Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard immunofluorometric assay system and analyzer. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance studies.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) test system designed for the quantitative measurement of thyroid stimulating hormone (TSH) levels, intended to aid in the diagnosis of thyroid or pituitary disorders and monitor TSH levels. It does not provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the AFIAS TSH-SP and AFIAS-6/SP Analyzer, as well as AFIAS TSH-VB and AFIAS-6/VB Analyzer, are "intended for in vitro diagnostic use" and "intended for use as an aid in the diagnosis of thyroid or pituitary disorders."

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including test cartridges, ID chips, and a fluorescence-scanning analyzer, indicating it is a hardware-based system with associated software, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The Intended Use/Indications for Use section explicitly states:

"AFIAS TSH-SP... is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites..."
"AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites..."
"AFIAS TSH-VB... is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites..."
"AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites..."

These statements clearly indicate that the device is intended for use in examining specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in serum, sodium-heparinized plasma samples. The test system is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.

AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in serum or plasma samples.

AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid individuals.

AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in venous whole blood samples.

Product codes (comma separated list FDA assigned to the subject device)

JLW, KHO

Device Description

AFIAS TSH-SP as well as AFIAS TSH-VB Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'lyophilized detection buffer', the 'diluent i.e. reconstitution buffer' as well as the 'test strip'; all of which are integral components of the test.
The test cartridge is an elongated structure having 140 mm length. 17 mm width and 17 mm height.

'AFIAS TSH-SP ID Chip' as well as 'AFIAS TSH-VB ID Chip' is a flat, rectangular device with its main body measuring 24 mm × 20 mm × 3 mm. Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the apical side of the main body.
The ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ID Chip' is an integral component of the test.
Before initiating the test run for testing a clinical sample or a calibrator/control using AFIAS TSH-SP or AFIAS TSH-VB test cartridge belonging to a new lot, the operator needs to mandatorily insert the lot-specific AFIAS TSH-SP or AFIAS TSH-VB ID Chip into one of the 'ID Chip Ports' of the AFIAS-6/SP or AFIAS-6/VB analyzer respectively.

AFIAS-6/SP as well as AFIAS-6/VB analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 42 cm (L) x 33.6 cm (W) x 29.3 cm (H). AFIAS-6 weighs 15.1 kg.
Either analyzer is a flourometer instrument of closed-system analyzer type. The operator does not have access to those configuration parameters that could affect the assay process, test analysis or result calculation or any other parameter that could affect test result outcome. These and other operational parameters can only be configured by the 'System Administrator' through software and/or firmware upgrade and modification of operational settings in consultation with the manufacturer or an authorized service provider.
With a simple computerized touchscreen user interface, the analyzer enables the operator to initiate the test run which is completed automatically and terminates with display of test result or an error message alert (in case of any procedural error and/or system malfunction).

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

Adult reference interval of AFIAS TSH-SP test was evaluated by testing serum samples collected from total 128 apparently healthy adults (65 males and 63 females) in the age group of 21-70 years.
Adult reference interval of AFIAS TSH-VB test was evaluated by testing sodium heparin venous whole blood samples collected from total 133 apparently healthy adults (69 males and 64 females) in the age group of 21-70 years.

Intended User / Care Setting

clinical laboratories and Point-of-Care (POC) sites

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) Limit of Blank:

Limit of Blank (LoB) of AFIAS TSH-SP and AFIAS TSH-VB tests have been evaluated as per CLSI EP 17-A2.
5 replicates each of 5 blank/TSH-depleted human serum as well as 5 blank/TSH-depleted whole blood samples were tested with 3 lots of test cartridges on 3 respective analyzers for 3 days; thus testing 75 replicates per lot/analyzer.
Limit of Blank (LoB) was calculated by non-parametric analysis of the data. -
Limit of Blank of AFIAS TSH-SP test is 0.03 µIU/ml and that of AFIAS TSH-VB test is 0.13 µIU/ml.

2) Limit of Detection:

Limit of Detection (LoD) of AFIAS TSH-SP and AFIAS TSH-VB tests have been evaluated as per CLSI EP 17-A2.
5 replicates each of 5 low TSH-spiked human serum as well as 5 low TSH-spiked whole blood samples were tested with 3 lots of test cartridges on 3 respective analyzers for 3 days; thus testing 75 replicates per lot/analyzer.
Limit of Detection (LoD) was calculated by parametric analysis of the data.
Limit of Detection of AFIAS TSH-SP test is 0.05 µIU/ml and that of AFIAS TSH--VB test is 0.2 µIU/ml.

3) Limit of Quantitation:

Limit of Quantitation (LoO) of AFIAS TSH-SP and AFIAS TSH-VB tests have been evaluated as per CLSI EP 17-A2.
For evaluating the LoQ of AFIAS TSH-SP test, 2 replicates of each of the 5 low TSH-spiked serum samples were tested daily in two different runs with two test cartridge lot/analyzer/operator combinations for 21 successive days.
For evaluating the LoQ of AFIAS TSH-VB test. 5 replicates of each of the 4 low TSH-spiked venous whole blood samples were tested daily in two different runs with two test cartridge lot/analyzer/operator combinations for 5 successive days.
Limit of Quantitation (LoQ) was calculated by considering accuracy goal of interassay CV ≤ 20%.
Limit of Quantitation of AFIAS TSH-SP test is 0.07 µIU/ml and that of AFIAS TSH--VB test is 0.3 µIU/ml.

