(106 days)
Not Found
No
The description details a standard immunoassay system based on CLEIA technology. There is no mention of AI, ML, or any computational analysis beyond basic signal processing to quantify the luminescent signal. The performance studies focus on analytical characteristics of the assay, not on the performance of an AI/ML algorithm.
No
This device is for in vitro diagnostic use, meaning it aids in diagnosis by quantifying a substance (TSH) in human serum. It does not provide direct treatment or prevention.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and that it is "to be used as an aid in the diagnosis of thyroid or pituitary disorders."
No
The device description clearly states it is an "assay system, including a set of immunoassay reagents" and operates on the "LUMIPULSE G System," indicating it is a hardware-based in vitro diagnostic device that utilizes chemical reactions and a specific instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use." This is the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
The description further clarifies that it is a "Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulation hormone (TSH) in human serum," which is a typical in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use.
Lumipulse G TSH-III is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulation hormone (TSH) in human serum on the LUMIPULSE G System.
Lumipulse GTSHIII is to be used as an aid in the diagnosis of thyroid or pituitary disorders.
Product codes (comma separated list FDA assigned to the subject device)
JLW
Device Description
Lumipulse GTSH-III is an assay system, including a set of immunoassay reagents, for the quantitative measurement of TSH in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. TSH in specimens specifically binds to anti-human TSH monoclonal antibody (mouse) 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-human TSH monoclonal antibody (mouse) specifically binds to TSH of the 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 TSH.
The Lumipulse G TSH-III Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following:
-
- Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 200 ug/mL anti-human TSH monoclonal antibody (mouse)-coated particles. protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
-
- Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.3 µg/mL alkaline phosphatase (ALP:calf)-labeled anti-TSH monoclonal antibody (mouse), protein stabilizers (bovine and calf) and chemical stabilizers in 0.15 M sodium chloride/MES buffer. Preservative: sodium azide.
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
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Intended User / Care Setting
Clinical and Hospital laboratories
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)
1. Analytical performance:
a. Precision/Reproducibility:
- 20 Day Precision: The Lumipulse G TSH-III demonstrated Within-Laboratory (Total) precision of ≤6.4% CV in a study run according to the Clinical and Laboratory Standards Institute (CLSI) Protocol EP5-A3. Five human serum-based panels 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. Key results showed Within-Laboratory (Total) %CV ranging from 1.9% to 6.4% across different TSH concentrations.
- Lot-To-Lot Reproducibility: Total precision for Lumipulse GTSH-III was determined to be ≤ 4.6% for the 3 panels in this study, ranging from 3.1% to 4.6%. Between-lot precision was ≤ 4.0%.
- Site to Site Reproducibility: Total precision for Lumipulse G TSH-III was ≤ 4.3% for the 3 panels, ranging from 2.9% to 4.3%. Between-site precision was ≤ 2.4%.
b. Linearity/Assay reportable range:
- Lumipulse GTSH-III on the LUMIPULSE G1200 System demonstrated linearity in the range of 0.001 to 227.804 µIU/mL.
- Linear regression: Serum: y = 1.03(x) + 0.001; R-squared: 0.9962.
- No high dose hook effect was observed for samples containing up to ~5,000 µIU/mL of TSH.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
- Calibrators are traceable to in-house reference calibrators, assigned to the 3rd International Standard, 2003 (code: 81/565) by NIBSC.
- Shelf life for Immunoreaction Cartridges and Calibrators is 12 months at 2-10°C.
- On-board stability on LUMIPULSE G1200 for Immunoreaction Cartridges is a maximum of 30 days. Calibrator curve storage is also a maximum of 30 days.
d. Detection limit:
- Limit of Blank (LoB): 0.0010 µIU/mL.
- Limit of Detection (LoD): 0.002 µIU/mL, determined consistent with CLSI guideline EP17-A2 (Eight low level specimens tested over 6 weeks using two LUMIPULSE G1200 Systems and two Lumipulse G TSH-III lots giving 480 determinations for each panel).
