ELECYSYS SHBG

K102814 · Roche Diagnostics · CDZ · Jan 20, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102814
• Device Name: ELECYSYS SHBG
• Applicant: Roche Diagnostics
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Jan 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

Immunoassay for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys SHBG Immunoassay is an in vitro diagnostic test used to measure sex hormone-binding globulin (SHBG) levels in human serum or plasma. The device utilizes an electrochemiluminescence immunoassay (ECLIA) sandwich assay protocol. It is designed for operation on Roche Elecsys and cobas e immunoassay analyzers by laboratory professionals. The system processes 10 µL samples to provide quantitative results, which are used by clinicians in conjunction with patient medical history and other clinical findings to aid in the diagnosis of androgen disorders. The assay is standardized against the 1st International Standard for SHBG (NIBSC code 95/560).

Clinical Evidence

Bench testing only. Performance was validated through method comparison against a commercially available SHBG assay (n=109), showing a correlation slope of 1.17 and intercept of -3.26. Precision studies demonstrated within-run CVs of 1.1–1.7% and total CVs of 1.8–4.0% on E170/e601 analyzers. Analytical sensitivity reported as LoB 0.500 nmol/L, LoD 0.800 nmol/L, and LoQ 2.00 nmol/L. No high-dose hook effect observed up to 1000 nmol/L. Interference testing confirmed no significant impact from hemoglobin, bilirubin, Intralipid, biotin, or rheumatoid factors.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA) sandwich assay. Analyzers: Elecsys and cobas e series. Sample volume: 10 µL. Traceability: NIBSC 95/560. Measuring range: 0.800–200 nmol/L. Reagent storage: 2-8 °C. Software: Embedded firmware on immunoassay analyzers.

Indications for Use

Indicated for the in vitro quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma as an aid in the diagnosis of androgen disorders.

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 SHBG Test System (K031717)

Submission Summary (Full Text)

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#### 510(k) Summary

JAN 2 0 2011
K10 2814

| Introduction | According to the requirements of 21 CFR 807.92, the following<br>information provides sufficient detail to understand the basis for a<br>determination of substantial equivalence. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>Name,<br>Address,<br>Contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br><br>Contact person: Kelly French<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Secondary contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Date Prepared: September 23, 2010 |
| Device Name | Proprietary names: Elecsys® SHBG Immunoassay System<br><br>Common name: SHBG test<br><br>Classification name: Radioimmunoassay, Testosterones and<br>Dihydrotestosterone |

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| <b>Device Description</b> | A device for the measurement of human SHBG in serum or plasma. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Substantial Equivalence</b> | The Elecsys SHBG Test System is substantially equivalent to other devices legally marketed in the United States. We claim equivalency to the currently marketed Elecsys SHBG Test System (K031717). |

*Continued on next page*

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| Premarket Notification, Traditional 510(k) for | | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Elecsys SHBG Assay | | |
| | Immunoassay Comparison | |
| Feature | Predicate Device: Elecsys SHBG<br>Assay (K031717) | Elecsys SHBG Assay |
| | General Assay Features | |
| Intended<br>Use/<br>Indications<br>for Use | Immunoassay for the <i>in vitro</i><br>quantitative determination of sex<br>hormone-binding globulin in human<br>serum and plasma. | Same |
| | The electrochemiluminescence<br>immunoassay “ECLIA” is intended<br>for use on Elecsys and cobas e<br>immunoassay analyzers. | |
| Assay<br>Protocol | Sandwich assay | Same |
| Detection<br>Protocol | Electrochemiluminescent<br>Immunoassay | Same |
| Application | 18 Minute | Same |
| Instrument<br>Platform | Roche Elecsys 1010, 2010/cobas e<br>411 and MODULAR ANALYTICS<br>E170/cobas e 601 | Same with the exception of the<br>removal of the Elecsys 1010<br>analyzer |
| Sample<br>Volume | 10 µL | Same |
| Sample<br>Type | Human serum and plasma treated with<br>lithium heparin. | Same |
| Traceability | The Elecsys SHBG assay has been<br>standardized against the 1st<br>International Standard for SHBG,<br>NIBSC code 95/560. | Same |
| Calibrator | Elecsys SHBG CalSet | Same |
| Immunoassay Comparison | | |
| Feature | Predicate Device: Elecsys SHGB Assay (K031717) | Elecsys SHBG Assay |
| | General Assay Features | |
| Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows:<br><br>MODULAR ANALYTICS E170, Elecsys 2010 and cobas e analyzers:<br>After 1 month (28 days) when using the same reagent lot After 7 days (when using the same reagent kit on the analyzer) Elecsys 1010 analyzer: With every reagent kit After 7 days (ambient temperature 20-25 °C) After 3 days (ambient temperature 25-32 °C) | Same with the exception of the removal of the Elecsys 1010 analyzer. |
| Controls | Elecsys PreciControl Universal 1 and 2 | Same |