4) Linearity and Reportable Range:

For evaluating linearity and measuring/reportable range of AFIAS TSH-SP test, a series of 22 test samples prepared by mixing a high TSH-spiked serum sample (TSH~100 µIU/mL) and a TSH-depleted serum sample (TSH ~ 0 µIU/mL) in various proportions, was tested in triplicate with the one lot of AFIAS TSH-SP test cartridges on one AFIAS-6/SP analyzer on the same day.
Similarly, for evaluating linearity and measuring/reportable range of AFIAS TSH-VB test, a series of 22 test samples prepared by mixing a high TSH-spiked venous whole blood sample (TSH~100 µIU/mL) and a TSH-depleted venous whole blood sample (TSH ~ 0 uIU/mL) in various proportions, was tested in triplicate with the one lot of AFIAS TSH-VB test cartridges on one AFIAS-6/VB analyzer on the same day.
Mean of the triplicate test results of each sample was plotted against its expected TSH concentration calculated mathematically.
The following linear regression equations were obtained: -
Serum: y = 1.0081x - 0.0785, R2=0.9993
Na-heparinized whole blood: y = 0.9824x + 0.216, R2=0.9997
Both tests showed linearity over the entire TSH concentration range (0~100 µIU/ml) tested for the study.
Measuring/reportable range of AFIAS TSH-SP test system has been programed as -0.07-80 uIU/ml while that of AFIAS TSH-VB test system has been programed as 0.3 -80.0 µIU/ml.

5) Susceptibility to High-dose Hook Effect:

For evaluating susceptibility to high dose hook (prozone) effect, a series of spiked samples having TSH concentrations 25, 50, 75, 100, 150, 200, 500, 1000, 1500, 2000, 2500 and 3000 uIU/ml was tested in triplicate with one lot of test cartridges using one analyzer on the same day by the same operator.
No hook/prozone effect was observed up to TSH concentration of 3000 µIU/ml.

6) Analytical specificity:

Susceptibility of AFIAS TSH-SP and AFIAS TSH-VB test systems to interference from various endogenous substances, heterophiles and drugs as well as cross-reactivity with endogenous TSH structural analogs (hFSH, hLH, and hCG) has been evaluated at specified concentrations of the interferants/cross-reactants as follows:
- Albumin/Protein (6 g/dL = 6000 mg/dL)
- Conjugated Bilirubin (20 mg/dL)
- Unconjugated Bilirubin (20 mg/dL)
- Human hemoglobin (100 mg/dL and 500 mg/dL)
- Triglycerides (3 g/dL = 3000 mg/dL)
- HAMA (138 ng/mL)
- Rheumatoid Factor (1500 IU/mL)
- Biotin (56 ng/mL)
- Levothyroxine (75 µg/L)
- Methimazole (36 mg/L)
- Metoprolol (4.99 mg/L)
- Human Follicle-stimulating Hormone/hFSH (1,200 mIU/ml)
- Human Luteinizing Hormone/hLH (1,200 mIU/ml)
- Human Chorionic Gonadotropin/hCG (1,200 mIU/ml)
AFIAS TSH-SP as well as AFIAS TSH-VB tests showed analyte recovery within the acceptable range of 90-110% in presence of specified concentrations of above substances thereby indicating insignificant interference/cross-reactivity.

7) Site-to-Site Precision/Reproducibility:

Reproducibility of AFIAS TSH-SP test system was evaluated by testing 5 replicates of each of the 4 serum samples (TSH levels ~0.5, ~5.0, ~15.0 & ~55.0 µIU/ml) with 3 lots of AFIAS TSH-SP test cartridges on 3 AFIAS-6/SP analyzers (1 analyzer per site) at 3 external point-of-care sites at the hands of 9 intended POC operators (3 operators per site).
Reproducibility of AFIAS TSH-VB test system was evaluated by testing 5 replicates of each of the 4 whole blood samples (TSH levels ~0.5, ~5.0, ~15.0 & ~55.0 µIU/ml) with 3 lots of AFIAS TSH-VB test cartridges on 3 AFIAS-6/VB analyzers (1 analyzer per site) at 3 external point-of-care sites at the hands of 9 intended POC operators (3 operators per site).
Key results:
Site-wise Statistical Analysis of External POC Sites Precision Study Data of AFIAS TSH-SP Test:
- Clinical Serum Sample 1: Total Imprecision SD 0.020, %CV 4.2 (Site 1); SD 0.018, %CV 3.7 (Site 2); SD 0.021, %CV 4.2 (Site 3)
- Clinical Serum Sample 2: Total Imprecision SD 0.288, %CV 5.9 (Site 1); SD 0.318, %CV 6.4 (Site 2); SD 0.233, %CV 4.6 (Site 3)
- Spiked Serum Sample 3: Total Imprecision SD 1.008, %CV 6.7 (Site 1); SD 0.749, %CV 5.0 (Site 2); SD 0.604, %CV 4.0 (Site 3)
- Spiked Serum Sample 4: Total Imprecision SD 3.003, %CV 5.5 (Site 1); SD 3.141, %CV 5.8 (Site 2); SD 2.883, %CV 5.4 (Site 3)
  Combined-sites Statistical Analysis of External POC Sites Precision Study Data of AFIAS TSH-SP Test:
- Clinical Serum Sample 1: Total Imprecision SD 0.020, %CV 4.0
- Clinical Serum Sample 2: Total Imprecision SD 0.280, %CV 5.6
- Spiked Serum Sample 3: Total Imprecision SD 0.801, %CV 5.3
- Spiked Serum Sample 4: Total Imprecision SD 2.965, %CV 5.5
  Site-wise Statistical Analysis of External POC Sites Precision Study Data of AFIAS TSH-VB Test:
- Clinical Venous Whole Blood Sample 1: Total Imprecision SD 0.029, %CV 6.3 (Site 1); SD 0.031, %CV 7.0 (Site 2); SD 0.029, %CV 6.4 (Site 3)
- Clinical Venous Whole Blood Sample 2: Total Imprecision SD 0.321, %CV 6.6 (Site 1); SD 0.350, %CV 7.0 (Site 2); SD 0.403, %CV 8.1 (Site 3)
- Spiked Venous Whole Blood Sample 3: Total Imprecision SD 1.161, %CV 7.3 (Site 1); SD 1.156, %CV 7.5 (Site 2); SD 0.995, %CV 6.2 (Site 3)
- Spiked Venous Whole Blood Sample 4: Total Imprecision SD 2.853, %CV 5.1 (Site 1); SD 2.977, %CV 5.3 (Site 2); SD 3.300, %CV 5.9 (Site 3)
  Combined-sites Statistical Analysis of External POC Sites Precision Study Data of AFIAS TSH-VB Test:
- Clinical Venous Whole Blood Sample 1: Total Imprecision SD 0.029, %CV 6.5
- Clinical Venous Whole Blood Sample 2: Total Imprecision SD 0.356, %CV 7.2
- Spiked Venous Whole Blood Sample 3: Total Imprecision SD 1.136, %CV 7.2
- Spiked Venous Whole Blood Sample 4: Total Imprecision SD 3.005, %CV 5.4

