(24 days)
Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone in human serum and plasma.
Sandwich principle. Total duration of assay: 18 minutes.
• 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)) 2+ 3
•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 text regarding the Elecsys® FSH Assay, focusing on acceptance criteria and study details.
This document describes a medical device, specifically an in vitro diagnostic (IVD) device. For IVDs, "acceptance criteria" often refer to performance characteristics that demonstrate the device is substantially equivalent to a predicate device and performs reliably. "Device performance" is typically reported through various analytical and sometimes clinical studies.
It's important to note that the provided text is a 510(k) summary, which is a submission to the FDA. It summarizes the information and doesn't always contain the full detail of the underlying studies.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Unit) | Predicate Device (Enzymun® FSH Assay) Performance | Elecsys® FSH Assay Performance (Reported Device) |
|---|---|---|---|
| Precision | %CV (Within-Run & Total) | Low: 2.1% (Within-Run), 2.3% (Total) | Low: 1.75% (Within-Run), 5.26% (Total) |
| Mid: 1.8% (Within-Run), 2.6% (Total) | Mid: 1.95% (Within-Run), 3.69% (Total) | ||
| High: 1.2% (Within-Run), 3.1% (Total) | High: 1.80% (Within-Run), 5.08% (Total) | ||
| Lower Detection Limit | Concentration (mIU/mL) | 0.50 mIU/mL | 0.10 mIU/mL |
| Linearity | Range (mIU/mL) | 0.50-150 mIU/mL (±10% deviation) | 0.10-200 mIU/mL (±10% deviation) |
| Method Comparison | Correlation Coefficient (r) | 0.993 (Least Squares) | 0.998 (Least Squares and Passing/Bablok) |
| Slope (y=mx+b) | 0.96 (Least Squares) | 1.10 (Least Squares), 1.09 (Passing/Bablok) | |
| Interfering Substances | Bilirubin (mg/dL) | No interference at 64.5 mg/dL | No interference at 25 mg/dL |
| Hemoglobin (g/dL) | No interference at 1 g/dL | No interference at 1 g/dL | |
| Lipemia (mg/dL) | No interference at 1250 mg/dL | No interference at 1500 mg/dL | |
| Biotin (ng/mL) | No interference at 90 ng/mL | No interference at 30 ng/mL | |
| Rheumatoid Factor (IU/mL) | No interference (specific value not given) | No interference at 1500 IU/mL | |
| Specificity (Cross-reactivity) | LH (% cross-reactivity) | 0.00% (at 1040 mIU/mL) |
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.