ACTIVE® Free Testosterone RIA

K191350 · Immunotech S.R.O. · CDZ · Dec 20, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191350
• Device Name: ACTIVE® Free Testosterone RIA
• Applicant: Immunotech S.R.O.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The ACTIVE® Free Testosterone RIA is a radioimmunoassay for the quantitative determination of free testosterone in human serum.

Device Story

Radioimmunoassay (RIA) kit; measures free testosterone levels in human serum; utilizes polyclonal capture antibody; modification involves change in polyclonal capture antibody; fundamental scientific technology remains unchanged from predicate; intended for clinical laboratory use; provides quantitative results for diagnostic assessment of testosterone levels.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the modified polyclonal capture antibody.

Technological Characteristics

Radioimmunoassay (RIA) test system; utilizes polyclonal capture antibody; in vitro diagnostic reagent kit; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the quantitative determination of free testosterone in human serum for clinical chemistry diagnostic purposes.

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Predicate Devices

• ACTIVE® Free Testosterone RIA (K952281)

Submission Summary (Full Text)

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December 20, 2019

Immunotech s.r.o. Vit Oburka Ouality and Regulatory Affairs Manager Radiova 1 Prague, 102 27 Cz

Re: K191350

Trade/Device Name: ACTIVE® Free Testosterone RIA Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: November 25, 2019 Received: November 25, 2019

Dear Vit Oburka:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191350

Device Name ACTIVE® Free Testosterone RIA

#### Indications for Use (Describe)

Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.

Free testosterone test is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

| 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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Image /page/3/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract symbol on the left and the word "IMMUNOTECH" in blue bold letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller letters.

# 510k Summary ACTIVE® Free Testosterone RIA

# 1. Submitted by:

Vit Oburka Quality and Regulatory Affairs Manager IMMUNOTECH s.r.o. Radiova 1, 102 27 Prague Czech Republic Tel.: [phone] Email: [e-mail]

# 2. Date of preparation:

October 19, 2019

# 3. Device Identification

| Proprietary Name: | ACTIVE® Free Testosterone RIA |
|--------------------|-------------------------------|
| Common Name: | Free Testosterone |
| Classification: | Class I, reserved |
| Product Codes: | CDZ |
| Regulation Number: | 21 CFR 862.1680 |

# 4. Predicate Device

| Proposed Device | Predicate | Manufacturer | License<br>Number |
|----------------------------------|----------------------------------|-------------------|-------------------|
| ACTIVE® Free<br>Testosterone RIA | ACTIVE® Free<br>Testosterone RIA | IMMUNOTECH s.r.o. | K952281 |

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#### Description 5.

#### Kit Content:

#### Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use)

Plastic tubes with rabbit anti-testosterone immunoglobulin immobilized to the inside wall of each tube.

#### 125|-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use)

At the time of manufacture, the vial contains 185 kBq, (<5 µCi), of 120-labeled testosterone analog in buffer with proteins (BSA), sodium azide (<0.1%) and a dye.

Calibrators: one 1.0 mL vial labeled 0, and seven 0.5 mL vials labeled 1-7 (ready-touse)

The calibrator vials contain from 0 to approximately 100 pg/mL (0 to approximately 346.7 pmol/L) of free testosterone in human serum with sodium azide (< 0.1%). The exact concentration is indicated on each vial label. Once opened, store at 2-8°C for up to 3 weeks, or at < -20°C until expiration date of kit. The calibrator values were established using an internal standard.

#### Controls: two 0.5 mL vials labeled 1, 2 (ready-to-use)

The vials contain free testosterone in human serum with sodium azide (<0.1%). The expected values are in the concentration range indicated in a supplement found in the kit. Once opened, store at 2-8°C for up to 3 weeks, or at < -20°C until expiration date of kit.

#### Principle

The radioimmunoassay of free testosterone is a competitive assay. The procedure follows the basic principle of radioimmunoassay where there is competition between a radioactive and a non-radioactive antigen for a mixed number of antibody binding sites. The amount of [125]]-labeled testosterone analog bound to the antibody is inversely proportional to the concentration of unlabeled free testosterone present. The separation of the free and bound antigen is achieved by decanting or aspirating the antibody-coated tubes. A standard curve is constructed and unknown free testosterone values are obtained from the curve by interpolation.

