ACCESS DHEA-S REAGENT ASSAY

K040181 · Beckman Coulter, Inc. · JKC · Mar 24, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040181
• Device Name: ACCESS DHEA-S REAGENT ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: JKC · Clinical Chemistry
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1245
• Device Class: Class 1

Intended Use

The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems. Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of adrenocortical diseases, as well as in the evaluation of adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. Patients with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, with persons overall androgen contribution to the defect in this disorder. The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Device Story

Competitive immunoenzymatic assay; uses anti-DHEA-S antibody-coated paramagnetic particles and DHEA-S labeled with alkaline phosphatase. Patient serum/plasma sample mixed with reagents in reaction vessel; enzyme conjugate competes with sample DHEA-S for antibody binding sites. Magnetic field retains bound materials; unbound washed away. Chemiluminescent substrate added; light production inversely proportional to DHEA-S concentration. Used on Access Immunoassay Systems (Access, Access 2, UniCel Dxl800, Synchron LXi725) in clinical laboratory settings. Output is quantitative DHEA-S concentration calculated via stored multi-point calibration curve. Results assist clinicians in diagnosing adrenal disorders and evaluating androgen-related conditions.

Clinical Evidence

Bench testing only. Method comparison study (n=263) against the Immulite DHEA-SO4 assay demonstrated a slope of 1.028, intercept of 6.6, and correlation coefficient (r) of 0.993. Imprecision studies across five levels (n=80 per level) showed within-run C.V.s ranging from 1.6% to 8.3% and total imprecision C.V.s ranging from 3.7% to 11.3%.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Reagents are liquid-stable. Calibrators derived from stabilized bovine serum albumin. Designed for use on Access Immunoassay Systems. Quantitative measurement of DHEA-S in serum/plasma.

Indications for Use

Indicated for quantitative measurement of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma. Used for differential diagnosis of adrenocortical diseases, evaluation of adrenal tumors, and assessment of hirsute female patients and patients with polycystic ovary syndrome.

Regulatory Classification

Identification

A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

Predicate Devices

• Immulite DHEA-SO4 Reagent (K935806)
• Access Ultrasensitive hGH Calibrators (K003098)

Submission Summary (Full Text)

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KO40181

### 510(k) Summary

#### Submitted By: 1.0

Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: [phone] FAX: [phone]

#### Date Submitted 2.0

January 26, 2004

#### Device Name(s): 3.0

Proprietary Names 3.1 Access® DHEA-S Reagent Access® DHEA-S Calibrators

Classification Names 3.2 3.2 Calibrator (21 CFR § 862.1150)

#### Legally Marketed Device 4.0

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|------------------------------|------------------------------------------|--------------------------------|------------------|
| Access DHEA-S Reagent | Immulite DHEA-SO4<br>Reagent | Diagnostic Products,<br>Corp.* | K935806 |
| Access DHEA-S<br>Calibrators | Access Ultrasensitive hGH<br>Calibrators | Beckman Coulter, Inc. | K003098 |

*Diagnostic Products, Corp., Los Angeles, CA

** Beckman Coulter, Inc., Chaska, MN

#### Device Description 5.0

The Access® DHEA-S Reagent is designed for optimal performance on the Access family of The Access® DriEA-S Reagent is dosigned or op. Access 2, Unicel Parties Comments Createms utilize a ന്നീധിരക്ടാം Systems, Indusing The Access Immunoassay Systems utilize and SYNCHRON EX® T25 Gilnoar andiyEstor the for quantitative analyte measurement. compellive biriding inimalloonizments two 50-test reagent packs and is packaged The Access DHEA-S Calibrators are separately from the associated calibrators. separately "Iron" the "disociation" call:a.ler" of the DHEA-S Reagent for generation of the Access designed for use with the Access Britiz's Access Immunoassay Systems. The Access callbration curve 'or 'Bookman' '60 mL bottles, one for each of six calibrator levels.

#### Intended Use 6.0

The Access DHEA-S assay is a paramagnetic particle, chemiluminescent inhumor The Access DrilLA-0 assay is a paramaghotic parantosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems. The Access DHEA-S Selum and prasma using the Access DHEA-S assay for the quantitative Calibrators are intended to oalbrate the Research in human serum and plasma using the Access Immunoassay Systems.

