K Number

Device Name

ELECSYS PSA ASSAY

Manufacturer

BOEHRINGER MANNHEIM CORP.

Date Cleared

1997-07-25

(266 days)

Product Code

LTJ

Regulation Number

866.6010

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 prostate cancer.

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 µL) 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard immunoassay based on chemical reactions and light detection, with results determined by a calibration curve. There is no mention of AI or ML in the device description, performance studies, or key metrics.

Therapeutic

No
This device is an immunoassay intended for in vitro quantitative determination of Prostate-Specific Antigen, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

Yes

Explanation: The device quantitatively determines Prostate-Specific Antigen to aid in the management of prostate cancer, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description clearly outlines a complex immunoassay process involving chemical reagents, incubation steps, magnetic capture of microparticles, and chemiluminescent emission measurement. These are all hardware-dependent processes and components, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma." The term "in vitro" is the key indicator of an IVD.
Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from the body, a characteristic of IVD testing.
Measurement: It performs a "quantitative determination," meaning it measures the amount of a substance (PSA) in the sample, which is a diagnostic function.
Diagnostic Purpose: The assay is used to "aid in the management of prostate cancer," indicating a diagnostic or monitoring purpose related to a disease.
Device Description: The description details a laboratory-based immunoassay process involving reagents and a measurement system, consistent with IVD technology.
Performance Studies: The inclusion of performance characteristics like precision, linearity, and method comparison are standard for demonstrating the analytical performance of an IVD.
Predicate Device: The mention of a "Predicate Device" (TOSOH AIA-PACK PA) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared IVD.

All these elements strongly point to this device being an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

LTJ

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 µL) 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision:
Modified NCCLS (ng/mL):
Control 1: N=60, Within-Run=1.88, %CV=1.1, Total=1.88, %CV=2.1
Control 2: N=60, Within-Run=14.00, %CV=1.2, Total=14.00, %CV=2.2
Pool 1: N=60, Within-Run=0.29, %CV=1.5, Total=0.29, %CV=2.9
Pool 2: N=60, Within-Run=3.95, %CV=1.8, Total=3.95, %CV=2.3
Pool 3: N=60, Within-Run=48.48, %CV=1.6, Total=48.48, %CV=2.3

Lower Detection Limit: 0.01 ng/mL; Functional: 0.07 ng/mL

Linearity: 0.01 - 100 ng/mL (with a deviation from a linear line of ±10%)

Method Comparison: Vs TOSOH AIA-PACK PA
Least Squares: $y = 0.86x + 0.01$, r=0.995, SEE = 0.251, N=365
Passing/Bablok: $y = 0.90x - 0.28$, r=0.995, SEE = 0.892, N=365

Interfering substances:
Bilirubin: No interference at 25 mg/dL
Hemoglobin: No interference at 1.0 g/dL
Lipemia: No interference at 1000 mg/dL
Biotin: No interference at 30 ng/mL

Specificity:
% Cross-reactivity:
PAP: none
ACT: none
PSA: 100%
PSA-ACT: 100%

Hook Effect: No Hook Effect up to 13,900 ng/ml PSA

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUL 25 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Boehringer Mannheim Corporation Laboratory Diagnostics Division c/o Ms. Mary Koning, Regulatory Affairs Specialist 2400 Bisso Lane P.O. Box 4117 Concord, California 94524

Re: K964351/S1 Elecsys® PSA Assay Trade Name: Requlatory Class: II Product Code: LTJ Dated: May 12, 1997 Received: May 13, 1997

Dear Ms. Koning:

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 to 895. A substantially equivalent determination assumes compliance 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 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.

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 requlation (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

JUL 2 5 1997

长964351

BOEHRINGER MANNHEIM CORPORATION

Introduction

510(k) Summary

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. Submitter name, address, contact | Boehringer Mannheim Corporation
2400 Bisso Lane
P.O. Box 4117
Concord, CA 94524-4117
(510) 674 - 0690, extension 8415

Contact Person: Mary Koning
Date Prepared: October 31, 1996 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Device name | Proprietary name: Elecsys® PSA Assay

Common name: Electrochemiluminescence assay for the determination of Prostate-Specific Antigen (PSA).