- Limit of Quantitation (LoQ)/Functional Sensitivity (FS): 0.006 µIU/mL, defined as the concentration of TSH that can be measured with an interassay CV of 20%, consistent with NACB Guideline. The device meets the definition of a third generation TSH assay.
e. Analytical specificity:
- Demonstrated average interference of ≤10% (for each compound) for a list of endogenous and therapeutic drug interferences (e.g., Free Bilirubin, Triglycerides, Hemoglobin, HAMA, Acetaminophen, Amiodarone).
- Cross-reactivity with FSH, hCG, hGH, and LH was evaluated at specific concentrations, showing minimal impact on TSH concentration measurements.
2. Comparison studies:
a. Method Comparison:
- Performed on the LUMIPULSE G1200 system, consistent with CLSI EP9-A3.
- Compared Lumipulse G TSH-III to Abbott ARCHITECT TSH using weighted Deming regression.
- Sample size: 141 serum samples.
- Key results: Correlation Coefficient (r) = 0.9838, Intercept = -0.0037, Slope = 0.97, Average Bias = -1.051 µIU/mL.
3. Expected values/Reference range:
- 0.389-3.764 µIU/mL, corresponding to the 2.5th and 97.5th percentiles from 116 healthy test subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a combination of blue and green shapes, with a white teardrop shape in the center. The company name is written in blue, with "FUJIREBIO" in a larger font size than "Diagnostics, Inc."
510(k) SUMMARY
Lumipulse® G TSH-III K171103
July 10, 2017 Date:
- Submitter: Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
- Contact Person: Stacey Dolan Manager, Regulatory Affairs Phone: (610) 240-3843 Fax: (610) 240-3803 Email: dolans@fdi.com
- Device Name: Lumipulse G TSH-III Immunoreaction Cartridges Classification: Class II JLW 75, Clinical Chemistry 21 CFR § 862.1690
- Predicate Device: K983442 Abbott Laboratories ARCHITECT TSH
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 GTSH-III is an assay system, including a set of immunoassay reagents, for the quantitative measurement of TSH in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. TSH in specimens specifically binds to anti-human TSH monoclonal antibody (mouse) 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-human TSH monoclonal antibody (mouse) specifically binds to TSH of the 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 TSH.
Lumipulse G TSH-III:
Lumipulse G TSH-III Immunoreaction Cartridges |REF 235294
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Image /page/1/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and green abstract symbol on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
The Lumipulse G TSH-III Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following:
-
- Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 200 ug/mL anti-human TSH monoclonal antibody (mouse)-coated particles. protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
-
- Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.3 µg/mL alkaline phosphatase (ALP:calf)-labeled anti-TSH monoclonal antibody (mouse), protein stabilizers (bovine and calf) and chemical stabilizers in 0.15 M sodium chloride/MES buffer. Preservative: sodium azide.
Lumipulse G TSH-III Calibrators CAL 231135, Liquid 1x3 concentrations
Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.
CAL 1 0 µIU/mL TSH calibrator (1 x 1.5 mL)
CAL 2 5 µIU/mL TSH calibrator (1 x 1.5 mL)
CAL 3 200 µIU/mL TSH calibrator (1 x 1.5 mL)
Contains thyroid stimulating hormone (TSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide
Device Intended Use:
Lumipulse G TSH-III Immunoreaction Cartridges
For in vitro diagnostic use.
Lumipulse G TSH-III is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulation hormone (TSH) in human serum on the LUMIPULSE G System.
Lumipulse GTSHIII is to be used as an aid in the diagnosis of thyroid or pituitary disorders.
Device Indications for Use: Same as Intended Use
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Image /page/2/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a blue and white abstract graphic on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc."
