(264 days)
cobas e 601 immunoassay analyzer, cobas e 801 Immunoassay Analyzer
No
The description focuses on a standard immunoassay technology (ECLIA) and calibration methods, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) assay designed to quantitatively determine CA 15-3 levels in human samples. It aids in the management of breast cancer patients by detecting recurrence and monitoring therapeutic response, but it does not directly treat or alleviate a disease or condition.
Yes
The device is described as an "Immunological in vitro assay for quantitative determination of CA 15-3" used "to aid in the management of breast cancer patients," including "in the early detection of recurrence" and "for monitoring response to therapy." These phrases clearly indicate its intended use for diagnosing and monitoring a medical condition.
No
The device is an in vitro diagnostic immunoassay kit intended for use on specific hardware analyzers (cobas e immunoassay analyzers). It involves reagents, microparticles, and electrochemiluminescence detection, which are all hardware components.
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".
- Device Description: The description details a "two-step sandwich immunoassay" and mentions testing "human serum and Li-heparin plasma", which are biological samples tested in vitro (outside the body).
- Performance Studies: The performance studies describe testing various characteristics of the assay using human serum and plasma samples, further confirming its in vitro nature.
N/A
Intended Use / Indications for 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 immunoassay analyzers.
Product codes
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 and plasma. It is intended for use on the cobas e 411 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 with the reagent barcode.
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
4.1. Precision
Precision of the Elecsys CA 15-3 II assay was evaluated on one cobas e 801 Immunoassay Analyzer according to CLSI EP5-A3 guideline. One reagent lot was evaluated.
The protocol consisted of testing 2 replicates of each control (PC Tumor Marker = PreciControl Tumor Marker) and five pooled human sera (HS) samples per run, 2 runs per day for 21 days. The samples were run in randomized order on the cobas e 801 analyzer.
4.2.1. Limit of Blank (LoB)
LoB of the Elecsys CA 15-3 II assay on the cobas e 801 Immunoassay Analyzer has been determined according to CLSI EP17-A2.
The Limit of Blank was determined by performing one run per day from three reagent lots on one cobas e 801 instrument, over six days. The testing included one blank sample with ten replicates per run for a total of sixty total blank replicates per reagent lot.
4.2.2. Limit of Detection (LoD)
LoD of the Elecsys CA 15-3 assay on the cobas e 801 Immunoassay Analyzer has been determined according to CLSI EP17-A2.
The Limit of Detection was determined by performing one run per day from three reagent lots on one cobas e 801 instrument, over six days. The testing included two replicates per sample (5 samples) per run for a total of sixty total blank replicates per sample per reagent lot.
4.2.3. Limit of Quantitation (LoQ)
The LoQ of the Elecsys CA 15-3 II assay was determined on the cobas e 801 Immunoassay Analyzer according to CLSI Guideline EP17-A2.
A set of ten human serum samples (single donors, native as well as diluted) with concentrations in the specified LoQ-area was evaluated for each of 3 reagent lots.
The Limit of Quantitation was determined by performing one run per day from three reagent lots on one cobas e 801 instrument, over five days. The testing included ten samples, each with five replicates per daily run over 5 days for a total of twenty five replicates per sample per reagent lot.
4.3. High-Dose Hook Effect
The high-dose hook effect of the Elecsys CA 15-3 II assay was assessed on the cobas e 801 analyzer in three-fold determination. Two samples were spiked with analyte to achieve high CA 15-3 concentrations. For each sample, a dilution series was performed using native human serum.
4.4. Linearity/Assay Reportable Range
Linearity of the Elecsys CA 15-3 II assay was evaluated using the cobas e 801 Immunoassay Analyzer according to CLSI EP6-A.
Three high analyte serum samples and three high analyte plasma samples (serum/plasma pool, spiked) were diluted with Elecsys Universal Diluent. 15 concentrations (dilutions) throughout the measuring range were prepared. Samples were assayed in 3-fold determination within a single run.
4.5. Endogenous Interferences
The effect on quantitation of analyte in the presence of endogenous interfering substances using the Elecsys CA 15-3 II was determined on the cobas e 801 Immunoassay analyzer using human serum samples.