8) Matrix Comparison:

Matching clinical serum, sodium heparin plasma and di-potassium EDTA plasma samples obtained from same study subjects were tested with one lot of AFIAS TSH-SP test cartridges on one AFIAS-6/SP analyzer for evaluating the effect of these anticoagulants on AFIAS TSH-SP test results.
Similarly, matching clinical sodium heparin venous whole blood and di-potassium -EDTA venous whole blood samples obtained from same study subjects were tested with one lot of AFIAS TSH-VB test cartridges on one AFIAS-6/VB analyzer for evaluating the effect of these anti-coagulants on AFIAS TSH-VB test results.
Key results:
- Serum vs. Sodium heparin plasma (0.09 – 77.52 µIU/mL): Number of Samples = 81, Linear Regression y = 0.9565x + 0.0424, Correlation Coefficient = 0.9998
- Serum vs. Di-Potassium EDTA plasma (0.09 – 77.52 µIU/mL): Number of Samples = 79, Linear Regression y = 0.9654x + 0.0131, Correlation Coefficient = 0.9997
- Sodium heparin venous whole blood vs. Di-Potassium EDTA venous whole blood (0.40 – 71.74 µIU/mL): Number of Samples = 63, Linear Regression y = 0.993x + 0.0325, Correlation Coefficient = 0.9998

9) Adult Reference Interval:

Adult reference interval of AFIAS TSH-SP test was evaluated by testing serum samples collected from total 128 apparently healthy adults (65 males and 63 females) in the age group of 21-70 years.
Adult reference interval of AFIAS TSH-VB test was evaluated by testing sodium heparin venous whole blood samples collected from total 133 apparently healthy adults (69 males and 64 females) in the age group of 21-70 years.
Non-parametric reference interval encompassing the central 95% frequency distribution of test results was determined as per CLSI C28-A3c Standard.
2.5th percentile and 97.5th percentile of distribution of test results was taken as the lower limit and upper limit respectively of the reference interval.
Adult reference intervals of AFIAS TSH-SP and AFIAS TSH-VB tests have been found to be 0.45-4.49 µIU/mL and 0.41-4.06 µIU/mL respectively.
The manufacturer claims 0.45-4.50 uIU/mL as adult reference interval of AFIAS TSH-SP test and 0.40-4.0 uIU/mL as the adult reference interval of AFIAS TSH-VB test.
However, the user laboratories should establish their own reference intervals for specific population and/or specific group(s) of population they may cater to.

10) Clinical Method Comparison:

Method comparison studies of AFIAS TSH-SP and AFIAS TSH-VB tests were carried out at three point-of-care clinical sites at the hands of typical POC operators.
183 serum samples (including 22 spiked serum samples) were tested in singlet with one lot AFIAS TSH-SP test cartridges on one AFIAS-6/SP analyzer per site.
Aliquot of each serum sample from across the three study sites was tested with the predicate device Access Fast hTSH (on the Access 2 system) at a centralized laboratory.
Similarly, 157 sodium heparinized venous whole blood samples (including 22 spiked venous whole blood samples) were tested in singlet with one lot AFIAS TSH-VB test cartridges on one AFIAS-6/VB analyzer per site.
Matching serum samples from across the three study sites were tested with the predicate device Access Fast hTSH (on the Access 2 system) at the centralized laboratory.
Correlation/comparability between the candidate test results of the tested samples and predicate test results of matching serum samples was evaluated by performing weighted deming regression analysis of the data.
Key results:
- AFIAS TSH-SP (0.07 – 79.91 µIU/mL): Compared Samples = 183, Weighted Deming Regression Equation y = 0.976x - 0.003, Correlation Coefficient = 0.9994
- AFIAS TSH-VB (0.31 – 76.26 µIU/mL): Compared Samples = 157, Weighted Deming Regression Equation y = 0.909x + 0.012, Correlation Coefficient = 0.9999

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K042281

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

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 13, 2017

BODITECH MED INC. HYUNG-JU OH GENERAL MANAGER (REGULATORY AFFAIRS) 43, GEODUDANJI 1-GIL, DONGNAE-MYEON CHUNCHEON-SI, GANG-WON-DO, SOUTH KOREA 200-883

Re: K170232

Trade/Device Name: AFIAS TSH-SP, AFIAS-6/SP Analyzer AFIAS TSH-VB, AFIAS-6/VB Analyzer Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW, KHO Dated: August 31, 2017 Received: September 5, 2017

Dear Hyung-Ju Oh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

1

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling 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/ResourcesforYou/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)

K170232

Device Name

AFIAS TSH-SP, AFIAS-6/SP Analyzer

Indications for Use (Describe)

AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in serum, sodium-heparinized plasma samples. The test system is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.

AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in serum or plasma samples.

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."

3

Indications for Use

K170232

510(k) Number (if known)

Device Name

AFIAS TSH-VB, AFIAS-6/VB Analyzer

Indications for Use (Describe)

AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid individuals.

AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in venous whole blood samples.

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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Section 5: 510(k) Summary

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

510(k) number: K170232

Preparation date: October 6, 2017

Device Type/Common Name: Radioimmunoassay, Thyroid-Stimulating Hormone

Trade/Proprietary Name : AFIAS TSH-SP, AFIAS-6/SP Analyzer AFIAS TSH-VB, AFIAS-6/VB Analyzer

Type of Submission	: Traditional 510(k) Submission
Basis for Submission	: Traditional 510(k) Submission for a New Device
Submitter	: Boditech Med Inc.
43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gang-won-do, 24398,
Republic of Korea (South Korea)
Phone No.: +82 33 243 1400
Fax No.: +82 33 243 9373
E-mail: ohj@boditech.co.kr
Website: www.boditech.co.kr
Contact Person	: Hyung-Ju Oh/General Manager (Regulatory Affairs)
Classification Regulation	: 21CFR § 862.1690 Thyroid stimulating hormone test system
Class	: II (for AFIAS TSH-SP Test Cartridge)
II (for AFIAS TSH-VB Test Cartridge)
I (for AFIAS-6/SP Analyzer)
I (for AFIAS-6/VB Analyzer)
Panel	: Clinical Chemistry
Product Code	: JLW; Thyroid stimulating hormone test system
KHO; Fluorometer for Clinical Use
Predicate Device	: Access Fast hTSH with Access 2 System
Predicate Device 'K' Number	: K042281

Intended Use/Indication for Use of AFIAS TSH-SP Test:

AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in serum, sodium-heparinized plasma, or EDTA

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plasma samples. The test system is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.

