(161 days)
Unknown
No
The summary describes a standard immunoassay and calibration process, with no mention of AI or ML technologies.
No
This device is an immunoassay for the quantitative determination of a tumor-associated antigen (CA 19-9) to aid in the management and monitoring of cancer patients, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as an "Immunoassay for the in vitro quantitative determination of CA 19-9 tumor associated antigen" and is indicated for "serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas" and "monitoring of disease status," which are direct diagnostic applications.
No
The device description clearly states it is an immunoassay with streptavidin microparticles and electrochemiluminescence detection, which are hardware components. It is intended for use on specific immunoassay analyzers, which are also hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "Immunoassay for the in vitro quantitative determination of CA 19-9 turnor associated antigen, in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD. It also describes the use of the assay to aid in the management of patients with pancreatic cancer by measuring a substance (CA 19-9) in a sample taken from the body (serum and plasma).
- Device Description: The description details a laboratory test method (two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection) performed on specific laboratory analyzers (Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170). This is consistent with an IVD.
- CALSET: The mention of a "CALSET" for calibrating the assay further supports its use as a quantitative laboratory test.
The entire description points to a test performed on biological samples outside of the body to provide information about a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of CA 19-9 turnor associated antigen, in human serum and plasma.
The assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in the monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Elecsys CA 19-9 is used for calibrating the quantitative Elecsys CA 19-9 assay on the Elecsys immunoassay systems.
Product codes
NIG, JIT
Device Description
The Elecsys CA 19-9 Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreas
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:
1010/2010
Within-run
2.9%-4.8% CV @ 11.1-185.4 U/mL
Total Precision
2.9%-4.4% CV @ 11.1-185.4 U/mL
E170
Within-run
1.2%-2.5% CV @ 5.2-379 U/mL
Total Precision
1.9%-8.0% CV @ 5.57-371 U/mL
Analytical sensitivity (LDL): 0.60 U/mL
Hook Effect: No high dose hook effect up to 500,000 U/mL
Limitations: The assay is unaffected by icterus (bilirubin 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. No interference was observed from rheumatoid factors up to a concentration of 1500 IU/mL. In vitro tests were performed on 27 commonly used pharmaceuticals. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. Elecsys CA 19-9 contains additives which minimize these effects. In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. Patients known to be genotypically negative for Lewis blood group antigens will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis blood group antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotype positive for the Lewis antigen may produce varying levels of CA 19-9 as the result of gene dosage effect.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K05023/
Elecsys® CA 19-9 Test System
JUL 6 - 2005
Roche Diagnostics
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. | |
|---|---|---|
| Submitter name, address, contact | Roche Diagnostics | |
| 9115 Hague Road | ||
| Indianapolis, IN 46250 | ||
| (317) 521-3544 | ||
| Contact Person: Kay A. Taylor | ||
| Device Name | Proprietary name: | Elecsys CA 19-9 Immunoassay |
| Elecsys CA 19-9 CalSet | ||
| Common name: | Immunological test for CA 19-9 antigen | |
| Calibrator | ||
| Classification name: | System, Test, Carbohydrate Antigen (CA 19-9), for monitoring and management of Pancreatic Cancer | |
| Calibrator, secondary | ||
| Device Description | The Elecsys CA 19-9 Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. |
1
Elecsys® CA 19-9 Test System
510(k) Summary, Continued
Immunoassay for the in vitro quantitative determination of CA 19-9 tumor Intended use associated antigen, in human serum and plasma. The assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in the monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay systems.
Elecsys CA 19-9 CalSet is used for calibrating the quantitative Elecsys CA 19-9 assay on the Elecsys immunoassay systems.
The Elecsys CA 19-9 immunoassay test system is substantially equivalent to Substantial other devices legally marketed in the United States. We claim equivalence to equivalence the Fujirebio Diagnostics CA 19-9 RIA cleared under K020566. Both products are intended for use in the quantitative determination of CA 19-9 tumor associated antigen in human serum and plasma.
