ELECSYS SHBG IMMUNOASSAY

K031717 · Roche Diagnostics Corp. · CDZ · Aug 5, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031717
• Device Name: ELECSYS SHBG IMMUNOASSAY
• Applicant: Roche Diagnostics Corp.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

Immunoassay for the in vitro quantitative determination 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 including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Device Story

Elecsys SHBG Immunoassay is an in vitro diagnostic test for quantitative measurement of SHBG in human serum or plasma. It utilizes electrochemiluminescence immunoassay (ECLIA) technology on Roche Elecsys family analyzers (1010, 2010, E170). The assay measures SHBG levels to assist clinicians in diagnosing androgen-related disorders and interpreting sex hormone concentrations. The device is intended for professional use in clinical laboratory settings. Results are provided to physicians to aid in clinical decision-making regarding endocrine health and hormone balance. The assay offers improved precision and a wider measuring range compared to the predicate device.

Clinical Evidence

No clinical studies performed. Evidence based on analytical bench testing: precision (within-run CV ≤2.7%, total CV ≤4.0%), linearity (85-115% recovery), and analytical specificity (no cross-reactivity with common hormones/proteins). Method comparison with predicate (n=109) showed linear regression y = 1.15x – 1.82, r = 0.981. Matrix comparison (n=44) between serum and Li-heparin plasma showed r = 0.998.

Technological Characteristics

Electrochemiluminescent sandwich immunoassay. Reagents: streptavidin-coated microparticles, biotinylated mouse monoclonal anti-SHBG, ruthenium-labeled mouse monoclonal anti-SHBG. Measuring range: 0.350–200 nmol/L. Standardized against NIBSC 95/560. Analyzers: Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170. Calibrators: equine serum matrix and human SHBG in human serum matrix.

Indications for Use

Indicated for patients requiring quantitative determination of sex hormone binding globulin (SHBG) as an aid in diagnosing androgen disorders (hirsutism, virilization, PCOS, adrenogenital syndrome, hyperandrogenism), interpreting testosterone/estradiol levels, investigating androgen-estrogen balance in gonadal/sexual dysfunction, and assessing peripheral hormone effects.

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

• DPC Immulite SHBG (K941797)

Submission Summary (Full Text)

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K 63/717

Elecsys® SHBG Immunoassay

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Roche Diagnostics Corporation

# SECTION III - 510k Summary

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Elecsys® SHBG Immunoassay Roche Diagnostics Corporation 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics Corporation name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3723 Contact Person: Theresa M. Ambrose Date Prepared: May 28, 2003 の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 Device Name Proprietary name: Elecsys® SHBG Immunoassay System Common name: SHBG test Classification name: Testosterone test system Device A device for the measurement of human SHBG in serum or plasma. Description Intended use For the in vitro quantitative determination of sex hormone binding globulin in human serum and plasma. Indications for An aid in the diagnosis of androgen disorders including hirsuitism, Use virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations

AUG - 5 2003

K 031 717

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## 510(k) Summary, Continued

| Substantial | | The Elecsys SHBG Immunoassay is substantially equivalent to other devices |
|-------------|--|---------------------------------------------------------------------------|
| equivalence | | legally marketed in the United States. We claim equivalence to the DPC |
| | | Immulite SHBG cleared under K941797. Both products are intended for use |
| | | in the quantitative determination of sex hormone binding globulin. |

Substantial The following table compares the Roche Elecsys SHBG Immunoassay with equivalence the predicate device. comparison

