(67 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, interpretation, or result generation.
No.
This device is an in vitro diagnostic (IVD) immunoassay designed to measure Prostate-Specific Antigen (PSA) levels. It is used to aid in the management of cancer patients by providing quantitative measurements, not to directly treat or cure a disease.
Yes
The device aids in managing cancer patients by measuring Prostate-Specific Antigen (PSA) levels, especially for serial measurements, which is a diagnostic function. It provides quantitative determination of PSA to assess disease status or progression.
No
The device is an immunoassay kit intended for use on a specific immunoassay analyzer, involving chemical reactions and hardware components for measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma." The term "in vitro" is the defining characteristic of an IVD.
- Device Description: The description details a laboratory test performed on biological samples (serum and plasma) using reagents and an analyzer. This is consistent with an IVD.
- Anatomical Site: It is listed as "Not Applicable (In vitro diagnostic)," further confirming its nature as a test performed outside the body.
The entire description points to a device designed to analyze biological samples in a laboratory setting to provide diagnostic information, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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 (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.
• 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.
• 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-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
Precision: Modified NCCLS (ng/mL):
Elecsys PSA, 2nd Gen.
Level HS1: N=60, Mean=0.30, Within-Run %CV=1.8, Total %CV=2.4
Level HS2: N=60, Mean=4.76, Within-Run %CV=2.5, Total %CV=2.9
Level HS3: N=60, Mean=51.1, Within-Run %CV=2.2, Total %CV=3.8
PC-TM1: N=60, Mean=2.33, Within-Run %CV=2.5, Total %CV=2.7
PC-TM2: N=60, Mean=17.2, Within-Run %CV=2.3, Total %CV=2.9
Elecsys PSA, 1st Gen.
Level HS1: N=60, Mean=0.29, Within-Run %CV=1.5, Total %CV=2.9
Level HS2: N=60, Mean=13.9, Within-Run %CV=1.8, Total %CV=2.3
Level HS3: N=60, Mean=48.5, Within-Run %CV=1.6, Total %CV=2.3
PC-TM1: N=60, Mean=1.88, Within-Run %CV=1.1, Total %CV=2.1
PC-TM2: N=60, Mean=14.0, Within-Run %CV=1.2, Total %CV=2.2
Method Comparison: Vs Elecsys PSA, 1st Gen. (on 2010), N=108.
Least Squares: y=1.0098x + 0.734, r=0.998
Passing Bablok: y=1.0335x + 0.219, r=0.998
Hook Effect: No Hook Effect up to 17,000 ng/ml PSA for Elecsys PSA, 2nd Gen. (15,000 ng/ml PSA for Elecsys PSA, 1st Gen.)
Key Metrics
Sensitivity Analytical: 0.002 ng/mL
Functional Sensitivity: 0.03 ng/mL
Linearity: 0.002 - 100 ng/mL (with a deviation from a linear line of ±10%)
Predicate Device(s)
K964351/S1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Elecsys® PSA on Elecsys 2010
の 2007年の1000年の1000年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に100000000000000000000000000000000000000000000000000000000000000000000000000
| 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.
Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, In 46250
(317) 845-3723 |
| | Contact Person: Priscilla A. Hamill |
| | Date Prepared: August 14, 1998 |
| 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 Elecsys® PSA 1st Gen.
(K964351/S1). |
| 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 (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.
• 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. |
| 4.
Device
Description
(con't) | ·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-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. 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 |
| 6.
Comparison to
predicate
device | The Boehringer Mannheim, a Roche Diagnostics Company Elecsys® PSA, 1st
Gen. is cleared for use on the Elecsys 2010 immunoassay analyzer
(K964351/S1). The application of the Elecsys® PSA, 2nd Gen. Assay on the
Elecsys 2010 immunoassay analyzer is substantially equivalent to the Elecsys
PSA, 1st Gen. assay. |
Continued on next page
1
2
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
Continued on next page
3
| 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:
Continued on next page
4
F.
Substantial
equivalence, cont.
Performance Characteristics:
| Feature | Elecsys PSA, 2nd Gen. | Elecsys PSA, 1st Gen. |
|---|---|---|
| Sensitivity | ||
| Analytical | ||
| Functional | 0.002 ng/mL | |
| 0.03 ng/mL | 0.002 ng/mL | |
| 0.03 ng/mL | ||
| Linearity | 0.002 - 100 ng/mL (with a | |
| deviation from a linear line | ||
| of ±10%) | 0.002 - 100 ng/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | ||
| Method | ||
| Comparison | Vs Elecsys PSA, 1st Gen. (on |
-
| |
| | Least Squares
$y=1.0098x + 0.734$
r=0.998
N=108 | |
| | Passing Bablok
$y=1.0335x + 0.219$
r=0.998
N=108 | |
| Hook Effect | No Hook Effect up to
17,000 ng/ml PSA | No Hook Effect up to
15,000 ng/ml PSA |
5
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
6
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 (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, "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 (800) 638-2041 or (301) 443-6597, 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
7
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 | |
| (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