Elecsys Testosterone II

K211685 · Roche Diagnostics · CDZ · May 6, 2022 · Clinical Chemistry

Device Facts

• Record ID: K211685
• Device Name: Elecsys Testosterone II
• Applicant: Roche Diagnostics
• Product Code: CDZ · Clinical Chemistry
• Decision Date: May 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 immunoassay analyzer. Measurements 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.

Device Story

Elecsys Testosterone II is an in vitro diagnostic immunoassay for quantitative testosterone measurement in human serum and plasma. It utilizes a competitive electrochemiluminescence immunoassay (ECLIA) principle on the cobas e 601 analyzer. The reagent kit includes streptavidin-coated microparticles, biotinylated monoclonal anti-testosterone antibodies, and a ruthenium-labeled testosterone derivative. The analyzer performs a competitive binding reaction; signal intensity is inversely proportional to the testosterone concentration in the sample. Results are calculated via a master curve calibrated by a 2-point calibration using the reagent barcode. The device is intended for use by laboratory professionals in clinical settings. Output is a quantitative testosterone value (ng/dL or nmol/L) used by clinicians to diagnose and monitor androgen-related endocrine disorders. The device provides standardized results traceable to ID-GC/MS, aiding in clinical decision-making for conditions like hypogonadism, puberty disorders, and virilization.

Clinical Evidence

No clinical data. Evidence consists of analytical performance testing including precision (CLSI EP05-A3), linearity, analytical specificity/interference (CLSI EP07-A3), and method comparison against the predicate device (Passing-Bablok regression: Y = 0.948x + 0.023, R = 0.998).

Technological Characteristics

Competitive ECLIA; streptavidin-coated microparticles; biotinylated monoclonal anti-testosterone antibody; ruthenium-labeled testosterone derivative. Analyzed on cobas e 601. Traceable to ID-GC/MS. Measuring range 12-1500 ng/dL. Reagents include MES buffer (pH 6.0) and preservatives.

Indications for Use

Indicated for in vitro quantitative determination of testosterone in human serum and plasma to aid in diagnosis and treatment of androgen-related disorders, including primary/secondary hypogonadism, delayed/precocious puberty, and male impotence; and in females, hirsutism and virilization due to tumors, polycystic ovaries, or adrenogenital syndromes.

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

• Elecsys Testosterone II (k093421)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2022

Roche Diagnostics Justin Davis Regulatory Affairs Manager 9115 Hague Road, PO Box 50416 Indianapolis, Indiana 46250

Re: K211685

Trade/Device Name: Elecsys Testosterone II Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: February 4, 2022 Received: February 7, 2022

Dear Justin Davis:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) k211685

Device Name

Elecsys Testosterone II

Indications for Use (Describe)

Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.Measurements 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) due to tumors, polycystic ovaries, and adrenogenital syndromes.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Elecsys Testosterone II 510(k) Summary

# K211685

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

In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).

The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys Testosterone II on the cobas e 601.

| Submitter Name | Roche Diagnostics |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 9115 Hague Road<br>P.O. Box 50416<br>Indianapolis, IN 46250-0457 |
| Contact | Justin Davis<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | May 27, 2021 |
| Proprietary Name | Elecsys Testosterone II |
| Common Name | Testosterone II Assay |
| Classification Name | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Product Codes,<br>Regulation Numbers | CDZ<br>21 CFR 862.1680 |
| Predicate Devices | Elecsys Testosterone II (K093421) |
| Establishment Registration | Roche Diagnostics GmbH Mannheim, Germany: 9610126<br>Roche Diagnostics GmbH Penzberg, Germany: 9610529<br>Roche Diagnostics Indianapolis, IN United States: 1823260 |

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#### 1. DEVICE DESCRIPTION

The Elecsys Testosterone II immunoassay makes use of a competitive test principle using streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2point calibration and master curve provided with the reagent bar code. The Elecsys Testosterone II reagent kit consists of a Reagent Pack (R1, R2, and M (Streptavidin-coated microparticles)).

