(23 days)
Not Found
No
The device description details a standard immunoassay process based on chemical reactions and light detection, with results determined via a calibration curve. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an immunoassay for the quantitative determination of alpha-fetoprotein, used to aid in the management of patients, not to provide therapy.
Yes
The device quantitatively determines alpha-fetoprotein (AFP) in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors, which is a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay process involving reagents, microparticles, and an analyzer (Elecsys 1010/2010) that performs physical steps like incubation, magnetic capture, and chemiluminescent measurement. This is a hardware-dependent system, not a software-only device.
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 alpha fetoprotein (AFP) in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay process involving the reaction of sample with reagents and measurement on an analyzer. This is characteristic of an IVD.
- Performance Studies: The performance studies described (Precision, Lower Detection Limit, Linearity, Method Comparison) are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" which is also an "Elecsys® AFP on Elecsys® 2010" further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory approval process for new IVDs.
The information provided clearly 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 alpha fetoprotein (AFP) in human serum and plasma.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
The assay is further indicated for the serial measurement of AFP to aid in the management of cancer patients.
Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
Product codes
LOJ
Device Description
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
-1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal AFP-specific antibody (60 µL), and a monoclonal AFP-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 (50 µL), the 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
human serum and plasma
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 Level (Modified NCCLS (IU/mL)):
Elecsys® 1010: HS1 (9.81 IU/mL, N=60, Within-Run %CV=1.01, Total %CV=2.25), HS2 (50.67 IU/mL, N=60, Within-Run %CV=1.02, Total %CV=2.69), HS3 (607.39 IU/mL, N=60, Within-Run %CV=1.52, Total %CV=4.61). Control 1 (7.72 IU/mL, N=60, Within-Run %CV=1.29, Total %CV=1.90), Control 2 (86.81 IU/mL, N=60, Within-Run %CV=1.39, Total %CV=2.29).
Elecsys® 2010: HS1 (12.8 IU/mL, N=60, Within-Run %CV=2.0, Total %CV=3.1), HS2 (42.6 IU/mL, N=60, Within-Run %CV=1.5, Total %CV=2.4), HS3 (566 IU/mL, N=60, Within-Run %CV=2.0, Total %CV=2.8). Control 1 (8.01 IU/mL, N=60, Within-Run %CV=2.8, Total %CV=3.4), Control 2 (86.8 IU/mL, N=60, Within-Run %CV=2.2, Total %CV=2.7).
Lower Detection Limit: 0.5 IU/mL for both Elecsys® 1010 and Elecsys® 2010.
Linearity: 0.5 - 1000 IU/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 = 0.980x + 0.639, r=0.992, N=153
Passing/Bablok: y = 1.031x - 0.208, r=0.992, N=153
Hook Effect: No Hook Effect up to 1,000,000 IU/mL AFP for both Elecsys® 1010 and Elecsys® 2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Currently marketed Elecsys® AFP on Elecsys® 2010. K973351
Reference Device(s)
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
a
| MAY 1 1998 | 510(k) Summary |
|---|---|
| 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 | Roche Diagnostics/Boehringer Mannheim Corporation |
| 4300 Hacienda Drive | |
| P.O. Box 9002 | |
| Pleasanton, CA 94566-0900 | |
| (925) 730-8215 | |
| Contact Person: Patricia M. Klimley | |
| Date Prepared: April 6, 1998 | |
| 2. | |
| Device name | Proprietary name: Elecsys® AFP Assay |
| Common name: Electrochemiluminescence assay for the determination of | |
| Alpha Fetoprotein (AFP). | |
| Classification name: Kit, Test , Alpha Fetoprotein | |
| 3. | |
| Predicate | |
| device | The Roche Diagnostics/Boehringer Mannheim Elecsys® AFP on Elecsys® |
| 1010 is substantially equivalent to other products in commercial distribution | |
| intended for similar use. Most notably it is substantially equivalent to the | |
| currently marketed Elecsys® AFP 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 (30 µL), biotinylated monoclonal AFP- | |
| specific antibody (60 µL), and a monoclonal AFP-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 (50 µL), the complex is bound to the solid phase via interaction | |
| of biotin and streptavidin. | |
| 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 alpha fetoprotein |
| (AFP) in human serum and plasma. | |
| The electrochemiluminescence immunoassay “ECLIA” is intended for use on | |
| the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010 | |
| immunoassay analyzers. | |
| 6. | |
| Comparison | |
| to predicate | |
| device | The Roche Diagnostics/Boehringer Mannheim Elecsys® AFP Assay has been |
| approved for use on the Elecsys 2010 immunoassay analyzer (K973351). | |
| The application of the Elecsys® AFP Assay on the Elecsys 1010 | |
| immunoassay analyzer is substantially equivalent to the same assay (Elecsys | |
| AFP Assay) on the Elecsys 2010. |
Continued on next page
1
..............................................................................................................................................................................