Intended Use/Indication for Use of AFIAS-6/SP Analyzer:

AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in serum or plasma samples.

Intended Use/Indication for Use of AFIAS TSH-VB Test:

AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid individuals.

Intended Use/Indication for Use of AFIAS-6/VB Analyzer:

AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in venous whole blood samples.

Description of AFIAS TSH-SP and AFIAS TSH-VB Test Cartridges:

AFIAS TSH-SP as well as AFIAS TSH-VB Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'lyophilized detection buffer', the 'diluent i.e. reconstitution buffer' as well as the 'test strip'; all of which are integral components of the test.

The test cartridge is an elongated structure having 140 mm length. 17 mm width and 17 mm height.

Description of AFIAS TSH-SP and AFIAS TSH-VB ID Chips:

'AFIAS TSH-SP ID Chip' as well as 'AFIAS TSH-VB ID Chip' is a flat, rectangular device with its main body measuring 24 mm × 20 mm × 3 mm. Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the apical side of the main body.

The ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ID Chip' is an integral component of the test.

Before initiating the test run for testing a clinical sample or a calibrator/control using AFIAS TSH-SP or AFIAS TSH-VB test cartridge belonging to a new lot, the operator needs to mandatorily insert the lot-specific AFIAS TSH-SP or AFIAS TSH-VB ID Chip into one of the 'ID Chip Ports' of the AFIAS-6/SP or AFIAS-6/VB analyzer respectively.

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Description of AFIAS-6/SP and AFIAS-6/VB Analyzer:

For performing AFIAS TSH-SP test on a clinical serum/plasma sample or a calibrator/control, AFIAS TSH-SP test cartridge needs to be used in conjunction with the AFIAS-6/SP analyzer.

Similarly, for performing AFIAS TSH-VB test on a clinical venous whole blood sample or a calibrator/control, AFIAS TSH-VB test cartridge needs to be used in conjunction with the AFIAS-6/VB analyzer.

AFIAS-6/SP as well as AFIAS-6/VB analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 42 cm (L) x 33.6 cm (W) x 29.3 cm (H). AFIAS-6 weighs 15.1 kg.

Either analyzer is a flourometer instrument of closed-system analyzer type. The operator does not have access to those configuration parameters that could affect the assay process, test analysis or result calculation or any other parameter that could affect test result outcome. These and other operational parameters can only be configured by the 'System Administrator' through software and/or firmware upgrade and modification of operational settings in consultation with the manufacturer or an authorized service provider.

With a simple computerized touchscreen user interface, the analyzer enables the operator to initiate the test run which is completed automatically and terminates with display of test result or an error message alert (in case of any procedural error and/or system malfunction).

Similarities between AFIAS TSH-SP (with AFIAS-6/SP Analyzer) and the predicate device Access Fast hTSH (with Access 2 System):

Following table shows the similarities between AFIAS TSH-SP (with AFIAS-6/SP Analyzer) and the predicate device Access Fast hTSH with Access 2 System

Similarities between AFIAS TSH-SP (with AFIAS-6/SP Analyzer)
and the predicate device Access Fast hTSH (with Access 2 System)
No.	Comparison
Parameter	Candidate Device/Test
AFIAS TSH-SP
(with AFIAS-6/SP Analyzer)	Predicate Device/Test
(Access hTSH Assay with
Access 2 Immunoassay System)
1	Nature of the
test	Quantitative in vitro diagnostic test
system for human TSH	Quantitative in vitro diagnostic
test system for human TSH
2	Intended use	Quantitative measurement of Thyroid
Stimulating Hormone (TSH) in human
serum and plasma samples	Quantitative determination of
thyroid stimulating hormone
(thyrotropin, hTSH) levels in
human serum and plasma
3	Indications for
use(s)	Indicated for use as an aid in the
diagnosis of thyroid or pituitary
disorders.	Indicated for use with patients
where an assessment of their
thyroid status is desired
4	Intended use
sites	Clinical laboratories and
POC sites (e.g. near-the-patient
laboratories of hospitals, out-patient
clinics, physician offices etc.)	Clinical laboratories and
hospitals

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| 5 Assay

methodology	Sandwich immunoassay	Sandwich immunoassay
6 Result unit	μIU/ml (= mIU/l)	μIU/ml (= mIU/l)

Differences between AFIAS TSH-SP (with AFIAS-6/SP Analyzer) and the predicate device Access Fast hTSH (with Access 2 System):

Following table shows the differences between AFIAS TSH-SP (with AFIAS-6/SP Analyzer) and the predicate device Access Fast hTSH with Access 2 System.

