ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND

K083867 · Beckman Coulter, Inc. · CDZ · Aug 27, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083867
• Device Name: ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
• Applicant: Beckman Coulter, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Aug 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access Sex Hormone Binding Globulin assay is indicated for use in the assessment of androgen disorders. The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.

Device Story

Access SHBG is a sequential two-step immunoenzymatic (sandwich) assay performed on Access Immunoassay Systems. Input: human serum or plasma sample. Process: sample incubated with paramagnetic particles coated with anti-SHBG antibody; SHBG binds to solid phase; alkaline phosphatase-conjugated anti-SHBG antibody added, binding to a different antigenic site; unbound materials washed away via magnetic field; chemiluminescent substrate (Lumi-Phos 530) added. Output: light production measured by luminometer, proportional to SHBG concentration; concentration determined via stored multi-point calibration curve. Used in clinical laboratory settings by trained personnel. Results aid clinicians in assessing androgen disorders.

Clinical Evidence

Bench testing only. Imprecision study (n=480) showed total CV <7% for concentrations >2 nmol/L. Analytical sensitivity: LoB 0.017 nmol/L, LoD 0.33 nmol/L. Linearity/dilution recovery (100-103%). Interference and cross-reactivity testing per CLSI EP7-A2 showed no significant interference from common endogenous/exogenous substances. Method comparison (n=158) against a commercially available enzyme immunoassay yielded a correlation coefficient of 0.94 (Passing Bablok: slope 1.09, intercept 1.84 nmol/L).

Technological Characteristics

Paramagnetic particle, chemiluminescent two-step sandwich immunoassay. Components: mouse monoclonal anti-SHBG antibodies, alkaline phosphatase conjugate, TRIS buffer, ProClin 300, sodium azide. Energy source: luminometer-based light detection. Form factor: reagent kit for automated immunoassay systems. Connectivity: integrated with Access Immunoassay Systems. Standards: CLSI EP5-A2 (precision), EP7-A2 (interference), EP17-A (LoD/LoB). Traceable to WHO 95/560 reference material.

Indications for Use

Indicated for use in the assessment of androgen disorders in human patients. For prescription use only; for in vitro diagnostic use.

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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AUG 2 7 2009

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: k083867

| Applicant: | Beckman Coulter, Inc.<br>Immunodiagnostics Development Center<br>1000 lake Hazeltine Drive<br>Chaska, MN 55318 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tyler Foutch<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 18, 2009 |
| Reagent<br>Classification Name: | Radioimmunoassay, testosterones and dihydrotestosterone |
| Trade Name: | Access SHBG Reagent* |
| Device Classification: | 21 CFR 862.1680 |
| Device Class: | Class I |
| Classification Panel: | Clinical Chemistry |
| Product Code: | CDZ |
| Calibrator<br>Classification Name: | Calibrator Secondary |
| Trade Name: | Access SHBG Calibrators* |
| Device Classification: | 21 CFR 862.1150 |
| Device Class: | Class II |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JIT |
| Controls<br>Classification Name: | Single (Specified) Analyte Controls (assayed and unassayed) |
| Trade Name: | Access SHBG QC* |
| Device Classification: | 21 CFR 862.1660 |
| Device Class: | Class I |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JJX |

* The Access SHBG assay and the Access UniCel Dxl 800 Immunoassay Analyzer are registered trademarks of Beckman Coulter, Inc.

Beckman Coulter, Inc. Access SHBG

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| Intended Use: | The Access SHBG assay is a paramagnetic particle,<br>chemiluminescent immunoassay for the quantitative<br>determination of Sex Hormone Binding Globulin levels in human<br>serum and plasma using the Access Immunoassay Systems.<br>The Access Sex Hormone Binding Globulin assay is indicated<br>for use in the assessment of androgen disorders. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Access SHBG Calibrators are intended to calibrate the<br>Access SHBG assay for the quantitative determination of Sex<br>Hormone Binding Globulin levels in human serum and plasma<br>using the Access Immunoassay Systems. |
| | The Access SHBG QC is intended for monitoring system<br>performance of the Access SHBG assay. |
| Device Description: | The Access SHBG assay is a sequential two-step<br>immunoenzymatic ("sandwich") assay. A sample is added to a<br>reaction vessel along with paramagnetic particles coated with<br>anti-SHBG antibody. During incubation, the SHBG antigen in<br>the sample binds to the immobilized anti-SHBG antibody on the<br>solid phase. Alkaline phosphatase conjugated anti-SHBG<br>antibody is then added and reacts with a different antigenic site<br>on the SHBG molecule. After incubation in a reaction vessel,<br>materials bound to the solid phase are held in a magnetic field<br>while unbound materials are washed away. Then, the<br>chemiluminescent substrate Lumi-Phos 530 is added to the<br>vessel and light generated by the reaction is measured with a<br>luminometer. The light production is directly proportional to the<br>concentration of SHBG in the sample. The amount of analyte in<br>the sample is determined from a stored, multi-point calibration<br>curve. |

Predicate Device:

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DPC Immulite SHBG" (K941797)

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** The IMMULITE SHBG assay and IMMULITE 2000 analyzer are registered trademarks of Siemens Healthcare Diagnostics.

