(105 days)
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.
Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
IBL Progesterone LIA - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the performance characteristics of the IBL Progesterone LIA. The acceptance criteria for these characteristics are not explicitly stated as distinct thresholds in the document, but rather the reported performance values themselves serve as the demonstration of the device's capability. For this analysis, we will interpret the reported performance as meeting the implicit acceptance criteria for a device of this type.
| Performance Metric | Reported Device Performance |
|---|---|
| Analytical Specificity (Cross-Reactivity) | |
| 17α-Hydroxyprogesteron | 1.84% |
| 6α-Methyl-17α-Hydroxyprogesteron | 1.41% |
| Pregnenolone | 0.41% |
| Deoxycorticosterone | 0.28% |
| Androsterone Sulfat | 0.25% |
| Androstenedion | 0.20% |
| Androsterone | 0.20% |
| DHEA-S | 0.11% |
| Corticosterone | 0.06% |
| Other substances tested | ≤ 0.1 % |
| Analytical Sensitivity (Limit of Detection) | 2.6 pg/mL (Mean signal (Zero-Standard) - 2SD) |
| Precision | |
| Intra-Assay (10 measurements) | Range (pg/mL): 11.5 - 822; CV (%): 6.0 - 0.7 |
| Inter-Assay (10 measurements) | Range (pg/mL): 10.6 - 817.1; CV (%): 18.8 - 3.4 |
| Linearity | Range (pg/mL): 7.5 - 779; Range (%): 78 - 120; Mean (%): 97 (Serial dilution up to 1:32) |
| Recovery | Range (pg/mL): 27 - 1497; Range (%): 82 - 121; Mean (%): 103 |
| Comparison Study | Correlation with a published RIA method: r² = 0.94, Regression formula: Y = 0.89 * RIA + 25.5 pg/mL |
| Normal Ranges (Reference Values) | Premenopausal Females (n=27 month profiles): Follicular phase: 28 - 82 pg/mL, Luteal phase (peak max): 127 - 446 pg/mL |
| Postmenopausal Females (n=6): 18 - 51 pg/mL | |
| Males (n=49): |
§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(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.