Classification name: System, Test , Prostate-Specific antigen |
| 3. Predicate device | We claim substantial equivalence to the TOSOH AIA-PACK PA. |
| 4. 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 µL) 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. |

Continued on next page:

page 25

510(k) Summary, Continued

{

ﻟﺴﻌﺮ

| 4.
Device
Description | •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. | Feature | Elecsys® PSA | AIA-PACK PA |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| 5.
Intended use | Immunoassay for the in vitro quantitative determination of Prostate-Specific
Antigen in human serum and plasma to aid in the management of prostate
cancer patients. | Reaction test
principle | Electrochemiluminescence | Two-site immuno-
enzymometric assay |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® PSA Assay is substantially equivalent
to other products in commercial distribution intended for similar use. Most
notably it is substantially equivalent to the currently marketed TOSOH AIA-
PACK PA.
The following table compares the Elecsys® PSA Assay with the predicate
device, TOSOH AIA-PACK PA. Specific data on the performance of the test
have been incorporated into the draft labeling in attachment 5. Labeling for
the predicate device is provided in attachment 6. | Sample | Serum and Plasma | Serum |
| Similarities: | | Instrument
required | Elecsys® 2010 | AIA-1200/AIA 600 |
| | •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
Standardizati
on | Stanford Reference Standard
(90% PSA-ACT + 10% free
PSA) | Different Material - Stanford
Reference Standard was
unavailable at time of assay
development |
| | •Assay range: 0-100 ng/ml | Calibration
Stability | A calibration is recommended
every 7 days if kit is not
consumed; 8 weeks with same
reagent lot if reagent is
consumed within 7 days. | A calibration is required every
30 days. |
| | •Assay methodology: Sandwich immunoassay | | | |
| | •Cross-Reactivity: 0% to PAP | | | |
| | Continued on next page | | | |

510(k) Summary, Continued

Differences:

Comparison to predicate
device cont.

Performance Characteristics:

Feature	Elecsys® PSA			AIA-PACK PA
Precision
Level	Modified NCCLS (ng/mL):
Control 1	Modified NCCLS (ng/mL):
Control 2	Modified NCCLS (ng/mL):
Pool 1	Precision (ng/mL):
A	Precision (ng/mL):
B	Precision (ng/mL):
C
N	60	60	60	20	20	20
Within-Run	1.88	14.00	0.29	6.61	51.68	95.10
%CV	1.1	1.2	1.5	2.9	3.9	3.0
Total	1.88	14.00	0.29	6.52	52.26	98.33
%CV	2.1	2.2	2.9	2.1	3.9	2.8
	Modified NCCLS (ng/mL):
	Pool 2	Pool 3
N	60	60
Within-Run	3.95	48.48
%CV	1.8	1.6
Total	3.95	48.48
%CV	2.3	2.3

Continued on next page page 27

K964351

510(k) Summary, Continued

Comparison
to predicate device, (cont.)

Performance Characteristics:

Feature	Elecsys® PSA	AIA-PACK PA
Lower
Detection
Limit	0.01 ng/mL
Functional: 0.07 ng/mL	0.1 ng/mL
Linearity	0.01 - 100 ng/mL (with a
deviation from a linear line of
±10%)	0.1 - 100 ng/mL
Method
Comparison	Vs TOSOH AIA-PACK PA
Least Squares
$y =0.86x + 0.01$
r=0.995
SEE = 0.251
N=365

Continued on next page

510(k) Number (if known): K964351 Device Name: Elecsys® PSA Assay Indications for Use:

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

Peter E. Maler

Division Sign-Off Division of Clinical 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
(Per 21 CFR 801.109)

Over-The Counter-Use

(Optional Format 1-2-96)