(127 days)
CHP
Not Found
No
The device description and performance studies detail a standard luminescence immunoassay based on competition principle and standard analytical validation methods. There is no mention of AI, ML, or image processing, which are common indicators of AI/ML use in medical devices.
No
This device is an in vitro diagnostic luminescence immunoassay used to measure Estradiol levels for diagnosis and monitoring, but it does not directly perform a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders." This indicates its purpose is to aid in diagnosing medical conditions.
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 Estradiol...". This directly identifies the device as intended for in vitro diagnostic purposes.
- Sample Type: The device measures analytes in biological samples (saliva and serum) which are tested outside of the body. This is a key characteristic of IVDs.
- Purpose: The measurements obtained are intended to be used "in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function." This indicates a medical purpose related to diagnosis and patient management.
- Device Description: The description of the luminescence immunoassay process confirms that the test is performed on samples in a laboratory setting, not directly on the patient.
The information provided clearly aligns with the definition 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 Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
CHP
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
Saliva and serum (for measurement of Estradiol)
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)
Normal Ranges in Saliva: Studies were performed to establish levels of estradiol in saliva throughout the menstrual cycles from 28 apparently healthy pre-menopausal women using no contraceptives (age 19 - 43). Three saliva samples were collected per day (morning, midday, and afternoon) and pooled and frozen prior to running the Estradiol LIA assay. Collection began at the last day of bleeding and continued daily until first day of bleeding. In addition, five postmenopausal women (age 42-62) and 40 males (age 20-63) were evaluated. One saliva sample was obtained for these 2 populations.
Comparison of Serum and Saliva: Comparison studies were performed using 50 saliva and 60 serum samples from adult healthy individuals. The saliva samples were tested on the IBL Estradiol 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 = 0.97 with a regression formula of Y=0.96RIA + 0.55. The serum samples were tested against a commercially available RIA test kit. The comparison with serum yielded r2 = 0.95 with a regression formula of Y= 1.00RIA - 4.83.
Serum to Saliva Comparison: A study was performed with the IBL Estradiol LIA to assess the levels of estradiol in serum versus those found in saliva. Saliva and serum pairs were collected at the same time between 10:00 AM and 4:00 PM. The paired samples were then run in the IBL Estradiol LIA test. The results of the comparison yielded the following regression formula - serum (pg/mL) = 43.491(saliva) - 4
§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(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.
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SUMMARY OF
SAFETY AND EFFECTIVENESS FOR IBL ESTRADIOL 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 Estradiol LIA having FDA assigned name: Estradiol test system, 21 CFR, 862.1260, categorized as Class 1 "exempt" medical devices for the Clinical Chemistry and Clinical Toxicology Panel, as Product Code CHP.
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 Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.
Device Performance:
Normal Ranges in Saliva
To establish a normal range in saliva for this test, studies were performed to establish levels of estradiol in saliva throughout the menstrual cycles from 28 apparently healthy pre-menopausal women using no contraceptives. Three saliva samples were collected per day (morning. midday, and afternoon) and pooled and frozen prior to running the Estradiol LIA assay. Collection began at the last day of bleeding and continued daily until first day of bleeding. In addition, five postmenopausal women and 40 males were evaluated for the studies. One saliva sample was obtained for these 2 populations. The Normal Ranges in saliva obtained for the studies are as follows:
| Normal ranges | Estradiol (pg/mL) | |
|---|---|---|
| ♀ | Premenopausal | |
| n=28 month profiles | ||
| age 19 - 43 | Follicular phase 0.6 - 10.4 | |
| Mid-cycle Peak 4.5 - 21.2 | ||
| Luteal phase 0.5 - 10.8 | ||
| ♀ | Postmenopausal n=5 | |
| age 42 - 62 | Trade/Device Name: IBL Estradiol LIA Test Regulation Number: 21 CFR 862.1260 Regulation Name: Estradiol test system Regulatory Class: Class I Product Code: CHP Dated: September 3, 2004 Received: September 7, 2004 |
Dear Mr. Lehnus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041349
Device Name: ________IBL Estradiol LIA Test
Indications For Use:
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041349
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