510(k) Summary, Continued
2
The following table compares the Elecsys® AFP Assay on Elecsys® 1010 with the predicate device, Elecsys® AFP Assay on 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 in attachment 6 will be replaced upon the clearance of this premarket notification submission with the combined Elecsys 2010 and 1010 insert (attachment 5).
Similarities:
·Intended Use: Immunoassay for the in vitro quantitative determination of Alpha Fetoprotein (AFP). The assay is further indicated for the serial measurement of AFP to aid in the management of cancer patients.
·Assay range: 0.5-1000 IU/mL
· Assay methodology: Sandwich immunoassay
·Kit (cat. No.) also cleared for use on the Elecsys 2010 (K973351 )
·Sample and reagent volumes
·Package insert
·Performance specifications
Continued on next page
3
510(k) Summary, Continued
Comparison
to predicate device cont.
| Differences: |
|---|
| -------------- |
| Feature | Elecsys® 1010 | Elecsys® 2010 |
|---|---|---|
| Instrument | ||
| required | Elecsys 1010 | Elecsys 2010 |
| Instrument | ||
| Type | Batch | Random access |
| Reagent | ||
| Storage Temp | ||
| (C) | Ambient Temperature | 20° C |
Performance Characteristics:
| Feature | Elecsys® 1010 | Elecsys® 2010 | |||||
|---|---|---|---|---|---|---|---|
| Precision | |||||||
| Level | Modified NCCLS (IU/mL): | ||||||
| HS1 | Modified NCCLS (IU/mL): | ||||||
| HS2 | Modified NCCLS (IU/mL): | ||||||
| HS3 | Modified NCCLS (IU/mL): | ||||||
| HS1 | Modified NCCLS (IU/mL): | ||||||
| HS2 | Modified NCCLS (IU/mL): | ||||||
| HS3 | |||||||
| N | 60 | 60 | 60 | 60 | 60 | 60 | |
| Within-Run | 9.81 | 50.67 | 607.39 | 12.8 | 42.6 | 566 | |
| %CV | 1.01 | 1.02 | 1.52 | 2.0 | 1.5 | 2.0 | |
| Total | 9.81 | 50.67 | 607.39 | 12.8 | 42.6 | 566 | |
| %CV | 2.25 | 2.69 | 4.61 | 3.1 | 2.4 | 2.8 | |
| Modified NCCLS (IU/mL): | Modified NCCLS (IU/mL): | ||||||
| Control 1 | Control 2 | Control 1 | Control 2 | ||||
| N | 60 | 60 | 60 | 60 | |||
| Within-Run | 7.72 | 86.81 | 8.01 | 86.8 | |||
| %CV | 1.29 | 1.39 | 2.8 | 2.2 | |||
| Total | 7.72 | 86.81 | 8.01 | 86.8 | |||
| %CV | 1.90 | 2.29 | 3.4 | 2.7 |
Continued on next page
4
510(k) Summary, Continued
| Feature | Elecsys® 1010 | Elecsys® 2010 |
|---|---|---|
| Lower | ||
| Detection Limit | 0.5 IU/mL | 0.5 IU/mL |
| Linearity | 0.5 - 1000 IU/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | 0.5 - 1000 IU/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | ||
| Method | ||
| Comparison | Vs Elecsys 2010 |
Least Squares
$y = 0.980x + 0.639$
r=0.992
N=153
Passing/Bablok
$y = 1.031x - 0.208$
r=0.992
N=153 | |
| Hook Effect | No Hook Effect up to
1,000,000 IU/mL AFP | No Hook Effect up to
1,000,000 IU/mL AFP |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
MAY 10000
Ms. Patricia M. Klimley Manager, Elecsys Regulatory Affairs Roche Diagnostics/ Boehringer Mannheim Corporation Laboratory Diaqnostics 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K981282 Trade Name: Elecsys® AFP Assay Requlatory Class: II Product Code: LOJ Dated: April 6, 1998 Received: April 8, 1998
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, qood manufacturing practice, labeling, and prohibitions aqainst 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 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6
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 Butman
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
7
510(k) Number (if known): 798 | 282
Device Name: Elecsys® AFP Assay
Indications For Use:
Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 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 | |||||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |||
| (Optional Format 1-2-96) | |||||
Vita E. Mafeni
(Division Sign-Off)
Division of Climical Laboratory DJ 510(k) Nurtiber .