For each interfering substance three human serum samples containing low (pooled sera), mid (pooled spiked sera) and high (pooled spiked sera) concentrations of CA 15-3 were tested.
4.6. Hemolysis/Bilirubin/Lipemia/Biotin
The evaluation involved spiking aliquots of serum samples with interfering substances (biotin, lipemia, hemoglobin, bilirubin) or and then comparing recovery to unspiked or reference samples. For HAMA and Rheumatoid Factors, specific serums were tested and recovery compared to reference samples. In all cases, the specification was met, indicating non-interference.
4.7. Exogenous Interferences – Anticoaqulants
The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys CA 15-3 II Immunoassay was determined by comparing values obtained from samples (native) drawn into Serum, and Li-Heparin plasma.
Forty nine native samples were tested with one reagent lot on one cobas e 801 Immunoassay Analyzer. Potential effects are assessed by Passing/Bablok regression analysis.
4.8. Method Comparison to cobas e 601 Immunoassay Analyzer
A method comparison was performed using the cobas e 601 immunoassay analyzer as predicate device. The study was performed on the cobas e 601 immunoassay analyzer (X) and on the cobas e 801 analyzer (Y).
A total of 190 human serum samples (all single donors, native samples) were measured with Elecsys CA 15-3 II immunoassay on both analyzers in singleton covering the entire measuring range. Mean values ranges between 5.14 - 290 U/mL for the cobas e 601 analyzer and between 4.24 – 273 U/mL for the cobas e 801 analyzer.
Evaluation was performed for all samples within the measuring range of both assays and in compliance with Standard Operation Procedures of Roche Diagnostics GmbH. Passing/Bablok and linear regression analysis was performed according to CLSI EP09-A3.
4.9. Reagent Stability
Study 1. On board reagent stability (16 weeks): Elecsys CA 15-3 II reagent kits can be stored on board of the analyzers for up to 16 weeks. A new calibration of the kit kept on-board is recommended every 28 days. Tested on one cobas e 801 Immunoassay Analyzer. Six human serum (HS) samples were tested in two-fold determination, with re-calibration at 5, 9, 13, and 17 weeks.
Study 2. Real-time stability (ongoing): Elecsys CA 15-3 II reagent stored at 2-8°C. Tested at T=0 and specified intervals (e.g., 0, 15, 19, 30 months for Lot 156423) using PreciControl Tumor Marker Level 1 and 2.
4.10. Sample Stability
Study 1. Sample stability at 2-8°C: Ten samples for each sample type (Serum, and Li-Heparin plasma) were measured after storage at 2-8°C for 9 days. Reference aliquot stored at -80°C. Measurements performed with three-fold determination on a cobas e 601 Immunoassay Analyzer. Samples were single donors (native, spiked, and diluted).
Study 2. Sample stability at Room Temperature (20-25°C): Ten samples for each sample type (Serum, and Li-Heparin plasma) were measured after storage at 20-25℃ for 8 days. Reference aliquot stored at -80℃. Measurements performed with three-fold determination on a cobas e 601 Immunoassay Analyzer. Samples were single donors (native, spiked, and diluted).
Study 3. Sample stability at -20°C (± 5 °C): Ten samples for each sample type (Serum, and Li-Heparin plasma) were measured after storage at -20°C for 53 weeks. Reference aliquot stored at -80°C. Measurements performed with three-fold determination on a cobas e 601 Immunoassay Analyzer. Samples were single donors (native, spiked, and diluted).
4.11. Calibration Stability
Study 1. Lot calibration stability: Calibration of an Elecsys CA 15-3 II reagent lot is recommended every 12 weeks. Elecsys CA 15-3 II was calibrated with a fresh reagent kit on Day 0 using a cobas e 801 Immunoassay Analyzer. After 13 weeks, a new reagent kit of the same lot was used and recovery of samples was determined using the calibration curve of day 0. Five human serum (HS) samples were tested; each sample was tested with two-fold determination.
Study 2. On-board calibration stability: Reagent On-board Calibration stability for the Elecsys CA 15-3 II assay was tested on one cobas e 801 Immunoassay Analyzer. A fresh Reagent cobas e pack was placed on the analyzer and calibrated. All samples were measured on day 0. On day 29 the same samples were measured with the same reagent kit kept under on-board conditions using the calibration curve established on day 0. Six human serum (HS) samples. Each sample was tested in two-fold determination.