Substantial Equivalence:
Comparison between the Lumipulse G TSH-III assay and Abbott ARCHITECT TSH assay
| Similarities and Difference | ||
|---|---|---|
| Lumipulse® G TSH-III | ||
| (Proposed Device) | Abbott ARCHITECT TSH | |
| (Predicate Device) | ||
| K983442 | ||
| Device Type | In vitro diagnostic | same |
| Classification | Class II | same |
| Regulation Number | 21CFR § 862.1690 | |
| Thyroid stimulating hormone | ||
| test system | same | |
| Product Usage | Clinical and Hospital | |
| laboratories | same | |
| Principle of Operation | Automated Quantitative | |
| Chemiluminscent Enzyme | ||
| Immunoassay (CLEIA) | Chemiluminescent | |
| Microparticle Immunoassay | ||
| (CMIA) | ||
| Specimen Collection | ||
| Method | Routine Phlebotomy | |
| Techniques | same | |
| Intended Use | For in vitro diagnostic use. | |
| Lumipulse G TSH-III is a | ||
| Chemiluminescent Enzyme | ||
| Immunoassay (CLEIA) for the | ||
| quantitative determination of | ||
| thyroid stimulation hormone | ||
| (TSH) in human serum on the | ||
| LUMIPULSE G System. | ||
| Lumipulse G TSH-III is to be | ||
| used as an aid in the | ||
| diagnosis of thyroid or | ||
| pituitary disorders. | The ARCHITECT TSH assay | |
| is a Chemiluminescent | ||
| Microparticle Immunoassay | ||
| (CMIA) for the quantitative | ||
| determination of human | ||
| Thyroid Stimulating Hormone | ||
| (TSH) in human serum and | ||
| plasma. | ||
| Instrument System | LUMIPULSE G System | ARCHITECT |
| Assay Type | Two-step sandwich | |
| immunoassay based on | ||
| chemiluminescent | ||
| technology | same | |
| Sample Volume | 60 μL | 200 μL |
| Type of Specimen | Human serum | Human serum or plasma |
| (lithium heparin, sodium | ||
| heparin or potassium EDTA) | ||
| Assay Range | 0.02 – 100 µIU/mL | 0.000 - 100.00 µIU/mL |
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Image /page/3/Picture/1 description: The image contains the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized blue and green graphic on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc.", which is positioned below it.
Performance Characteristics
Data were generated using the LUMIPULSE G1200 System.
-
- Analytical performance:
- a. Precision/Reproducibility:
20 Day
The Lumipulse G TSH-III demonstrated Within-Laboratory (Total) precision of ≤6.4% CV in a study run according to the Clinical and Laboratory Standards Institute (CLSI) Protocol EP5-A3. Five human serum-based panels 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. Within-Laboratory (Total) precision combines Within-run, Between-run and Between-day precision data. Data from this study are summarized below.
| | | Within-Run
(Repeatability) | | Between Run | | Between-Day | | Within-
Laboratory
(Total) | |
|---------|------------------|-------------------------------|------|-------------|------|-------------|------|----------------------------------|------|
| Sample | Mean
(µIU/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Panel 1 | 0.365 | 0.012 | 3.3% | 0.000 | 0.0% | 0.001 | 0.2% | 0.012 | 3.3% |
| Panel 2 | 1.029 | 0.018 | 1.8% | 0.044 | 4.3% | 0.042 | 4.1% | 0.063 | 6.2% |
| Panel 3 | 4.533 | 0.086 | 1.9% | 0.018 | 0.4% | 0.000 | 0.0% | 0.088 | 1.9% |
| Panel 4 | 8.773 | 0.098 | 1.1% | 0.261 | 3.0% | 0.427 | 4.9% | 0.510 | 5.8% |
| Panel 5 | 73.991 | 1.585 | 2.1% | 2.125 | 2.9% | 3.950 | 5.3% | 4.757 | 6.4% |
Lot-To-Lot Reproducibility for Combined Data
The precision analyses for the combined lot-to-lot analysis determined the total precision for Lumipulse GTSH-III to be ≤ 4.6% for the 3 panels in this study. The total precision of Lumipulse GTSH-III for the 3 panels ranged from 3.1% to 4.6%. The between-lot precision for Lumipulse G TSH-III was ≤ 4.0%.