Differences between AFIAS TSH-SP (with AFIAS-6/SP Analyzer)
and the predicate device Access Fast hTSH (with Access 2 System)
	Comparison	Candidate Device/Test	Predicate Device/Test
No.	Parameter	AFIAS TSH-SP	(Access hTSH Assay with
		(with AFIAS-6/SP Analyzer)	Access 2 Immunoassay System)
		- Clinical laboratories
		- Central laboratories of hospitals	- Clinical laboratories
1	Intended use	- Near-the-patient/POC laboratories of	- Central laboratories of
	sites	hospitals	hospitals
		- Out-patient clinics
		- Physician offices
			Paramagnetic particle
2		Assay principle Immunofluorometric assay	chemiluminiscent
			immunoassay
3	Test device	Self-contained, unitized, ready-to-use,	Ready to use reaction vessel
		disposable test cartridge	containing reagents
4	Associated	AFIAS-6/SP Analyzer	Access 2 Immunoassay
	instrument		System
5		Test throughput 1-6 samples at a time	Batch testing with random
			access
		Reaction/incubation time =15 minutes
	Turnaround
time	Time for first result in a batch of 6	20 min for Fast hTSH
6		samples = ~ 16 minutes	45 min for HYPERsensitive
		Time to last result in batch of 6 samples	hTSH
		= ~18 minutes
		For serum and plasma samples:
	Sample volume	200 µ1 (minimum 150 µ1)
7		required per test For Calibrators/Controls	Minimum 300 µL
		200 µ1 (minimum 150 µ1)
	Sample volume	For serum and plasma samples:	55 µL for Fast hTSH
8		100 µ1	110 uL for HYPERsensitive
	utilized per test	For Calibrators/Controls: 100 ul	hTSH
	Limit of		0.03 µIU/ml for Fast hTSH
9	Quantitation	0.07 µIU/ml with inter-assay CV ≤ 20%	assay
	/Functional		0.01 µIU/ml for
	Sensitivity		HYPERsensitive hTSH assay

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| 10 | Measuring/
reportable range | 0.07-80.00 µIU/ml | 0.03-100 µIU/ml for Fast
hTSH assay
0.01-100 µIU/ml for
HYPERsensitive hTSH assay |
|----|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 11 | Calibration | Lot-specific master calibration
curve/equation is encoded in the 'Lot-
specific AFIAS TSH-SP ID Chip' which
needs to be inserted in one of the 'ID
Chip Ports' of AFIAS-6/SP analyzer
prior to using that AFIAS TSH-SP test
cartridge lot for the first time.
AFIAS-6/SP can store the information
of up to 100 ID Chips most recently
inserted in it for performing AFIAS
TSH-SP or other AFIAS tests.
This AFIAS TSH-SP test cartridge lot-
specific master calibration curve is
further automatically adjusted by
periodic duplicate testing of two levels
of AFIAS TSH Calibrators by the user at
its discretion. | Manual calibration by testing
Access HYPERsensitive
hTSH Calibrators is required
every 28 days |
| 12 | Operational
environment | Ambient temperature 1535°C
Internal/system temperature 33-37°C | 1530℃ |

Similarities between AFIAS TSH-VB (with AFIAS-6/VB Analyzer) and the predicate device Access Fast hTSH (with Access 2 System):

Following table shows the similarities between AFIAS TSH-VB (with AFIAS-6/VB Analyzer) and the predicate device Access Fast hTSH with Access 2 System

| No. | Comparison
Parameter | Candidate Device/Test
AFIAS TSH-VB
(with AFIAS-6/VB Analyzer) | Predicate Device/Test
(Access hTSH Assay with
Access 2 Immunoassay System |
|-----|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 1 | Nature of the
test | Quantitative in vitro diagnostic test
system for human TSH | Quantitative in vitro diagnostic
test system for human TSH |
| 2 | Intended use | Quantitative measurement of Thyroid
Stimulating Hormone (TSH) in Sodium
heparinized or EDTA venous whole
blood samples | Quantitative determination of
thyroid stimulating hormone
(thyrotropin, hTSH) levels in
human serum and plasma |
| 3 | Indications for
use(s) | Indicated for monitoring TSH levels in
euthyroid and hypothyroid individuals. | Indicated for use with patients
where an assessment of their
thyroid status is desired |

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| | Intended use | Clinical laboratories and POC sites (e.g.
near-the-patient laboratories of | Clinical laboratories and | | |
|---|----------------------|-------------------------------------------------------------------------------|---------------------------|--|--|
| | sites | hospitals, out-patient clinics, physician
offices etc.) | hospitals | | |
| 1 | Assay
methodology | Sandwich immunoassay | Sandwich immunoassay | | |
| | 6 Result unit | uIU/ml (= mIU/l) | uIU/ml (= mIU/l) | | |

Differences between AFIAS TSH-VB (with AFIAS-6/VBAnalyzer) and the predicate device Access Fast hTSH (with Access 2 System):

Following table shows the differences between AFIAS TSH-VB (with AFIAS-6/VB Analyzer) and the predicate device Access Fast hTSH with Access 2 System.

| Differences between AFIAS TSH-VB (with AFIAS-6/VB Analyzer)

and the predicate device Access Fast hTSH (with Access 2 System)
No.	Comparison Parameter	Candidate Device/Test
AFIAS TSH-VB
(with AFIAS-6/VB Analyzer)	Predicate Device/Test
(Access hTSH Assay with
Access 2 Immunoassay System)
1	Intended use sites	- Clinical laboratories

Central laboratories of hospitals
Near-the-patient/POC laboratories of hospitals
Out-patient clinics
Physician offices | - Clinical laboratories
Central laboratories of hospitals |
| 2 | Assay principle | Immunofluorometric assay | Paramagnetic particle chemiluminiscent immunoassay |
| 3 | Test device | Self-contained, unitized, ready-to-use, disposable test cartridge | Ready to use reaction vessel containing reagents |
| 4 | Associated instrument | AFIAS-6/VB Analyzer | Access 2 Immunoassay System |
| 5 | Test throughput | 1-6 samples at a time | Batch testing with random access |
| 6 | Turnaround time | Reaction/incubation time =15 minutes
Time for first result in a batch of 6 samples = ~16 minutes
Time to last result in batch of 6 samples = ~18 minutes | 20 min for Fast hTSH
45 min for HYPERsensitive hTSH |
| 7 | Sample volume required per test | For venous whole blood samples: 150 $\mu$ l (minimum 100 $\mu$ l)
For Calibrators/Controls 200 $\mu$ l (minimum 150 $\mu$ l) | Minimum 300 $\mu$ L |
| 8 | Sample volume utilized per test | For venous whole blood samples: 50 $\mu$ l
For Calibrators/Controls: 100 $\mu$ l | 55 $\mu$ L for Fast hTSH
110 $\mu$ L for HYPERsensitive hTSH |