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Image /page/5/Picture/0 description: The image shows the Immunotech logo. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller, non-bold letters.

#### 6. Intended use:

Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.

Free testosterone test is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

#### Clinical Significance:

Free Testosterone is often measured in conjunction with other androgens (DHEA/DHEA-S, androstenedione, 17α-hydroxyprogesterone), SHBG and gonadotropins (LH and FSH) to evaluate reproductive abnormalities in children, men and women.

#### 7. Comparison to Predicate(s):

The following tables shows similarities and differences between the predicate identified in Section 4. of this summary.

Similarities between the Predicate Device and the Proposed Device:

| | Predicate | Proposed Device |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary and<br>Established<br>Names | ACTIVE® Free Testosterone<br>RIA | ACTIVE ® Free Testosterone<br>RIA |
| Antibody | Polyclonal Rabbit<br>Testosterone Antiserum,<br>A140, DSL | Polyclonal Rabbit<br>Testosterone Antibody, 20-<br>TR05T, Fitzgerald |
| Intended use | Same<br>Radioimmunoassay for the<br>quantitative measurement of<br>free testosterone in human<br>serum. This assay is intended<br>for in vitro diagnostic use. | Same<br>Radioimmunoassay for the<br>quantitative measurement of<br>free testosterone in human<br>serum. This assay is intended<br>for in vitro diagnostic use. |
| Principal<br>Warning and<br>Precautions | | Same |
| Materials<br>Provided | | Same |
| Materials<br>required, but not<br>provided | | Same |
| Specimen<br>collection,<br>processing, | | Same |

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Image /page/6/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, it says "A BECKMAN COULTER COMPANY" in smaller, black letters.

| storage and<br>dilution | |
|-------------------------|------|
| Procedure | Same |
| Quality Control | Same |
| Packaging | Same |
| Stability | Same |

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Image /page/7/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, it says "A BECKMAN COULTER COMPANY" in smaller, regular font.

These are the study results from the validation and verification activities conducted to support the change in polyclonal antibody.

Information describing new proposed assay:

