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 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.

AI/ML Overview

The Lumipulse® G TSH-III Immunoreaction Cartridges is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum on the LUMIPULSE G System. It is intended for in vitro diagnostic use, as an aid in the diagnosis of thyroid or pituitary disorders.

The study presented focuses on demonstrating the analytical performance and method comparison of the Lumipulse G TSH-III assay against the predicate device, Abbott ARCHITECT TSH assay, to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit from study results and CLSI guidelines)	Reported Device Performance (Lumipulse G TSH-III)
Precision/Reproducibility
Within-Laboratory (Total) Precision (20-Day)	≤ 6.4% CV (as demonstrated by predicate and industry standards)	≤ 6.4% CV (range 1.9% - 6.4% across 5 panels)
Lot-to-Lot Reproducibility (Total Precision)	≤ 4.6% CV (as demonstrated)	≤ 4.6% CV (range 3.1% - 4.6% across 3 panels)
Between-Lot Precision	≤ 4.0% CV (as demonstrated)	≤ 4.0% CV
Site-to-Site Reproducibility (Total Precision)	≤ 4.3% CV (as demonstrated)	≤ 4.3% CV (range 2.9% - 4.3% across 3 panels)
Between-Site Precision	≤ 2.4% CV (as demonstrated)	≤ 2.4% CV
Linearity/Assay Reportable Range	Linear correlation (R-squared close to 1) over a wide range; no high dose hook effect	Linear in the range of 0.001 to 227.804 µIU/mL (y = 1.03x + 0.001; R-squared: 0.9962); No high dose hook effect observed up to ~5,000 µIU/mL
Detection Limits
Limit of Blank (LoB)	Low as possible for diagnostic utility (consistent with CLSI EP17-A2)	0.0010 µIU/mL
Limit of Detection (LoD)	Low as possible for diagnostic utility (consistent with CLSI EP17-A2)	0.002 µIU/mL
Limit of Quantitation (LoQ)/Functional Sensitivity (FS)	≤ 0.02 µIU/mL for third-generation TSH assays (NACB Guideline)	≤ 0.006 µIU/mL
Analytical Specificity (Interference)	Average interference ≤ 10% for each compound	≤ 10% interference for tested endogenous and therapeutic drug compounds
Method Comparison (vs. Abbott ARCHITECT TSH)	High correlation coefficient (r) and acceptable slope/intercept relative to predicate	n=141; r = 0.9838; Intercept = -0.0037 (95% CI: -0.0064 to -0.0010); Slope = 0.97 (95% CI: 0.93 to 1.01); Average Bias = -1.051 µIU/mL

2. Sample Size for the Test Set and Data Provenance

Precision/Reproducibility (20-Day): 5 human serum-based panels, assayed in replicates of two at two separate times of the day for 20 days (n=80 for each sample). The origin of these human serum-based panels is not explicitly stated regarding country or retrospective/prospective nature, but they are described as "human serum-based panels."
Lot-to-Lot Reproducibility: 3 panels, specific sample size (replicates/days) not explicitly stated but part of a larger precision analysis.
Site-to-Site Reproducibility: 3 panels (Lot A), specific sample size (replicates/days) not explicitly stated but part of a larger precision analysis.
Linearity/Assay Reportable Range: High and low sample pools, number of samples not explicitly stated beyond "patient samples."
Detection Limit (LoB & LoD): 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.
Analytical Specificity: Human serum specimens with TSH concentrations of approximately 0.566, 2.530, and 67.515 ulU/mL, supplemented with potentially interfering compounds.
Cross-reactivity: Human serum specimens with TSH concentrations of approximately 0.566, 2.530, and 67.515 µIU/mL, supplemented with potentially cross-reacting compounds (n=3 for each test concentration).
Method Comparison: 141 serum samples, ranging from 0.026 to 84.299 µIU/mL (Lumipulse G TSH-III) and 0.030 to 89.930 µIU/mL (ARCHITECT TSH). The provenance (e.g., country of origin, retrospective/prospective) of these samples is not specified beyond being "patient samples."
Expected values/Reference range: 116 healthy test subjects. Provenance is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of immunoassay performance study typically does not involve human expert adjudication for ground truth of individual measurements in the same way imaging or diagnostic accuracy studies might. The "ground truth" for the performance characteristics (precision, linearity, detection limits, specificity) is based on the inherent analytical properties of the reference materials, calibrated instruments, and statistical methodologies (e.g., CLSI protocols). For the method comparison, the predicate device (Abbott ARCHITECT TSH) serves as the comparator, and its established performance is implicitly relied upon.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The "ground truth" for analytical performance is derived from well-defined reference materials, established concentrations, and statistical analyses following recognized CLSI protocols. For method comparison, the reference measurements from the predicate device serve as the comparison point.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not an imaging or diagnostic aid that involves human readers interpreting cases with or without AI assistance. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. All performance characteristics (precision, linearity, detection limits, analytical specificity, and method comparison) evaluate the Lumipulse G TSH-III assay's performance as a standalone algorithm/device. The results reported are direct measurements from the LUMIPULSE G System.

