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 measure of PSA to aid in the management of prostate cancer.

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

Device Description

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37°C).
·1st incubation (9 minutes): Sample (40 µL), a biotinylated monoclonal PSA-specific antibody (60 uL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (60 uL) react to form a sandwich complex.
·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
•The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
•Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criteria	Elecsys 1010 Reported Performance	Elecsys 2010 (Predicate) Performance
Lower Detection Limit	0.006 ng/mL	0.002 ng/mL
Functional Detection Limit	0.07 ng/mL	0.03 ng/mL
Linearity	0.01 - 100 ng/mL (deviation $\pm$ 10%)	0.01 - 100 ng/mL (deviation $\pm$ 10%)
Method Comparison (vs 2010)	y=0.9978x + 0.0040, r=0.9915 (Least Squares)y=0.9825x + 0.0935, r=0.9915 (Passing Bablock)	Not shown/Applicable
Hook Effect	No Hook Effect up to 15,000 ng/ml PSA	No Hook Effect up to 15,000 ng/ml PSA
Intended Use	Immunoassay for in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma to aid in the management of prostate cancer patients.	Immunoassay for 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	0-100 ng/ml
Assay Methodology	Sandwich immunoassay	Sandwich immunoassay
Cross-Reactivity (to PAP)	0%	0%

Note: The document explicitly states the Elecsys 1010 device is compared to the Elecsys 2010. The acceptance criteria for the Elecsys 1010 are implicitly defined by showing its performance in comparison to the already approved Elecsys 2010. For features like intended use, assay range, methodology, and cross-reactivity, the Elecsys 1010 is stated to be similar, implying these are directly met by mirroring the predicate. For performance metrics like detection limits and linearity, specific values are provided for both devices, and the method comparison data (Elecsys 1010 vs. Elecsys 2010) serves as the primary evidence of meeting similarity/equivalence.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Method Comparison: N=91
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions the comparison of the Elecsys 1010 to the Elecsys 2010.

3. Number of Experts and Qualifications for Ground Truth of the Test Set

This information is not provided in the document. The study pertains to an in-vitro diagnostic device measuring PSA levels, not an imaging device or a device requiring human interpretation for its primary output. Therefore, expert consensus for ground truth is not typically applicable in the same way as for subjective diagnostic tasks.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for a quantitative in-vitro diagnostic test where the "ground truth" is a measured analytical value. The method comparison uses statistical analysis (Least Squares and Passing Bablock regression) of quantitative results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No, a MRMC study was not done. This type of study is relevant for scenarios where human readers interpret data (e.g., medical images) and an AI assists them. This document describes an automated in-vitro diagnostic device (PSA assay) where the output is a quantitative measurement, not interpreted by human readers in the same context.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the Elecsys 1010. The performance characteristics listed (Lower Detection Limit, Functional Detection Limit, Linearity, Hook Effect) are all measures of the device's intrinsic analytical performance when operating in a standalone capacity. The "Method Comparison" against the Elecsys 2010 also demonstrates the standalone performance against a predicate.

7. Type of Ground Truth Used

The ground truth for the performance characteristics (detection limits, linearity, hook effect) would be established through analytical reference methods or certified reference materials to accurately define the true PSA concentration.
For the "Method Comparison" study, the Elecsys 2010 immunoassay analyzer itself served as the reference/comparator for the Elecsys 1010 result, meaning the results from the Elecsys 2010 were treated as the comparative 'ground truth' for evaluating the Elecsys 1010's agreement.

8. Sample Size for the Training Set

This information is not provided in the document. For an immunoassay, the "training set" would typically refer to the data used for developing and optimizing the assay reagents, calibration curves, and instrument parameters. The provided document focuses on the validation of the finalized device.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the document. Similar to point 8, the ground truth for an immunoassay's development/training phase would involve using well-characterized samples with known PSA concentrations, likely established through reference methods or certified materials, to ensure accurate calibration and assay performance optimization.

