(16 days)
No
The description details a standard immunoassay technology (ECLIA) and calibration method, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic immunoassay intended for quantitative determination of CA 15-3 to aid in the management of breast cancer patients, specifically for early detection of recurrence and monitoring response to therapy. It is not a therapeutic device.
Yes
The device is described as an "Immunological in vitro assay for quantitative determination of CA 15-3 in human serum, Li-heparin and EDTA plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid in the early detection of recurrence in previously treated stage II and III breast cancer patients and for monitoring response to therapy in metastatic breast cancer patients." This clearly indicates its use in diagnostic processes.
No
The device description explicitly states it is a "Test System" and describes physical components like "streptavidin microparticles" and its use on "cobas e immunoassay analyzers," which are hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "Immunological in vitro assay".
- Sample Type: It analyzes "human serum, Li-heparin and EDTA plasma", which are biological samples taken from the body but tested outside the body.
- Purpose: The purpose is to "aid in the management of breast cancer patients" by measuring a specific marker (CA 15-3) in these samples. This is a diagnostic purpose performed in vitro.
- Device Description: The description further clarifies it's a "two-step sandwich immunoassay" and uses "electrochemiluminescence detection", all of which are techniques used in in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Immunological in vitro assay for quantitative determination of CA 15-3 in human serum, Li-heparin and EDTA plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid
- in the early detection of recurrence in previously treated stage II and III breast cancer patients
- for monitoring response to therapy in metastatic breast cancer patients
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
MOI
Device Description
The Elecsys CA 15-3 II Test System is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection for the quantitative determination of CA 15-3 in human serum, Li-heparin plasma and EDTA plasma. It is intended for use on the cobas e 801 immunoassay analyzer. The cobas e family of analyzers employs the electrochemiluminescence "ECLIA" technology.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided via the cobas link.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
4. NON-CLINICAL PERFORMANCE EVALUATION
Non-clinical performance evaluation for the Elecsys CA 15-3 II are briefly summarized below:
4.1. Precision
Precision and reproducibility of the Elecsys CA 15-3 II were demonstrated under K171605.
4.2. Analytical Sensitivity
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) of the Elecsys CA 15-3 II were demonstrated under K171605.
4.3. High-Dose Hook Effect
High-Dose Hook Effect of the Elecsys CA 15-3 II was demonstrated under K171605.
4.4. Linearity/Assay Reportable Range
Linearity/Assay Reportable Range of the Elecsys CA 15-3 II was demonstrated under K171605.
4.5. Endogenous Interferences
Endogenous Interferences of the Elecsys CA 15-3 II was demonstrated under K171605.
4.6. Exogenous Interferences – Anticoagulants
4.6.1 Serum/Li-Heparin Plasma Comparison
The performance of the Elecsys CA 15-3 II using Li-heparin plasmas sample comparing to serum sample on the cobas e 801 analyzer was demonstrated under K171605.
4.6.2 Serum/K2-EDTA Plasma Comparison
A study was performed to demonstrate that K2-EDTA plasma samples vield comparable values as serum samples by the Elecsys CA 15-3 II assay on the cobas e 801 analyzer. 44 serum/plasma paired samples were tested in singleton with one reagent lot on one cobas e 801 Immunoassav Analyzer. Potential effects were assessed by Passing/Bablok regression analysis. The data are summarized in the following table:
| N | Range (U/mL) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | |
|---|---|---|---|---|---|
| Serum vs. K2-EDTA Plasma | 44 | 8.37–298 | 0.985 (0.955–1.036) | -0.279 (-1.143–0.288) | 0.997 |
Conclusion:
The 44 serum/plasma pairs fulfilled the acceptance criteria for Passing Bablock Analysis. The data supports the addition of K2-EDTA plasma type.
4.7. Method Comparison to cobas e 601 Immunoassay Analyzer
Method Comparison of the Elecsys CA 15-3 II on the cobas e 801 to the cobas e 601 immunoassay analyzer was demonstrated under K171605.
