(176 days)
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No
The device description details a standard Radioimmunoassay (RIA) method, which is a well-established laboratory technique that does not inherently involve AI or ML. The summary does not mention any AI/ML terms or processes.
No
The described device is an in-vitro diagnostic assay used for the quantitative determination of Unconjugated Estriol in human serum, which serves as a diagnostic aid. It does not directly treat or alleviate a disease or condition.
Yes
The intended use explicitly states that the "measurement of Unconiugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress."
No
The device is a diagnostic assay kit that utilizes a competitive binding protein assay format with radio-labeled components and requires analysis in a gamma counter. This involves physical reagents and hardware, not just 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 from the human body to provide diagnostic information.
- Device Description: The description details a "competitive binding protein assay" using "human serum" and analyzing the results in a "gamma counter." This describes a laboratory test performed on a biological sample.
- Performance Studies: The performance studies involve "patient samples" and compare the results to another assay, which is typical for validating an IVD.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, 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 RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconiugated 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 RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assav. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estricl present in the sample.
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=126) were collected and assaved 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Linear regression analysis of the results obtained for the comparison gave the equation Y=0.58(X) + -0.03 with a correlation coefficient of (r) = 0.97.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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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tangnostic Systems Laboratones, Inc 445 Medical Center Boule ar: Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220
Image /page/0/Picture/1 description: The image shows a handwritten number "K155356" in bold, black ink. Below the number, the text "MAY 15 1996" is printed in a simple, sans-serif font, also in black ink. The number appears to be a reference or identification code, while the date indicates when the image was taken or when the document was created.
Customer Assistance Center Tel 800 231 7970 Fax 713.338.189 5
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 3700 ULTRA-SENSITIVE UNCONJUGATED ESTRIOL Name of Device: RIA Kit Radioimmunoassay, UNCONJUGATED ESTRIOL Classification Name: 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
Date: March 6, 1996
The DSL Ultra-Sensitive Unconjugated Estriol RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assav. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estricl present in the sample.
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconiugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA is substantially equivalent to the DPC FREE ESTRIOL RIA.
To demonstrate substantial equivalence between the two assays, patient samples (n=126) were collected and assaved 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=0.58(X) + -0.03 with a correlation coefficient of (r) = 0.97.