Summary

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510(k) Summary

JAN = 6 1998

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page 25

PSA on Elecsys Elecsys® 1010

07/1180 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. Boehringer Mannheim Corporation 1. Submitter 4300 Hacienda Drive name, P.O. Box 9002 address, Pleasanton, CA 945660900 contact (510) 730-8215 Contact Person: Patricia M. Klimley Date Prepared: November 6, 1997 Proprietary name: Elecsys® PSA Assay 2. Device name Common name: Electrochemiluminescence assay for the determination of Prostate-Specific Antigen (PSA). Classification name: System, Test, Prostate-Specific antigen We claim substantial equivalence to the Elecsys® PSA Assay on Elecsys 3. Predicate 2010. device The Elecsys® test principle is based on sandwich principle. Total duration of 4. Device assay: 18 minutes (37°C). Description ·1st incubation (9 minutes): Sample (40 µL), a biotinylated monoclonal PSAspecific antibody (60 uL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (60 uL) react to form a sandwich complex. ·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.

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510(k) Summary, Continued

4.DeviceDescription	•The reaction mixture is aspirated into the measuring cell where themicroparticles are magnetically captured onto the surface of the electrode.Unbound substances are then removed with ProCell. Application of a voltageto the electrode then induces chemiluminescent emission which is measuredby a photomultiplier (0.4 second read frame).•Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided viathe reagent bar code.
5.Intended use	Immunoassay for the in vitro quantitative determination of Prostate-SpecificAntigen in human serum and plasma to aid in the management of prostatecancer patients.
6.Comparisonto predicatedevice	The Boehringer Mannheim Elecsys® PSA Assay has been approved for useon the Elecsys 2010 immunoassay analyzer (K964351/S1). The applicationof the Elecsys® PSA Assay on the Elecsys 1010 immunoassay analyzer issubstantially equivalent to the same assay (Elecsys PSA Assay) on theElecsys 2010.

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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. Labeling for the predicate device provided in attachment 6 will be replaced upon the approval of this premarket approval submission with the combined Elecsys 2010 and 1010 insert (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: 0% to PAP

·Kit (cat. no. 1731262) approved for use on the Elecsys 2010 (K964351/S1)

·Sample and reagent volumes

·Reaction temperature and incubation times

·Package insert

·Performance specifications

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510(k) Summary, Continued

Differences:

Comparison to predicate
device cont.

(

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

Performance Characteristics:

Feature	Elecsys 1010	Elecsys 2010
LowerDetection Limit	0.006 ng/mLFunctional: 0.07 ng/mL	0.002 ng/mLFunctional: 0.03 ng/mL
Linearity	0.01 - 100 ng/mL (with adeviation from a linear line of$\pm$ 10%)	0.01 - 100 ng/mL (with adeviation from a linear line of$\pm$ 10%)
MethodComparison	Vs Elecsys 2010Least Squaresy=0.9978x + 0.0040r=0.9915N=91Passing Bablocky=0.9825x + 0.0935r=0.9915N=91	Not shown
Hook Effect	No Hook Effect up to15,000 ng/ml PSA	No Hook Effect up to15,000 ng/ml PSA

Continued on next page

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

JAN - 6 199

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia M. Klimley Manager, Regulatory Affairs Boehringer Mannheim Corporation Laboratory Diagnostics 4300 Hacienda Drive Pleasanton, California 94566-0900

Re : K974189 Elecsys® PSA Assay Trade Name: Requlatory Class: II Product Code: LTJ Dated: November 6, 1997 Received: November 7, 1997

Dear Ms. Klimley:

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 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, 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 regulatory 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.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. TO determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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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12/22/97

11:09

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

Device Name: Elecsys® PSA Assay

Indications For Use:

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

Peter E. Maleni

(Division Sign-Off) Division of Chineal Laboratury Devices 510(k) Number -

(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 6 (Per 21 CFR 801.109)

(Optional Format 1-2-96)

. .

Regulation Number and Section

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
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.(b)
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.