#### 2. INDICATIONS FOR USE

Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

Measurements 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.

#### TECHNOLOGICAL CHARACTERISTICS 3.

The reagent working solutions include:

Rack Pack (kit placed on the analyzer).

- . M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidincoated microparticles 0.72 mg/mL; preservative.
- R1 Anti-testosterone-Ab~biotin (gray cap), 1 bottle, 10 mL: Biotinylated monoclonal . anti-testosterone antibody (sheep) 40 ng/mL: releasing reagent 2-bromoestradiol: MES buffer 50 mmol/L, pH 6.0; preservative.
- R2 Testosterone-peptide~Ru(bpy)=+ (black cap), 1 bottle, 9 mL: Testosterone derivative, . labeled with ruthenium complex 1.5 ng/mL; MES buffer 50 mmol/L, pH 6.0; preservative.

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The following table compares the updated Elecsys Testosterone II with its predicate device, the current Elecsys Testosterone II (K093421).

| Feature | Candidate Device<br>Elecsys Testosterone II (K211685) | Predicate Device<br>Elecsys Testosterone II (K093421) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Immunoassay for the in vitro quantitative<br>determination of testosterone in human<br>serum and plasma.<br>The electrochemiluminescence<br>immunoassay “ECLIA” is intended for use<br>on the cobas e 601 immunoassay analyzer | Same |
| Indications for<br>Use | Measurements of testosterone are used in<br>the diagnosis and treatment of disorders<br>involving the male sex hormones<br>(androgens), including primary and<br>secondary hypogonadism, delayed or<br>precocious puberty, impotence in males<br>and, in females hirsutism (excessive hair)<br>and virilization (masculinization) due to<br>tumors, polycystic ovaries, and<br>adrenogenital syndromes. | Same |
| Assay Method | Competitive Principle | Same |
| Detection<br>Method | Electrochemiluminescence immunoassay<br>(ECLIA) | Same |
| Instrument<br>Platform | cobas e 601 | Same |
| Sample<br>Type/Matrix | Human serum, plasma | Same |
| Traceability/<br>Standardization | ID-GC/MS ("Isotope Dilution - Gas<br>Chromatography/Mass Spectrometry"). | Same |
| Sample<br>Anticoagulants | Li-heparin, K2-EDTA and K3-EDTA<br>plasma. | Same |
| Calibrator | Testosterone II CalSet II<br>Calibrators 1 and 2 | Same |
| Calibration<br>Method | Traceability: This method has been<br>standardized via ID-GC/MS (“Isotope<br>Dilution - Gas Chromatography/Mass<br>Spectrometry”). Every Elecsys reagent set<br>has a barcoded label containing specific<br>information for calibration of the particular<br>reagent lot. The predefined master curve is<br>adapted to the analyzer using the relevant<br>CalSet. | Same |
| Feature | Candidate Device<br>Elecsys Testosterone II (K211685) | Predicate Device<br>Elecsys Testosterone II (K093421) |
| Calibration<br>Interval | Calibration must be performed once per<br>reagent lot using fresh reagent (i.e. not<br>more than 24 hours since the reagent kit<br>was registered on the analyzer). Calibration<br>interval may be extended based on<br>acceptable verification of calibration by the<br>laboratory.<br>Renewed calibration is recommended as<br>follows:<br>• after 1 month (28 days) when using the<br>same reagent lot<br>• after 7 days (when using the same reagent<br>kit on the analyzer)<br>• as required: e.g. quality control findings<br>outside the defined limits. | Same |
| Controls | Controls for the various concentration<br>ranges should be run individually at least<br>once every 24 hours when the test is in use,<br>once per reagent kit, and following each<br>calibration.<br>The control intervals and limits should be<br>adapted to each laboratory's individual<br>requirements. Values obtained should fall<br>within the defined limits. Each laboratory<br>should establish corrective measures to be<br>taken if values fall outside the defined<br>limits. | Same |
| Reagent<br>Stability | unopened at 2-8 °C up to the stated<br>expiration date<br>after opening at 2-8 °C 12 weeks<br>on the analyzer 8 weeks | Same |
| Measuring<br>Range | 2.50-1500 ng/dL or 0.087-52.0 nmol/L<br>(defined by the Limit of Detection and the<br>maximum of the master curve). | Same |