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| Immunoassay Comparison | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Feature | Predicate Device: Elecsys SHBG Assay (K031717) | Elecsys SHBG Assay |
| General assay features | | |
| Reagent<br>Stability/<br>Storage | Store at 2-8 °C. Store the Elecsys SHBG reagent kit upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.<br><br>Stability:<br>Unopened at 2-8 °C—up to the stated expiration date<br>After opening at 2-8 °C—12 weeks<br>On MODULAR ANALYTICS E170 and cobas e 601—7 weeks<br>On Elecsys2010 and cobas e 411—7 weeks<br>On Elecsys 1010- 4 weeks (stored alternately in the refrigerator and on the analyzer – ambient temperature 20-25 °C; up to 20 hours opened in total) | Same with the exception of the removal of the Elecsys 1010 analyzer. |

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| Feature | Predicate Device: Elecsys SHBG Assay (K031717) | Elecsys SHBG Assay | | | | |
|-----------------|-------------------------------------------------------------|----------------------------------------|--------|----------|-----------|------|
| Measuring Range | 0.350-200 nmol/L | 0.800 -200 nmol/L | | | | |
| Expected Values | Males: 10-80 nmol/L<br>Females, non-pregnant: 20-130 nmol/L | Reference ranges for the SHBG (nmol/L) | | | | |
| | | N | Median | 5th Perc | 95th perc | |
| | | Males 20-49 years | 136 | 33.5 | 16.5 | 55.9 |
| | | Males ≥ 50 years | 78 | 40.8 | 19.3 | 76.4 |
| | | Females 21-49 years | 89 | 64.3 | 24.6 | 122 |
| | | Females ≥ 50 years | 71 | 57.4 | 17.3 | 125 |

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| Feature | Immunoassay Comparison | | | | |
|-----------------------------|-------------------------------------------------------------------------------------------------|--------|-------------|--------------------|------|
| | Predicate Device: Elecsys<br>SHBG Assay (K031717)<br>(18 Minute) | | | Elecsys SHBG Assay | |
| Expected<br>Values<br>cont. | Labeled Performance Characteristics | | | | |
| | Reference ranges for Testosterone II (nmol/L) | | | | |
| | N | Median | 5th<br>Perc | 95th<br>perc | |
| | Males<br>20-49<br>years | 136 | 18.6 | 8.64 | 29.0 |
| | Males<br>≥ 50<br>years | 78 | 16.5 | 6.68 | 25.7 |
| | Females<br>21-49<br>years | 89 | 0.941 | 0.290 | 1.67 |
| | Females<br>≥ 50<br>years | 71 | 0.563 | 0.101 | 1.42 |
| | Calculation for obtaining FTI (or FAI):<br>%FTI = (Testosterone (nmol/L) ÷ SHBG (nmol/L)) x 100 | | | | |
| | Reference ranges for Free Testosterone Index (FTI) /<br>Free Androgen Index (FAI) (nmol/L) | | | | |
| | N | Median | 5th<br>Perc | 95th<br>perc | |
| | Males<br>20-49<br>years | 136 | 57.2 | 35.0 | 92.6 |
| | Males<br>≥ 50<br>years | 78 | 38.2 | 24.3 | 72.1 |
| | Females<br>21-49<br>years | 89 | 1.53 | 0.297 | 5.62 |
| | Females<br>≥ 50<br>years | 71 | 1.15 | 0.187 | 3.63 |