| IFU Claim | Proposed Device | | | | | | |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------|-----------------|----------------------------------|---------------------------------|---------------------------|
| Expected<br>Values<br>Claim<br>expansion<br>through<br>stratification | Each laboratory should establish its own reference ranges. | | | | | | |
| Men (age in years) | n | Median<br>(pg/mL) | Min<br>(pg/mL) | Max<br>(pg/mL) | 2.5th<br>Percentile<br>(pg/mL) | 97.5th<br>Percentile<br>(pg/mL) | |
| 20-29 | 30 | 15.40 | 7.54 | 27.79 | 8.68 | 25.09 | |
| 30-39 | 30 | 14.94 | 6.77 | 22.36 | 8.85 | 21.40 | |
| 40-49 | 30 | 11.48 | 7.37 | 20.47 | 7.56 | 18.64 | |
| 50 and<br>above | 30 | 9.05 | 4.52 | 15.05 | 5.72 | 14.21 | |
| All | 120 | 12.35 | 4.52 | 27.79 | 6.76 | 22.76 | |
| Women | n | Median<br>(pg/mL) | Min<br>(pg/mL) | Max<br>(pg/mL) | 2.5th<br>Percentile<br>e (pg/mL) | 97.5th<br>Percentile<br>(pg/mL) | |
| Follicular<br>Phase | 32 | 1.48 | 0.59 | 4.28 | 0.64 | 3.41 | |
| Luteal<br>Phase | 32 | 1.44 | 0.59 | 3.31 | 0.60 | 2.95 | |
| Preovulatory Peak | 21 | 1.51 | 0.81 | 3.79 | 0.90 | 3.79 | |
| Postmenopausal | 13 | 1.17 | 0.33 | 1.97 | 0.36 | 1.85 | |
| Contraceptives | 19 | 1.45 | 0.49 | 2.81 | 0.57 | 2.70 | |
| Random Women | n | Median<br>(pg/mL) | Min<br>(pg/mL) | Max<br>(pg/mL) | 2.5th<br>Percentile<br>e (pg/mL) | 97.5th<br>Percentile<br>(pg/mL) | |
| All | 120 | 1.29 | 0.33 | 4.28 | 0.49 | 2.87 | |
| Boys | n | Median<br>(pg/mL) | Min<br>(pg/mL) | Max<br>(pg/mL) | 2.5th<br>Percentile<br>e (pg/mL) | 97.5th<br>Percentile<br>(pg/mL) | |
| | Infant | 18 | < 0.13 | < 0.13 | 0.31 | < 0.13 | 0.28 |
| | Child | 48 | 0.56 | 0.13 | 12.79 | 0.16 | 12.65 |
| | Adolescent | 30 | 15.10 | 1.71 | 32.09 | 1.88 | 28.55 |
| | Boys | N | Median (pg/mL) | Minimum (pg/mL) | Maximum (pg/mL) | 2.5th Percentile (pg/mL) | 97.5th Percentile (pg/mL) |
| | 6 months-9 years | 36 | 0.20 | <0.13 | 0.62 | <0.13 | 0.54 |
| | 10-11 years | 20 | 0.67 | 0.41 | 5.11 | 0.42 | 5.00 |
| | 12-13 years | 20 | 6.21 | 0.60 | 27.21 | 0.63 | 23.27 |
| | Girls | n | Median (pg/mL) | Min (pg/mL) | Max (pg/mL) | 2.5th Percentile (pg/mL) | 97.5th Percentile (pg/mL) |
| | Infant | 34 | < 0.13 | < 0.13 | 0.42 | < 0.13 | 0.33 |
| | Child | 55 | 0.46 | < 0.13 | 2.53 | < 0.13 | 1.90 |
| | Adolescent | 30 | 1.37 | 0.57 | 3.27 | 0.64 | 3.23 |
| | Girls | N | Median (pg/mL) | Minimum (pg/mL) | Maximum (pg/mL) | 2.5th Percentile (pg/mL) | 97.5th Percentile (pg/mL) |
| | 6 months-9 years | 69 | 0.24 | <0.13 | 0.86 | <0.13 | 0.57 |
| | 10-12 years | 20 | 0.88 | 0.37 | 2.53 | 0.41 | 2.25 |
| | 13-16 years | 20 | 1.42 | 0.57 | 3.27 | 0.65 | 3.24 |
| Performance characteristic<br>Measured<br>according to<br>CLSI<br>guidelines | <b>Sensitivity</b><br>Limit of Blank (LoB) of 0.05 pg/mL.<br>Limit of detection (LoD): 0.13 pg/mL<br>Limit of Quantitation (LoQ): 0.37 pg/mL<br><br><b>Specificity</b><br>The antibody used in the immunoassay is highly specific for free testosterone.<br>Low cross reactivities were obtained against several related molecules. | | | | | | |

IMMUNOTECH s.r.o. Radiová 1, 102 27 Praha 10 tel.: [phone] tel.: [phone] E-mail: [e-mail] www.immunotech.cz

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Image /page/8/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract shape on the left and the word "IMMUNOTECH" in bold blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller letters.

tel.: [phone]
tel.: [phone]

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Image /page/9/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract shape on the left and the word "IMMUNOTECH" in bold blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller black letters. The logo is clean and professional, and the colors are consistent.

| | Precision<br>Repeatability and within-laboratory precision<br>For repeatability the coefficients of variation were<br>found below or equal to 13.2% for serum samples. For within laboratory<br>precision the coefficients of variation were found below or equal to 19.3% for serum samples. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Measurement range | Measurement range (from LoQ to the highest calibrator): 0.37 pg/mL to approximately 100 pg/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Interference<br>New data CLSI<br>guidelines | Substance Interferent concentration Hemoglobin 641 µg/mL Conjugated bilirubin 199 µg/mL Unconjugated bilirubin 92.7 µg/mL Biotin 1,020 ng/mL Ascorbic acid 40.5 µg/mL Ibuprofen 122 µg/mL Cholesterol 0.75 mg/mL Heparin 7,248 ng/mL Prednisone 384 ng/mL Prednisolone 1,294 ng/mL Protein (γ-globulin) 49.5 mg/mL Rheumatoid factor 3.45 IU/mL Acetylsalicylic acid 24.2 µg/mL Triglycerides 3.35 mg/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Linearity | Criterion Result Linear throughout the measuring range of the kit (from LoQ to the highest calibrator) Linear within 0.30 – 114.11 pg/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cross-reactivity<br>Different methodology<br>of cross-reactivity<br>testing | Pooled normal serum Compound Cross-reactant conc. (ng/mL) Cross reactivity (%) 19-Nortestosterone 8.62 0.068 11-Ketotestosterone 102 0.020 11beta-Hydroxytestosterone 14.1 0.029 Androstenediol 14.8 0.010 Methyltestosterone 96.5 0.017 Androstenedione 92.4 0.006 Norethindrone 1,056 0.001 5α-Androstane-3α,17β-diol 1,076 0.002 5β-Androstane-3,17-dione 1011 ND 5α-Androstane-3,17-dione 846 0.001 Danazol 921 0.001 Estradiol 946 0.001 Progesterone 956 0.001 Deoxycorticosterone 911 ND | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

