(260 days)
Not Found
No
The device description and performance studies focus on standard fluorescence detection and quantitative analysis based on a stored standard curve. There is no mention of AI or ML algorithms for data processing, interpretation, or decision-making.
No
The device is described as being for "in vitro DIAGNOSTIC USE ONLY" and is an "aid to clinicians in the diagnosis of thyroid disease," which indicates a diagnostic rather than therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for in vitro DIAGNOSTIC USE ONLY" and is "an aid to clinicians in the diagnosis of thyroid disease." This directly indicates its purpose as a diagnostic device.
No
The device description clearly outlines a hardware component, the "FREND™ System," which is a bench top fluorescence reader with a touchscreen interface and mechanical functions. The software operates this hardware and processes data from a physical cartridge containing reagents and a sample.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states "FREND™ TSH is designed for in vitro DIAGNOSTIC USE ONLY".
- Measurement of Analytes: It measures Thyroid Stimulating Hormone (TSH) in human serum and lithium heparin plasma.
- Purpose: It is used "as an aid to clinicians in the diagnosis of thyroid disease."
- Sample Type: It uses biological samples (serum and plasma).
- Setting: It is intended for use in "clinical laboratories".
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FREND™ TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND™ system.
FREND™ TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.
Product codes
JLW
Device Description
FREND™ TSH, performed using the FREND™ system, is an in vitro diagnostic test for the quantitative measurement of TSH in serum and lithium heparin plasma samples. The FREND™TSH is performed completely within the single-use plastic cartridge once serum or plasma has been placed in the sample well and is for use upon prescription by the attending physician in clinical laboratories with qualified technologists. FREND™ TSH on the FREND™ system has been shown to yield TSH results that are equivalent to those obtained with other previously cleared FDA in vitro diagnostic devices measuring TSH quantitatively in serum and/or plasma.
The FREND™ System is a bench top fluorescence reader containing a simple computerized touchscreen user interface, easily manipulated to order tests, display results and operate the mechanical functions of the instrument. The specimen is added with a transfer pipette to the sample inlet of a single use cartridge by the operator, allowing the appropriate volume of sample (35 uL) to be delivered into the FREND™ TSH cartridge. The cartridge is then placed into the FREND™ system, which is programmed to begin analysis once the sample has reacted with the reagents. All reactions occur in the self-contained plastic cartridge and the reading is done in the cartridge as well. The FREND™ system has a slot that accepts the FREND™ TSH test cartridge containing the reagents and sample, and is programmed to analyze the test when the sample has fully reacted with the on-board in-cartridge reagents. Cartridges are loaded manually one by the operator. The reaction and analysis time is approximately 5 minutes. TSH quantitation is based on the ratio of fluorescence detected by the FREND™ System at the FREND™ TSH test and reference windows in the plastic cartridge compared to a standard curve stored in the TSH Code Chip that is included with each box of the device. A higher ratio of fluorescence is indicative of a higher TSH concentration. In other words, the magnitude of the fluorescent ratio is directly proportional to the amount of TSH in the sample. A high-level schematic and process diagram of the FREND™ system are included in the User Manual. Results of the test are displayed on the screen and can be printed on an optional printer.
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
The clinical study for expected values included apparently healthy ambulatory adults (195 males and 191 females ages 18 - 71).
Intended User / Care Setting
clinical laboratories upon prescription by the attending physician / clinical laboratories with qualified technologists. End Users: Technologists working in a clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1) Accuracy
* Dilution Linearity: Specimens from a high TSH concentration pool were diluted with a TSH depleted serum pool. Linearity was demonstrated from 10%.
* Pharmaceutical Interferents: Acetaminophen (1324 µM), Diltiazem (15 µM), Erythromycin (81.6 µM), Verapamil (4.4 µM) were tested. No significant interference (
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
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510(k) Summary: FREND™ TSH
MAR 1 4 2014
510(k) Number:
Summary Preparation Date:
March 13, 2014
Submitted by:
NanoEnTek, Inc. 12F, 5 Digital-ro, 26-gil, Guro-gu Seoul, 152-740, Korea
Jimmy Chen Owner/Operator jim@nanoentek.com
Contact:
Judith E Loebel Director, Clinical and Regulatory Affairs DOCRO, Inc. (CRO assigned as contact with the FDA) 1 Jacks Hill Road Suite 1 A&B Oxford, CT 06478 USA
Proprietary Names:
FREND™ TSH
Common Names: Quantitative TSH Immunoassay
Regulatory Information:
Regulation section: 862.1690 Radioimmunoassay, Thyroid Stimulating Hormone
Classification: Class II .
