The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders.

The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.

Device Description

The MAGLUMI 2000 system is a floor model, fully automated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software.

MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(<0.1%) and ProClin® 300; Calibrator Low-TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Calibrator High- TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Buffer- tris buffer, HAMA Blocker, BSA, NaN3(<0.1%) and ProClin® 300; ABEI Label- labeled with anti-TSH monoclonal antibody (mouse), tris buffer, containing BSA, NaN3(<0.1%) and ProClin® 300; Control 1- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 2- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 3- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300.

AI/ML Overview

The provided text describes the performance characteristics of the MAGLUMI 2000 TSH assay and MAGLUMI 2000 Immunoassay Analyzer. Below is an attempt to extract and organize the information as requested, though some categories may not be fully addressed due to the nature of the document (a 510(k) summary for a diagnostic test, not an AI-powered device).

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a table format alongside device performance for all aspects. However, performance characteristics are presented, from which implied acceptance ranges can be inferred (e.g., for precision, interference, and linearity). The comparison study shows the performance relative to a predicate device.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	CV% within acceptable limits for diagnostic assays.	Within-Run CV: 1.38% - 4.73%Between-Run CV: 0% - 4.38%Between-Day CV: 0% - 2.90%Total CV: 2.447% - 5.95% (Across various control, calibrator, and serum pools)
Linearity	Good correlation (R²) and close agreement between observed/expected values across the measuring range.	Measuring Range: 0.02 - 91.78 µIU/mLRelationship: Observed = 1.0001 (Expected) + 0.0474, R² = 0.9990
Detection Limit	Quantifiable detection limits.	LOB: 0.001 µIU/mLLOD: 0.006 µIU/mLLOQ: 0.01 µIU/mL
Hook Effect	No hook effect observed within the specified range.	No hook effect observed up to 3000 µIU/mL.
Interference	No significant deviation from expected results with common interfering substances.	No interference observed for: - Conjugate Bilirubin (60 mg/dL)- Hemoglobin (2000 mg/dL)- Triglycerides (1000 mg/dL)- Acetaminophen (20 mg/dL)- Ibuprofen (50 mg/dL)- Aspirin (50 mg/dL)- Biotin (10 ng/mL)- Unconjugate bilirubin (40 mg/dL)- Rheumatoid factor (124 IU/mL)- Human anti-mouse antibodies (HAMA) (300 ng/mL)- Total protein (12.5 mg/mL)
Specificity (Cross-reactivity)	Low cross-reactivity with structurally related hormones.	Less than 2% cross-reactivity with hCG (200 IU/mL), FSH (1500 mIU/mL), and LH (600 mIU/mL).
Method Comparison	Good correlation with predicate device.	Correlation with ADVIA CENTAUR TSH assay: Y = 1.0178X - 0.0773, R² = 0.9974 (for TSH values 0.02 - 91.78 uIU/mL)
Expected Values/Reference Range	Establishment of a normal range for the intended population.	Normal Range: 0.658 – 4.864 µIU/mL (based on 126 healthy adult samples, central 95% frequency distribution).
Stability (Reagents)	Stable for specified duration under given conditions.	Accelerated Stability (Controls, Calibrators): 12 months at 2-8°C.Shelf Life Stability (Reagent Kit): 12 months at 2-8°C.Open Kit Stability: 4 weeks at 2-8°C.
Traceability	Traceable to an international standard.	Traceable to the WHO international standard for human TSH (IRP 81/565) for controls and calibrators.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Precision Study:
- Sample Size: 4 controls, 2 calibrators, 6 spiked patient serum pools, and 4 native patient sample pools. Each level analyzed 80 times (20 days x 2 runs/day x duplicate) per instrument. (Total N = 240 samples per level across 3 instruments for calculated statistics in the table).
- Data Provenance: Not specified (e.g., country of origin). The study design (e.g., "collected over 20 days") suggests prospective testing during the assay development/validation phase.
Linearity Study:
- Sample Size: 2 primary samples to create a series of intermediate serum dilutions (number of intermediate dilutions not explicitly stated, but 11 data points shown in the table).
- Data Provenance: Not specified.
Detection Limit Study:
- Sample Size: Not explicitly stated, derived from CLSI EP17-A guidelines.
- Data Provenance: Not specified.
Interference Study:
- Sample Size: Human serum samples with low and high TSH concentrations were used for each interfering substance (e.g., "0.97 and 5.4" or "0.7 and 6.1" µIU/mL). The number of individual samples is not described, but it involved at least two TSH concentrations for each interferent.
- Data Provenance: Not specified.
Specificity Study:
- Sample Size: Human serum samples with various TSH concentrations (number not specified) spiked with potential cross-reactants.
- Data Provenance: Not specified.
Comparison Studies:
- Sample Size: 337 patient serum samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Expected Values/Reference Range:
- Sample Size: 126 serum samples.
- Data Provenance: From "normal, apparently healthy adult (22 years and older) individuals." Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is a diagnostic assay for a biomarker (TSH), not an image-based AI device requiring expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for the test sets (e.g., precision, linearity, interference) is based on the known concentrations of controls, calibrators, spiked samples, or comparison to a predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As a diagnostic assay, "adjudication" in the sense of reconciling divergent expert opinions on an output is not relevant. The performance studies evaluate the assay's analytical characteristics against established scientific protocols and reference methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a diagnostic immunoassay system, not an AI-assisted diagnostic tool requiring human readability.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is an automated immunoassay system (MAGLUMI 2000 Immunoassay Analyzer) performing the quantitative determination of TSH using a specific assay (MAGLUMI 2000 TSH assay). Its performance is inherently "standalone" in that it produces a quantitative result from a sample without human interpretive intervention post-assay. The results are then interpreted by clinicians.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the analytical performance studies (precision, linearity, detection limits, interference, specificity) is primarily based on:

