FREND TSH (REAGENT CARTRIDGE)

K131928 · Nanoentek USA, Inc. · JLW · Mar 14, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131928
• Device Name: FREND TSH (REAGENT CARTRIDGE)
• Applicant: Nanoentek USA, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Mar 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended 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.

Device Story

FREND™ TSH is a quantitative fluorescent immunoassay for TSH measurement in human serum or lithium heparin plasma. The system consists of a benchtop fluorescence reader and single-use plastic cartridges. The operator adds 35 uL of sample to the cartridge inlet; the system automatically performs analysis after reaction. TSH quantitation relies on the ratio of fluorescence detected at test and reference windows within the cartridge, compared against a standard curve stored in a device-specific Code Chip. Results are displayed on a touchscreen and can be printed. Used in clinical laboratories by qualified technologists to aid clinicians in diagnosing thyroid disease. The device provides rapid, point-of-care-style quantitative results, facilitating timely clinical decision-making regarding thyroid function.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP05-A2, EP06-A, EP07-A2, EP09-A2, EP14-A2, EP17-A, C28-A3). Precision study (n=4 samples, 20 days) showed total CV% between 4.1% and 9.6%. Linearity confirmed (r=0.999) across 0.06–25.0 mIU/L range. Method comparison (n=438) vs. predicate yielded slope 0.951, R²=0.9849. No significant interference from bilirubin, triglycerides, hemoglobin, total protein, common drugs, HAMA, or RF. No hook effect up to 2500 mIU/L. Reference range established using 386 healthy individuals.

Technological Characteristics

Fluorescence immunoassay using microfluidic flow. Materials: disposable plastic cartridge with dry-loaded reagents (mouse monoclonal/goat polyclonal anti-Beta-TSH, fluorescent nanoparticles). Energy source: FREND System fluorescence reader. Connectivity: Code Chip for lot-specific calibration. Sterilization: Not specified. Software: Embedded system-controlled analysis.

Indications for Use

Indicated for quantitative measurement of TSH in human serum and lithium heparin plasma to aid clinicians in diagnosing thyroid disease. For prescription use only in clinical laboratories.

Regulatory Classification

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.

Predicate Devices

• TOSOH ST AIA-PACK TSH (K972586)

Submission Summary (Full Text)

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#### 510(k) Summary: FREND™ TSH

MAR 1 4 2014

#### 510(k) Number:

K131928:

#### 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 [e-mail]

#### 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

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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 <0.06 mIU/L to 25.54 mIU/L (Slope = 0.977, y-Intercept = 0.17, Sw = 0.28, r = 0.999). Correlation with the expected linearity was excellent showing less than the allowable non-linearity. Performance requirement was verified over the measurement interval.

| FREND™ TSH Linearity | | | | | |
|----------------------|--------|--------|--------|--------|------------|
| % Level | Rep. 1 | Rep. 2 | Rep. 3 | Mean | Linear Fit |
| 0 | 0.01 | 0.01 | 0.03 | 0.017 | 0.173 |
| 10 | 2.85 | 2.78 | 2.78 | 2.803 | 2.714 |
| 20 | 5.61 | 5.37 | 5.47 | 5.483 | 5.255 |
| 30 | 8.47 | 7.80 | 8.53 | 8.267 | 7.796 |
| 40 | 9.60 | 9.43 | 10.62 | 9.883 | 10.337 |
| 50 | 12.2 | 13.17 | 12.51 | 12.627 | 12.878 |
| 60 | 15.63 | 15.64 | 14.27 | 15.180 | 15.418 |
| 70 | 18.72 | 17.43 | 17.63 | 17.927 | 17.959 |
| 80 | 21.88 | 20.09 | 20.37 | 20.780 | 20.500 |
| 90 | 22.38 | 23.37 | 23.68 | 23.143 | 23.041 |
| 100 | 25.91 | 25.32 | 25.40 | 25.543 | 25.582 |

#### FREND™ TSH is linear from 0.06 ~ 25.0 mlU/L

Figure 1

Non-linearity is less than allowable non-linearity: 20% up to 1 mlU/L then 10%.