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Panel: Chemistry and Toxicology (DCTD))
Product Code(s): JLW Radioimmunoassay, Thyroid Stimulating Hormone
Other codes used by predicate devices: None
Predicate Devices: TOSOH ST AIA-PACK TSH (K972586)
Indications for Use:
510(k) Number: K131928
Device Name: FREND™ TSH
Indications for Use:
FREND™ TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND™ system.
FREND™ TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.
Technological Characteristics:
There are no technological characteristics of FREND™ TSH that are different or with which the agency is unfamiliar. FREND™ TSH, performed using the FREND™ system. is an in vitro diagnostic test for the quantitative measurement of TSH in serum and lithium heparin plasma samples. The FREND™TSH is performed completely within the single-use plastic cartridge once serum or plasma has been placed in the sample well and is for use upon prescription by the attending physician in clinical laboratories with qualified technologists. FREND™ TSH on the FREND™ system has been shown to yield TSH results that are equivalent to those obtained with other previously cleared FDA in vitro diagnostic devices measuring TSH quantitatively in serum and/or plasma.
The FREND™ System is a bench top fluorescence reader containing a simple computerized touchscreen user interface, easily manipulated to order tests, display results and operate the mechanical functions of the instrument. The specimen is
2
added with a transfer pipette to the sample inlet of a single use cartridge by the operator, allowing the appropriate volume of sample (35 uL) to be delivered into the FREND™ TSH cartridge. The cartridge is then placed into the FREND™ system, which is programmed to begin analysis once the sample has reacted with the reagents. All reactions occur in the self-contained plastic cartridge and the reading is done in the cartridge as well. The FREND™ system has a slot that accepts the FREND™ TSH test cartridge containing the reagents and sample, and is programmed to analyze the test when the sample has fully reacted with the on-board in-cartridge reagents. Cartridges are loaded manually one by the operator. The reaction and analysis time is approximately 5 minutes. TSH quantitation is based on the ratio of fluorescence detected by the FREND™ System at the FREND™ TSH test and reference windows in the plastic cartridge compared to a standard curve stored in the TSH Code Chip that is included with each box of the device. A higher ratio of fluorescence is indicative of a higher TSH concentration. In other words, the magnitude of the fluorescent ratio is directly proportional to the amount of TSH in the sample. A high-level schematic and process diagram of the FREND™ system are included in the User Manual. Results of the test are displayed on the screen and can be printed on an optional printer.
Expected Values
As with every clinical diagnostic test, a reference interval corresponding to the characteristics of the population being tested should be determined by each laboratory. Historically, it has been shown that there are neither racial differences nor gender differences in the reference interval for TSH so creating a single adult reference interval is reasonable and justified per literature.
During a clinical study run to support the FREND™ TSH substantial equivalence to a marketed product with the same indication, TSH measurements were performed on the serum of 385 apparently healthy ambulatory adults (195 males and 191 females ages 18 - 71) who stated they had no known thyroid conditions. All samples were assayed in singlicate on the FREND™ TSH and the predicate device. A single value, determined as an outlier in both the test and the predicate devices, was removed from the data set after which a non-parametric reference interval encompassing the central 95% of the results was determined. Male and female results were separately analyzed with no significant difference found in the calculated reference intervals. Therefore, a single reference interval has been determined.
FREND™ TSH Reference Interval: 0.49 ~ 3.82 mlU/L
With 90% confidence limits the following ranges were estimated:
| Lower Reference Interval Range | 0.42 ~ 0.59 mIU/L |
|---|---|
| Upper Reference Interval Range | 3.24 ~ 4.30 mlU/L |
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As in all in vitro diagnostic testing, a TSH result generated using the FREND™ TSH on the FREND™ system should be interpreted in the light of other clinical findings and diagnostic procedures. Any TSH results not correlating with the clinical condition should be repeated and other testing performed to clarify the situation.
Performance Characteristics
Performance characteristics were evaluated for FREND™ TSH as follows:
1) Accuracy
1a) Dilution Linearity - Specimens from a high TSH concentration pool were diluted with a TSH depleted serum pool according to the CLSI EP06-A document. Linearity was demonstrated from Slope: 0.951 (95% Cl: 0.940; 0.962) v-Intercept: 0.0266 (95% CI: -0.0258; 0.0790) Sylx: 0.475 Number of Samples: 438 Measuring Range: 0.09 ~ 24.96 mIU/L
Comparability using CLSI guideline EP09-A2-IR, Section 7, shows that the difference in concentration between that measured by the test device and that expected (predicate device) is less than the allowable difference and that the two methods compare favorably.