### Technical Characteristics Comparison Table between updated Table 1: Elecsys Testosterone II and current Elecsys Testosterone II

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| Feature | Candidate Device<br>Elecsys Testosterone II (K211685) | Predicate Device<br>Elecsys Testosterone II (K093421) |
|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Precision was evaluated on one cobas e<br>601 analyzer according to CLSI guideline<br>EP05-A3. The protocol consisted of testing<br>5 Aliquots of each control (PreciControl<br>Universal level 1 and PreciControl<br>Universal level 2) and human serum<br>samples (HS1-HS5) per run, 1 run per day<br>for 5 days with 3 lots. Repeatability and<br>intermediate precision (SD and CV values)<br>were calculated according to CLSI<br>EP05-A3. | Precision was evaluated on one 2010<br>analyzer according to CLSI guideline EP05-<br>A. The protocol consisted of testing 5<br>Aliquots of each control (PreciControl<br>Universal level 1 and PreciControl Universal<br>level 2) and human serum samples (HS1-<br>HS5) per run, 1 run per day for 5 days with 3<br>lots. Repeatability and intermediate precision<br>(SD and CV values) were calculated<br>according to CLSI EP05-A. |
| Precision | Precision was determined using Elecsys<br>reagents, human serum and controls in a<br>protocol (EP05-A3) of the CLSI (Clinical<br>and Laboratory Standards Institute): 2 runs<br>per day in duplicate each for 21 days (n =<br>84). | Precision was determined using Elecsys<br>reagents, pooled human sera and controls in a<br>separate study according to protocol (EP5-A)<br>of the CLSI (Clinical and Laboratory<br>Standards Institute): 2 runs per day in<br>duplicate each for 21 days (n = 84). |
| LoB | 1.50 ng/dL or 0.052 nmol/L | Limit of Blank: 1.2 ng/dL |
| LoD | 2.50 ng/dL or 0.087 nmol/L | Same |
| LoQ | 12.0 ng/dL or 0.416 nmol/L | Same |

