(391 days)
The Nichols Advantage™ Chemiluminescence Erythropoietin Immunoassay is intended for use with the Nichols Advantage™ Specialty System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
The Nichols Advantage™ EPO assay is a two-site chemiluminescence assay. Total assay duration is 30 minutes at 37°C.
14 Incubation: 20 minutes at 37℃. Sample or control (200uL), biotinylated polyclonal antibody (40uL), acridinium labeled mouse monoclonal antibody (10uL) are pipetted into a reaction well on the cuvette strip. Each antibody binds to a separate and distinct antigenic site on EPO to form a sandwich complex.
204 Incubation: 10 minutes at 37°C. Streptavidin coated magnetic particles (20uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the high affinity interaction of blotin and streptavidin. The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically capfured onto the surface of the reaction well wall.
Acridinum esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in dilute acid and Trigger 2 solution contains sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidizes the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light which is quantified in 2 seconds, and is expressed in relative light units (RLU) by the integrated system luminometer.
The amount of bound labeled antibody in RLU's is directly proportional to the concentration of EPO in the sample. 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 codes.
The provided text describes the Nichols Advantage® Chemiluminescence Erythropoietin Immunoassay. Here's a breakdown of the requested information based on the document:
Acceptance Criteria and Device Performance
The document does not explicitly state formal "acceptance criteria" with pass/fail thresholds. Instead, it compares the performance characteristics of the new device (Nichols Advantage™ EPO) with those of a legally marketed predicate device (Nichols Chemiluminescence EPO kit). The underlying assumption is that if the new device demonstrates comparable performance to the predicate, it meets the requirements for substantial equivalence.
Table of Performance Characteristics (Comparison to Predicate Device):
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Nichols Advantage™ EPO) |
|---|---|---|
| Precision (Within-Run) | %CV comparable to predicate device | Mean (mU/mL): 12.5, %CV: 10.4 |
| Mean (mU/mL): 92, %CV: 3.3 | ||
| Mean (mU/mL): 168, %CV: 2.6 | ||
| Mean (mU/mL): 502, %CV: 4.5 | ||
| Precision (Total) | %CV comparable to predicate device | Mean (mU/mL): 12.5, %CV: 13.6 |
| Mean (mU/mL): 92, %CV: 5.5 | ||
| Mean (mU/mL): 168, %CV: 3.8 | ||
| Mean (mU/mL): 502, %CV: 5.6 | ||
| Recovery | Value comparable to predicate device (93-120%) | 87-111% |
| Parallelism | Value comparable to predicate device (84-108%) | 91-116% |
| High Dose Hook | Value comparable to predicate device (50,000 mU/mL) | 7,500 mU/mL |
| Specificity & Cross-Reactivity (Human Transferrin) |
§ 864.7250 Erythropoietin assay.
(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”