4

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Comparative Analysis - 438 serum samples obtained from subjects both 1b) apparently normal and with thyroid conditions as well as other undisclosed diseases and conditions and stored at -70° C under monitored conditions for less than one year, were analyzed using both the FREND™ TSH and another commercially available TSH fluorescent immunoassay. Results generated using the FREND™ TSH on the FREND™ System (y) were compared to those obtained using a previously FDA cleared TSH assay (x). Results of this study are shown below:

> 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<br>TSH<br>Conc.<br>(mIU/L) | Interferent | Material<br>added | % Cross<br>Reactivity |
|-----------------------------------|-------------|-------------------|-----------------------|
| 0.49 | hCG | 200,000<br>mIU/mL | 2 x $10^{-8}$ |
| 0.55 | LH | 500<br>mIU/mL | 2 x $10^{-4}$ |
| 0.55 | FSH | 500<br>mIU/mL | -5 x $10^{-6}$ |
| 6.22 | hCG | 200,000<br>mIU/mL | 3 x $10^{-7}$ |
| 6.06 | LH | 500<br>mIU/mL | 3 x $10^{-5}$ |
| 6.06 | FSH | 500<br>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 (<10%) from the tested drugs at the listed concentration that would affect the interpretation of a TSH result as assayed on the FREND™ TSH:

| Tested Drug | Concentration Tested (µM) |
|---------------|---------------------------|
| Acetaminophen | 1324 |
| Diltiazem | 15 |
| Erythromycin | 81.6 |
| Verapamil | 4.4 |

Figure 5

#### Interference from Common Medications

#### 6) High Dose Hook Effect Testing (Prozone Detection)

No High Dose Hook effect was seen in samples with a TSH concentration as high as 2500 mIU/L.

#### 7) Reagent Stability Studies

Reagent stability studies based on procedures and criteria in the NanoEnTek quality system showed that the cartridges for FREND™ TSH are good for at least one year from the date of manufacturer if stored refrigerated appropriately as directed. Stability of the cartridges at room temperature (22~28°C) was found to be six months.

#### 8) Matrix Study

TSH concentrations in 40 sample pairs, each with serum and lithium heparin plasma aliquots, were measured using the FREND™ TSH. Linear regression analysis of serum results (x) compared to lithium heparin plasma results (y) yielded the following equation (r = 0.992, i2 = 0.985), indicating FREND TSH can be measured equally well in serum and lithium heparin plasma:

$$\mathbf{y} = \mathbf{0.995x} - \mathbf{0.320}$$

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### CLIA '88 - Complexity Categorization.

NanoEnTek has a previous reagent cartridge assay cleared by 510(k) in the US and this has been assigned a moderate complexity classification. The predicate TSH device is also marketed as a MODERATE complexity device. The logical assumption is that the FREND™ TSH does not require a high complexity classification and there is a valid argument because of the ease of use for assigning the FREND™ TSH a MODERATE COMPLEXITY categorization.

### Substantial Equivalence

NanoEnTek has developed the FREND™ TSH for the FREND™ system and completed the necessary analytical and clinical validation studies to demonstrate the performance characteristics of the test for use as supporting data for this 510(k) premarket notification and for its claim of substantial equivalence.

In conclusion, the performance study results summarized below support the claim of substantial equivalence of the FREND™ TSH to the Predicate Device. Detailed data is filed in the 510(k) documentation.

## Figure 6 Comparative Characteristics: FREND™ TSH and Predicate Device

| | Device | Predicate |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Items | FREND™ TSH | ST AIA-PACK<br>TSH |
| 510(k) Number | K131928 | K972586 |
| Regulations | 862.1690 Radioimmunoassay, Thyroid Stimulating Hormone | Same |
| Product Code | JLW | Same |
| Device Class | II | Same |
| Intended Use | Quantitative measurement of TSH | Same |
| Indications for Use | To quantitatively measure TSH in serum, heparin plasma | Same |
| Warnings and<br>Precautions | For use in clinical laboratories upon prescription by the attending<br>physician | Same |
| Contra-indications | Should not be used to measure TSH in patients who have<br>received therapeutic doses of mouse monoclonal antibody<br>therapeutics. Not to be used for newborn screening. | Same |
| Similar Assay<br>Sensitivity (LoD) | Measured at 0.06 mIU/L | Measured at<br>0.03 mIU/L |

### Similarities

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| Items | Device | Predicate |
|------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------|
| | FREND™ TSH | ST AIA-PACK<br>TSH |
| Interference from<br>Drugs | No interference found in the drugs that were tested at the<br>concentrations they were tested. | Same |
| Test Vessel | Disposable single-use reaction vessel | Same |
| Sample Type | Serum and lithium heparin plasma | Same |
| Sample Prep | Prepare serum/plasma from whole blood | Same |
| Quality control | Internal procedural/instrument quality controls; External QC at<br>normal and elevated levels. | Same |
| Interpretation of<br>Results | Comparing fluorescence for sample against a standard<br>calibration curve | Same |
| Reaction Type | Antibody/antigen complexes | Same |
| Type of Test | Fluorescent immunoassay detecting TSH | Same |
| Sample Carry-over | None detected - single use cartridge | Same- single<br>use cup |
| Endogenous<br>Interference | None by Bilirubin, Triglyceride, Cholesterol, Total Protein<br>detected in testing performed | Same |
| End Users | Technologists working in a clinical laboratory | Same |
| Result<br>Comparability | Results across the range of 0.09 – 24.96 mIU/L equivalent<br>between ST AIA-PACK TSH and FREND™ TSH | Same |
| Reference Int. | 0.49 – 3.82 mIU/L | 0.47-4.09<br>mIU/L |