Key Metrics
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Predicate Device(s)
CA 15-3 II Assay (K001468)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
February 27, 2018
Roche Diagnostics Adennis Cora Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250
Re: K171605
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: May 26, 2017 Received: June 1, 2017
Dear Adennis Cora:
This letter corrects our substantially equivalent letter of February 20, 2018.
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 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
1
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 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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 O
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) K171605
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 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 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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Elecsys CA 15-3 II 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.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys CA 15-3 II.
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 | April 14, 2017 |
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 | CA 15-3 II Assay (K001468) |
Establishment Registration | For the Elecsys CA 15-3 II, the establishment registration number for Roche |
Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg, | |
Germany, 9610529. The establishment registration number for Roche | |
Diagnostics in the United States is 1823260. |
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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 and plasma. It is intended for use on the cobas e 411 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 with the reagent barcode.
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.
1.3. -Control
PreciControl Tumor Marker is used for the quality control verification of the performance of the assay on the cobas e analyzers.
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2. INDICATIONS FOR USE
Immunological in vitro assay for quantitative determination of CA 15-3 in human serum and Liheparin 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 (K001468). In summary, the Elecsys CA15-3 II described in this submission is substantially equivalent to the predicate device.
| Feature | CA 15-3 II
(Cleared K001468) | Elecsys CA 15-3 II |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended use | For the quantitative determination of
CA 15-3 in human serum and
plasma. | for quantitative determination of CA
15 3 in human serum and
Li-heparin plasma |
| Indication for use | To aid in the management of breast
cancer patients. In conjunction with
other clinical and diagnostic
procedures, serial testing with CA 15-
3 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. | Same |
| Sample Type | Human serum and plasma treated
with heparin (Li-, Na-) or K3-EDTA
plasma | human serum and
Li-heparin plasma |
| Analytical Specificity | Based on monoclonal 115D8 and
DF3 antibodies available from
Centocor | Same |
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| Feature | CA 15-3 II
(Cleared K001468) | Elecsys CA 15-3 II |
|-----------------------|---------------------------------|---------------------------------|
| Instrument Platform | Elecsys 2010 | |
| | MODULAR ANALYTICS E170 | |
| | cobas e 411 | cobas e 801 |
| | cobas e 601 | |
| | cobas e 602 | |
| Measuring Range | 1.0 - 300 U/mL | 3 - 300 U/mL |
| | Determined by LDL (2SD) | Determined by LOQ (Per EP17-A2) |
| Biotin | Added to R2 | Same |
| Prewash | No Prewash | Prewash Added |
| Sample Dilution | 1:10 | 1:20 |
| LoD | 10% above the upper limit of the measuring range.
Linearity/Assay Reportable Range 4.4.
Linearity of the Elecsys CA 15-3 II assay was evaluated using the cobas e 801 Immunoassay Analyzer according to CLSI EP6-A.
Three high analyte serum samples and three high analyte plasma samples (serum/plasma pool, spiked) were diluted with Elecsys Universal Diluent. 15 concentrations (dilutions) throughout the measuring range were prepared. Samples were assayed in 3-fold determination within a single run.
The linearity data were analyzed with regards to linear, quadratic and cubic polynomials according to CLSI EP6-A. In a first step, a linearity check was performed with a first order (linear) regression and then with higher order models (quadratic and cubic).
All deviations were within predetermined acceptance criteria.
Endogenous Interferences 4.5.
The effect on quantitation of analyte in the presence of endogenous interfering substances using the Elecsys CA 15-3 II was determined on the cobas e 801 Immunoassay analyzer using human serum samples.
For each interfering substance three human serum samples containing low (pooled sera), mid (pooled spiked sera) and high (pooled spiked sera) concentrations of CA 15-3 were tested.
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4.6. Hemolysis/Bilirubin/Lipemia/Biotin
Biotin:
One aliguot of each serum sample was spiked with the interfering substance, another aliquot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments.
The recovery for each sample was calculated by comparison to the reference (unspiked) sample.
