(65 days)
DSL 8700 Estrone RIA
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No
The device description details a standard radioimmunoassay (RIA) process, which is a biochemical technique and does not involve AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is an in vitro diagnostic assay used for the quantitative determination of Estrone-Sulfate in human biological samples. It assists in the diagnosis and treatment of disorders but does not directly apply therapy to a patient.
Yes.
The document states that the assay is "intended for in vitro diagnostic use in the diagnosis and treatment of numerous disorders".
No
The device description clearly outlines a laboratory assay kit involving reagents, radio-labeled substances, antibodies, centrifugation, and analysis using a gamma counter. These are all physical components and processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is "intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma" and is used "for in vitro diagnostic use in the diagnosis and treatment of numerous disorders". This directly aligns with the definition of an IVD, which is a medical device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a laboratory test (RIA assay) performed on biological samples (serum or plasma) outside of the body ("in vitro").
- Performance Studies: The inclusion of performance studies comparing the device to a predicate device further supports its classification as a medical device intended for diagnostic use.
N/A
Intended Use / Indications for Use
The DSL 5400 Estrone-Sulfate RIA kit was developed for the quantitative measurement of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenormea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.
Product codes
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Device Description
The RIA format is a competitive binding protein assay. Radio-labeled Estrone-Sulfate competes with un-labeled Estrone-Suffate in the serum or plasma sample for binding sites to the Estrone-Sulfate antiserum provided with the kit. Separation of free from bound Estrone-Sulfate is achieved by the addition of a second antibody containing goat anti-rabbit gamma clobulin serum with polvethviene giveol as a precipitating aid, centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled Estrone-Sulfate bound to the antibody is inversely proportional to the concentration of the Estrone-Sulfate 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
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Summary of Performance Studies
To demonstrate substantial equivalence between the two assays, patient samples (n=43) were collected and assayed using both methods. Samples were chosen based on expected Estrone-Sulfate 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=0.04(X) + 2.89 with a correlation coefficient of (r) = 0.82.
Key Metrics
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Predicate Device(s)
DSL 8700 Estrone RIA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1280 Estrone test system.
(a)
Identification. An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.(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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K970915 MAY 16 1997
Diaanostic Systems Laboratories, Inc 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 281.332.9678 Fax 281.554.4220
Customer Assistance Center Tel 800.231.7970 Fax 281.338.1895 Email mktg@dslobs.com
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 5400 Estrone-Sulfate RIA Kit Name of Device: Radioimmunoassav. Estrone-Sulfate Classification Name: Analyte Code and Name: Estrone-Sulfate Regulatory Class: -
- Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:281-332-9678
- Date: March 11, 1997
The DSL 5400 Estrone-Sulfate RIA kit was developed for the quantitative measurement of Estrone-Sulfate in human serum or EDTA plasma. The RIA format is a competitive binding protein assay. Radio-labeled Estrone-Sulfate competes with un-labeled Estrone-Suffate in the serum or plasma sample for binding sites to the Estrone-Sulfate antiserum provided with the kit. Separation of free from bound Estrone-Sulfate is achieved by the addition of a second antibody containing goat anti-rabbit gamma clobulin serum with polvethviene giveol as a precipitating aid, centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled Estrone-Sulfate bound to the antibody is inversely proportional to the concentration of the Estrone-Sulfate present in the sample.
The DSL 5400 Estrone-Sulfate RIA assay is intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenormea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.
The DSL 5400 Estrone-Sulfate RIA is substantially equivalent to the DSL 8700 Estrone RIA. Both kits have the same intended use.
To demonstrate substantial equivalence between the two assays, patient samples (n=43) were collected and assayed using both methods. Samples were chosen based on expected Estrone-Sulfate 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=0.04(X) + 2.89 with a correlation coefficient of (r) = 0.82.