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#### Comparison to the Predicate 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary:

| Access DHEA-S<br>Reagent | Similarities | |
|--------------------------|----------------------------|-------------------------------------------------------|
| | Intended Use | Same as Diagnostic Products |
| | Methodology | Immulite DHEA-SO4 Reagent |
| | Antibody source (rabbit) | |
| | Chemiluminescent substrate | |
| | Liquid-stable reagents | |
| | Differences | |
| | Sample Type | DHEA-S: Serum, Plasma<br>DHEA-SO4: Serum |
| | Sample Volume | DHEA-S: 10 µL<br>DHEA-SO4: 5 µL |
| | Reportable Range | DHEA-S: 2 - 1000 µg/dL<br>DHEA-SO4: 15-1000 µg/dL |
| | Analytical Sensitivity | DHEA-S: 2 µg/dL<br>DHEA-SO4: 3 µg/dL |
| | Calibrator Matrix | DHEA-S: Liquid-stable<br>DHEA-SO4: Lyophillized |
| | Calibration Scheme | DHEA-S: 6-point curve<br>DHEA-SO4: 2-point adjustment |

The Access DHEA-S Calibrators and the predicate calibrator utilize the same test methodology specific to Access Immunoassay Systems. Each calibrator is intended for use in a different analyte test system. Both calibrators are derived from a stabilized bovine serum albumin preparation. The Access DHEA-S Calibrators are liquid stable while the predicate calibrator is lyophilized and requires preparation.

#### 8.0 Summary of Performance Data

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Assay equivalence is demonstrated through method comparison, linearity, and imprecision experiments.

| Access DHEA-S Method Comparison Study Results | | | | | |
|-----------------------------------------------|-------|-----------|-------|-----|-------------------------|
| Candidate Method | Slope | Intercept | r | n | Predicate Method |
| Access DHEA-S Assay | 1.028 | 6.6 | 0.993 | 263 | Immulite DHEA-SO4 Assay |

| Sample | Mean (µg/dL) | S.D. (µg/dL) | %C.V. | N |
|---------|--------------|------------------------|-------|----|
| | | Within-Run Imprecision | | |
| Level 1 | 10.3 | 0.86 | 8.3 | 80 |
| Level 2 | 34.4 | 1.10 | 3.2 | 80 |
| Level 3 | 123.9 | 5.90 | 4.8 | 80 |
| Level 4 | 347.3 | 8.92 | 2.6 | 80 |
| Level 5 | 736.1 | 12.10 | 1.6 | 80 |
| | | Total Imprecision | | |
| Level 1 | 10.3 | 1.16 | 11.3 | 80 |
| Level 2 | 34.4 | 1.76 | 5.1 | 80 |
| Level 3 | 123.9 | 7.99 | 6.4 | 80 |
| Level 4 | 347.3 | 15.40 | 4.4 | 80 |
| Level 5 | 736.1 | 27.20 | 3.7 | 80 |

Access DHEA-S Estimated Imprecision

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human figures.

MAR 2 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kaemer Blvd., W-104 P.O. Box 8000 Brea, California 92822-8000

Re: k040181

> Trade/Device Name: Access® DHEA-S Reagent and Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT: JKC Dated: January 26, 2004 Received: January 27, 2004

Dear Ms. Tang:

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).

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Page 2

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.

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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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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# Indications for Use

## 510(k) Number (if known): K040181

## Device Name: Access® DHEA-S Reagent and Calibrators

Indications For Use:

The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay The Access DFIEA O doody is a para. Regiveroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Measurement of dehydroepiandrosterone sulfate may be used in the differential Measurement of "donyarooplanars well as in the evaluation of adrenocortical diseases, diagnosis of Ouoning o cynaremer as ia and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. PHEA with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, with persons overal androgen contribution to the defect in this disorder.

The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay The Accoss Drill F O commination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert C. G.

Page 1 of

Division Sign-Qff

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040181