(60 days)
K964351/S1
Not Found
No
The description details a standard immunoassay based on chemical reactions and optical detection, with results determined by a calibration curve. There is no mention of AI or ML algorithms being used for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) immunoassay designed to quantitatively measure Prostate-Specific Antigen (PSA) in human serum and plasma, which is used for diagnostic purposes and to aid in the management of prostate cancer, not for direct treatment or therapy.
Yes
The device is described as an "Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma" and is "further indicated for serial measure of PSA to aid in the management of prostate cancer." This indicates its use in aiding diagnosis and management of a disease.
No
The device is an in vitro diagnostic immunoassay kit that relies on chemical reactions and hardware analyzers (Elecsys 2010 and 1010) to function, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma." The phrase "in vitro" is the key indicator that this device is used to test samples outside of the living body.
- Device Description: The description details a laboratory-based immunoassay process involving chemical reactions with biological samples (serum and plasma) and specialized equipment (analyzers). This is characteristic of an IVD.
- Input Imaging Modality: It is listed as "Not Applicable (In vitro diagnostic device)," further confirming its classification.
- Anatomical Site: It is listed as "Not Applicable (In vitro diagnostic device)," again consistent with an IVD.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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)
Comparison of Elecsys PSA on Elecsys 1010 vs Elecsys 2010.
Lower Detection Limit: Elecsys 1010: 0.006 ng/mL, Functional: 0.07 ng/mL. Elecsys 2010: 0.002 ng/mL, Functional: 0.03 ng/mL.
Linearity: 0.01 - 100 ng/mL (with a deviation from a linear line of ± 10%) for both Elecsys 1010 and Elecsys 2010.
Method Comparison (Elecsys 1010 vs Elecsys 2010):
Least Squares: y=0.9978x + 0.0040, r=0.9915, N=91
Passing Bablock: y=0.9825x + 0.0935, r=0.9915, N=91
Hook Effect: No Hook Effect up to 15,000 ng/ml PSA for both Elecsys 1010 and Elecsys 2010.
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.
K964351/S1
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
§ 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.
0
510(k) Summary
JAN = 6 1998
Continued on next page
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.
1
510(k) Summary, Continued
.
.
| 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. | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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. | |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® PSA Assay has been approved for use
on the Elecsys 2010 immunoassay analyzer (K964351/S1). The application
of the Elecsys® PSA Assay on the Elecsys 1010 immunoassay analyzer is
substantially equivalent to the same assay (Elecsys PSA Assay) on the
Elecsys 2010. | |
2
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
Continued on next page
3
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 |
|---|---|---|
| Lower | ||
| Detection Limit | 0.006 ng/mL | |
| Functional: 0.07 ng/mL | 0.002 ng/mL | |
| Functional: 0.03 ng/mL | ||
| Linearity | 0.01 - 100 ng/mL (with a | |
| deviation from a linear line of | ||
| $\pm$ 10%) | 0.01 - 100 ng/mL (with a | |
| deviation from a linear line of | ||
| $\pm$ 10%) | ||
| Method | ||
| Comparison | Vs Elecsys 2010 |
Least Squares
y=0.9978x + 0.0040
r=0.9915
N=91
Passing Bablock
y=0.9825x + 0.0935
r=0.9915
N=91 | Not shown |
| Hook Effect | No Hook Effect up to
15,000 ng/ml PSA | No Hook Effect up to
15,000 ng/ml PSA |
Continued on next page
4
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.
5
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
6
12/22/97
11:09
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 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.
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)
. .