(30 days)
K/DEN number: Not Found
No
The device description details a standard competitive binding protein assay (EIA) and does not mention any AI or ML components. The performance study is a simple comparison of results between two assay methods.
No
The device is an in vitro diagnostic assay used for the quantitative determination of Unconjugated Estriol in human serum, which aids in the diagnosis and treatment of fetoplacental distress. It does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress."
No
The device description clearly describes a laboratory assay kit involving reagents, incubation, washing, and absorbance measurement, which are physical components and processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Unconjugated Estriol in human serum" and is used as a "diagnostic aid in the diagnosis and treatment of fetoplacental distress." This clearly indicates it's used to analyze a sample taken from the human body (serum) to provide information for diagnosis and treatment.
- Device Description: The description details a laboratory assay (EIA) that measures a substance in a biological sample (serum). This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The performance study involves testing patient samples using the device, which is typical for demonstrating the performance of an IVD.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
Product codes
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Device Description
The DSL Ultra-Sensitive Unconjugated Estriol EIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The ElA format is a competitive binding protein assay. Horseradish peroxidase labelled unconiugated estriol competes with un-labeled Unconjugated Estrict in the serum sample for antibody binding sites. After incubation and washing the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the decree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
To demonstrate substantial equivalence between the two assays, patient samples (n = 106) were collected and assayed using both methods. Samples were chosen based on expected Unconjugated Estriol levels so that samples with low, intermediate and high levels would be evaluated.
Summary of Performance Studies
Substantial equivalence was demonstrated by comparing the DSL Ultra-Sensitive Unconjugated Estriol EIA kit to the DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA using 106 patient samples.
Linear regression analysis of the results obtained for the comparison gave the equation Y=0.85(X) -0.11 with a correlation coefficient of (r) = 0.93.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows a stylized logo consisting of the letters 'd' and 'L' intertwined. The 'd' is formed by a curved shape with a vertical line extending downwards, while the 'L' is a simple right angle shape. The logo has a halftone effect, creating a dotted texture throughout the design. The background is plain white.
AUG 23 RS
Clagnostic Systems Urboratones, Inc. 445 Modical Canter Boulevard Websiter Texas 77598-1217 USA Tel 713.332.9678 Fox 713.554.4220
Customer Assistance Center Tal 800.231.7970 Fax 713.338.1895
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-3700 ULTRA-SENSITIVE UNCONJUGATED Name of Device: ESTRIOL EIA Kit Classification Name: Enzyme Immunoassay, UNCONJUGATED ESTRIOL Analyte Code and Name: Unconjugated Estriol Requiatory Class:
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster. Texas 77598 Phone:713-332-9678
July 19, 1996 Date:
The DSL Ultra-Sensitive Unconjugated Estriol EIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The ElA format is a competitive binding protein assay. Horseradish peroxidase labelled unconiugated estriol competes with un-labeled Unconjugated Estrict in the serum sample for antibody binding sites. After incubation and washing the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the decree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement.
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA is substantially equivalent to the DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA.
To demonstrate substantial equivalence between the two assays, patient samples (n = 106) were collected and assayed using both methods. Samples were chosen based on expected Unconjugated Estriol levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y=0.85(X) -0.11 with a correlation coefficient of (r) = 0.93.