Data from this study are summarized below.
| Between-Lot | Between Day | Between Run | Within-Run (Repeatability) | Within-Laboratory (Total) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Mean (µIU/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Panel 2 | 1.046 | 0.029 | 2.8% | 0.000 | 0.0% | 0.005 | 0.5% | 0.020 | 1.9% | 0.036 | 3.4% |
| Panel 4 | 8.895 | 0.209 | 2.3% | 0.000 | 0.0% | 0.041 | 0.5% | 0.177 | 2.0% | 0.277 | 3.1% |
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Image /page/4/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. On the left is a blue and green abstract symbol. To the right of the symbol is the company name in blue, with "FUJIREBIO" on the top line and "Diagnostics, Inc." on the bottom line.
| | Between-Lot | | Between Day | | Between Run | | Within-Run
(Repeatability) | | Within-
Laboratory
(Total) | | |
|---------|------------------|-------|-------------|-------|-------------|-------|-------------------------------|-------|----------------------------------|-------|------|
| Sample | Mean
(µIU/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Panel 5 | 77.333 | 3.071 | 4.0% | 1.044 | 1.3% | 0.712 | 0.9% | 1.181 | 1.5% | 3.525 | 4.6% |
Site to Site Reproducibility for Combined Data
The precision analyses for the combined site-to-site analysis for Lot A determined the total precision for Lumipulse G TSH-III to be ≤ 4.3% for the 3 panels in this study. The total precision of Lumipulse G TSH-III in the study ranged from 2.9% to 4.3%. The between-site precision for Lumipulse G TSH-III was ≤ 2.4%.
Data from this study are summarized below.
| | Between Site | | Between Day | | Between Run | | Within-Run
(Repeatability) | | Reproducibility
(Total) | | |
|---------|------------------|-------|-------------|-------|-------------|-------|-------------------------------|-------|----------------------------|-------|------|
| Sample | Mean
(µIU/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Panel 2 | 1.049 | 0.025 | 2.4% | 0.010 | 0.9% | 0.019 | 1.8% | 0.032 | 3.0% | 0.046 | 4.3% |
| Panel 4 | 9.015 | 0.095 | 1.1% | 0.087 | 1.0% | 0.112 | 1.2% | 0.200 | 2.2% | 0.263 | 2.9% |
| Panel 5 | 76.043 | 0.662 | 0.9% | 0.000 | 0.0% | 1.888 | 2.5% | 1.757 | 2.3% | 2.662 | 3.5% |
b. Linearity/assay reportable range:
Lumipulse GTSH-III on the LUMIPULSE G1200 System demonstrated linearity in a study consistent with the guidelines in the CLSI Protocol EP6-A. High and low sample pools were created using patient samples that contained naturally expressed TSH. The linearity was found in the range of 0.001 to 227.804 µIU/mL. Lumipulse G TSH-III correlated with expected concentrations according to the linear regression formulas:
Serum: y = 1.03(x) + 0.001; R-squared: 0.9962
High dose hook is a phenomenon whereby very high level specimens may read within the dynamic range of the assay. For Lumipulse G TSH-III on the LUMIPULSE G1200 System, no high dose hook effect was observed for samples containing up to ~5,000 µIU/mL of TSH.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):
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Image /page/5/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left, followed by the company name in blue text. The graphic appears to be a combination of water droplets and vertical lines in shades of blue and green. The text "Diagnostics, Inc." is smaller and positioned below "FUJIREBIO".
The calibrators for use with the Lumipulse GTSH-III are prepared gravimetrically and are traceable to in-house reference calibrators, whose values have been assigned to the 3rd International Standard, 2003 (code: 81/565) by the National Institute for Biological Standards and Control (NIBSC).
3 Bottles (1.5 mL each) are supplied for the Lumipulse G TSH-III Calibrators. Preservative: Sodium azide. The calibrators are at the following concentrations:
| Calibrator Level | TSH Concentration (µIU/mL) |
|---|---|
| CAL 1 | 0 |
| CAL 2 | 5 |
| CAL 3 | 200 |
Master calibration data are recorded in a two-dimensional bar code on the Immunoreaction Cartridge case. The calibration curve is created based on the recorded master calibration data and the calibration data. The TSH concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in µIU/mL.
