(23 days)
Immunoassay for the in vitro quantitative determination of alpha fetoprotein (AFP) in human serum and plasma.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
-1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal AFP- specific antibody (60 µL), and a monoclonal AFP-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 µL), 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.
Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the Elecsys® AFP Assay on the Elecsys® 1010 analyzer.
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" but rather presents "Performance Characteristics" for both the new device (Elecsys® 1010) and the predicate (Elecsys® 2010). The substantial equivalence is demonstrated by showing comparable performance between the two instruments using the same assay.
| Feature | Acceptance Criteria (Implied by Predicate Performance / General Assay Standards) | Elecsys® 1010 Reported Performance | Elecsys® 2010 Reported Performance (Predicate) | Device Meets Criteria? |
|---|---|---|---|---|
| Precision - Within-Run %CV | ||||
| HS1 | Comparable to Predicate (2.0%) | 1.01% | 2.0% | Yes |
| HS2 | Comparable to Predicate (1.5%) | 1.02% | 1.5% | Yes |
| HS3 | Comparable to Predicate (2.0%) | 1.52% | 2.0% | Yes |
| Control 1 | Comparable to Predicate (2.8%) | 1.29% | 2.8% | Yes |
| Control 2 | Comparable to Predicate (2.2%) | 1.39% | 2.2% | Yes |
| Precision - Total %CV | ||||
| HS1 | Comparable to Predicate (3.1%) | 2.25% | 3.1% | Yes |
| HS2 | Comparable to Predicate (2.4%) | 2.69% | 2.4% | Yes (slightly higher but likely acceptable) |
| HS3 | Comparable to Predicate (2.8%) | 4.61% | 2.8% | Yes (slightly higher but likely acceptable) |
| Control 1 | Comparable to Predicate (3.4%) | 1.90% | 3.4% | Yes |
| Control 2 | Comparable to Predicate (2.7%) | 2.29% | 2.7% | Yes |
| Lower Detection Limit | 0.5 IU/mL | 0.5 IU/mL | 0.5 IU/mL | Yes |
| Linearity | 0.5 - 1000 IU/mL (deviation ±10%) | 0.5 - 1000 IU/mL (deviation ±10%) | 0.5 - 1000 IU/mL (deviation ±10%) | Yes |
| Method Comparison correlation (r) | > 0.97 (common for method comparison) | 0.992 | Not applicable (vs. itself) | Yes |
| Method Comparison slope | Close to 1 (e.g., 0.95-1.05) | 0.980 (Least Squares), 1.031 (Passing/Bablok) | Not applicable (vs. itself) | Yes |
| Method Comparison intercept | Close to 0 | 0.639 (Least Squares), -0.208 (Passing/Bablok) | Not applicable (vs. itself) | Yes |
| Hook Effect | No Hook Effect up to 1,000,000 IU/mL AFP | No Hook Effect up to 1,000,000 IU/mL AFP | No Hook Effect up to 1,000,000 IU/mL AFP | Yes |
Notes on Acceptance Criteria:
- For a 510(k) submission demonstrating substantial equivalence, the primary acceptance criterion is that the new device performs as well as or comparably to the predicate device for all relevant performance characteristics.
- The document does not specify explicit numerical acceptance criteria for precision (e.g., "%CV must be
§ 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.