4.8. Stability (Reagent, Sample, Calibration)
Stability (Reagent, Sample, Calibration) of the Elecsys CA 15-3 II was demonstrated under K171605.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Elecsys CA 15-3 II (K171605)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
June 22, 2018
Roche Diagnostics Adennis Cora Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250
Re: K181492
Trade/Device Name: Elecsys CA 15-3 II Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: MOI Dated: June 5, 2018 Received: June 6, 2018
Dear Adennis Cora:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kelly Oliner-S
For Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181492
Device Name Elecsys CA 15-3 II
Indications for Use (Describe)
Immunological in vitro assay for quantitative determination of CA 15-3 in human serum, Li-heparin and EDTA plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid
- · in the early detection of recurrence in previously treated stage II and III breast cancer patients
- · for monitoring response to therapy in metastatic breast cancer patients
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is ___________K181492
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Adennis Cora |
| Phone: (317) 521-3915 | |
| FAX: (317) 521-2324 | |
| Email: adennis.cora_gress@roche.com | |
| Date Prepared | May 10, 2018 |
| Proprietary Name | Elecsys CA 15-3 II |
| Common Name | Elecsys Cancer Antigen 15-3 II |
| Classification Name | System, Test, Immunological, Antigen, Tumor |
| Product Codes, | |
| Regulation Numbers | MOI, 866.6010 |
| Predicate Devices | Elecsys CA 15-3 II (K171605) |
| Establishment Registration | For the Elecsys CA 15-3 II, the establishment registration number for Roche |
| Diagnostics GmbH manufacturing in Penzberg, Germany is 9610529, and for | |
| Roche Diagnostics GmbH packaging in Mannheim, Germany is 9610126. The | |
| establishment registration number for Roche Diagnostics in the United States is |
- |
4
1. DEVICE DESCRIPTION
The Elecsys CA 15-3 II Test System is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection for the quantitative determination of CA 15-3 in human serum, Li-heparin plasma and EDTA plasma. It is intended for use on the cobas e 801 immunoassay analyzer. The cobas e family of analyzers employs the electrochemiluminescence "ECLIA" technology.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided via the cobas link.
1.1. Reagents
The cobas e pack includes:
- . Streptavidin-coated microparticles
- . Reagent 1 (Biotinylated monoclonal antibody (115D8; mouse) 1.75 mg/L)
- . Reagent 2 (Monoclonal anti-CA 15-3 antibody (DF3; mouse) labeled with ruthenium complex 10 mg/L)
1.2. Calibration
Traceability: This method has been standardized against the Elecsys CA 15-3 assay. This in turn has been standardized against the Enzymun Test CA 15-3 method and CA 15-3 RIA by Fujirebio Diagnostics. The predefined master curve is adapted to the analyzer using the relevant CalSet. Calibration frequency: Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the cobas e pack was registered on the analyzer). Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Control 1.3.
PreciControl Tumor Marker is used for the quality control verification of the performance of the assay on the cobas e analyzers.
5
2. INDICATIONS FOR USE
Immunological in vitro assay for quantitative determination of CA 15 3 in human serum.
Li-heparin and EDTA plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid
- in the early detection of recurrence in previously treated stage II and III breast cancer patients .
- for monitoring response to therapy in metastatic breast cancer patients .
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
TECHNOLOGICAL CHARACTERISTICS 3.
The following table compares the Elecsys CA 15-3 II with its predicate device, CA 15-3 (K171605). In summary, the Elecsys CA15-3 II described in this submission is substantially equivalent to the predicate device.
