(67 days)
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.
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.
Here's an analysis of the provided text regarding the Elecsys® PSA on Elecsys 1010, focusing on acceptance criteria and the supporting study:
The document is a 510(k) summary for the Elecsys® PSA Assay on the Elecsys 1010 analyzer. It seeks to establish substantial equivalence to the same assay run on the Elecsys 2010. The study presented is a method comparison study.
Acceptance Criteria and Reported Device Performance:
The document implicitly uses the performance of the predicate device (Elecsys® PSA on Elecsys 2010) as the de facto acceptance criteria for the new device (Elecsys® PSA on Elecsys 1010). The goal is to demonstrate that the performance characteristics of the Elecsys 1010 system are comparable to the Elecsys 2010 system.
| Feature | Predicate Device (Elecsys 2010) Acceptance Criteria (Implicit) | Elecsys 1010 Reported Performance |
|---|---|---|
| Sensitivity | ||
| Analytical | 0.002 ng/mL (Reference performance) | 0.006 ng/mL |
| Functional | 0.03 ng/mL (Reference performance) | 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (deviation from linear line of ±10%) | 0.01 - 100 ng/mL (deviation from linear line of ±10%) |
| Method Comparison | Not explicitly stated as an acceptance criterion, but the performance of y=x is implicitly desired | 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 |
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: 154 samples were used for the method comparison study.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an in vitro diagnostic device (immunoassay for PSA levels), not an imaging or diagnostic AI device where human experts establish ground truth for a test set.
- The "ground truth" for the test set in this context is the measurement obtained from the predicate device (Elecsys 2010).
-
Adjudication method for the test set:
- Not applicable. As this is an in vitro diagnostic device comparing its results to a predicate device, there is no adjudication process involving multiple human readers for a test set in the traditional sense.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of images or other complex data. This submission is for an automated immunoassay.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is essentially a standalone algorithm performance study. The Elecsys® PSA assay on the Elecsys 1010 operates as an automated system, and its performance is evaluated directly against the predicate device. There is no human "in the loop" in generating the raw quantitative PSA result, though the result would be interpreted by a clinician.
-
The type of ground truth used:
- The "ground truth" for the method comparison study is the results obtained from the predicate device, the Elecsys® PSA Assay on the Elecsys 2010 analyzer. The objective is to show agreement between the new device and the predicate.
-
The sample size for the training set:
- This being a 510(k) for an immunoassay, the concept of a "training set" for an AI model's ground truth is not directly applicable. The assay itself is a chemical and mechanical process, not a machine learning algorithm that learns from data.
- However, the calibration of the Elecsys 1010 (and 2010) involves a 2-point calibration and a master curve provided via the reagent bar code. The data used to establish these calibration curves and the assay parameters would be analogous to a "training" process in a broader sense, but no sample size for this is provided.
-
How the ground truth for the training set was established:
- Again, the typical "ground truth for training set" framework for AI is not applicable here.
- For the immunoassay, the "ground truth" for calibration and assay development would have been established through a rigorous process of using reference materials, certified calibrators, and possibly comparison to established reference methods (though not detailed in this summary). This process ensures the accuracy and reliability of the assay's measurements.
{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 Corporation9115 Hague RoadIndianapolis, 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.DeviceDescription -con't | •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-generatedby 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-SpecificAntigen in human serum and plasma. The Elecsys PSA assay is furtherindicated for serial measurement of PSA to aid in the management of cancerpatients.The electrochemiluminescence immunoassay "ECLIA" is intended for use on theBoehringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers. |
| 6.Comparison topredicatedevice | The Boehringer Mannheim, a Roche Diagnostics Company Elecsys® PSA 2ndGen. Assay has a premarket notification under review for use on the Elecsys2010 immunoassay analyzer. The application of the Elecsys® PSA Assay onthe Elecsys 1010 immunoassay analyzer is substantially equivalent to thesame 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 |
|---|---|---|
| Instrumentrequired | Elecsys 1010 | Elecsys 2010 |
| InstrumentSystem | Batch | Random access |
| ReagentStorage 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 |
|---|---|---|
| SensitivityAnalytical | 0.006 ng/mL | 0.002 ng/mL |
| Functional | 0.03 ng/mL | 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (with adeviation from a linear line of±10%) | 0.01 - 100 ng/mL (with adeviation from a linear line of±10%) |
| MethodComparison | Vs Elecsys 2010 | |
| Least Squares$y=0.9948x - 0.0642$r=0.996N=154Passing Bablok$y=0.9965x + 0.0112$r=0.996N=154 | ||
| Hook Effect | No Hook Effect up to17,000 ng/ml PSA | No Hook Effect up to17,000 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
§ 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.