(67 days)
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Not Found
No
The description details a standard immunoassay based on chemical reactions and optical detection, with results determined via a calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making.
No
This device is an immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) and is used to aid in the management of cancer patients; it does not directly treat or prevent a disease.
Yes
The device is an immunoassay for the quantitative determination of PSA, which is used to aid in the management of cancer patients, indicating its role in diagnosis and monitoring.
No
The device is an immunoassay kit and analyzer system, which involves chemical reagents, physical reactions, and hardware components (analyzer). It is 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 the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Device Description: The description details a laboratory-based assay involving the reaction of biological samples (serum and plasma) with reagents (antibodies, microparticles) to measure a specific analyte (PSA). This process is characteristic of an in vitro diagnostic test.
- Anatomical Site: The "Not Applicable (In vitro diagnostic)" entry further confirms that the device is not used directly on a patient's body.
Therefore, based on the provided information, this device clearly falls under the category of an In Vitro Diagnostic.
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 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 and 1010 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 (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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison:
Vs Elecsys 2010
Least Squares
y=0.9948x - 0.0642
r=0.996
N=154
Passing Bablok
y=0.9965x + 0.0112
r=0.996
N=154
Key Metrics
Sensitivity: Analytical 0.006 ng/mL (Elecsys 1010), 0.002 ng/mL (Elecsys 2010). Functional 0.03 ng/mL (Elecsys 1010), 0.03 ng/mL (Elecsys 2010).
Linearity: 0.01 - 100 ng/mL (with a deviation from a linear line of ±10%) for both Elecsys 1010 and Elecsys 2010.
Hook Effect: No Hook Effect up to 17,000 ng/ml PSA for both Elecsys 1010 and Elecsys 2010.
Predicate Device(s)
Elecsys® PSA Assay on Elecsys 2010.
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
K9897948
510(k) Summary
Elecsys® PSA on Elecsys 1010
| 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 13, 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 Assay on Elecsys 2010. |
| 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. |
| Continued on next page |
page 25
1
510(k) Summary, continued
| 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 and 1010 immunoassay analyzers. |
| 6.
Comparison to
predicate
device | The Boehringer Mannheim, a Roche Diagnostics Company Elecsys® PSA 2nd
Gen. Assay has a premarket notification under review for use on the Elecsys
2010 immunoassay analyzer. The application of the Elecsys® PSA Assay on
the Elecsys 1010 immunoassay analyzer is substantially equivalent to the
same assay on the Elecsys 2010.
Continued on next page |
2
510(k) Summary, continued
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.
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
• Kit (cat. nos. 1731262 & 1731696) on the Elecsys 1010 and 2010
·Sample and reagent volumes
·Reaction temperature and incubation times
•Package insert
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 |
の 2007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年には、1000年には1000年に1000
Performance Characteristics:
| Feature | Elecsys 1010 | Elecsys 2010 |
|---|---|---|
| Sensitivity | ||
| Analytical | 0.006 ng/mL | 0.002 ng/mL |
| Functional | 0.03 ng/mL | 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | 0.01 - 100 ng/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | ||
| Method | ||
| Comparison | Vs Elecsys 2010 | |
| Least Squares | ||
| $y=0.9948x - 0.0642$ | ||
| r=0.996 | ||
| N=154 |
Passing Bablok
$y=0.9965x + 0.0112$
r=0.996
N=154 | |
| Hook Effect | No Hook Effect up to
17,000 ng/ml PSA | No Hook Effect up to
17,000 ng/ml PSA |
のお得なので、その他のお店は、おすすめに、おすすめには、お気になると、お店は、お店は、お店は、
4
Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Ms. Priscilla A. Hamill Requlatory Affairs Consultant Roche Diagnostics, Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Tennessee 46250
Re: K982948 Elecsys® PSA Assay Trade Name: Regulatory Class: II Product Code: LTJ Dated: August 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 legally 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.
OCT 2 7 1998
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 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
5
Page 2
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) Additionally, for questions on the promotion and 594-4588. 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 Gutman
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
K 98 2948 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 and 1010 immunoassay analyzers.
(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 __
(Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number