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# Reagents:

## Similarities

| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Type | Immunoassay | Immunoassay |
| Intended Use | The Access SHBG assay is a<br>paramagnetic particle,<br>chemiluminescent immunoassay for<br>the quantitative determination of Sex<br>Hormone Binding Globulin levels in<br>human serum and plasma using the<br>Access Immunoassay Systems.<br>The Access SHBG assay is indicated<br>for use in the assessment androgen<br>disorders. | For in vitro diagnostic use with the<br>IMMULITE 2000 Analyzer-for the<br>quantitative measurement of SHBG in<br>serum, as an aid in the differential<br>diagnosis of hirsutism. |
| Assay Format | Chemiluminescent, two-site sandwich<br>immunoassay | Chemiluminescent, two-site sandwich<br>immunoassay |
| Sample types | Human serum or plasma (heparin). | Human serum or plasma (heparin). |
| Method | Access SHBG was compared to the predicate device. | |
| Comparison | 158 samples ranging 5.7 nmol/L to 184.5 nmol/L were evaluated and the<br>correlation coefficient obtained was 0.94. | |
| Differences | | |
| Characteristics | Access SHBG Immunoassay ' | DPC Immulite SHBG (predicate) |
| Composition | Access Reagent Pack<br>Well R1a: Paramagnetic particles<br>coated with mouse monoclonal anti-<br>SHBG, protein (bovine, mouse)<br>buffered matrix, <0.1% sodium azide,<br>0.1% ProClin.<br>Well R1b: Mouse monoclonal anti-<br>SHBG alkaline phosphate (bovine)<br>conjugate, buffered matrix with protein<br>(bovine). <0.1% sodium azide, 0.1%<br>ProClin.<br>Well R1c: TRIS buffer with <0.1%<br>sodium azide and 0.1% ProClin 300. | SHBG Bead Pack<br>200 beads, coated with monoclonal<br>murine anti-SHBG.<br>SHBG Reagent Wedge<br>11.5 mL alkaline phosphatase (bovine calf<br>intestine) conjugated to polyclonal rabbit<br>anti-SHBG antibody in buffer. |
| Analytical<br>Sensitivity | Limit of Blank 0.017 nmol/L.<br>Limit of Detection 0.33 nmol/L | 0.2 nmol/L |
| Interferences | The Access SHBG assay utilized the<br>CLSI EP7-A2 guidance evaluating a<br>high and low patient sample spiked<br>with interferents at a high and low<br>levels. The Access did not show<br>significant interference with<br>triglycerides (Intralipid), protein<br>(human serum albumin), bilirubin,<br>cortisol, hemoglobin, estradiol,<br>testosterone, 5α-DHT, 11-<br>Deoxycortisol acetaminophen,<br>acetylsalicylic acid, alpha-fetoprotein<br>(AFP), heparin, ibuprofen, GAS6,<br>laminin, multivitamin supplement<br>thyroglobulin (Tg), thyroxine-binding<br>globulin (TBG), transferrin at relevant<br>levels. | The DPC device exhibits no interference<br>with 30 µL/mL of packed red blood cells,<br>200 mg/L bilirubin, 100,000 ng/mL<br>cortisol, 5 g/dL protein (human serum<br>albumin). 20.000 ng/mL testosterone,<br>3,600 pg/mL estradiol, 20,000 ng/mL 5a-<br>DHT, and 4000 ng/mL 11-Deoxycortisol. |
| Analytical Range | 0.33 nmol/L to ~200 nmol/L | 0.2 nmol/L to 180 nmol/L. |
| Analytical<br>Specificity | The Access SHBG assay utilized the<br>CLSI EP7-A2 quidance evaluating a<br>high and low patient sample spiked<br>with interferents at a high and low<br>levels. The Access did not show<br>significant cross-reactivity with 5a-<br>dihydroxytestosterone, 11-<br>deoxycotrisol, estradiol, GAS6,<br>laminin, protein S, testosterone,<br>alpha-fetoprotein, thyroglobulin,<br>thyroxine-binding globulin, and<br>transferrin. | The DPC assay exhibits no cross-<br>reactivity with 400 IU/mL alpha-<br>fetoprotein, 300 ng/mL thyroglobulin, 193<br>µL thyroxine-binding globulin, and 4<br>mg/mL transferrin. |
| Expected Values | Males (20-50 years of age), 151<br>subjects, mean 38.2 nmol/L; 95<br>Percentile, 13.3-89.5 nmol/L. | Males, 122 subjects, mean 32 nmol/L; 95<br>Percentile, 13-71 nmol/L. |
| | Females (non-pregnant, 20-46 years<br>of age), 141 subjects, mean 47.2<br>nmol/L; 95 Percentile 18.2-135.5<br>nmol/L.<br>Females (post-menopausal 47-91<br>years of age) 131 subjects, mean<br>49.6 nmol/L; 95 Percentile, 16.8-125.2<br>nmol/L. | Females (non-pregnant), 111 subjects,<br>mean 51 nmol/L; 95 Percentile, 18-114<br>nmol/L. |