In conclusion, the specification was met for all substances tested, as each substance was found to be non-interfering at the spiked concentration.
Lipemia:
One aliquot of each serum sample was spiked with the interfering substance, and another aliguot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments.
The recovery for each sample was calculated by comparison to the reference (unspiked) sample.
In conclusion, the specification was met for all substances tested, as each substance was found to be non-interfering at the spiked concentration.
Hemoglobin:
Fresh hemolysate was prepared from fresh EDTA or heparin blood. One aliquot of each serum sample was spiked with the hemolysate (interfering pool), another aliquot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments. The recovery for each sample was calculated by comparison to the reference (unspiked) sample.
In conclusion, the specification was met for all substances tested, as each substance was found to be non-interfering at the spiked concentration.
Bilirubin:
One aliquot of each serum sample was spiked with the interfering substance, and another aliquot with was spiked with the same volume of the solvent (0.1 mol/L NaOH) of the interfering
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substance (dilution pool). The interfering pool was then dilution pool in 10% increments.
HAMA:
The effect of the presence of human anti-mouse antibodies on the Elecsys CA 15-3 II assay was assessed on the cobas e 801 Immunoassay Analyzer.
The specified HAMA-serum with a concentration of 805 ng/mL and the related reference serum (without interferent) was measured in two-fold determination over 3 levels. Recovery of the HAMA-serum compared to the reference serum sample was calculated.
In conclusion, the specification was met for all substances tested, as each substance was found to be non-interfering at the spiked concentration.
Rheumatoid Factors Interference:
One aliquot of each serum sample was spiked with the interfering substance. and another aliquot with the same volume of the solvent (buffer matrix) of the interfering substance (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments.
The recovery for each sample was calculated by comparison to the reference sample.
In conclusion, the specification was met for all substances tested, as each substance was found to be non-interfering at the spiked concentration.
4.7. Exogenous Interferences – Anticoaqulants
The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys CA 15-3 II Immunoassay was determined by comparing values obtained from samples (native) drawn into Serum, and Li-Heparin plasma.
Forty nine native samples were tested with one reagent lot on one cobas e 801 Immunoassay Analyzer. Potential effects are assessed by Passing/Bablok regression analysis.
11
4.8. Method Comparison to cobas e 601 Immunoassay Analyzer
A method comparison was performed using the cobas e 601 immunoassay analyzer as predicate device. The study was performed on the cobas e 601 immunoassay analyzer (X) and on the cobas e 801 analyzer (Y).
A total of 190 human serum samples (all single donors, native samples) were measured with Elecsys CA 15-3 II immunoassay on both analyzers in singleton covering the entire measuring range. Mean values ranges between 5.14 - 290 U/mL for the cobas e 601 analyzer and between 4.24 – 273 U/mL for the cobas e 801 analyzer.
Evaluation was performed for all samples within the measuring range of both assays and in compliance with Standard Operation Procedures of Roche Diagnostics GmbH. Passing/Bablok and linear regression analysis was performed according to CLSI EP09-A3.
4.9. Reagent Stability
To test reagent stability, two studies were executed with one study completed including:
Study 1. On board reagent stability (16 weeks)
Study 2. A real-time stability study is ongoing to support shelf-life stability claim.
Study 1- Onboard reagent stability (for 16 weeks) 4.9.1. -
Elecsys CA 15-3 II reagent kits can be stored on board of the analyzers for up to 16 weeks.
A new calibration of the kit kept on-board is recommended every 28 days.
Onboard Reagent Stability and Calibration Stability for the Elecsys CA 15-3 II assay was tested on one cobas e 801 Immunoassay Analyzer.
A fresh cobas e pack was placed on the analyzer and calibrated. Reference values for the samples tested were determined (day 0). After 5, 9, 13 and 17 weeks the same samples were measured with the same reagent kit kept under onboard condition. Re-calibration was performed at every measuring time point.
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Samples tested include six human serum (HS) sample was tested in two-fold determination. The human serum samples used were pooled sera for sample ranges low, Decision range 1 and 2, and pooled spiked sera for sample ranges medium and high.
Study 2 - Reagent Real-time Stability 4.9.2.
