(75 days)
Not Found
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay for measuring unconjugated estriol. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on traditional analytical metrics like precision, regression, and specificity.
No
This device is an in vitro diagnostic method used to measure unconjugated estriol in human serum, which is used for evaluating fetal well-being. It is not intended for treatment or prevention of disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum... Measurements of uE, are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation." This clearly defines it as a diagnostic device.
No
The device is described as an "in vitro diagnostic method" intended to measure unconjugated estriol in human serum on the "Bayer Immuno 1™ system." This indicates it is a method performed on a specific hardware system (the Bayer Immuno 1™), not a standalone software application. The performance studies also detail laboratory-based metrics like precision and specificity, which are characteristic of IVD assays performed on hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum..." and "Measurements of uE, are used in evaluating fetal well-being...". This clearly indicates the device is used to perform tests on samples taken from the human body (serum) to provide information for medical purposes (evaluating fetal well-being).
- Device Description: The description reiterates that it is an "in vitro diagnostic method" intended to measure unconjugated estriol in human serum.
These statements directly align with the definition of an In Vitro Diagnostic device, which is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions.
N/A
Intended Use / Indications for Use
This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System. Measurements of unconjugated estriol are used to evaluate fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.
Product codes (comma separated list FDA assigned to the subject device)
CGI
Device Description
Not Found
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)
Listed below is a comparison of the performance of the Bayer Immuno 1™ Unconjugated Estriol method and a similar device granted clearance of substantial equivalence (Diagnostic Products Corporation Coat-a-Count Free Estriol RIA method). The information below was extracted from the Bayer Immuno 1 Unconjugated Estriol method sheet and the DPC Free Estriol RIA Package Insert.
Precision (within-run): (n = 20 over 10 days)
mean: 0.41, % CV: 3.6%
mean: 3.60, % CV: 3.2%
mean: 6.49, % CV: 1.5%
mean: 11.37, % CV: 2.3%
Precision (total): (inter-assay only presented) (n = 20 over 10 days)
mean: 0.41, % CV: 4.9%
mean: 3.60, % CV: 3.4%
mean: 6.49, % CV: 2.3%
mean: 11.37, % CV: 2.7%
Regression Equation: y = 0.87x + 0.62, where: y = Immuno 1 uE3 Assay, x = DPC Coat-a-Count Free Estriol RIA, n = 249, r = 0.98, Sy.x = 1.23, range = 0 to 30 ng/ml
Specificity: Cross Reactants Spiked into Normal Human Serum Pools:
Estriol-3-sulfate: Bayer Immuno 1 uE3 % Crossreactivity: 1.70%
Estriol-3-(β-D-glucuronide): Bayer Immuno 1 uE3 % Crossreactivity: 1.60%
Estriol-16-α-(β-D-glucuronide): Bayer Immuno 1 uE3 % Crossreactivity: 0.05%
Estriol-17-β-(β-D-glucuronide): Bayer Immuno 1 uE3 % Crossreactivity: 0.08%
Estradiol: Bayer Immuno 1 uE3 % Crossreactivity: 0.44%
Estrone: Bayer Immuno 1 uE3 % Crossreactivity: 0.06%
Estrone-β-D-glucuronide: Bayer Immuno 1 uE3 % Crossreactivity: 0.07%
Estrone-3-sulfate: Bayer Immuno 1 uE3 % Crossreactivity: 0.06%
16-Epiestriol: Bayer Immuno 1 uE3 % Crossreactivity: 0.30%
17-Epiestriol: Bayer Immuno 1 uE3 % Crossreactivity: 1.00%
Cortisol: Bayer Immuno 1 uE3 % Crossreactivity: not detected
11-deoxycortisol: Bayer Immuno 1 uE3 % Crossreactivity: not detected
5α-Dihydroxytestosterone: Bayer Immuno 1 uE3 % Crossreactivity: not detected
Testosterone: Bayer Immuno 1 uE3 % Crossreactivity: not detected
16a-Hydroxyestrone: Bayer Immuno 1 uE3 % Crossreactivity: 7.60%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1265 Estriol test system.
(a)
Identification. An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk 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.
0
Attachment 3
Summary of Safety and Effectiveness
1114121
MA
ുവള
Unconjugated Estriol Method for the Bayer Immuno 1" System
Listed below is a comparison of the performance of the Bayer Immuno 1™ Unconjugated Estriol method and a similar device granted clearance of substantial equivalence (Diagnostic Products Corporation Coat-a-Count Free Estriol RIA method). The information below was extracted from the Bayer Immuno 1 Unconjugated Estriol method sheet and the DPC Free Estriol RIA Package Insert.
Intended Use
This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System. Measurements of unconjugated estriol are used to evaluate fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.
| uEstriol Method: | Bayer Immuno 1™ | DPC Coat-a-Count® | |||
|---|---|---|---|---|---|
| Part Number: | Reagents | T01-3987-51 | kit(s) | TKEF1 (100) | |
| TKEF5 (500) | |||||
| Calibrators | T03-3986-01 | ||||
| Expected Values: |