tel.: [phone]
tel.: [phone]

E-mail: [e-mail]
www.immunotech.cz

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Image /page/10/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, the text "A BECKMAN COULTER COMPANY" is written in a smaller, sans-serif font.

| Androsterone | 1.002 | ND |
|--------------------------------------|-----------------------|-------------|
| Epiandosterone | 943 | ND |
| DHEA | 896 | ND |
| Estriol | 882 | ND |
| Estrone | 913 | ND |
| Corticosterone | 951 | ND |
| Cortisol | 857 | ND |
| Pregnenolone | 944 | ND |
| DHT | 168 | 0.020 |
| Androstanediol Glucuronide | 1,031 | ND |
| DHEA-S | 922 | ND |
| 5α -Androstan-3β, 17β diol | 98.0 | 0.005 |
| rhSHBG | 10,407 | ND |
| ND = Non-Detectable (< 0.1%) | | |
| | Pooled depleted serum | |
| Compound | | Cross |
| | Crossreactant conc. | reactivity |
| | (ng/ml) | (%) |
| 19-Nortestosterone | 43.6 | 0.116 |
| 11-Ketotestosterone | 6.59 | 0.026 |
| 11beta-Hydroxytestosterone | 2.62 | 0.029 |
| Androstenediol | 91.6 | 0.024 |
| Methyltestosterone | 11.1 | 0.005 |
| | | 0.004 |
| Androstenedione | 10.5 | |
| Norethindrone | 40.0 | 0.002 |
| 5α -Androstane-3α,17β -diol | 749 | ND |
| 5ß -Androstane-3,17-dione | 746 | ND |
| 5a -Androstane-3,17-dione | 747 | ND |
| Danazol | 79.2 | 0.001 |
| Estradiol | 820 | ND |
| Progesterone | 8,330 | ND |
| Deoxycorticosterone | 7,681 | ND |
| Androsterone | 8,280 | ND |
| Epiandosterone | 7,634 | ND |
| DHEA | 8,362 | ND |
| Estriol | 8,981 | ND |
| | 8,442 | ND |
| Estrone | | |
| Corticosterone | 7,197 | ND |
| Cortisol | 79,944 | ND |
| Pregnenolone | 83,919 | ND |
| DHT | 96.1 | 0.013 |
| Androstanediol Glucuronide | 8,111 | ND |
| DHEA-S | 89,418 | ND |
| 5α -Androstan-3β, 17β diol<br>rhSHBG | 43.1<br>10,407 | 0.001<br>ND |

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Image /page/11/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract symbol on the left and the word "IMMUNOTECH" in blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller, black letters.

| Method<br>comparison | The current version Active® Free Testosterone RIA (Method A) was compared to previous version Active® Free Testosterone RIA (Method B): | | | | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------|--------|-----------|--------|
| | n | Range (pg/mL) | Slope | Intercept | R |
| | 278 | 0.26 – 101.21 | 1.0078 | 0.0759 | 0.9956 |

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Image /page/12/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, resembling interconnected bars. To the right of the symbol is the word "IMMUNOTECH" in bold, blue letters. Below "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in a smaller, non-bold font.

#### 8. Performance Characteristics - Analytical Performance

Performance characteristics were measured to align product with current industry standards (data measured according to CLSI guidelines).

#### 9. Conclusion:

The conclusions drawn from the non-clinical testing (discussed above) supports a substantial equivalence decision.

Verification of the changes does not raise any new items of safety and effectiveness.