Known concentrations: For controls, calibrators, and spiked samples.
Comparison to a legally marketed predicate device: For method comparison (ADVIA CENTAUR TSH assay).
International standards: Traceability to WHO international standard for human TSH (IRP 81/565).
Established scientific protocols: CLSI guidelines.

8. The sample size for the training set

This document describes the validation of a diagnostic immunoassay system, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The performance studies detailed are for validation.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 14, 2017

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD c/o JOE SHIA, DIRECTOR LSI INTERNATIONAL INC. 504E DIAMOND AVE., SUITE F GAITHERSBURG MD 20877

Re: K162698

Trade/Device Name: MAGLUMI 2000 TSH. MAGLUMI 2000 Immunoassay Analyzer Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW. JJE Dated: May 29, 2017 Received: June 5, 2017

Dear Joe Shia:

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,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162698

Device Name MAGLUMI 2000 TSH

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K162698

Device Name MAGLUMI 2000 Immunoassay Analyzer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K162698

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

1. Date:	July 12, 2017
2. Submitter:	Shenzhen New Industries Biomedical Engineering Co., Ltd.No.16, Jinhui Road, Pingshan New District, ShenzhenChina 518122
3. Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite FGaithersburg, MD 20878Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com

1. Device Name: MAGLUMI 2000 TSH MAGLUMI 2000 Immunoassay System Classification: Class II (assay); Class I (instrument)

Product Code	CFR #	ProductAbbreviation	Product Name
JLW	862.1690	TSH	Thyroid Stimulating Hormone
JJE	862.2160		Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

1. Predicate Devices: K083844, Siemens ADVIA Centaur TSH3 K151792, Siemens Trinidad Immunoassay (IM) System
1. Intended Use:

1. Device Description:

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MAGLUMI 2000 System:

MAGLUMI 2000 TSH assay:

MAGLUMI 2000 TSH kit consists of the following reagents:

Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(<0.1%) and ProClin® 300

Calibrator Low-TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300

Calibrator High- TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300

Buffer- tris buffer, HAMA Blocker, BSA, NaN3(<0.1%) and ProClin® 300

ABEI Label- labeled with anti-TSH monoclonal antibody (mouse), tris buffer, containing BSA, NaN3(<0.1%) and ProClin® 300

Control 1- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300

Control 2- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300

Control 3- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300.

Standard/Guidance Documents 8.
Clinical and Laboratory Standards Institute EP5-A2 – Evaluation of Precision Performance of Clinical Chemistry Devices-Approved Guideline-Second Edition.

Clinical and Laboratory Standards Institute EP6-A - Evaluation of the Linearity of Quantitative Analytical

Clinical and Laboratory Standards Institute EP17-A2: Evaluation of detection Capability for Clinical Laboratory Measurement Procedures

Clinical and Laboratory Standards Institute EP7-A2 - Interference Testing in Clinical Chemistry Clinical and Laboratory Standards Institute EP9-A2 – Method Comparison and Bias Estimation Using Patient Samples

