(105 days)
Not Found
Not Found
No
The device description details a standard immunoassay based on luminescence and competition principles. There is no mention of AI, ML, or any computational methods beyond direct comparison to a standard curve. The performance studies focus on analytical characteristics and comparison to a traditional method, not on the performance of an AI/ML algorithm.
No.
The device is used for the "diagnosis and treatment of disorders of the ovaries" and as "an aid for confirmation of ovulation," which indicates a diagnostic rather than a therapeutic purpose.
Yes
The Intended Use / Indications for Use section states that "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." This explicitly indicates a diagnostic purpose.
No
The device description clearly outlines a luminescence immunoassay (LIA) which is a laboratory-based test involving physical reagents, incubation, washing, and measurement of luminescence. This is a hardware-dependent process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva." This directly identifies the device as intended for in vitro diagnostic purposes.
- Sample Type: The device analyzes saliva, which is a biological sample taken from the body, a key characteristic of IVDs.
- Purpose: The measurements are used "in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation." This indicates the results are used for medical purposes related to diagnosis and treatment, which is the core function of an IVD.
- Device Description: The description details a laboratory-based immunoassay method (LIA) for analyzing the sample, further supporting its use in a diagnostic setting.
The information provided clearly aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JLS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were performed to establish levels of progesterone throughout the menstrual cycles of pre-menopausal women. Saliva samples were collected from apparently healthy females known to be pre-menopausal and using no contraceptives. Three saliva samples were collected per day and pooled and frozen prior to running the Progesterone LIA assay. Collection began at the last day of bleeding and continued daily until first day of bleeding. A total of 27 premenopausal women, six postmenopausal women and 49 males were evaluated for the studies.
Comparison studies were performed using saliva samples from 97 adult healthy populations. These samples were tested with the IBL Progesterone LIA and compared to a published procedure that used a modification in the handling of saliva for a typical RIA test. Results from measuring the saliva samples in both methods yielded a correlation of r2 = 0.94 with a regression formula of Y=0.89*RIA + 25.5 pg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity (Limit of Detection): 2.6 pg/mL
Intra-Assay (10) Precision: Range (pg/mL) 11.5 - 822, CV (%) 6.0 - 0.7
Inter-Assay (10) Precision: Range (pg/mL) 10.6 - 817.1, CV (%) 18.8 - 3.4
Linearity: Range (pg/mL) 7.5 - 779, Range (%) 78 - 120, Mean (%) 97
Recovery: Range (pg/mL) 27 - 1497, Range (%) 82 - 121, Mean (%) 103
Normal ranges:
♀ Premenopausal (n = 27 month profiles): Follicular phase 28 - 82 pg/mL, Luteal phase (peak max) 127 - 446 pg/mL
♀ Postmenopausal, n = 6: 18 - 51 pg/mL
♂ 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.
0
JUL 22 2004
SUMMARY OF
SAFETY AND EFFECTIVENESS FOR IBL PROGESTERONE LIA
Manufacturer: IBL Immuno Biological Laboratories Flughafenstrasse 52A, D-22335 Hamburg Germany
Contact Information: Lehnus & Associates Gary Lehnus 150 Cherry Lane Rd. East Stroudsburg, PA 18301 Tel: (570) 620-0198
Device Name / Classification:
The device trade name is the IBL Progesterone LIA having FDA assigned name: Progesterone test system, 21 CFR, 862.1620, categorized as Class I "exempt" medical devices for the Clinical Chemistry and Clinical Toxicology Panel, as Product Code JLS.
Device Description:
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.
Device Intended Use:
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.
Device Performance:
Studies were performed to establish levels of progesterone throughout the menstrual cvcles of pre-menopausal women. Saliva samples were collected from apparently healthy females known to be pre-menopausal and using no contraceptives. Three saliva samples were collected per day and pooled and frozen prior to running the Progesterone LIA assay. Collection began at the last day of bleeding and continued daily until first day of bleeding. A total of 27 premenopausal women, six postmenopausal women and 49 males were evaluated for the studies.
Comparison studies were performed using saliva samples from 97 adult healthy populations. These samples were tested with the IBL Progesterone LIA and compared to a published procedure that used a modification in the handling of saliva for a typical RIA test. Results from measuring the saliva samples in both methods yielded a correlation of r2 = 0.94 with a regression formula of Y=0.89*RIA + 25.5 pg/mL.
1
| Analytical Specificity
| (Cross Reactivity) | Substance | % Cross-reactivity | ||
|---|---|---|---|---|
| 17α-Hydroxyprogesteron | 1.84 | |||
| 6α-Methyl- | ||||
| 17α-Hydroxyprogesteron | 1.41 | |||
| Pregnenolone | 0.41 | Cross-reactivity of | ||
| other substances | ||||
| tested ≤ 0.1 % | ||||
| Deoxycorticosterone | 0.28 | |||
| Androsterone Sulfat | 0.25 | |||
| Androstenedion | 0.20 | |||
| Androsterone | 0.20 | |||
| DHEA-S | 0.11 | |||
| Corticosterone | 0.06 | |||
| Analytical Sensitivity | ||||
| (Limit of Detection) | 2.6 pg/mL | Mean signal (Zero-Standard) - 2SD | ||
| Precision | Range (pg/mL) | CV (%) | ||
| Intra-Assay (10) | 11.5 - 822 | 6.0 - 0.7 | ||
| Inter-Assay (10) | 10.6 - 817.1 | 18.8 - 3.4 | ||
| Linearity | Range (pg/mL) | Range (%) | Mean (%) | Serial dilution up to |
| 7.5 - 779 | 78 - 120 | 97 | 1 : 32 | |
| Recovery | Range (pg/mL) | Range (%) | Mean (%) | |
| 27 - 1497 | 82 - 121 | 103 |
The overall performance of the IBL Progesterone LIA is shown below:
ﺑﺮﻧﺎﻣ
| Normal ranges | Progesterone (pg/mL) | |
|---|---|---|
| ♀ | Premenopausal | |
| (n = 27 month profiles) | Follicular phase | |
| 28 - 82 pg/mL | ||
| Luteal phase | ||
| (peak max) 127 - 446 pg/mL | ||
| ♀ | Postmenopausal, n = 6 | 18 - 51 pg/mL |
| ♂ | n = 49 |