| Feature | Elecsys SHBG<br>Immunoassay | DPC Immulite SHBG<br>(predicate) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in-vitro quantitative<br>determination of SHBG in<br>serum and plasma. | For the quantitative<br>measurement of SHBG, as an<br>aid in the differential<br>diagnosis of hirsuitism. |
| Indication for Use | An aid in the diagnosis of<br>androgen disorders including<br>hirsuitism, virilization,<br>polycystic ovarian syndrome,<br>adrenogenital syndrome, and<br>hyperandrogenism;<br>the correct interpretation of<br>testosterone and estradiol<br>concentrations; investigation<br>of the androgen-estrogen<br>balance in gonadal and sexual<br>dysfunction; assessment of<br>the peripheral effect of<br>hormones which regulate<br>SHBG concentrations | For the quantitative<br>measurement of SHBG as an<br>aid in the differential<br>diagnosis of hirsuitism. |
| Assay Protocol | Electrochemiluminescent<br>Immunoassay | Chemiluminescent<br>Immunoassay |
| Traceability / Standardization | 1st International Standard for<br>SHBG NIBSC code 95/560 | DPC's IRMA-Count SHBG<br>assay |
| Feature | Elecsys SHBG<br>Immunoassay | DPC Immulite SHBG<br>(predicate) |
| Calibration Interval | E170/E2010<br>After 1 month when using the same reagent lot After 7 days when using the same reagent kit E1010 With every reagent kit After 7 days (20-25°C) After 3 days (25-32°C) | 2 weeks |
| Sample Type | Human serum and Li-heparin plasma | Human serum |
| Reagent Stability | Unopened Up to stated expiration date stored at 2-8°C Opened 12 weeks at 2-8° 7weeks on E170/ 2010 4 weeks on E1010 (20-25° ambient temp - up to 20 hours opened in total) | 7 days at 2-8°C 2 months at -20°C |
| Calibrator | Elecsys SHBG CalSet | SHBG Adjustors |
| Controls | Elecsys PreciControl<br>Universal 1 and 2 | SHBG Controls |
| Expected Values | Males: 10-80 nmol/L<br><br>Females: 20-130 nmol/L | Males: Central 95% 13-71 nmol/L; Median 32 nmol/L<br><br>Females: Central 95% 18-114 nmol/L; Median 51 nmol/L* |
| Instrument | Elecsys family of analyzers<br>(Elecsys 1010, Elecsys 2010 and Elecsys E170<br>MODULAR Analytics<br>Immunoassay Analyzers) | IMMULITE Analyzers |
| Measuring Range | 0.350-200 nmol/L | 0.2-180 nmol/L |
| Feature | Elecsys SHBG Immunoassay | DPC Immulite SHBG<br>(predicate) |
| Precision | E170<br>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 E1010/2010 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 | Within-run 4.1-7.7 %CV from 4.5-121 nmol/L Total 5.8% - 13% CV from 6.0-105 nmol/L |
| Hook Effect | No high dose hook effect up to 1000 nmol/L | No high-dose hook effect up to 11,000 nmol/L |
| Analytical<br>sensitivity (LDL) | 0.35 nmol/L | 0.2 nmol/L |

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Roche Diagnostics Corporation

#### Elecsys® SHBG Immunoassay

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## 510(k) Summary, Continued

The performance characteristics of the Elecsys SHBG Immunoassay and the Substantial equivalence predicate device are compared in the table below. performance characteristics

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| Feature | Elecsys SHBG Immunoassay | DPC Immulite SHBG (predicate) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations/Warnings/Precautions | No interference from bilirubin up to 60 mg/dL No interference from hemoglobin up to 2.9 g/dL No interference from Intralipid up to 2700 mg/dL No interference with biotin up to 60 ng/mL No interference from rheumatoid factor up to 1160 IU/mL No interference from 16 commonly used pharmaceuticals In patients receiving high biotin doses > 5 mg/dL, sample should not be taken until 8 hours after administration. Erroneous findings may be obtained in samples from patients who have been treated with monoclonal mouse antibodies In rare cases interference due to extremely high titers of antibodies to ruthenium or streptavidin can occur | Lipemia may interfere Fibrin clots may cause erroneous results Results from hemolyzed specimens should be interpreted with caution No interference from packed red blood cells up to 30 uL/mL No interference from bilirubin up to 200mg/L No interference from hemoglobin up to 10000 mg/dL Heterophilic antibodies in human serum can react with assay components to cause interference. SHBG results should be interpreted in conjunction with measures of the hormones with which it binds, notably testosterone. |

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

AUG - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa M. Ambrose, Ph.D., FACB Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250

Re: k031717

> Trade/Device Name: Elecsys® SHBG Immunoassay Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS, CDZ, JJY Dated: May 28, 2003 Received: June 3, 2003

Dear Dr. Ambrose:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Elecsys® SHBG Immunoassay

Roche Diagnostics Corporation

### Indications for Use Statement

510(k) Number (if known): N/A K/31717

Device Name:

#### Elecsys® SHBG Immunoassay

Indications For Use:

Immunoassay for the in vitro quantitative determination 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 including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Albert Sant

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Division Sign-Off for: Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k031717