Image /page/4/Figure/3 description: This image is a scatter plot with a linear regression line. The plot contains 438 samples, and the regression equation is y = 0.9509x + 0.0267, with an R-squared value of 0.9849. The x and y axes range from 0.00 to 30.00, and the data points are clustered closely around the regression line, indicating a strong positive correlation.
Figure 2 Comparability to Predicate Device
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2) Precision
Precision was determined as described in the CLSI protocol EP05-A2. Four clinical samples were assayed in replicates of two at two separate times per day for twenty days using a single lot of FREND™ TSH cartridge. The findings follow showing repeatability, between-run, between-day and withinlaboratory precision data.
| Mean TSH | Repeatability | Between-run | Between-day | Within-laboratory | |||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | Conc. (mIU/L) | SD (mIU/L) | CV% | SD (mIU/L) | CV% | SD (mIU/L) | CV% | SD (mIU/L) | CV% |
| 1 | 0.496 | 0.043 | 8.6 | 0.012 | 2.4 | 0.017 | 3.4 | 0.047 | 9.6 |
| 2 | 5.948 | 0.353 | 5.9 | 0.082 | 1.4 | 0.031 | 0.5 | 0.364 | 6.1 |
| 3 | 11.989 | 0.555 | 4.6 | 0.375 | 3.1 | 0.156 | 1.3 | 0.688 | 5.7 |
| 4 | 23.763 | 0.846 | 3.6 | 0.478 | 2.0 | 0.000 | 0.0 | 0.972 | 4.1 |
Figure 3 FREND™ Single Site Single Lot Precision
3) Specificity
The a- subunits of luteinizing hormone (LH), follicle stimulating hormone (FSH), human chorionic qonadotropin (hCG) and thvroid stimulating hormone (TSH) are all very similar though their ß- subunits are not. Because of the structural similarities, the specificity of the FREND™ TSH must be examined in the presence of large amounts of these possible cross-reactants. The following substances were evaluated for potential cross-reactivity with the FREND™ TSH at the concentrations indicated below in Figure 4. Testing was done according to the CLSI protocol EP07-A. No significant cross-reactivity was found.
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| Sample
TSH
Conc.
(mIU/L) | Interferent | Material
added | % Cross
Reactivity |
|-----------------------------------|-------------|-------------------|-----------------------|
| 0.49 | hCG | 200,000
mIU/mL | 2 x $10^{-8}$ |
| 0.55 | LH | 500
mIU/mL | 2 x $10^{-4}$ |
| 0.55 | FSH | 500
mIU/mL | -5 x $10^{-6}$ |
| 6.22 | hCG | 200,000
mIU/mL | 3 x $10^{-7}$ |
| 6.06 | LH | 500
mIU/mL | 3 x $10^{-5}$ |
| 6.06 | FSH | 500
mIU/mL | 1 x $10^{-4}$ |
Figure 4 Specificity of FREND™ TSH
4) Analytical Sensitivity
The Limit of Detection (LoD) for the FREND™ TSH was measured using the CLSI EP17-A protocol. The analytical sensitivity of the FREND™ TSH was determined to be 0.06 mlU/L.
5) Interference
Interference is defined in this instance as recovery outside of 10% of the known specimen mean concentration. In other words, recovery from 90% to 110% of the expected TSH is considered acceptable performance. The interference studies were performed using the recommendations in the CLSI EP07-A protocol. Results were:
Endogenous Interferents
- Added hemoglobin (up to 500 mg/dL) does not interfere with the assay. . Average TSH recovery was 98.8%.
- Added conjugated bilirubin (up to 20 mg/dL) does not interfere with the assay. . Average recovery was 100.0%.
- . Added total protein up to 12.0 g/dL does not interfere with the assay. Average recovery was 100.4%.
- . Added triglyceride up to 3 g/dL does not interfere with this assay. Average recovery was 101.6%.
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- Added HAMA to 52.5 ng/mL did not interfere with the assay. Average recovery . was 93.3%. Higher concentrations of HAMA exhibited interference> 10%.
- RF at 53.8 IU/mL did not interfere with the assay. Average recovery was . 91.4%. Higher concentration of RF did show interference > 10%.
Pharmaceutical Interferents
The following common medications were tested for interference with the FREND™ TSH. The testing showed no significant interference ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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