In the real-time stability study, the Elecsys CA 15-3 II reagent was stored at 2-8°C. The stored assay reagents were tested at time point T=0 (after manufacturing) and at specified intervals over the shelf life of the device. Testing was performed using PreciControl Tumor Marker Level 1 and 2 (1yophilized, stored at +2 to +8°C) for lot-numbers 156423, 158287 and 174942.
Data for lot no. (in months):
156423 for the time-points at 0, 15, 19, 30
158287 for the time-points at 0, 13, 17, 25
174942 for the time-points at 0, 12, 15, 19
The average on-test recovery value will be calculated as percent recovery compared to the reference value (assigned value for PreciControl Tumor Marker Level 1 and 2).
4.10. Sample Stability
To test sample stability, three studies were completed, including:
Study 1. Sample stability at 2-8°C
Study 2. Sample stability at Room Temperature (20-25°C)
- Study 3. Sample stability -20°C (± 5 °C)
- 4.10.1. Study 1-Sample Stability at 2-8°C
Ten samples for each sample type (Serum, and Li-Heparin plasma) were aliquoted and measured after storage at 2-8°C for 9 days. The aliguot for the reference value was stored at -80°C and measured at the same time point. Measurements were performed with three-fold determination on a cobas e 601 Immunoassay Analyzer and recovery was calculated as percent of the reference value. The samples used were all single donors (native, spiked as well as diluted).
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4.10.2. Study 2-Sample Stability at Room Temperature (20-25°C)
Ten samples for each sample type (Serum, and Li-Heparin plasma) were aliquoted and measured after storage at 20-25℃ for 8 days. The aliquot for the reference value was stored at -80℃ and measured at the same time point.
Measurements were performed with three-fold determination on a cobas e 601 Immunoassay Analyzer and recovery was calculated as percent of the reference value.
The samples used were all single donors (native, spiked as well as diluted).
4.10.3. Study 3-Sample Stability at -20°C (+5°C)
Ten samples for each sample type (Serum, and Li-Heparin plasma) were aliquoted and measured after storage at - 20°C for 53 weeks. The aliquot for the reference value was stored at -80°C and measured at the same time point.
Measurements were performed with three-fold determination on a cobas e 601 Immunoassav Analyzer and recovery was calculated as percent of the reference value.
The samples used were all single donors (native, spiked as well as diluted).
4.11. Calibration Stability
To test calibration stability, two studies were completed, including:
Study 1. Lot calibration stability
Study 2. On-board calibration stability
4.11.1. Study 1-Lot Calibration Stability
Calibration of an Elecsys CA 15-3 II reagent lot is recommended every 12 weeks. During that time period fresh reagent kits of the same lot can be used without calibration using the calibration curve of the Day 0 reagent kit.
Elecsys CA 15-3 II was calibrated with a fresh reagent kit on Day 0 using a cobas e 801 Immunoassay Analyzer. After 13weeks a new reagent kit of the same lot was used and recovery of samples was determined using the calibration curve of day 0.
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Five human serum (HS) samples were tested; each sample was tested with two-fold determination. The human serum samples used were pooled diluted sera for sample range low. pooled sera for Decision range, and pooled spiked sera for sample ranges medium and high.
4.11.2. Study 2-On-board Calibration Stability
Elecsys CA 15-3 II reagent kits can be stored on board of the analyzers for up to 28 days without a new calibration.
Reagent On-board Calibration stability for the Elecsys CA 15-3 II assay was tested on one cobas e 801 Immunoassay Analyzer.
A fresh Reagent cobas e pack was placed on the analyzer and calibrated. All samples were measured on day 0. On day 29 the same samples were measured with the same reagent kit kept under on-board conditions using the calibration curve established on day 0.
Samples tested include six human serum (HS) samples. Each sample was tested in two-fold determination. The human serum samples used were pooled diluted sera for sample range low. pooled sera for Decision range, and pooled spiked sera for sample ranges medium and high,
5. CONCLUSIONS
The information provided in this 510(k) Premarket Notification will support a determination of substantial equivalence for the Elecsys CA 15-3 II test system. The data supports a safe, effective device which performs as well as or better than the predicate device.