypercalcemia and
hypocalcemia resulting from
disorders of calcium metabolism. | The DiaSorin LIAISON 1-84 PTH Assay
is an in vitro chemiluminescent
immunoassay (CLIA) intended for the
quantitative determination of parathyroid
hormone (1-84) in human serum and
EDTA plasma. Measurements of
parathyroid hormone levels are used in
the differential diagnosis of
hypercalcemia and hypocalcemia
resulting from disorders of calcium
metabolism. The test has to be
performed on the LIAISON® Analyzer
family. |
| SIMILARITIES | | |
| Classification | Class II | Same |
| Product Code | CEW | Same |
| Regulation | 21 CFR § 862.1545 | Same |
| Sample Type | human serum and plasma | Same |
| Antibody | Goat polyclonal | Same |
| Reagent Storage | Store at 2-10°C | Store at 2-8°C |
| Measuring Range | 4.0 - 1800.0 pg/mL | 4.0 - 1800 pg/mL |
| Sample Size | 150 µL (for Sample Cups)
300 µL (for Sample Tubes) | 150 µL |
| DIFFERENCES | | |
| Instrument | LUMIPULSE G System | LIAISON Analyzer |
| Methodology | CLEIA | CLIA |
| | 2 level set (1 vial/level): | 4 level set (1 vial/level): |
| | • Level 1: 0 pg/mL | • Level 1: 10 pg/mL |
| Calibrators | • Level 2: 5000 pg/mL | • Level 2: 80 pg/mL |
| | | • Level 3: 400 pg/mL |
| | | • Level 4: 1450 pg/mL |
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L. STANDARDS/GUIDANCE DOCUMENTS REFERENCED
- CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; . Approved Guideline-Third Edition
- CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
- . CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition
- . CLSI EP09c, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition
- CLSI EP14-A2, Evaluation of Matrix Effects; Approved Guideline-Second Edition ●
- CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement ● Procedures; Approved Guideline
- CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved . Guideline
- CLSI C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical . Laboratory; Approved Guideline-Third Edition
M. TEST PRINICIPLE
Lumipulse G whole PTH is an assay system, including a set of immunoassay reagents and calibrators, for the quantitative measurement of whole parathyroid hormone (whole PTH) in specimens based on Chemiluminescent Enzyme Immunoassay (CLEIA) technology by a one-step sandwich immunoassay method on the LUMIPULSE G System. In the first reaction, alkaline phosphatase (ALP: calf )-labelled anti-PTH polyclonal antibody (goat), PTH in specimens, and anti-PTH polyclonal antibody (goat) - coated ferrite particles specifically bind to form antibody immunocomplexes. The particles are washed and rinsed to remove unbound materials. The Substrate Solution is then added and mixed with the particles in the enzyme reaction. AMPPD* contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Finally, the Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of the dephosphorylated AMPPD. The Luminescent signal reflects the amount of whole РТН.
*AMPPD: 3-(2'-spiroadmantane)-4-methoxy-4-(3"-phosphoryloxy)phenyl-1,2-dioxetane disodium salt
N. PERFORMANCE CHARACTERISTICS
1. Analytical Performance
a. Reproducibility/Precision
20-Day Precision
The single site precision study was conducted using the Lumipulse G whole PTH at the internal laboratory according to CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures. A panel of seven native human serum
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samples targeting the measuring range were assayed in replicates of two at two separate times of the day for 20 days (n=80 for each sample) using one LUMIPULSE G1200 System and one lot of Lumipulse G whole PTH. Lumipulse G whole PTH demonstrated precision ≤4 % (total %CV). Within-Laboratory (Total) precision combines Within-run, Between-run and Between-day precision data. The data are presented below.
| Sample | Mean
(pg/mL) | Within-Run | | Between Run
Within Day | | Between-Day | | Total | |
|-----------------|-----------------|------------|-----|---------------------------|-----|-------------|-----|-------|-----|
| | n=80 | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Control Level 1 | 38.7 | 1.10 | 3% | 0.28 | 1% | 0.25 | 1% | 1.16 | 3% |
| Control Level 2 | 291.7 | 4.62 | 2% | 3.43 | 1% | 2.30 | 1% | 6.19 | 2% |
| Serum 1 | 8.4 | 0.34 | 4% | 0.00 | 0% | 0.00 | 0% | 0.34 | 4% |
| Serum 2 | 37.2 | 0.85 | 2% | 0.78 | 2% | 0.00 | 0% | 1.15 | 3% |
| Serum 3 | 84.8 | 1.72 | 2% | 0.57 | 1% | 0.25 | 0% | 1.83 | 2% |
| Serum 4 | 258.8 | 5.37 | 2% | 1.90 | 1% | 2.60 | 1% | 6.26 | 2% |
| Serum 5 | 404.7 | 7.91 | 2% | 5.28 | 1% | 5.41 | 1% | 10.94 | 3% |
| Serum 6 | 813.6 | 15.35 | 2% | 14.31 | 2% | 9.65 | 1% | 23.10 | 3% |
| Serum 7 | 1385.3 | 30.80 | 2% | 28.47 | 2% | 12.87 | 1% | 43.88 | 3% |
Lot-to-Lot Precision
The lot-to-lot study was conducted using three lots of Lumipulse G whole PTH and Calibrators at the internal laboratory according to CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures. Each lot combination was tested on a different LUMIPULSE G1200 System (n=3). A panel of four native human serum samples targeting the measuring range and two levels of controls were assayed in duplicate in two runs per day across 8 days (n=32) replicates per lot). Lumipulse G whole PTH demonstrated precision ≤4% (inter-lot %CV).