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Beckman Coulter, Inc.
Access SHBG , 510(k) Summary

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# Reagents:

Beckman Coulter, Inc.
Access SHBG

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510(k) Summary

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# Access SHBG
OIVD 510(k) Submission: 510(k) Summary

## Calibrators

#### Similarities

| Characteristics | Access SHBG Immunoassay | DPC IMMULITE SHBG (predicate) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Access SHBG Calibrators are<br>intended to calibrate the Access<br>SHBG assay for the quantitative<br>determination of Sex Hormone<br>Binding Globulin levels in human<br>serum and plasma using the Access<br>Immunoassay Systems. | IMMULITE Adjustors (Low, High) are used<br>for calibrating the quantitative IMMULITE<br>SHBG assay on the IMMULITE 2000<br>systems. |

#### Differences

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| Differences | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
| Calibrator<br>Components | S0: Lyophilized buffered protein<br>(bovine) matrix, <0.1% sodium azide,<br>0.5% Proclin 300<br>S1-S5: Lyophilized purified human<br>SHBG, protein (bovine) buffered<br>matrix, at levels of approximately 3, 9,<br>27, 80 and 200 nmol/L, with <0.1%<br>sodium azide, 0.5% ProClin 300. | Two vials (Low and High) of lyophilized<br>SHBG in a nonhuman protein/buffer<br>matrix. |
| Traceability | WHO 95/560 | DPC's IRMA-Count SHBG assay |

Beckman Coulter, Inc. Access SHBG

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510(k) Summary

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# Controls

#### Similarities

| Characteristics | Access SHBG Immumoassay | DPC IMMULITE SHBG (predicate) |
|-----------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | The Access SHBG QC is intended for<br>monitoring system performance of the<br>Access SHBG assay. | IMMULITE SHBG Controls are used for<br>monitoring system performance of the<br>IMMULITE SHBG assay. |

#### Differences

| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Calibrator<br>Components | QC1: Lyophilized purified human<br>SHBG at a level of approximately 10<br>nmol/L, protein (bovine) buffered<br>matrix, <0.1% sodium azide, 0.5%<br>ProClin 300.<br>QC2: Lyophilized purified human<br>SHBG at a level of approximately 100<br>nmol/L, protein (bovine) buffered<br>matrix, <0.1% sodium azide, 0.5%<br>ProClin 300. | Two vials (LSHC1, LSHC2) of lyophilized<br>SHBG in a nonhuman protein/buffer<br>matrix. |

Beckman Coulter, Inc.
Access SHBG .

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510(k) Summary

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### Summary of Analytical Studies

#### Imprecision:

This assay exhibits a total imprecision of <7% at concentrations greater than 2nmol/L. The study consisted of four patient samples at varying SHBG levels, on three separate pack lots, in duplicate, running for 20 different days, completing 2 runs per day, over a period of 28 days on two Dxl 800 instruments provided the following data, analyzed via analysis of variance (ANOVA).

| | Mean<br>(n=480) | Within-run | | Total | |
|----------|-----------------|------------|--------|-------|--------|
| SampleID | (nmol/L) | SD | CV (%) | SD | CV (%) |
| 1 | 6.3 | 0.3 | 4.7 | 0.3 | 5.4 |
| 2 | 38 | 1.8 | 4.6 | 2.0 | 5.3 |
| 3 | 80 | 3.6 | 4.5 | 4.4 | 5.5 |
| 4 | 171 | 8.1 | 4.8 | 9.0 | 5.2 |

A polynomial regression of all imprecision data (4 samples spanning the range of the assay), provides an overall estimation of the imprecision. Data was further analyzed utilizing linear modeling plotting the log of the sample concentration by the log of the standard deviation, as shown in the following table, and determining the upper limit of 95% confidence interval of this regression fit.