7. Type of Ground Truth Used

Precision/Reproducibility: Based on repeated measurements of samples with established concentrations, and statistical analysis of variability.
Linearity/Assay Reportable Range: Established using prepared high and low sample pools with known TSH concentrations and assessed by linear regression analysis.
Detection Limits (LoB, LoD, LoQ/FS): Determined statistically from measurements of very low concentration samples according to CLSI guidelines.
Analytical Specificity/Cross-reactivity: Determined by measuring samples spiked with known concentrations of interfering or cross-reacting substances.
Method Comparison: Compared against the measurements obtained from a legally marketed predicate device (Abbott ARCHITECT TSH), which itself has established performance characteristics.
Traceability of Calibrators: Traceable to the 3rd International Standard, 2003 (code: 81/565) by the National Institute for Biological Standards and Control (NIBSC).

8. Sample Size for the Training Set

The document describes performance studies, which are typically validation studies. It does not explicitly mention a "training set" in the context of an AI/machine learning model. For a traditional immunoassay, the "training" aspect is more akin to the assay development and optimization process, not a distinct dataset used for machine learning. The calibrators and controls are used for instrument calibration and assay quality control, not as a training set for an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the context of an AI training set. For an immunoassay, the "ground truth" for calibrators and controls is established through gravimetric preparation and traceability to international standards (e.g., NIBSC 3rd International Standard for TSH).

Summary

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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 G TSH-III:

Lumipulse G TSH-III Immunoreaction Cartridges |REF 235294

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The Lumipulse G TSH-III 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 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.
1. 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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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 § 862.1690Thyroid stimulating hormonetest system	same
Product Usage	Clinical and Hospitallaboratories	same
Principle of Operation	Automated QuantitativeChemiluminscent EnzymeImmunoassay (CLEIA)	ChemiluminescentMicroparticle Immunoassay(CMIA)
Specimen CollectionMethod	Routine PhlebotomyTechniques	same
Intended Use	For in vitro diagnostic use.Lumipulse G TSH-III is aChemiluminescent EnzymeImmunoassay (CLEIA) for thequantitative determination ofthyroid stimulation hormone(TSH) in human serum on theLUMIPULSE G System.Lumipulse G TSH-III is to beused as an aid in thediagnosis of thyroid orpituitary disorders.	The ARCHITECT TSH assayis a ChemiluminescentMicroparticle Immunoassay(CMIA) for the quantitativedetermination of humanThyroid Stimulating Hormone(TSH) in human serum andplasma.
Instrument System	LUMIPULSE G System	ARCHITECT
Assay Type	Two-step sandwichimmunoassay based onchemiluminescenttechnology	same
Sample Volume	60 μL	200 μL
Type of Specimen	Human serum	Human serum or plasma(lithium heparin, sodiumheparin or potassium EDTA)
Assay Range	0.02 – 100 µIU/mL	0.000 - 100.00 µIU/mL

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Performance Characteristics

Data were generated using the LUMIPULSE G1200 System.

1. 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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	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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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.

1. LoB and LoD
  The LoB for Lumipulse G TSH-III on the LUMIPULSE G1200 System was 0.0010

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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.

1. 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.
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

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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	MeanConcentrationwith Cross-reactant(µIU/mL) (n=3)	MeanConcentrationwithoutCross-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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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	CorrelationCoefficient(r)	Intercept(95% CI)	Slope(95% CI)	AverageBias(µIU/mL)
141	0.9838	-0.0037-0.0064 to-0.0010	0.970.93 to1.01	-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.

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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

Regulation Number and Section

§ 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.