Continued on next page

#### 510(k) Summary, continued

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| Immunoassay Comparison | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Feature | Predicate Device: Elecsys SHBG Assay (K031717) (18 Minute) | Elecsys SHBG Assay |
| | Labeled Performance Characteristics | |
| Precision | E1010/ 2010/ 411<br>Within Run 2.1 – 2.7 % CV from 14.1 -204 nmol/L Total 2.6 -5.6% CV from 14.1 -204 nmol/L E170/ e601 Within run 1.1 – 1.7% CV from 14.9 - 219 nmol/L Total 1.8 - 4.0% CV from 14.9 -219 nmol/L | Same with the exception of the removal of the Elecsys 1010 analyzer. |
| Analytical<br>Sensitivity | Limit Detection Level (LDL):<br>0.35 nmol/L | Limit of Blank (LoB): 0.500 nmol/L<br>Limit of Detection (LoD): 0.800 nmol/L<br>Limit of Quantitation (LoQ): 2.00 nmol/L |
| Hook Effect | There is no high-dose hook effect at SHBG concentrations up to 1000 nmol/L | Same |

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| Immunoassay Comparison | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Feature | Predicate Device: Elecsys SHBG Assay (K031717) (18 Minute) | Elecsys SHBG Assay |
| Labeled Performance Characteristics | | |
| Limitations | The assay is unaffected by:<br>Hemoglobin < 2.9 mg/dL Bilirubin < 60 g/dL Intralipid <2700 mg/dL Biotin < 60 ng/mL Rheumatoid factors up to 1160 IU/mL In vitro tests were performed on 16 commonly used pharmaceuticals. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. These effects are minimized by suitable test design. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. | Same |

Continued on next page

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| Feature | | Immunoassay Comparison | | | |
|----------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------|----------------------|
| | | Predicate Device: Elecsys SHBG<br>Assay (K031717) (18 Minute) | | Elecsys SHBG Assay | |
| | | Labeled Performance Characteristics | | | |
| Method<br>Comparison | | A comparison of the Elecsys SHBG assay (y) with a commercially available<br>SHBG assay (x) using clinical samples gave the following correlation:<br>n = 109<br>Min =11.2 nmol/L<br>Max = 155 nmol/L | | Passing/Bablok | Linear<br>Regression |
| | | Slope | | 1.17 | 1.15 |
| | | Intercept | | -3.26 | -1.82 |
| | | Tau / r | | 0.909 | 0.981 |

Confidentiality Roche Diagnostics Corporation requests that the FDA not disclose the nature or existence of the premarket notification until the substantial equivalence decision has been reached.

We trust that the information provided in this Premarket Notification Closing will support a determination of substantial equivalence for the Elecsys SHBG Immunoassay.

> If you should have questions or require further information, please do not hesitate to contact me.

· Phone: [phone] · FAX: [phone] [e-mail]

Sincerely,

Kelly French, RN, BSN, RAC Regulatory Affairs Consultant US Regulatory Submissions Roche Diagnostics Corporation

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Ms. Kelly French Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416 -

JAN 20 201

Re: k102814 Trade Name: Elecsys SHBG Regulation Number: 21 CFR §862.1680 Regulation Name: Radioimmunoassay, testosterone and dihydrotestosterone Regulatory Class: Class I, reserved Product Codes: CDZ Dated: December 15, 2010 Received: December 16, 2010

Dear Ms. French:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): .

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#### Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indication for Use

510(k) Number (if known): K102814

Device Name: Elecsys SHBG

Indication For Use:

Immunoassay for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k102814