| Substantial
equivalence -
comparison | The following table compares the Roche Elecsys CA 19-9 Immunoassay with
the predicate device. |
| -------------------------------------------- | -------------------------------------------------------------------------------------------------- |
|---|
| Feature | Elecsys CA 19-9 | Fujirebio CA 19-9 RIA
(predicate) |
|--------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro quantitative
determination of CA 19-9 tumor-
associated antigen in serum and
plasma. | In vitro quantitative
determination of CA 19-9
tumor-associated antigen in
serum and plasma. |
| Indication for Use | An aid in the management of
patients with cancers of the
exocrine pancreas. | An aid in the management of
patients with cancers of the
exocrine pancreas. |
| Assay Principle | Electrochemiluminescent
immunoassay | Radioimmunoassay |
| Sample Type | Human serum and plasma | Human serum and plasma |
2
| Feature | Elecsys CA 19-9 | Fujirebio CA 19-9 RIA
(predicate) |
|-----------------|--------------------------------------------------|-------------------------------------------------------------------------------------------|
| Calibrator | Elecsys CA 19-9 CalSet (2
levels) | CA 19-9 Standard set (6 levels
including 0) |
| Controls | PreciControl Tumor Marker (2
level) | Defibrinated human plasma
containing 2 levels of Ca 19-9 |
| Instrument | Elecsys 1010, 2010 and
MODULAR ANALYTICS E170 | Manual method or semi-automated with commercially
available rinsing/aspiration systems |
| Measuring range | 0.60 - 1000 U/mL | 0.9 - 240 U/mL |
510(k) Summary, Continued
The performance characteristics of the Elecsys CA 19-9 Immunoassay and Substantial equivalence the predicate device are compared in the table below. performance characteristics
| Feature | Elecsys CA 19-9 | Fujirebio CA 19-9 RIA
(predicate) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Precision | 1010/2010
Within-run
2.9%-4.8% CV @ 11.1-185.4 U/mL
Total Precision
2.9%-4.4% CV @ 11.1-185.4 U/mL
E170
Within-run
1.2%-2.5% CV @ 5.2-379 U/mL
Total Precision
1.9%-8.0% CV @ 5.57-371 U/mL | Average variability ranged from
6.7% (44 U/mL) to 15.4% (8 U/mL). |
| Analytical
sensitivity (LDL) | 0.60 U/mL | 0.9 U/mL |
| Hook Effect | No high dose hook effect up to
500,000 U/mL | None up to 1,250,000 U/mL |
3
510(k) Summary, Continued
| Feature | Elecsys CA 19-9 | Fujirebio CA 19-9 RIA
(predicate) |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | The assay is unaffected by icterus (bilirubin 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. No interference was observed from rheumatoid factors up to a concentration of 1500 IU/mL. In vitro tests were performed on 27 commonly used pharmaceuticals. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. Elecsys CA 19-9 contains additives which minimize these effects. In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. | This assay should not be performed on clotted, icteric, hemolyzed or lipemic samples. Human anti-mouse antibodies (HAMA) may be present in samples from patients who have received mouse monoclonal antibodies for immunotherapy. Such sample may show false elevated or depressed values when tested with this method. Results for patients suspected of having such antibodies should be carefully evaluated and interpreted in the context of the clinical status of the patient. Can be used with serum and plasma prepared using different anti-coagulants (ACD-A, Citrate, EDTA, and Heparin). However, it is recommended that if the specimen type is changed during patient monitoring, the patient should be rebaselined to negate any potential biases due to specimen type. Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis antigen may be produce varying levels of CA 19-9 based on gene dosage effect. |
4
510(k) Summary, Continued
| Feature | Elecsys CA 19-9 | Fujirebio CA 19-9 RIA
(predicate) |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Limitations | For diagnostic purposes, the results
should always be assessed in
conjunction with the patient's
medical history, clinical
examination and other findings. | |
| | Patients known to be genotypically
negative for Lewis blood group
antigens will be unable to produce
the CA 19-9 antigen even in the
presence of malignant tissue.
Phenotyping for the presence of
the Lewis blood group antigen may
be insufficient to detect true Lewis
antigen negative individuals. Even
patients who are genotype positive
for the Lewis antigen may produce
varying levels of CA 19-9 as the
result of gene dosage effect. | |
।
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing the branches of the department.
Roche Diagnostics Corp. c/o Ms Kay A. Taylor 9115 Hague Rd. Indianapolis, IN 46250
JUL 6 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K050231
Trade/Device Name: Elecsys CA 19-9 Immunoassay Elecsys CA 19-9 CalSet Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: NIG, JIT Dated: January 21, 2005 Received: January 26, 2005
Dear Ms Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) -premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
6
Page 2 –
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, P Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510{k} Number (if known): K050231
Device Name: Elecsys CA 19-9 Immunoassay Elecsys CA 19-9 CalSet
Indications For Use:
IMMUNOASSAY
Immunoassay for the in vitro quantitative determination of CA 19-9 turnor associated antigen, in human serum and plasma.
The assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in the monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
CALSET
Elecsys CA 19-9 is used for calibrating the quantitative Elecsys CA 19-9 assay on the Elecsys immunoassay systems. Prescription Use XXX AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Trena Chen
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050251