(63 days)
Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma.
Sandwich principle. Total duration of assay: 18 minutes.
• 1st incubation (9min.): 20 µL of sample, a biotinylated monoclonal LH-specific antibody (75 µL) and a monoclonal LH-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
• 2nd incubation (9min.): 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)3)2+)
•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.
The provided text describes the performance characteristics of the Elecsys® LH Assay and compares it to a predicate device, the Enzymun-Test® LH. The document acts as a 510(k) Summary, indicating that the study is for regulatory submission to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for each performance metric but rather presents "Performance Characteristics" for both the new Elecsys® LH and the predicate Enzymun-Test® LH. The implication is that the Elecsys® LH's performance should be comparable to or better than the predicate device for substantial equivalence.
| Feature | Acceptance Criteria (Implied: Comparable to or better than Predicate) | Elecsys® LH Reported Performance |
|---|---|---|
| Precision | Similar %CV values to predicate across low, mid, and high levels. | Low: Within-Run Mean 0.54 mIU/mL, %CV 1.82%; Total Mean 0.54 mIU/mL, %CV 5.17% |
| Mid: Within-Run Mean 9.38 mIU/mL, %CV 1.13%; Total Mean 9.38 mIU/mL, %CV 1.97% | ||
| High: Within-Run Mean 50.72 mIU/mL, %CV 0.81%; Total Mean 50.72 mIU/mL, %CV 1.99% | ||
| Lower Detection Limit | Comparable to or lower than predicate (0.50 mIU/mL). | 0.10 mIU/mL |
| Linearity | Comparable to predicate range (0.5 - 150 mIU/mL) with a deviation of ±10%. | 0.1 - 200 mIU/mL (with a deviation from a linear line of ±10%) |
| Method Comparison | Strong correlation with the predicate device (r value close to 1). | Vs Enzymun-Test® LH: |
| Least Squares: y = 1.00x - 0.199, r = 0.993, SEE = 1.141 | ||
| Passing/Bablok: y = 0.964x + 0.040, r = 0.993, SEE = 0.456 | ||
| Interfering substances | No interference at or above specific concentration limits for bilirubin, hemoglobin, lipemia, biotin, and rheumatoid factor. | No interference at: |
| Bilirubin: 25.0 mg/dL | ||
| Hemoglobin: 1 g/dL | ||
| Lipemia: 1500 mg/dL | ||
| Biotin: 30 ng/mL | ||
| Rheumatoid Factor: 1500 U/mL | ||
| Specificity (Cross-reactivity) | Low or no cross-reactivity with FSH, HCG, TSH, HGH, HPL (e.g., |
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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.