Shelf life
The shelf life for Lumipulse G TSH-III Immunoreaction Cartridges and the Lumipulse G TSH-III Calibrators is 12 months at 2-10°C.
On board the LUMIPULSE G1200
The Lumipulse G TSH-III Immunoreaction Cartridges are stored at 12°C. To reduce risk for any misuse, the package insert states "The Lumipulse G TSH-III Immunoreaction Cartridges can be stored 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 GTSH-III Immunoreaction Cartridges and the Lumipulse GTSH-III 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)/ Functional Sensitivity (FS) of the Lumipulse G TSH-III on the LUMIPULSE G1200 is ≤ 0.006 ulU/mL.
-
- LoB and LoD
The LoB for Lumipulse G TSH-III on the LUMIPULSE G1200 System was 0.0010
- LoB and LoD
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Image /page/6/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. The logo features a stylized graphic element on the left, consisting of blue and green shapes. To the right of the graphic is the company name "FUJIREBIO" in a bold, blue sans-serif font, with "Diagnostics, Inc." in a smaller font size below it.
µIU/mL. The LoD for Lumipulse G TSH-III on the LUMIPULSE G1200 System was 0.002 µIU/mL, determined consistent with the CLSI guideline EP17-A2. Eight low level specimens were tested over 6 weeks using two LUMIPULSE G1200 Systems and two Lumipulse G TSH-III lots giving 480 determinations for each panel.
-
- LoQ/FS
FS is defined as the concentration of TSH that can be measured with an interassay CV of 20%. The LoQ/FS for the Lumipulse G TSH-III on the LUMIPULSE G1200 System was 0.006 µIU/mL. determined consistent with the NACB Guideline: Laboratory Support for the Diagnosis and Monitoring of Thyroid Disease. Based on this study, the Lumipulse G TSH-III on the LUMIPULSE G1200 System meets the definition of a third generation TSH assav.
- LoQ/FS
-
e. Analytical specificity:
Lumipulse G TSH-III on the LUMIPULSE G1200 System demonstrated an average interference of ≤10% (for each compound) in a study consistent with the quidelines in the CLSI Protocol EP7-A2. Human serum specimens with TSH concentrations of approximately 0.566, 2.530, and 67.515 ulU/mL were supplemented with potentially interfering compounds. The following compounds were tested using Lumipulse G TSH-III and found not to interfere with the assay.
| Endogenous Interferences | Test Concentration |
|---|---|
| Free Bilirubin (unconjugated) | 60 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Triglycerides (Intralipid 20% Emulsion) | 3,000 mg/dL |
| Hemoglobin | 500 mg/dL |
| Total Protein (Human Serum Albumin) | 12 g/dL |
| Immunoglobulin G (IgG) | 5 g/dL |
| Cholesterol | 500 mg/dL |
| Uric Acid | 24 mg/dL |
| Human Anti-Mouse Antibodies (HAMA) | 1,268 ng/mL |
| Rheumatoid Factor (RF) | 1,000 IU/mL |
| Therapeutic Drug Interferences | Test Concentration |
| Acetaminophen | 20 mg/dL |
| Acetylsalicylic Acid | 65 mg/dL |
| Amiodarone | 0.6 mg/dL |
| Atropine | 20 mg/dL |
| Ascorbic Acid | 6.5 mg/dL |
| Caffeine | 6 mg/dL |
| Carbamezapine | 1.2 mg/dL |
| Dexamethasone | 0.06 mg/dL |
| EDTA | 0.1 mg/dL |
7
| 1% |
|---|
| 6 mq/dL |
| 2 mg/dL |
| 3000 U/L |
| 50 mg/dL |
| 0.03 mg/dL |
| 0.23 mg/dL |
| 4 mg/dL |
Lumipulse GTSH-III on the LUMIPULSE G1200 System was evaluated for cross-reactivity of the assay with other substances that are similar in structure to TSH in a study consistent with the guidelines in the CLSI Protocol EP7-A2. Human serum specimens with TSH concentrations of approximately 0.566, 2.530, and 67.515 µIU/mL were supplemented with potentially cross-reacting compounds. The following compounds were tested at the concentrations listed below and the level of TSH in the samples was then determined.