### Figure 7

### Comparative Characteristics: FREND™ TSH and Predicate Device

### Differences

| Items | Device | Predicate |
|----------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | FREND™ TSH | ST AIA-PACK PA |
| Random Access/<br>Degree of Automation | No random access, mainly manual<br>manipulation | Random access, semi-<br>automated |
| Test Throughput | Single Test 5 minutes to result. | Single test 18 minutes;<br>50 tests 68 minutes. |
| Calibration Standard | WHO International Standard Hormone,<br>hormone for immunoassay, NIBSC code:<br>81/565 | WHO 2nd International<br>Reference Preparation 80/558<br>(1983) |

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### Figure 8 - Summary

### Performance Validation Studies Supporting Substantial Equivalence

| No. | Study | Summary of Results |
|-----|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Analytical Sensitivity/<br>Limit of Detection<br>(LoD) | FRENDTM TSH Limit of Detection (LoD) was<br>determined to be 0.06 mIU/L. Sensitivity on the<br>predicate device is listed as being 0.03 mIU/L.<br>Similar sensitivity limits. |
| 2. | Interfering Substances | The FRENDTM TSH was tested for interference<br>with endogenous materials such as hemoglobin,<br>bilirubin, triglycerides, and total protein, at levels<br>equivalent to those tested by the predicate<br>device. Neither assay showed clinically significant<br>interference. |
| 3. | Specificity | Specificity testing with biological substances with<br>similar structures (LH, FSH, βHCG) was<br>performed and showed insignificant interference<br>with both the test and predicate devices. |
| 4. | Carry-over | Both the test system and the predicate system<br>use disposable pipette tips and an individual<br>reaction vessel to prevent possible carryover. |
| 5. | Reference Intervals | Independent Reference Intervals were calculated<br>for both the test and predicate devices using the<br>same pool of apparently healthy subjects. The<br>Reference Interval for both methods was<br>determined to be approximately 0.5 – 4.0 mIU/L |
| 6. | Comparability | 438 samples were analyzed on both devices –<br>the TOSO ST AIA-PACKTM TSH and the<br>FRENDTM TSH. Descriptive statistics for the<br>comparability show equivalent performance.<br>Thyroid status was equivalent between methods<br>98.4% of the time in the study. |
| 7. | Precision | Precision Material testing demonstrated<br>acceptable performance throughout the<br>measurement range of the assay for both test and<br>predicate devices. |

### Overall Conclusions from the Document

The information and data in this 510(k) document demonstrate that the FREND™ TSH is an accurate, reliable test that correlates well with current cleared methods for the quantitation of serum and lithium heparin plasma

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TSH. The contents of this submission demonstrate that the FREND™ TSH on the FREND™ system is substantially equivalent to its predicate device and, therefore, safe and effective for its intended use, measuring quantitatively TSH in human serum and lithium heparin plasma.

#### Substantial Equivalence Conclusions

The FREND™ TSH is as safe and effective as the "Predicate Device", the TOSOH ST AIA-PACK™ TSH assay. FREND™ TSH has a similar Intended Use and Indications for Use: the quantitative measurement of TSH in serum and heparinized plasma, similar technological and performance characteristics, and principles of operation as its predicate device. The differences between the FREND™ TSH and its predicate device raise no new issues of safety or effectiveness. Performance data, analytical and clinical, demonstrate that the FREND™ TSH is as safe and effective as the "Predicate Device". Thus, the FREND™ TSH must be found to be substantially equivalent to the TOSOH ST AIA-PACK TSH.

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Public Health Service

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

March 14, 2014

NANOEN TEK USA, INC. C/O JUDITH LOEBEL DOCRO 1 JACKS HILL ROAD, SUITES A & B OXFORD CT 06478

Re: K131928

Trade/Device Name: FRENDTM TSH Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW Dated: February 4, 2014 Received: February 7, 2014

Dear Ms. Loebel:

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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Page 2-Ms. Loebel

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Courtney H. Lias -S

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) k131928

Device Name FREND™ TSH

Indications for Use (Describe)

FREND™ TSH is designed for in viro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulaing 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 as an aid to clinicians in the diagnosis of thyroid discase.

. •

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (1/14)

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