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| Feature | Candidate Device<br>Elecsys Testosterone II (K211685) | | | Predicate Device<br>Elecsys Testosterone II (K093421) | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------|
| Cross Reactivity | Cross-Reactant | Concentration<br>(ng/mL) | Cross-<br>Reactivity<br>[%] | Cross-Reactant | Concentration<br>(ng/mL) | Cross-<br>Reactivity<br>[%] |
| | DHEA-S | 50000 | 0.003 | DHEA-S | 50000 | < 0.003 |
| | Androstenedione | 100 | 3.15 | Androstenedione | 100 | < 2.50 |
| | Danazol | 1000 | 0.504 | Danazol | 1000 | < 0.500 |
| | Estradiol | 5000 | 0.211 | Estradiol | 1000 | < 0.160 |
| | Ethisterone | 300 | 3.57 | Ethisterone | 1000 | < 2.40 |
| | 19-<br>Norethisterone | 40 | 5.51 | 19-<br>Norethisterone | 40 | < 6.00 |
| | Norgestrel | 1000 | 0.539 | Norgestrel | 1000 | < 0.910 |
| | △5-Androstene-<br>3β17β-diol | 1000 | 0.289 | △5-Androstene-<br>3β17β-diol | 1000 | < 0.290 |
| | Testosterone<br>propionate | 100 | 0.718 | Testosterone<br>propionate | 100 | < 2.46 |
| | 5α-Androstane-<br>3β, 17β-diol | 500 | 2.15 | 5α-Androstane-<br>3β, 17β-diol | 1000 | < 2.11 |
| | 5α-<br>Dihydrotestosterone | 500 | 1.30 | 5α-<br>Dihydrotestosterone | 500 | < 0.860 |
| | 11β-OH-<br>Testosterone | 50 | 20.6 | 11β-OH-<br>Testosterone | 100 | < 18.0 |
| | 11keto-<br>Testosterone | 200 | 4.87 | 11keto-<br>Testosterone | 1000 | < 3.22 |
| | Prednisone | 5000 | n.d. | Prednisone | 1000 | n.d. |
| | Prednisolone | 5000 | n.d. | Prednisolone | 1000 | n.d. |
| | Progesterone | 5000 | 0.009 | Progesterone | 1000 | < 0.002 |
| | Cortisol | 5000 | n.d. | Cortisol | 1000 | <0.010 |
| | Cortisone | 5000 | n.d. | Cortisone | 2000 | n.d. |
| | Dexamethasone | 5000 | n.d. | Dexamethasone | 2000 | n.d. |
| | Estrone | 5000 | n.d. | Estrone | 1000 | <0.004 |
| DHEA | 5000 | 0.014 | DHEA | 1000 | < 0.016 | |
| Biotin | This assay has no biotin interference in<br>serum concentrations up to<br>1200 ng/mL | | | < 30 ng/mL | | |
| Special Drug<br>Interference | Testosterone Undecanoate or Nandrolone.<br>Both strongly interfered with Testosterone<br>and produced elevated recovery values. | | | None | | |
| Method<br>Comparison | Updated Elecsys Testosterone II Biotin<br>assay on the cobas e 601 analyzer (y)<br>compared to current Elecsys Testosterone II<br>assay on the cobas e 601 analyzer (x). | | | Elecsys Testosterone II assay on the<br>cobas e 801 analyzer (y) with the Elecsys<br>Testosterone II assay on the cobas e 601<br>analyzer (x). | | |

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| Feature | | Candidate Device<br>Elecsys Testosterone II (K211685) | | Predicate Device<br>Elecsys Testosterone II (K093421) |
|---------|-------------------------------------|-------------------------------------------------------|-------------------------------------|-------------------------------------------------------|
| | Passing/Bablok | Linear regression | Passing/Bablok | Linear regression |
| | $y = 0.948x + 0.023$<br>$T = 0.976$ | $y = 0.950x - 0.871$<br>$r = 0.998$ | $y = 0.961x - 0.015$<br>$T = 0.975$ | $y = 0.958x - 0.006$<br>$r = 0.999$ |

#### NON-CLINICAL PERFORMANCE EVALUATION 4.

The non-clinical performance studies for Elecsys Testosterone II are summarized below. The following performance data are provided in support of the substantial equivalence determination:

- Precision (5-Day and 21-Day) according to CLSI EP5-A3 .
- Analytical Sensitivity: LoB, LoD and LoQ according to CLSI EP17-A2 .
- Linearity according to CLSI EP6-A .
- Endogenous Interferences Hemoglobin, Intralipid, Bilirubin, and Rheumatoid Factors .
- Biotin Interference (CLSI EP07-A3) .
- Common Drug Interferences .
- Special Drug Interferences .
- Analytical Specificity/ Cross Reactivity (CLSI EP17-A2) .
- Matrix Comparison Anticoagulants .
- Method Comparison to Predicate .
- Reagent Stability (CLSI EP25-A) .
- . Lot Calibration Stability (CLSI EP25-A)

All performance specifications were met.

#### 4.1. Precision

#### 21 Day Precision 4.1.1.

Precision was evaluated on one cobas e 601 analyzer according to CLSI guideline EP05-A3. The protocol consisted of testing 2 replicates of 2 controls and 5 samples.

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Each control and sample underwent 2 runs per day over 21 days using 1 reagent lot. Repeatability and intermediate precision were calculated according to CLSI EP05-A3. Assay calibration was done as specified in the package insert.

#### 4.1.2. 5 Day Precision

Precision was evaluated on one cobas e 601 analyzer according to CLSI guideline EP05-A3. The protocol consisted of testing 5 Aliquots of each control (PreciControl Universal Level 1 and Level 2) and human serum samples per run, 1 run per day for 5 days with 3 lots.

