ELECSYS PSA, MODEL 2010

K982949 · Boehringer Mannheim Corp. · LTJ · Oct 27, 1998 · Immunology

Device Facts

• Record ID: K982949
• Device Name: ELECSYS PSA, MODEL 2010
• 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 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 immunoassay analyzer.

Device Story

Elecsys PSA Assay is an in vitro diagnostic immunoassay for quantitative PSA measurement in human serum and plasma. Used on the Boehringer Mannheim Elecsys 2010 analyzer, the device employs a sandwich electrochemiluminescence immunoassay (ECLIA) principle. Input consists of 20 µL patient sample incubated with biotinylated monoclonal PSA-specific antibody and ruthenium-labeled monoclonal PSA-specific antibody. Streptavidin-coated microparticles bind the complex to a solid phase. The mixture is magnetically captured on an electrode; unbound substances are washed away. Voltage application induces chemiluminescent emission, measured by a photomultiplier. Results are calculated via a 2-point calibration curve and master curve provided by reagent bar code. The assay aids clinicians in managing cancer patients through serial PSA monitoring. The system is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=60 per level), analytical sensitivity (0.002 ng/mL), functional sensitivity (0.03 ng/mL), and linearity (0.002-100 ng/mL). Method comparison against the 1st Gen. predicate (N=108) yielded a correlation of r=0.998 (Passing Bablok: y=1.0335x + 0.219). Hook effect testing showed no interference up to 17,000 ng/mL.

Technological Characteristics

Sandwich electrochemiluminescence immunoassay (ECLIA). Uses biotinylated monoclonal antibodies and ruthenium-labeled monoclonal antibodies with streptavidin-coated microparticles. Energy source: electrical voltage applied to electrode to induce chemiluminescence. Detection: photomultiplier. Connectivity: reagent bar code for master curve input. System: Elecsys 2010 immunoassay analyzer.

Indications for Use

Indicated for in vitro quantitative determination of PSA in human serum and plasma to aid in the 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 1st Gen. (K964351/S1)

Submission Summary (Full Text)

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## 510(k) Summary

## Elecsys® PSA on Elecsys 2010

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| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.<br>Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Road<br>Indianapolis, In 46250<br>[phone] |
| | Contact Person: Priscilla A. Hamill |
| | Date Prepared: August 14, 1998 |
| 2.<br>Device name | Proprietary name: Elecsys® PSA Assay<br>Common name: Electrochemiluminescence assay for the determination of<br>Prostate-Specific Antigen (PSA). |
| | Classification name: System, Test , Prostate-Specific antigen |
| 3.<br>Predicate<br>device | We claim substantial equivalence to the Elecsys® PSA 1st Gen.<br>(K964351/S1). |
| 4.<br>Device<br>Description | The Elecsys® test principle is based on sandwich principle. Total duration of<br>assay: 18 minutes (37° C).<br>• 1st incubation (9 minutes): Sample (20 µL), a biotinylated monoclonal PSA-<br>specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled<br>with a ruthenium complex (70 µL) react to form a sandwich complex.<br>• 2nd incubation (9 minutes): After addition of streptavidin-coated<br>microparticles (40 µL), the entire complex is bound to the solid phase via<br>interaction of biotin and streptavidin. |
| 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 immunoassay analyzer |
| 6.<br>Comparison to<br>predicate<br>device | The Boehringer Mannheim, a Roche Diagnostics Company Elecsys® PSA, 1st<br>Gen. is cleared for use on the Elecsys 2010 immunoassay analyzer<br>(K964351/S1). The application of the Elecsys® PSA, 2nd Gen. Assay on the<br>Elecsys 2010 immunoassay analyzer is substantially equivalent to the Elecsys<br>PSA, 1st Gen. assay. |

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The following table compares the Elecsys® PSA, 2nd Gen. with the predicate device, Elecsys® PSA, 1st Gen. Specific data on the performance of this test for Elecsys 2010 and Elecsys 1010, 2nd Gen. (separate premarket notification) 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

· Application to Elecsys 1010 and 2010 immunoassay analyzers

·Reaction temperature and incubation times

·Performance specifications

#### Differences:

·Capture antibody

·Sample and reagent volumes

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| Feature | Elecsys PSA, 2nd Gen. | | | Elecsys PSA, 1st Gen. | | |
|----------------|-------------------------|--------|------|-------------------------|--------|------|
| Precision | Modified NCCLS (ng/mL): | | | Modified NCCLS (ng/mL): | | |
| Level | HS1 | HS2 | HS3 | HS1 | HS2 | HS3 |
| N | 60 | 60 | 60 | 60 | 60 | 60 |
| Mean | 0.30 | 4.76 | 51.1 | 0.29 | 13.9 | 48.5 |
| Within-Run %CV | 1.8 | 2.5 | 2.2 | 1.5 | 1.8 | 1.6 |
| Total %CV | 2.4 | 2.9 | 3.8 | 2.9 | 2.3 | 2.3 |
| | Modified NCCLS (ng/mL): | | | Modified NCCLS (ng/mL): | | |
| | PC-TM1 | PC-TM2 | | PC-TM1 | PC-TM2 | |
| N | 60 | 60 | | 60 | 60 | |
| Mean | 2.33 | 17.2 | | 1.88 | 14.0 | |
| Within-Run %CV | 2.5 | 2.3 | | 1.1 | 1.2 | |
| Total %CV | 2.7 | 2.9 | | 2.1 | 2.2 | |

### Performance Characteristics:

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#### F.

Substantial
equivalence, cont.

#### Performance Characteristics:

| Feature | Elecsys PSA, 2nd Gen. | Elecsys PSA, 1st Gen. |
|-----------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Sensitivity<br>Analytical<br>Functional | 0.002 ng/mL<br>0.03 ng/mL | 0.002 ng/mL<br>0.03 ng/mL |
| Linearity | 0.002 - 100 ng/mL (with a<br>deviation from a linear line<br>of ±10%) | 0.002 - 100 ng/mL (with a<br>deviation from a linear line of<br>±10%) |
| Method<br>Comparison | Vs Elecsys PSA, 1st Gen. (on<br>2010) | |
| | Least Squares<br>$y=1.0098x + 0.734$<br>r=0.998<br>N=108 | |
| | Passing Bablok<br>$y=1.0335x + 0.219$<br>r=0.998<br>N=108 | |
| Hook Effect | No Hook Effect up to<br>17,000 ng/ml PSA | No Hook Effect up to<br>15,000 ng/ml PSA |

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Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with three curved lines below them.

OCT 2 7 1998 Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics, Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Tennessee 46250

Re : K982949 Elecsys® PSA Assay Trade Name: Requlatory Class: II Product Code: LTJ Dated: Auqust 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 leqally 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.

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 Requlations, 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 beqin 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 diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and 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 Toutman

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

Enclosure

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K982949

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 immunoassay analyzer.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |

Cater E. Mokerin
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices KG83749
510(k) Number