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| 9 | Limit of
Quantitation
/Functional
Sensitivity | 0.3 µIU/ml with inter-assay CV ≤ 20% | 0.03 µIU/ml for Fast hTSH
assay
0.01 µIU/ml for
HYPERsensitive hTSH assay |
|----|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 10 | Measuring/
reportable range | 0.3-80 µIU/ml | 0.03-100 µIU/ml for Fast
hTSH assay
0.01-100 µIU/ml for
HYPERsensitive hTSH assay |
| 11 | Calibration | Lot-specific master calibration
curve/equation is encoded in the 'Lot-
specific AFIAS TSH-VB ID Chip'
which needs to be inserted in one of the
'ID Chip Ports' of AFIAS-6/VB
analyzer prior to using that AFIAS TSH-
VB test cartridge lot for the first time.
AFIAS-6/VB can store the information
of up to 100 ID Chips most recently
inserted in it for performing AFIAS
TSH-VB or other AFIAS tests.
Each AFIAS TSH-VB test cartridge lot-
specific master calibration curve is
further automatically adjusted by
periodic duplicate testing of two levels
of AFIAS TSH Calibrators by the user at
its discretion. | Manual calibration by testing
Access HYPERsensitive
hTSH Calibrators is required
every 28 days |
| 12 | Operational
environment | Ambient temperature 1535°C
Internal/system temperature 33-37°C | 1530°C |

Summary of Performance Evaluation Studies:

1) Limit of Blank:

-Limit of Blank (LoB) of AFIAS TSH-SP and AFIAS TSH-VB tests have been evaluated as per CLSI EP 17-A2.
5 replicates each of 5 blank/TSH-depleted human serum as well as 5 blank/TSH-depleted whole blood samples were tested with 3 lots of test cartridges on 3 respective analyzers for 3 days; thus testing 75 replicates per lot/analyzer.
Limit of Blank (LoB) was calculated by non-parametric analysis of the data. -
Limit of Blank of AFIAS TSH-SP test is 0.03 µIU/ml and that of AFIAS TSH-VB test is 0.13 µIU/ml.

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2) Limit of Detection:

Limit of Detection (LoD) of AFIAS TSH-SP and AFIAS TSH-VB tests have been evaluated as per CLSI EP 17-A2.
5 replicates each of 5 low TSH-spiked human serum as well as 5 low TSH-spiked whole blood samples were tested with 3 lots of test cartridges on 3 respective analyzers for 3 days; thus testing 75 replicates per lot/analyzer.
-Limit of Detection (LoD) was calculated by parametric analysis of the data.
Limit of Detection of AFIAS TSH-SP test is 0.05 µIU/ml and that of AFIAS TSH--VB test is 0.2 µIU/ml.

3) Limit of Quantitation:

Limit of Quantitation (LoO) of AFIAS TSH-SP and AFIAS TSH-VB tests have been evaluated as per CLSI EP 17-A2.
-For evaluating the LoQ of AFIAS TSH-SP test, 2 replicates of each of the 5 low TSH-spiked serum samples were tested daily in two different runs with two test cartridge lot/analyzer/operator combinations for 21 successive days.
-For evaluating the LoQ of AFIAS TSH-VB test. 5 replicates of each of the 4 low TSH-spiked venous whole blood samples were tested daily in two different runs with two test cartridge lot/analyzer/operator combinations for 5 successive days.
-Limit of Quantitation (LoQ) was calculated by considering accuracy goal of interassay CV ≤ 20%.
Limit of Quantitation of AFIAS TSH-SP test is 0.07 µIU/ml and that of AFIAS TSH--VB test is 0.3 µIU/ml.

4) Linearity and Reportable Range:

For evaluating linearity and measuring/reportable range of AFIAS TSH-SP test, a series of 22 test samples prepared by mixing a high TSH-spiked serum sample (TSH~100 µIU/mL) and a TSH-depleted serum sample (TSH ~ 0 µIU/mL) in various proportions, was tested in triplicate with the one lot of AFIAS TSH-SP test cartridges on one AFIAS-6/SP analyzer on the same day.
-Similarly, for evaluating linearity and measuring/reportable range of AFIAS TSH-VB test, a series of 22 test samples prepared by mixing a high TSH-spiked venous whole blood sample (TSH~100 µIU/mL) and a TSH-depleted venous whole blood sample (TSH ~ 0 uIU/mL) in various proportions, was tested in triplicate with the one lot of AFIAS TSH-VB test cartridges on one AFIAS-6/VB analyzer on the same day.
-Mean of the triplicate test results of each sample was plotted against its expected TSH concentration calculated mathematically.
The following linear regression equations were obtained: -

Serum: y = 1.0081x - 0.0785, R2=0.9993

Na-heparinized whole blood: y = 0.9824x + 0.216, R2=0.9997

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-Both tests showed linearity over the entire TSH concentration range (0~100 µIU/ml) tested for the study.
Measuring/reportable range of AFIAS TSH-SP test system has been programed as -0.07-80 uIU/ml while that of AFIAS TSH-VB test system has been programed as 0.3 -80.0 µIU/ml.

5) Susceptibility to High-dose Hook Effect:

For evaluating susceptibility to high dose hook (prozone) effect, a series of spiked samples having TSH concentrations 25, 50, 75, 100, 150, 200, 500, 1000, 1500, 2000, 2500 and 3000 uIU/ml was tested in triplicate with one lot of test cartridges using one analyzer on the same day by the same operator.
-No hook/prozone effect was observed up to TSH concentration of 3000 µIU/ml.