Repeatability and intermediate precision were calculated according to CLSI EP05-A3. Assay calibration was done as specified in the package insert.

#### Analytical Sensitivity 4.2.

Analytical Sensitivity limits (LoB, LoQ) were determined using CLSI EP17-A2.

These studies and acceptance criteria have been reviewed and found to be acceptable. These data support the LoB, LoD, LoQ claims as reported in the package labeling.

#### Linearity/Assay Reportable Range 4.3.

For linearity, one lot was tested on one cobas e 601 with one run. One human serum sample with high analyte content above the measuring range was diluted to the lower end of the measuring range with various amounts of human serum sample without analyte content. The dilution series contained 25 steps. Samples were assayed in 3-fold determinations. Data Analysis was determined according to CLSI EP06-A.

#### Endogenous Interferences 4.4.

The effect on quantitation of analyte in the presence of endogenous interfering substances was determined for testosterone concentrations and a dilution set of the added interfering substances.

The endogenous interference study and acceptance criteria have been reviewed and found to be acceptable. These data supports the endogenous interferences claims as reported in the package labeling.

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#### Biotin Interference 4.5.

One aliguot of each testosterone sample was spiked with biotin up to 3600 ng/mL. Another aliquot of the sample was spiked with the same volume of the interfering endogenous substance (without interfering substance). The recovery (absolute deviation or % recovery) was calculated for each sample compared to the expected value. Data supports the biotin interference claim of to ≤ 1200 ng/mL, as reported in the package labeling.

#### 4.6. Common Drug Interferences

The common drug interference study and acceptance criteria have been reviewed and found to be acceptable. These data supports the common drug interferences claims as reported in the package labeling.

#### Special Drug Interferences 4.7.

The effect on quantitation of analyte in the presence of drugs was determined by comparing values obtained from samples spiked with one special pharmaceutical compound with the reference sample (unspiked). All samples used were Native sample pools. Samples (with testosterone concentrations near 0.5 ng/mL and near 5.0 ng/mL) were divided into aliquots and spiked with the special drug interferents, Testosterone Undecanoate. The reference sample without drug was spiked with the respective amount of solvent.

#### Analytical Specificity/Cross-Reactivity 4.8.

The analytical specificity of the Elecsys Testosterone II assay was determined with one reagent lot on one cobas e 601 analyzer using a human serum matrix with one testosterone level (0.5 ng/mL). The sample aliquots were spiked with potential cross-reactants. These data supports the analytical specificity claims as reported in the package labeling.

#### Sample Matrix Comparison 4.9.

The effect on quantitation of analyte in the presence of anticoagulants on the Elecsys Testosterone II assay were determined. All samples used were Native or spiked samples. Values obtained from serum samples (reference) were compared to Li-Heparin, K2-EDTA and K3-EDTA plasma. At least 40 serum/plasma pairs were tested in one run on one cobas e 601 analyzer. Data was assessed by Passing/Bablok regression analysis.

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### 4.10. Method Comparison to Predicate

Serum samples were measured internally using both the current and updated reagent formulations. One hundred sixty eight (168) samples that span the measuring range were tested with one run per sample (no replicates). To sufficiently cover the measuring range, Native single samples and spiked single samples were used. Equivalence of the current Elecsys Testosterone II (K093421) assay and the updated Elecsys Testosterone II assay were evaluated using:

• Calculation: Scatter-plot of numerical values of the current assay (x-axis) versus the updated assay (y-axis).

• Passing-Bablok analysis for slope and intercept was performed for the updated lot against the current lot.

## 4.11. Stability Studies

The stability studies and acceptance criteria have been reviewed and found to be acceptable. The stability data supports the claims as reported in the package labeling.

#### 5. CONCLUSIONS

The information provided in this 510(k) Premarket Notification will support a determination of substantial equivalence for the Elecsys Testosterone II. The data from the analytical studies demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.