| Feature | Predicate | Candidate |
|---|---|---|
| Assay | CA 15-3 II | |
| (Cleared K171605) | Elecsys CA 15-3 II | |
| (K181492) | ||
| Intended use | Immunological in vitro assay for | |
| quantitative determination of CA | ||
| 15-3 in human serum and Li- | ||
| heparin plasma to aid in the | ||
| management of breast cancer | ||
| patients. In conjunction with | ||
| other clinical and diagnostic | ||
| procedures, serial testing with | ||
| this assay is an aid | ||
| • in the early detection of | ||
| recurrence in previously treated | ||
| stage II and III breast cancer | ||
| patients | ||
| • for monitoring response to | ||
| therapy in metastatic breast | ||
| cancer patients | ||
| The electrochemiluminescence | ||
| immunoassay “ECLIA” is | ||
| intended for use on cobas e | Immunological in vitro assay | |
| for quantitative determination of | ||
| CA 15-3 in human serum, Li- | ||
| heparin and EDTA plasma to | ||
| aid in the management of breast | ||
| cancer patients. In conjunction | ||
| with other clinical and | ||
| diagnostic procedures, serial | ||
| testing with this assay is an aid | ||
| • in the early detection of | ||
| recurrence in previously | ||
| treated stage II and III breast | ||
| cancer patients | ||
| • for monitoring response to | ||
| therapy in metastatic breast | ||
| cancer patients | ||
| The electrochemiluminescence | ||
| immunoassay “ECLIA” is | ||
| intended for use on cobas e |
6
| Feature | Predicate | Candidate |
|---|---|---|
| Sample Type | Human serum and Li-heparin | |
| plasma | Human serum, Li-heparin and | |
| K2-EDTA plasma | ||
| Analytical Specificity | Based on monoclonal 115D8 and | |
| DF3 antibodies available from | ||
| Fujirebio Diagnostics, its | ||
| licensees and its representatives | Same | |
| Instrument Platform | cobas e 801 | Same |
| Measuring Range | 3 – 300 U/mL | |
| Determined by LOQ (Per EP17- | ||
| A2) | Same | |
| Calibrator | CA 15-3 II CalSet | Same |
| Control | PreciControl Tumor Marker | Same |
| Traceability | The method has been | |
| standardized against the | ||
| Enzymun-Test CA 15-3 method. | ||
| This in turn has been | ||
| standardized against the CA 15-3 | ||
| RIA from Fujirebio Diagnostics. | Same | |
| Prewash | Prewash needed | Same |
NON-CLINICAL PERFORMANCE EVALUATION 4.
Non-clinical performance evaluation for the Elecsys CA 15-3 II are briefly summarized below:
4.1. Precision
Precision and reproducibility of the Elecsys CA 15-3 II were demonstrated under K171605.
Analytical Sensitivity 4.2.
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) of the Elecsys CA 15-3 II were demonstrated under K171605.
High-Dose Hook Effect 4.3.
High-Dose Hook Effect of the Elecsys CA 15-3 II was demonstrated under K171605.
4.4. Linearity/Assay Reportable Range
Linearity/Assay Reportable Range of the Elecsys CA 15-3 II was demonstrated under K171605.
7
Endogenous Interferences 4.5.
Endogenous Interferences of the Elecsys CA 15-3 II was demonstrated under K171605.
Exogenous Interferences – Anticoagulants 4.6.
4.6.1 Serum/Li-Heparin Plasma Comparison
The performance of the Elecsys CA 15-3 II using Li-heparin plasmas sample comparing to serum sample on the cobas e 801 analyzer was demonstrated under K171605.
4.6.2 Serum/K2-EDTA Plasma Comparison
A study was performed to demonstrate that K2-EDTA plasma samples vield comparable values as serum samples by the Elecsys CA 15-3 II assay on the cobas e 801 analyzer. 44 serum/plasma paired samples were tested in singleton with one reagent lot on one cobas e 801 Immunoassav Analyzer. Potential effects were assessed by Passing/Bablok regression analysis. The data are summarized in the following table:
| | N | Range
(U/mL) | Slope
(95% CI) | Intercept
(95% CI) | Correlation
Coefficient |
|-----------------------------|----|-----------------|------------------------|--------------------------|----------------------------|
| Serum vs.
K2-EDTA Plasma | 44 | 8.37–298 | 0.985
(0.955–1.036) | -0.279
(-1.143–0.288) | 0.997 |
Conclusion:
The 44 serum/plasma pairs fulfilled the acceptance criteria for Passing Bablock Analysis. The data supports the addition of K2-EDTA plasma type.
Method Comparison to cobas e 601 Immunoassay Analyzer 4.7.
Method Comparison of the Elecsys CA 15-3 II on the cobas e 801 to the cobas e 601 immunoassay analyzer was demonstrated under K171605.
Stability (Reagent, Sample, Calibration) 4.8.
Stability (Reagent, Sample, Calibration) of the Elecsys CA 15-3 II was demonstrated under K171605.
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5. CONCLUSIONS
The information provided in this 510(k) Premarket Notification will support extending the sample type to include K2-EDTA plasma for the Elecsys CA 15-3 II test system on cobas e 801. The data supports a safe, effective device which performs as well as the predicate device.