| Sample | Replicates | Mean (pg/mL) | Inter-lot %CV |
|---|---|---|---|
| Control Level 1 | 96 | 39.1 | 4% |
| Control Level 2 | 96 | 293.0 | 2% |
| Serum 1 | 96 | 8.6 | 3% |
| Serum 2 | 96 | 38.0 | 3% |
| Serum 3 | 96 | 86.3 | 3% |
| Serum 4 | 96 | 261.2 | 3% |
Site-to-site Precision:
The site-to-site precision studies were conducted using the Lumipulse G whole PTH at the internal laboratory and two additional sites according to CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures. A panel of five native serum samples targeting the measuring range were assayed in triplicate at two separate times of the day for five days using three LUMIPULSE G1200 instruments (one per site). Two lots of reagents were utilized for testing, and the data from both 5-day precision studies for Panels 1-5 were combined for the site-to-site analysis. Lumipulse G whole PTH demonstrated precision ≤ 6.7% (total %CV). Within-Laboratory (Total)
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precision combines within-run, between-run and between-day precision, and data are presented below.
| Sample | Mean
(pg/mL) | Between
Sites | | Between
Days
Within
Sites | | Between
Runs
Within Days
Within Lots | | Within
Runs | | Total | |
|---------|-----------------|------------------|------|------------------------------------|------|-----------------------------------------------|------|----------------|------|-------|------|
| | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Serum 1 | 8.8 | 0.4 | 4.7% | 0.1 | 1.1% | 0.2 | 2.3% | 0.3 | 3.4% | 0.6 | 6.3% |
| Serum 2 | 36.8 | 1.2 | 3.4% | 0.6 | 1.7% | 1.8 | 4.9% | 0.9 | 2.5% | 2.5 | 6.7% |
| Serum 3 | 83.9 | 2.1 | 2.5% | 0.9 | 1.0% | 3.3 | 3.9% | 2.2 | 2.6% | 4.5 | 5.4% |
| Serum 4 | 254.6 | 5.3 | 2.1% | 2.7 | 1.1% | 12.3 | 4.8% | 5.0 | 2.0% | 14.5 | 5.7% |
| Serum 5 | 1270.1 | 39.0 | 3.1% | 0.0 | 0.0% | 44.8 | 3.5% | 21.5 | 1.7% | 63.2 | 5.0% |
b. Linearity/Assay Reportable Range
Linearity:
Lumipulse G whole PTH on the LUMIPULSE G1200 demonstrated linearity in a study consistent with the guidelines in CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures. High and low sample pools were created using patient serum samples that contained naturally expressed whole PTH. The linearity was found in the range 1.4 pg/mL - 2190.3 pg/mL. Lumipulse G whole PTH correlated with expected concentrations per the linear regression formula:
y= - 0.36519+1.091572x; R2=0.9984
The measuring range of the assay will be 4.0 pg/mL - 1800.0 pg/mL.
c. Traceability, Stability, Expected Values (controls, calibrators, or methods)
Expected Values:
Lumipulse G whole PTH Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G whole PTH on the LUMIPULSE G System for the quantitative determination of whole PTH in human serum and plasma. Two bottles (1.5 mL and 3.0 mL each) are supplied for the Lumipulse G whole PTH Calibrator kit which contain MES buffer with protein (bovine) stabilizer. Preservative: mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methyl-isothiazolin-3(2H)-one
The calibrators are at the following concentrations:
| Calibrator | Concentration (pg/mL) |
|---|---|
| CAL 1 | 0 |
| CAL 2 | 5000 |
Traceability:
Calibration of the Lumipulse G whole PTH is traceable to in-house reference calibrators whose values have been assigned to the 1st international standard for Parathyroid
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Hormone 1-84 (code: 95/646) provided by the National Institute for Biological Standards and Controls (NIBSC).
Shelf life:
The shelf life for Lumipulse G whole PTH Immunoreaction Cartridges and the Lumipulse G whole PTH Calibrators is 12 months at 2–10°C. It is not recommended that the reagents are frozen.
On-board the LUMIPULSE G1200:
The Lumipulse G whole PTH Immunoreaction Cartridges are sealed unit dose stored at 2-10°C. To reduce risk for any misuse, the package insert states "The Lumipulse G whole PTH 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 whole PTH Immunoreaction Cartridges and the Lumipulse G whole PTH 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) for the Lumipulse G whole PTH were determined in accordance with the CLSI Guideline EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. Four blank and four low level serum specimens were tested over three days with two Lumipulse G whole PTH lots giving 60 determinations for each panel per lot for the LoB and LoD Studies. For the LOQ Study, 5 low level serum were tested on 2 LUMIPULSE G1200 Systems with 2 Lumipulse G whole PTH lots across several days.
The LoB for Lumipulse G whole PTH on the LUMIPULSE G1200 System was determined to be 0.0 pg/mL.
The LoD for Lumipulse G whole PTH on the LUMIPULSE G1200 System was determined to be 0.295 pg/mL.
The LoQ is defined as the concentration of PTH (1-84) that can be measured with an interassay CV of 10%. The LoQ for Lumipulse G whole PTH on the LUMIPULSE G1200 System was determined to be 2.128 pg/mL.
e. Analytical Specificity/Cross Reactivity
The cross reactivity study followed the guidance of CLSI EP07-A2, Interference Testing in Clinical Chemistry. Lumipulse G whole PTH on the LUMIPULSE G1200 System was evaluated for cross-reactivity of the assay with other substances that are
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similar in structure to whole PTH and truncated versions of whole PTH. No cross reactivity was observed for the tested concentrations of each cross reactant listed below on a panel of serum samples with naturally occurring whole PTH (n=4 panel members).
| Cross Reactant | Concentration Tested (pg/mL) | % Cross Reactivity |
|---|---|---|
| Calcitonin | 500000 |