| Interferent # | Interferent | Sample ID | Mean
Concentration
with Cross-
reactant
(µIU/mL) (n=3) | Mean
Concentration
without
Cross-
reactant
(µIU/mL) (n=3) |
|---------------|-------------------------|-------------|--------------------------------------------------------------------|--------------------------------------------------------------------------|
| 1 | FSH
(5000 mIU/mL) | Serum Pool1 | 0.564 | 0.555 |
| | | Serum Pool2 | 2.419 | 2.355 |
| | | Serum Pool3 | 68.301 | 69.236 |
| 2 | hCG
(200,000 mIU/mL) | Serum Pool1 | 1.218 | 0.538 |
| | | Serum Pool2 | 2.564 | 2.282 |
| | | Serum Pool3 | 67.427 | 67.387 |
| 3 | hGH
(100 ng/mL) | Serum Pool1 | 0.693 | 0.666 |
| | | Serum Pool2 | 2.466 | 2.572 |
| | | Serum Pool3 | 66.279 | 67.052 |
| 4 | LH
(1000 mIU/mL) | Serum Pool1 | 0.581 | 0.569 |
| | | Serum Pool2 | 2.337 | 2.491 |
| | | Serum Pool3 | 67.548 | 70.063 |
2. Comparison studies:
a. Method Comparison
The Lumipulse G TSH-III method comparison as performed on the LUMIPULSE G1200 system in a study consistent with the guidelines in CLSI EP9-A3.
The weighted Deming regression method was used to compare Lumipulse G TSH-III to
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Image /page/8/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left, featuring blue and white shapes, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font, while "Diagnostics, Inc." is in a smaller font below it.
Abbott ARCHITECT TSH. The serum samples tested ranged from 0.026 to 84.299 µIU/mL for Lumipulse G TSH-III and 0.030 to 89.930 µIU/mL for ARCHITECT TSH. The data are summarized in the following table.
| Lumipulse G TSH-III vs. Abbott ARCHITECT TSH | ||||
|---|---|---|---|---|
| n | Correlation | |||
| Coefficient | ||||
| (r) | Intercept | |||
| (95% CI) | Slope | |||
| (95% CI) | Average | |||
| Bias | ||||
| (µIU/mL) | ||||
| 141 | 0.9838 | -0.0037 | ||
| -0.0064 to | ||||
| -0.0010 | 0.97 | |||
| 0.93 to | ||||
| 1.01 | -1.051 |
3. Expected values/Reference range:
0.389-3.764 µIU/mL
These values correspond to the 2.5" and 97.5" percentiles of results obtained from a total of 116 healthy test subjects examined. 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.
Standard/Guidance Document Referenced:
- CLSI EP5-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved ● Guideline - Third Edition
- . CLSI EP28-A3c - Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition
- CLSI EP17-A2 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline Second Edition
- CLSI EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A ● Statistical Approach; Approved Guideline
- . CLSI EP9-A3 – Measurement Procedure Comparison and Bias Estimation Using Patient Samples; approved Guideline - Third Edition
- CLSI EP7-A2 - Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition
- CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents: Approved Guideline ●
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
- Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions (December 3, 2015)
- Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (August 4, 2015)
Conclusion
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The results of these analytical) and clinical studies demonstrate that the Lumipulse G TSH-III assay is substantially equivalent to the performance of the Abbott ARCHITECT TSH assay.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2017
FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN MANAGER, REGULATORY AFFAIRS 201 GREAT VALLEY PARKWAY MALVERN PA 19355
Re: K171103
Trade/Device Name: Lumipulse G TSH-III Immunoreaction Cartridges Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW Dated: July 10, 2017 Received: July 11, 2017
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
12
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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