ELECSYS PSA, MODEL # ELECSYS 1010

K982948 · Boehringer Mannheim Corp. · LTJ · Oct 27, 1998 · Immunology

Device Facts

• Record ID: K982948
• Device Name: ELECSYS PSA, MODEL # ELECSYS 1010
• Applicant: Boehringer Mannheim Corp.
• Product Code: LTJ · Immunology
• Decision Date: Oct 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of cancer patients. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers.

Device Story

Elecsys PSA Assay is an in vitro diagnostic immunoassay for quantitative PSA measurement in human serum/plasma. Operates on Elecsys 1010 analyzer using electrochemiluminescence (ECLIA) sandwich principle. Process: 20 µL sample incubated with biotinylated monoclonal PSA-specific antibody and ruthenium-labeled monoclonal PSA-specific antibody; complex bound to streptavidin-coated microparticles; microparticles magnetically captured on electrode; voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-generated calibration curve using 2-point calibration and reagent bar-coded master curve. Used in clinical laboratory settings by trained personnel. Output provides quantitative PSA levels to assist clinicians in managing cancer patients.

Clinical Evidence

Bench testing only. Method comparison study (N=154) vs. Elecsys 2010 showed high correlation (Least Squares: y=0.9948x - 0.0642, r=0.996; Passing Bablok: y=0.9965x + 0.0112, r=0.996). Analytical sensitivity 0.006 ng/mL; functional sensitivity 0.03 ng/mL. Linearity 0.01-100 ng/mL (±10% deviation). No hook effect up to 17,000 ng/mL.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA); sandwich principle. Uses biotinylated monoclonal antibodies and ruthenium-complex labeled antibodies. Solid phase: streptavidin-coated microparticles. Detection: photomultiplier measurement of chemiluminescent emission induced by electrode voltage. Instrument: Elecsys 1010 (batch analyzer). Reagent storage: 20-25°C.

Indications for Use

Indicated for in vitro quantitative determination of PSA in human serum and plasma; serial measurement of PSA to aid in management of cancer patients.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Elecsys® PSA Assay on Elecsys 2010

Submission Summary (Full Text)

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K9897948

## 510(k) Summary

# Elecsys® PSA on Elecsys 1010

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.<br>Submitter name, address, contact | Boehringer Mannheim Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>[phone] <p>Contact Person: Priscilla A. Hamill</p> <p>Date Prepared: August 13, 1998</p> |
| 2.<br>Device name | Proprietary name: Elecsys® PSA Assay <p>Common name: Electrochemiluminescence assay for the determination of Prostate-Specific Antigen (PSA).</p> <p>Classification name: System, Test, Prostate-Specific antigen</p> |
| 3.<br>Predicate device | We claim substantial equivalence to the Elecsys® PSA Assay on Elecsys 2010. |
| 4.<br>Device Description | The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C). <p>•1st incubation (9 minutes): Sample (20 µL), a biotinylated monoclonal PSA-specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (70 µL) react to form a sandwich complex.</p> <p>•2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.</p> |
| | Continued on next page |

page 25

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## 510(k) Summary, continued

-

| 4.<br>Device<br>Description -<br>con't | •The reaction mixture is aspirated into the measuring cell where the<br>microparticles are magnetically captured onto the surface of the electrode.<br>Unbound substances are then removed with ProCell. Application of a voltage<br>to the electrode then induces chemiluminescent emission which is measured<br>by a photomultiplier (0.4 second read frame).<br>•Results are determined via a calibration curve which is instrument-generated<br>by 2-point calibration and a master curve provided via the reagent bar code. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.<br>Intended use | Immunoassay for the in vitro quantitative determination of Prostate-Specific<br>Antigen in human serum and plasma. The Elecsys PSA assay is further<br>indicated for serial measurement of PSA to aid in the management of cancer<br>patients.<br>The electrochemiluminescence immunoassay "ECLIA" is intended for use on the<br>Boehringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers. |
| 6.<br>Comparison to<br>predicate<br>device | The Boehringer Mannheim, a Roche Diagnostics Company Elecsys® PSA 2nd<br>Gen. Assay has a premarket notification under review for use on the Elecsys<br>2010 immunoassay analyzer. The application of the Elecsys® PSA Assay on<br>the Elecsys 1010 immunoassay analyzer is substantially equivalent to the<br>same assay on the Elecsys 2010.<br>Continued on next page |

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### 510(k) Summary, continued

The following table compares the Elecsys® PSA on the Elecsys 1010 with the predicate device,Elecsys® PSA on the Elecsys 2010. Specific data on the performance of this test for both the Elecsys 1010 and 2010 have been incorporated into the draft labeling in attachment 5.

#### Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of prostate-specific antigen. The assay is further indicated for serial measurement of PSA to aid in the management of cancer patients.

•Assay range: 0-100 ng/ml

• Assay methodology: Sandwich immunoassay

· Cross-Reactivity: None to PAP and ACT

·Specificity: Equimolar recognition of PSA-ACT and free PSA

• Kit (cat. nos. 1731262 & 1731696) on the Elecsys 1010 and 2010

·Sample and reagent volumes

·Reaction temperature and incubation times

•Package insert

Continued on next page

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### 510(k) Summary, continued

6.

Differences:

Comparison to predicate device cont.

| Feature | Elecsys 1010 | Elecsys 2010 |
|--------------------------------|--------------|---------------|
| Instrument<br>required | Elecsys 1010 | Elecsys 2010 |
| Instrument<br>System | Batch | Random access |
| Reagent<br>Storage Temp<br>(C) | 20-25C | 37C |

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#### Performance Characteristics:

| Feature | Elecsys 1010 | Elecsys 2010 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Sensitivity<br>Analytical | 0.006 ng/mL | 0.002 ng/mL |
| Functional | 0.03 ng/mL | 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (with a<br>deviation from a linear line of<br>±10%) | 0.01 - 100 ng/mL (with a<br>deviation from a linear line of<br>±10%) |
| Method<br>Comparison | Vs Elecsys 2010 | |
| | Least Squares<br>$y=0.9948x - 0.0642$<br>r=0.996<br>N=154<br><br>Passing Bablok<br>$y=0.9965x + 0.0112$<br>r=0.996<br>N=154 | |
| Hook Effect | No Hook Effect up to<br>17,000 ng/ml PSA | No Hook Effect up to<br>17,000 ng/ml PSA |

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Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Ms. Priscilla A. Hamill Requlatory Affairs Consultant Roche Diagnostics, Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Tennessee 46250

Re: K982948 Elecsys® PSA Assay Trade Name: Regulatory Class: II Product Code: LTJ Dated: August 14, 1998 Received: August 21, 1998

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

OCT 2 7 1998

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4588. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbrandinq by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

.

Enclosure

.

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K 98 2948 510(k) Number (if known): N/A

Device Name: Elecsys® PSA Assay

Indications For Use:

Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of cancer patients.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use **__**
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number