1. Substantial Equivalence Information

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Item	Predicate Device	Subject Device
Intended Use/Indication for Use	Automated, immunoassay analyzer designed toperform in vitro diagnostic tests on clinicalspecimens	Same
Principles of AssayOperation	Chemiluminescence using magnetic-particle solidphase and chemiluminescent label	Same
Type of System	Random Access and Batch	Random Access,Batch,STAT
Throughput Rate	120 to 240 tests/hr	Up to 180 tests/hr
Optical System	PMT used in photon counting mode	Same
Test Processing	Sample scheduling optimized for throughput;continuous operation	Same
Sample Container	Sample cups or primary tubes may be used	Same
Dispense System	Automated pipetting of samples using precisionsyringe	Same
Sample Type	Serum, plasma, urine, whole blood hemolysate,amniotic	Serum only
Sample Volume	10 to 200 μl	5 to 200 μl
Calibration	2 point user run calibration	Same
Controls	Capability to dilute controls	Same
Item	Predicate Device	Subject Device
Intended Use/Indication for Use	For in vitro diagnostic use in the quantitativedetermination of thyroid-stimulating hormone (TSH,thyrotropin) in serum and plasma using the ADVIACentaur XP system.A thyroid stimulating hormone test system is adevice intended to measure thyroid stimulatinghormone, also known as thyrotrophin andthyrotrophic hormone, in serum and plasma.Measurements of thyroid stimulating hormoneproduced by the anterior pituitary are used in thediagnosis of thyroid or pituitary disorders.	For in vitro chemiluminescentimmunoassay in the quantitativedetermination of thyroid-stimulating hormone (TSH) inhuman serum using theMAGLUMI 2000 fully- autochemiluminescenceimmunoassay system. Themeasurement of TSH is used inthe diagnosis of thyroiddisorders. The Maglumi 2000system is intended forprescription use.
Specimen	Serum , heparinized plasma, EDTA plasma	serum
Measured Analyte	Thyroid-stimulating hormone	same
Measurement	Quantitative	same
Test principle	Sandwich chemiluminescent immunoassay	same
Detection Antibody	Monoclonal murine anti-TSH antibody BSAconjugate labeled with acridinium ester (AE)	anti-TSH monoclonalantibody labeled with ABEI
Capture Antibody	Anti-fluorescein labeled (FITC) monoclonal murineanti-TSH antibody covalently bound toparamagnetic particles (PMP)	anti-TSH monoclonalantibody bound to magneticmicrobeads
Measuring range	0.008 $ μ $ IU/ml – 150 $ μ $ IU/ml	0.02 $ μ $ IU/ml-91.78 $ μ $ IU/ml(0.02mIU/L-91.78mIU/L)
Sample size	100 $ μ $ L	same
Calibration	2 Point	same
Calibrator	Lyophilized TSH-Ultra low and high Calibrators, 2levels	Low and high Calibrators, 2levels, ready for use
Calibratorspackaging	Provided with reagent kit	same
Automated	Yes	same

Instrument Similarities and Differences

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Assay Similarities and Differences

Test Principle

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The MAGLUMI TSH assay is a sandwich chemiluminescence immunoassay. The sample (or calibrator/control, if applicable), magnetic particles coated with anti-TSH monoclonal antibody, buffer and ABEI labeled with another monoclonal antibody are mixed thoroughly and incubated at 37°C, forming sandwich of immuno-complexes. After precipitation in a magnetic field, the supernatant is decanted and then a wash cycle is performed. Subsequently, the starters are added to initiate a chemiluminescent reaction. The light signal is measured by a photomultiplier within 3 seconds as relative light units (RLUs), which is indicative of TSH concentration present in samples, calibrators or controls.

11. Performance Characteristics

1. Analytical Performance
- a. Precision

The precision was determined using the CLSI EP5-A2 protocol as a guide. The study was conducted on three different instruments with four controls, two calibrators, six spiked patient serum pools and four native patient sample pools. The data was collected over 20 days in duplicate with 2 runs per day with a total of 80 samples analyzed per level on each instrument. The results obtained are summarized in the following tables:

Sample	Mean	Within-Run		Between-Run		Between-Day		Total
	(N=240)	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Control 1	0.221	0.010	4.73%	0.005	2.40%	0.0059	2.696%	0.013	5.95%
Control 2	0.620	0.027	1.38%	0.013	2.04%	0.011	1.718%	0.032	5.12%
Control 3	6.546	0.277	4.23%	0.233	3.57%	0.066	1.008%	0.368	5.62%
Control 4	17.961	0.711	3.96%	0.354	1.97%	0.2836	1.579%	0.843	4.70%
Calibrator low	0.330	0.015	4.50%	0.014	4.38%	0	0%	0.019	5.86%
Calibrator high	38.037	1.372	3.61%	0.363	0.96%	0.411	1.080%	1.478	3.89%
Serum Pool 1	1.257	0.05	3.95%	0.035	2.82%	0.029	2.296%	0.067	5.37%
Serum Pool 2	6.401	0.102	1.60%	0.164	2.56%	0	0%	0.157	2.447%
Serum Pool 3	11.880	0.472	3.97%	0.42	3.56%	0.177	1.490%	0.66	5.54%
Serum Pool 4	38.67	1.221	3.24%	0.788	2.09%	0.489	1.30%	1.533	4.07%
Serum Pool 5	64.309	2.371	3.69%	2.022	3.14%	0	0%	3.109	4.83%
Native patient sample pool 1	0.577	0.025	4.33%	0.012	2.08%	0.01	1.73%	0.029	5.02%
Native patient sample pool 2	1.137	0.048	4.222%	0.032	2.81%	0.033	2.90%	0.067	5.89%
Native patient sample pool 3	5.026	0.201	3.992%	0.098	1.95%	0.105	2.079%	0.247	4.907%
Native patient sample pool 4	9.750	0.429	4.401%	0.139	1.42%	0.094	0.960%	0.460	4.723%

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b. Linearity

The linearity of the MAGLUMI TSH method was determined following the CLSI EP6-A procedure. Two samples were identified having TSH concentrations covering the reportable range. A series of intermediate serum samples were prepared by diluting the high level sample (105 uIU/mL) with the low level sample (0 uIU/mL). The obtained results are shown in the following tables.

