(138 days)
FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The FastPack® IP Sex Hormone Binding Globulin Immunoassay employs a sandwich immunoassay principle. Endogenous SHBG in a patient sample, calibrator, or control is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-SHBG antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-SHBG antibody linked to biotin will bind to streptavidin coated paramagnetic particles (PMP). After incubation, washing steps (using a Tris buffer containing detergents) occur to separate bound from unbound anti-SHBG monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of SHBG in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.
Here's an analysis of the provided text regarding the FastPack® IP Sex Hormone Binding Globulin Immunoassay's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a separate section. However, based on the comparative effectiveness study against a predicate device and the presented performance data, we can infer some implied acceptance ranges or targets for the new device.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (%CV) | Similar to or better than predicate (≤ 5.5% for all listed). Stated target: Within-run: ≤ 10%, Between-run: ≤ 8%, Between-day: ≤ 8% | Reagent lot 1, analyzer 1, calibrator lot 1: |
- Within-Run: 2.74% - 6.95%
- Between-Run: 0.00% - 7.79%
- Between-Day: 0.00% - 4.96%
- Total: 3.21% - 7.06%
Reagent lot 2, analyzer 2, calibrator lot 2:
- Within-Run: 4.16% - 7.74%
- Between-Run: 0.00% - 6.56%
- Between-Day: 1.25% - 7.44%
- Total: 5.04% - 11.53%
Reagent lot 3, analyzer 3, calibrator lot 3:
- Within-Run: 3.4% - 9.60%
- Between-Run: 0.0% - 7.21%
- Between-Day: 0.0% - 6.05%
- Total: 4.0% - 12.05% |
| Linearity | Assay linear within a specified range (Predicate: 0.33 - 200 nmol/L) | Linear from LOQ (0.80 nmol/L) to 174 nmol/L |
| Interfering Substances | No interference at specified levels (similar to predicate) | No interference with listed compounds (e.g., conjugated bilirubin 40 mg/dL, hemoglobin 1.0 g/dL, lipid 1000 mg/dL, d-Biotin 0.2 mg/dL) and cross-reactants (e.g., Transferrin 0.5 g/dL, Testosterone 2.5 mg/dL, etc.) at specified concentrations. Rheumatoid factor up to 1000 IU/mL and human anti-mouse IgG up to 4 µg/mL also showed no cross-reactivity. Six known heterophile samples did not generate detectable interference. |
| Method Comparison | Strong correlation to predicate (Predicate R2 = 0.94) | R = 0.985, Slope (95% CI): 0.993 (0.967-1.019), y-intercept (95% CI): -0.614 (-2.21 to 0.982), R2 = 0.971 |
| Sample Type Equivalence| Equivalence between serum and plasma | Strong correlation between serum and lithium-heparin plasma via Passing-Bablok regression: Slope (95% CI): 0.960 (0.920-1.00), y-intercept (95% CI): 1.859 (-0.89 to 4.61), R = 0.990, R2 = 0.979. Absolute bias 1.117 nmol/L, % Bias 1.928%. |
| LOB | Not explicitly stated for acceptance, but a calculated value | 0.08 nmol/L SHBG |
| LOD | Not explicitly stated for acceptance, but a calculated value | 0.20 nmol/L SHBG |
| LOQ | Lowest sample with
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.