(112 days)
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 for data analysis, interpretation, or decision-making.
No
This device is an immunoassay intended for in vitro quantitative determination of carcinoembryonic antigen (CEA) to aid in the management of cancer patients; it is a diagnostic tool, not a therapeutic one.
Yes
The device performs an immunoassay to quantitatively determine Carcinoembryonic Antigen (CEA) levels in human serum and plasma, which is used to aid in the management of cancer patients. This is a diagnostic function, as it helps identify or monitor a disease state.
No
The device is an immunoassay kit and associated analyzer, which are physical components used to perform a chemical reaction and measure the results. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) 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.
- Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from a patient.
- Purpose: The purpose is to "aid in the management of cancer patients" by measuring a specific analyte (CEA) in these samples. This is a diagnostic purpose.
- Device Description: The description details a laboratory-based immunoassay process involving reagents and an analyzer, which is typical of IVD devices.
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 carcinoembryonic antigen (CEA) in human serum and plasma. The Elecsys CEA assay if further indicated for serial measurement of CEA to aid in the management of cancer patients. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
Product codes
DHX
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 uL), biotinylated monoclonal CEA-specific antibody (60 uL), and a monoclonal CEA-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 uL), 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
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (Modified NCCLS (ng/mL)):
Elecsys® 1010:
- Level Control 1: N=60, Within-Run %CV=2.36, Total %CV=3.07
- Level Control 2: N=60, Within-Run %CV=1.71, Total %CV=2.09
- Pool 2: N=60, Within-Run %CV=1.57, Total %CV=2.83
- Pool 3: N=60, Within-Run %CV=2.89, Total %CV=3.97
Elecsys® 2010:
- Level Control 1: N=60, Within-Run %CV=2.5, Total %CV=3.6
- Level Control 2: N=60, Within-Run %CV=1.7, Total %CV=3.0
- Pool 1: N=60, Within-Run %CV=5.0, Total %CV=5.4
- Pool 2: N=60, Within-Run %CV=1.6
- Pool 3: N=60, Within-Run %CV=1.3
Lower Detection Limit:
- Elecsys® 1010: 0.2 ng/mL
- Elecsys® 2010: 0.2 ng/mL
Linearity:
- Elecsys® 1010: 0.2 - 1000 ng/mL (with a deviation from a linear line of ±10%)
- Elecsys® 2010: 0.2 - 1000 ng/mL (with a deviation from a linear line of ±10%)
Method Comparison (Vs Elecsys 2010 for Elecsys® 1010):
- Least Squares: y=1.006x - 0.64, r=0.995, N=117
- Passing/Bablok: y=0.958x + 0.14, r=0.995, N=117
Hook Effect:
- Elecsys® 1010: No Hook Effect up to 200,000 ng/mL CEA
- Elecsys® 2010: No Hook Effect up to 200,000 ng/mL CEA
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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
JUN 2 9 1998
:
KC980887
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 | Boehringer Mannheim Corporation
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94566-0900
(510) 730-8215
Contact Person: Patricia M. Klimley
Date Prepared: March 6, 1998 |
| 2.
Device name | Proprietary name: Elecsys® CEA Assay
Common name: Electrochemiluminescence assay for the determination of
Carcinoembryonic antigen (CEA).
Classification name: Kit, Test , Carcinoembryonic antigen |
| 3.
Predicate device | The Boehringer Mannheim Elecsys® CEA 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® CEA 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 uL), biotinylated monoclonal CEA-
specific antibody (60 uL), and a monoclonal CEA-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 uL), the 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-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 carcinoembryonic
antigen (CEA) in human serum and plasma. The Elecsys CEA assay if further
indicated for serial measurement of CEA to aid in the management of cancer
patients.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on
the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
Summary |
Continued on next page
1
510(k) Summary, Continued
2
6. Comparison to predicate device
The Boehringer Mannheim Elecsys® CEA Assay has been approved for use on the Elecsys 2010 immunoassay analyzer (K964368). The application of the Elecsys® CEA Assay on the Elecsys 1010 immunoassay analyzer is substantially equivalent to the same assay (Elecsys CEA Assay) on the Elecsys 2010.
The following table compares the Elecsys® CEA Assay on Elecsys® 1010 with the predicate device, Elecsys® CEA 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 Carcinoembryonic Antigen (CEA). The assay is further indicated for the serial measurement of CEA to aid in the management of cancer patients.
- ·Assay range: 0-1000 ng/mL
- · Assay methodology: Sandwich immunoassay
- ·Kit (cat. No.) also cleared for use on the Elecsys 2010 (K964368 )
·Sample and reagent volumes
·Package insert
- ·Performance specifications
3
510(k) Summary, Continued
Differences:
Comparison to predicate device cont.
| 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 | Modified NCCLS (ng/mL): | Modified NCCLS (ng/mL): | |||
| Level | Control 1 | Control 2 | Control 1 | Control 2 | Pool 1 |
| N | 60 | 60 | 60 | 60 | 60 |
| Within-Run | 4.44 | 32.96 | 4.9 | 34.1 | 2.2 |
| %CV | 2.36 | 1.71 | 2.5 | 1.7 | 5.0 |
| Total | 4.44 | 35.51 | 4.9 | 34.1 | 2.2 |
| %CV | 3.07 | 2.09 | 3.6 | 3.0 | 5.4 |
| Modified NCCLS (ng/mL): | Modified NCCLS (ng/mL): | ||||
| Pool 2 | Pool 3 | Pool 2 | Pool 3 | ||
| N | 60 | 60 | 60 | 60 | |
| Within-Run | 11.86 | 113.64 | 19.6 | 528 | |
| %CV | 1.57 | 2.89 | 1.6 | 1.3 | |
| Total | 11.86 | 113.64 | 19.6 | 528 | |
| %CV | 2.83 | 3.97 | 2.3 | 2.0 |
Continued on next page
4
510(k) Summary, Continued
- September 2017
| Performance Characteristics: | ||
|---|---|---|
| Feature | Elecsys® 1010 | Elecsys® 2010 |
| Lower | ||
| Detection Limit | 0.2 ng/mL | 0.2 ng/mL |
| Linearity | 0.2 - 1000 ng/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | 0.2 - 1000 ng/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | ||
| Method | ||
| Comparison | Vs Elecsys 2010 |
Least Squares
$y=1.006x - 0.64$
$r=0.995$
$N=117$
Passing/Bablok
$y=0.958x + 0.14$
$r=0.995$
$N=117$ | |
| Hook Effect | No Hook Effect up to
200,000 ng/mL CEA | No Hook Effect up to
200,000 ng/mL CEA |
Performance Characteristics:
:
!
5
Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health and 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 a stylized image of an eagle.
JUN 2 9 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Patricia M. Klimley Manager, Regulatory Affairs Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K980887 / S1 Trade Name: Elecsys® CEA Assay Requlatory Class: II Product Code: DHX Dated: May 4, 1998 Received: May 5, 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, 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 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 requlation 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 Requlations.
6
Paqe 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 labelinq regulation (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, "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): K980887
Device Name: Elecsys® CEA Assay
Intended use
Intended use
Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen in
the serial Immunoassay for the in vitro qualificant and is further indicated for serial
human serum and plasma. The Elecsys assement of capcer natients. measurement of CEA to aid in the management of cancer patients. The electrochemiluminescence immunoassay "ECLA" is intended for use on the
The electrochemiluminescence immunoassay "ECLA" is intended for use on the The electrochemiummescence Inindhoussay - 2 commentsay analyzers.
Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
Peter. Mapes
(Division Sign ()ft) 298868 Division and Division ! 510(x) Number -
(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)