Sample	Observed ( $\mu$ IU/mL)	Expected ( $\mu$ IU/mL)
L	0	0
0.99524L	0.4896	0.5
0.9524L	4.983	5
0.9L	10.691	10.5
0.8L	21.652	21
0.7L	30.785	31.5
0.6L	42.555	42
0.5L	52.278	52.5
0.4L	62.105	63
0.3L	75.052	73.5
0.2L	83.218	84
0.1L	94.807	94.5
H	-	105

The assay are linear between 0.02 and 91.78μIU/mL with the following relationship: Observed = 1.0001 (Expected) + 0.0474, R2 = 0.9990

c. Stability and Traceability
The standardization of the MAGLUMI TSH method is traceable to the WHO international standard for human TSH (IRP 81/565).

All TSH controls are traceable to the WHO international standard for human TSH (IRP 81/565). All TSH calibrators are traceable to the WHO international standard for human TSH (IRP 81/565). Accelerated stability study at 37℃ showed that all controls are stable for 12 months at 2-8°C. Accelerated stability study at 37°C showed all that calibrators are stable for 12 months at 2-8°C. Shelf life stability experiments showed that the reagent is stable for 12 months at 2-8ºC.

Open kit is stable for four weeks at 2-8°C.

d. Detection Limit
Detection limit studies were performed following CLSI EP17-A guidelines. The following values for the test have been verified.

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LOB	0.001 µIU/ml
LOD	0.006 µIU/ml
LOQ	0.01 µIU/ml

Hook effect: The test was not found susceptible to hook effect as it would display signal increases with increasing TSH concentration. No hook effect was observed at TSH concentrations up to 3000 µIU/mL

e. Interference

Clinical serum samples may contain substances that could potentially interfere with the test. The following compounds were added to human serum samples with a low TSH concentration and a high TSH concentration. None of the serum samples showed any deviation from the expected results. No interference was observed for these compounds at the levels indicated below.

Interference	Human Serum TSHConcentrations (µIU/mL)	InterferenceSubstance
Conjugate Bilirubin	0.97 and 5.4	60 mg/dL
Hemoglobin	0.97 and 5.4	2000 mg/dL
Triglycerides	0.97 and 5.4	1000 mg/dL
Acetaminophen	0.7 and 6.1	20 mg/dl
Ibuprofen	0.7 and 6.1	50 mg/dl
Aspirin	0.7 and 6.1	50 mg/dl
Biotin	0.7 and 6.1	10 ng/ml
Unconjugate bilirubin	0.7 and 6.1	40 mg/dl
Rheumatoid factor	0.7 and 6.1	124 IU/ml
human anti-mouse antibodies(HAMA)	0.13 and 4.71	300ng/mL
Total protein	0.7 and 6.1	12.5 mg/ml

Specificity f.

Human serum samples with various TSH concentrations were spiked with potential cross reactants FSH, LH, and hCG dissolved in PBS with 1% BSA and tested in MAGLUMI TSH system. Controls were prepared by spiking samples with equal volumes of the PBS-BSA solution used in dissolving the FSH, LH, and hCG. The concentrations of spiked and control samples were recorded, and the cross reactivity were calculated. Less than 2% cross-reactivity was found for hCG, FSH, and LH at 200 IU/ml, 1500 mIU/mL and 600 mIU/mL respectively.

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1. Comparison Studies
  Patient serum samples (n=337) with TSH values ranging from 0.02 - 91.78 uIU/mL were collected and evaluated. Linear regression was used to correlate the MAGLUMI TSH assay to the ADVIACENTAUR TSH assay.The results yielded the following linear regression equation:

Y = 1.0178X - 0.0773, R2 =0.9974

1. Expected values/Reference range:
  A total of 126 serum samples from normal, apparently healthy adult (22 years and older) individuals were tested according to the procedure in CLSI C28-A3. The expected normal range is 0.658 – 4.864 uIU/mL based on the central 95% of the frequency distribution.
1. Conclusion
  Based on the test principle and acceptable performance characteristics including precision, interference, specificity and method comparison of the device, it is concluded that the MAGLUMI 2000 TSH is substantially equivalent to the predicate.

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.