| Dose (nmol/L) | Estimated CV% | Estimated SD |
|---------------|---------------|--------------|
| 2 | 5.3% | 0.11 |
| 5 | 5.3% | 0.27 |
| 10 | 5.3% | 0.53 |
| 15 | 5.3% | 0.79 |
| 25 | 5.3% | 1.32 |
| 40 | 5.3% | 2.11 |
| 60 | 5.3% | 3.17 |
| 80 | 5.3% | 4.22 |
| 100 | 5.3% | 5.27 |
| 150 | 5.3% | 7.89 |
| 180 | 5.3% | 9.47 |

Beckman Coulter, Inc. Access SHBG

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Analytical Sensitivity:

Limit of Blank (Analytical Sensitivity)

Limit of Blank (LoB) for Access SHBG was determined to be 0.017 nmol/L. LoB was tested using a protocol based on CLSI EP17-A. The 97.5% upper confidence limit of this estimate was determined as LoB.

#### Limit of Detection

Limit of Detection (LoD) of Access SHBG assay was determined to be 0.33 nmol/L, based on the lowest level sample where the beta-percentile (defined as the percentage of observations below LoB) was 5% or less. The LoD study was run under a protocol based on CLSI EP17-A.

Dilution Recovery (Linearity): Dilution recovery studies were performed by diluting three serum samples at 206.58 nmol/L (sample 1), 35.81 nmol/L (sample 2), and 2.90 nmol/L (sample 3) respectively, with Access Wash Buffer II. Sample mean recovery values were 103% Mean Recovery for sample 1. 101% Mean Recovery for sample 2. and 100% Mean Recovery for sample 3.

#### Methods Comparison (External Site):

A comparison of 158 values, with a range of observations of 5.7-184.5 nmol/L, using the Access SHBG assay on the UniCel Dxl 800 immunoassay system and a commercially available enzyme immunoassay system gave the following statistical data using Passing Bablok calculations:

- Intercept (95% Confidence Interval)= 1.84 (0.54-3.00) nmol/L ●
- Slope (95% Confidence Interval)= 1.09 (1.06-1.12) .
- Correlation Coefficient (r2)= 0.94 .

Beckman Coulter, Inc. Access SHBG

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Analytical Specificity: There was no significant interference from compounds tested based on EP7-A2. Compounds include Acetaminophen, Acetylsalicylic acid, Alpha-Fetoprotein (AFP), conjugated and unconjugated Bilirubin, Cortisol, 11-deoxycortisol, 5a-dihydroxytestosterone, Hemoglobin, Heparin, Human serum albumin (HSA), Ibuprofen, Estradiol, GAS6, Laminin, Multivitamin supplement, Protein S, Testosterone, Thyroglobulin (Tg), Thyroxine-binding Globulin (TBG), Transferrin, Triglycerides (Intralipid).

Additionally, there was no cross-reactivity for molecules tested based on EP7-A2. Molecules include Alpha-Fetoprotein, Cortisol, 5α-dihydroxytestosterone, 11-deoxycortisol, Estradiol, GAS6, Laminin, Protein S, Testosterone, Thyroglobulin (Tg), Thyroxine-binding Globulin (TBG), Transferrin.

Stability: SHBG reagents are stable for 28 days after opening, calibrators are stable for 28 days after opening, and controls are stable for 28 days after opening. The calibration curve is stable for 28 days.

#### Conclusion

As summarized above the Access SHBG, SHBG Calibrators, and SHBG QC on the Access Immunoassay Systems are substantially equivalent to the DPC Immulite SHBG assay for the measurement Sex Hormone Binding Globulin in serum or plasma. Substantial equivalence for the reagent and calibrators has been demonstrated as recommended by the FDA quidance for Industry "Format for Traditional and Abbreviated 510(k)s" (Issued on August 12, 2005) and for controls as recommended by the FDA Guidance for Industry "Points to Consider Document on Assaved and Unassayed Quality Control Material" (Draft Guidance released for comment on February 3, 1999).

Beckman Coulter, Inc. Access SHBG

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Beckman Coulter, Inc. c/o Mr. Tyler Foutch 1000 Lake Hazeltine Dr. Chaska, MN 55318-1084

AUG 2 7 2009

Re: k083867

> Trade/Device Name: Access Sex Hormone Binding Globulin Reagent Regulation Number: 21 CFR § 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved Product Code: CDZ, JIT, JJX Dated: July 20, 2009 Received: July 22, 2009

Dear Mr. Foutch:

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 of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H

Courtney C. Harper, Ph.D. Acting 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): k083867

Device Name: Access Sex Hormone Binding Globulin Reagent

For in vitro diagnostic use.

Indication For Use:

The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access Sex Hormone Binding Globulin assay is indicated for use in the assessment of androgen disorders.

The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.

The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.

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

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

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

Carol Benson

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

510(k) K083867

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