(237 days)
Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer.
These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential).
This immunoassay is indicated for use as an aid in the detection of recurrent ovarian carcinoma. This immunoassay is further indicated for use in monitoring patients for disease progress or response to therapy.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzers.
For use in the verification of the callbration established by the Elecsys CA 125 II reagent on the Elecsys and cobas e immunoassay analyzers.
The CA 125 II assay employs a sandwich test principle using biotinylated monoclonal CA 125-specific antibody and a monoclonal CA 125-specific antibody labeled with a ruthenium complex to form a sandwich complex. The use of streptavidin-coated microparticles serves as the solid phase for the 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 (5-point-calibration) provided with the reagent bar code.
The CA 125 II application is identical to the predicate assay (K972162). This submission is being done to modernize the labeling by adding the LoB, LoD and LoQ data and to change the sample:reagent ratio from 40:60μL to 20:70μL. Additionally, based on internal stability data the calibration frequency has been extended from 4 to 8 weeks.
The Elecsys CA 125 II CalCheck is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2 and 3. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's a breakdown of the acceptance criteria and the study details for the Elecsys CA 125 II Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table (Table 1) between the predicate device (Elecsys CA 125 II, K972162) and the candidate device (Elecsys CA 125 II Assay), highlighting both similarities and differences, including labeled performance characteristics. Since explicit "acceptance criteria" are not given in a numerical form that can be directly compared to "reported performance" for each item, I will present the key performance characteristics detailed for the candidate device as its reported performance, implicitly indicating what was demonstrated to FDA for substantial equivalence.
| Acceptance Criteria (Implied / Predicate) | Reported Device Performance (Candidate Device) |
|---|---|
| General Assay Features | |
| Intended Use/Indications for Use | Largely similar indications, but explicitly mentions K2-EDTA and K3-EDTA, as well as Li-heparin plasma tubes with separating gel. Specific to cobas e 411 analyzer. |
| Assay Protocol | Same (sandwich test principle) |
| Detection Protocol | Same (Electrochemiluminescent Assay) |
| Applications | Same (18 minute application) |
| Instrument Platform | cobas e 411 analyzer (Predicate: Elecsys 2010, cobas e 411, MODULAR Analytics E170, cobas e 601 and cobas e 602 immunoassay analyzers) |
| Sample: Reagent Ratio | 20:70 μL (Predicate: 40:60 μL) |
| Sample Type | Human serum and Li-heparin, K2-EDTA and K3-EDTA, as well as Li-heparin plasma tubes containing separating gel (Predicate: Broader, including Na-NH4+-heparin, K2-EDTA, K3-EDTA, sodium citrate plasma). |
| Reagents | Same |
| Calibrator | Elecsys CA 125 II CalSet II (K140112) (Predicate: Elecsys CA 125 II CalSet (K003969)) |
| Calibration Interval | After 8 weeks when using the same reagent lot (Predicate: After 1 month (28 days)). Other conditions are similar. |
| Controls | Same (Elecsys PreciControl Tumor Marker) |
| Traceability/Standardization | Same (standardized against Enzymun-Test CA 125 II, which was standardized against CA 125 II RIA from Fujirebio Diagnostics). |
| Reagent Stability (on analyzers) | 6 weeks (Predicate: 4 weeks) |
| Labeled Performance Characteristics | |
| Measuring Range | 2 (LoQ) - 3000 U/mL (Predicate: 0.6 (LDL) - 5000 U/mL) |
| Precision (cobas e411 analyzers) | Intra-Assay/Within-run (Repeatability): |
| 3.1% CV @ 14.70 U/mL | |
| 3.0% CV @ 3.07 U/mL | |
| 2.6% CV @ 2399 U/mL | |
| 1.9% CV @ 34.95 U/mL | |
| 0.9% CV @ 120.7 U/mL | |
| 1.1% CV @ 329.6 U/mL | |
| Total (Intermediate): | |
| 4.1% CV @ 14.70 U/mL | |
| 4.2% CV @ 3.07 U/mL | |
| 3.4% CV @ 2399 U/mL | |
| 3.0% CV @ 34.95 U/mL | |
| 1.3% CV @ 120.7U/mL | |
| 1.3% CV @ 329.6U/mL | |
| LoB | 0.6 U/mL (Predicate: Not Reported) |
| LoD | 1.2 U/mL (Predicate: Not Reported) |
| LoQ | 2 U/mL (Predicate: Not Reported) |
| Lower Detection Limit | N/A (Functional Sensitivity 0.6 U/mL for Predicate, but now explicit LoD/LoQ are reported for candidate). |
| Performance Characteristics | |
| Hook Effect | No high-dose hook effect at CA 125 concentrations up to 50,000 U/mL (Predicate: up to 20,000 U/mL). |
| Limitations (Interferences) | Unaffected by: Hemolysis |
§ 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.