6) Analytical specificity:

Susceptibility of AFIAS TSH-SP and AFIAS TSH-VB test systems to interference from various endogenous substances, heterophiles and drugs as well as cross-reactivity with endogenous TSH structural analogs (hFSH, hLH, and hCG) has been evaluated at specified concentrations of the interferants/cross-reactants as follows:
- . Albumin/Protein (6 g/dL= 6000 mg/dL)
- . Conjugated Bilirubin (20 mg/dL)
- . Unconjugated Bilirubin (20 mg/dL)
- 트 Human hemoglobin (100 mg/dL and 500 mg/dL)
- " Triglycerides (3 g/dL= 3000 mg/dL)
- 트 HAMA (138 ng/mL)
- . Rheumatoid Factor (1500 IU/mL)
- . Biotin (56 ng/mL)
- . Levothyroxine (75 µg/L)
- 트 Methimazole (36 mg/L)
- 트 Metoprolol (4.99 mg/L)
- . Human Follicle-stimulating Hormone/hFSH (1,200 mIU/ml)
- . Human Luteinizing Hormone/hLH (1,200 mIU/ml)
- . Human Chorionic Gonadotropin/hCG (1,200 mIU/ml)
AFIAS TSH-SP as well as AFIAS TSH-VB tests showed analyte recovery within the acceptable range of 90-110% in presence of specified concentrations of above substances thereby indicating insignificant interference/cross-reactivity.

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7) Site-to-Site Precision/Reproducibility:

Reproducibility of AFIAS TSH-SP test system was evaluated by testing 5 replicates of । each of the 4 serum samples (TSH levels ~0.5, ~5.0, ~15.0 & ~55.0 µIU/ml) with 3 lots of AFIAS TSH-SP test cartridges on 3 AFIAS-6/SP analyzers (1 analyzer per site) at 3 external point-of-care sites at the hands of 9 intended POC operators (3 operators per site).
The results are summarized in the following tables:

Site-wise Statistical Analysis of External POC Sites Precision Study Data of
AFIAS TSH-SP Test
Serum
Sample
Tested	Precision
Study
Site	Number of
Replicates
(n)	Mean
TSH
(µIU/mL)	Lot-to-Lot
Imprecision		Day-to-Day
Imprecision		Total
Imprecision
				SD	% CV	SD	% CV	SD	% CV
Clinical
Serum
Sample 1	Site 1	15	0.49	0.003	0.7	0.006	1.3	0.020	4.2
Clinical
Serum
Sample 1	Site 2	15	0.49	0.003	0.7	0.009	1.8	0.018	3.7
Clinical
Serum
Sample 1	Site 3	15	0.50	0.009	1.8	0.011	2.2	0.021	4.2
Clinical
Serum
Sample 2	Site 1	15	4.91	0.034	0.7	0.187	3.8	0.288	5.9
Clinical
Serum
Sample 2	Site 2	15	4.96	0.057	1.1	0.154	3.1	0.318	6.4
Clinical
Serum
Sample 2	Site 3	15	5.03	0.029	0.6	0.145	2.9	0.233	4.6
Spiked
Serum
Sample 3	Site 1	15	14.96	0.423	2.8	0.658	4.4	1.008	6.7
Spiked
Serum
Sample 3	Site 2	15	14.93	0.240	1.6	0.280	1.9	0.749	5.0
Spiked
Serum
Sample 3	Site 3	15	15.26	0.423	2.8	0.277	1.8	0.604	4.0
Spiked
Serum
Sample 4	Site 1	15	54.26	0.496	0.9	1.385	2.6	3.003	5.5
Spiked
Serum
Sample 4	Site 2	15	54.35	2.136	3.9	1.381	2.5	3.141	5.8
Spiked
Serum
Sample 4	Site 3	15	53.53	0.596	1.1	2.306	4.3	2.883	5.4

| Combined-sites Statistical Analysis of External POC Sites Precision Study Data of

AFIAS TSH-SP Test
Serum
Sample Tested	Number of
Replicates
(n)	Mean
TSH
(µIU/mL)	Lot-to-Lot
Imprecision		Day-to-Day
Imprecision		Total
Imprecision
			SD	% CV	SD	% CV	SD	% CV
Clinical Serum
Sample 1	45	0.49	0.005	1.0	0.007	1.5	0.020	4.0
Clinical Serum
Sample 2	45	4.97	0.028	0.6	0.072	1.5	0.280	5.6
Spiked Serum
Sample 3	45	15.05	0.297	2.0	0.244	1.6	0.801	5.3
Spiked Serum
Sample 4	45	54.05	0.468	0.9	0.531	1.0	2.965	5.5

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Similarly, reproducibility of AFIAS TSH-VB test system was evaluated by testing 5 i replicates of each of the 4 whole blood samples (TSH levels ~0.5, ~5.0, ~15.0 & ~55.0 µIU/ml) with 3 lots of AFIAS TSH-VB test cartridges on 3 AFIAS-6/VB analyzers (1 analyzer per site) at 3 external point-of-care sites at the hands of 9 intended POC operators (3 operators per site).

Site-wise Statistical Analysis of External POC Sites Precision Study Data of
AFIAS TSH-VB Test
Venous Whole
Blood
Sample	Precision
Study Site	Number
of
Replicates
(n)	Mean
TSH
(µIU/mL)	Lot-to-Lot
Imprecision		Day-to-Day
Imprecision		Total
Imprecision
				SD	% CV	SD	% CV	SD	% CV
Clinical Venous
Whole Blood
Sample 1	Site 1	15	0.45	0.008	1.7	0.015	3.4	0.029	6.3
Clinical Venous
Whole Blood
Sample 1	Site 2	15	0.44	0.005	1.2	0.013	2.8	0.031	7.0
Clinical Venous
Whole Blood
Sample 1	Site 3	15	0.46	0.004	0.9	0.024	5.3	0.029	6.4
Clinical Venous
Whole Blood
Sample 2	Site 1	15	4.88	0.116	2.4	0.273	5.6	0.321	6.6
Clinical Venous
Whole Blood
Sample 2	Site 2	15	5.00	0.105	2.1	0.183	3.7	0.350	7.0
Clinical Venous
Whole Blood
Sample 2	Site 3	15	5.01	0.186	3.7	0.200	4.0	0.403	8.1
Spiked Venous
Whole Blood
Sample 3	Site 1	15	15.97	0.532	3.3	0.581	3.6	1.161	7.3
Spiked Venous
Whole Blood
Sample 3	Site 2	15	15.31	0.425	2.8	0.563	3.7	1.156	7.5
Spiked Venous
Whole Blood
Sample 3	Site 3	15	16.10	0.344	2.1	0.712	4.4	0.995	6.2
Spiked Venous
Whole Blood
Sample 4	Site 1	15	55.77	0.906	1.6	0.944	1.7	2.853	5.1
Spiked Venous
Whole Blood
Sample 4	Site 2	15	56.57	0.450	0.8	1.326	2.3	2.977	5.3
Spiked Venous
Whole Blood
Sample 4	Site 3	15	55.71	1.791	3.2	2.349	4.2	3.300	5.9

