(47 days)
DSL 2700 DHEA-S RIA
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No
The device description details a standard radioimmunoassay (RIA) which is a laboratory technique based on competitive binding, not AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
This device is for in vitro diagnostic use to measure DHEA-S levels in human serum, which aids in diagnosis and treatment, but it does not directly treat or prevent a disease and is therefore not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas."
No
The device is a laboratory assay kit that utilizes radioimmunoassay (RIA) technology, which involves physical reagents, centrifugation, and a gamma counter. This is a hardware-based diagnostic method, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas."
This statement clearly indicates that the device is intended for use in examining specimens derived from the human body (in this case, human serum) to provide information for the diagnosis and treatment of a medical condition. This is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
Product codes
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Device Description
The DSL C2700 DHEA-S-7 RIA kit was developed for the quantitative measurement of DHEA-S in human serum. The RIA format is a competitive binding protein assay. Radio-labeled DHEA-S competes with un-labeled DHEA-S in the serum sample for binding sites to the DHEA-S antiserum provided with the kit. Separation of free from bound DHEA-S is achieved by the centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled DHEA-S bound to the antibody is inversely proportional to the concentration of the DHEA-S 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=418) were collected and assayed using both methods. Samples were chosen based on expected DHEA-S 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=0.76(X) + 36.2 with a correlation coefficient of (r) = 0.98.
Key Metrics
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Predicate Device(s)
DSL 2700 DHEA-S RIA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
(a)
Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.(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
SEP 10 1995
Image /page/0/Picture/1 description: The image shows a sequence of characters, which appear to be handwritten. The sequence is "K962895". The characters are bold and black against a white background.
Diagnostic Systems Laboratories, Inc 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220
Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL C2700 DHEA-S-7 RIA Kit Name of Device: Radioimmunoassay, DHEA-S Classification Name: Analyte Code and Name: DHEA-S-7 Requiatory Class: -
- John Willis Submitter: Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
Date: July 24, 1996
The DSL C2700 DHEA-S-7 RIA kit was developed for the quantitative measurement of DHEA-S in human serum. The RIA format is a competitive binding protein assay. Radio-labeled DHEA-S competes with un-labeled DHEA-S in the serum sample for binding sites to the DHEA-S antiserum provided with the kit. Separation of free from bound DHEA-S is achieved by the centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled DHEA-S bound to the antibody is inversely proportional to the concentration of the DHEA-S present in the sample.
The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
The DSL C2700 DHEA-S-7 RIA is substantially equivalent to the DSL 2700 DHEA-S RIA. Both kits have the same intended use.
To demonstrate substantial equivalence between the two assays, patient samples (n=418) were collected and assayed using both methods. Samples were chosen based on expected DHEA-S 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=0.76(X) + 36.2 with a correlation coefficient of (r) = 0.98.