The results are summarized in the following tables:

| Combined-sites Statistical Analysis of External POC Sites Precision Study Data of

AFIAS TSH-VB Test
Venous Whole Blood
Sample	Number of
Replicates
(n)	Mean
TSH
(µIU/mL)	Lot-to-Lot
Imprecision		Day-to-Day
Imprecision		Total
Imprecision
			SD	% CV	SD	% CV	SD	% CV
Clinical Venous Whole
Blood Sample 1	45	0.45	0.005	1.0	0.012	2.6	0.029	6.5
Clinical Venous Whole
Blood Sample 2	45	4.96	0.125	2.5	0.103	2.1	0.356	7.2
Spiked Venous Whole
Blood Sample 3	45	15.79	0.206	1.3	0.362	2.3	1.136	7.2
Spiked Venous Whole
Blood Sample 4	45	56.02	0.199	0.4	0.750	1.3	3.005	5.4

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8) Matrix Comparison:

Matching clinical serum, sodium heparin plasma and di-potassium EDTA plasma samples obtained from same study subjects were tested with one lot of AFIAS TSH-SP test cartridges on one AFIAS-6/SP analyzer for evaluating the effect of these anticoagulants on AFIAS TSH-SP test results.
Similarly, matching clinical sodium heparin venous whole blood and di-potassium -EDTA venous whole blood samples obtained from same study subjects were tested with one lot of AFIAS TSH-VB test cartridges on one AFIAS-6/VB analyzer for evaluating the effect of these anti-coagulants on AFIAS TSH-VB test results.

| Sr.
No. | Sample matrices compared
& TSH Range of Compared Results | Number of
Samples | Linear Regression
Equation | Correlation
Coefficient |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------|-------------------------------|----------------------------|
| Measuring/reportable range of AFIAS TSH-SP Test = 0.07-80.0 µIU/ml | | | | |
| 1 | Serum vs. Sodium heparin plasma
(0.09 – 77.52 µIU/mL) | 81 | y = 0.9565x + 0.0424 | 0.9998 |
| 2 | Serum vs. Di-Potassium EDTA
plasma
(0.09 – 77.52 µIU/mL) | 79 | y = 0.9654x + 0.0131 | 0.9997 |
| | | | | |
| Measuring/reportable range of AFIAS TSH-VB Test = 0.3-80.0 µIU/ml | | | | |
| 3 | Sodium heparin venous whole blood
vs. Di-Potassium EDTA venous
whole blood
(0.40 – 71.74 µIU/mL) | 63 | y = 0.993x + 0.0325 | 0.9998 |

The data and regression analysis are summarized below:

9) Adult Reference Interval:

Adult reference interval of AFIAS TSH-SP test was evaluated by testing serum samples collected from total 128 apparently healthy adults (65 males and 63 females) in the age group of 21-70 years.
Adult reference interval of AFIAS TSH-VB test was evaluated by testing sodium heparin venous whole blood samples collected from total 133 apparently healthy adults (69 males and 64 females) in the age group of 21-70 years.
Non-parametric reference interval encompassing the central 95% frequency distribution of test results was determined as per CLSI C28-A3c Standard.
2.5th percentile and 97.5th percentile of distribution of test results was taken as the । lower limit and upper limit respectively of the reference interval.
Adult reference intervals of AFIAS TSH-SP and AFIAS TSH-VB tests have been found to be 0.45-4.49 µIU/mL and 0.41-4.06 µIU/mL respectively.

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The manufacturer claims 0.45-4.50 uIU/mL as adult reference interval of AFIAS । TSH-SP test and 0.40-4.0 uIU/mL as the adult reference interval of AFIAS TSH-VB test.
। However, the user laboratories should establish their own reference intervals for specific population and/or specific group(s) of population they may cater to.

10) Clinical Method Comparison:

Method comparison studies of AFIAS TSH-SP and AFIAS TSH-VB tests were carried । out at three point-of-care clinical sites at the hands of typical POC operators.
183 serum samples (including 22 spiked serum samples) were tested in singlet with one lot AFIAS TSH-SP test cartridges on one AFIAS-6/SP analyzer per site.

Aliquot of each serum sample from across the three study sites was tested with the predicate device Access Fast hTSH (on the Access 2 system) at a centralized laboratory.

। Similarly, 157 sodium heparinized venous whole blood samples (including 22 spiked venous whole blood samples) were tested in singlet with one lot AFIAS TSH-VB test cartridges on one AFIAS-6/VB analyzer per site.
Matching serum samples from across the three study sites were tested with the predicate device Access Fast hTSH (on the Access 2 system) at the centralized laboratory.
Correlation/comparability between the candidate test results of the tested samples and predicate test results of matching serum samples was evaluated by performing weighted deming regression analysis of the data as summarized in the following table:

| TSH Range of Candidate Test
Results included in the
Regression Analysis of
Method Comparison Data | Number of
Samples | Weighted Deming
Regression Equation
(with 95% Confidence Intervals
for Slope and Y-intercept) | Correlation
Coefficient |
|------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------------------|----------------------------|
| AFIAS TSH-SP
0.07 – 79.91 µIU/mL | Compared = 183 | $y = 0.976x - 0.003$
(0.969-0.981) (-0.0055 – -0.0007) | 0.9994 |
| AFIAS TSH-VB
0.31 – 76.26 µIU/mL | Compared = 157 | $y = 0.909x + 0.012$
(0.904-0.913) (0.006-0.017) | 0.9999 |

Conclusion:

Based on the intended use, principle and non-clinical as well as clinical performance characteristics described above, AFIAS TSH-SP (with AFIAS-6/SP analyzer) and AFIAS TSH-VB (with AFIAS-6/VB analyzer) test systems are substantially equivalent to the predicate device Acces Fast hTSH (with Access 2 System).