(14 days)
DSL 3800 Androstenedione RIA
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No
The device description details a standard competitive binding protein assay (EIA) and analysis via spectrophotometry, which are traditional laboratory techniques and do not involve AI/ML. The performance studies describe a comparison study using linear regression, not AI/ML model training or evaluation.
No
The device is an assay for quantitative determination of androstenedione, used in diagnosis and treatment, but it does not directly treat or prevent a disease. It provides diagnostic information.
Yes
The intended use explicitly states that the measurement of androstenedione is used in the "diagnosis and treatment of females with excessive levels of androgen production."
No
The device description clearly describes a physical assay kit with reagents, microtitration wells, and a requirement for analysis in a spectrophotometer, indicating it is a hardware-based diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of androstenedione in human serum." This is a measurement performed in vitro (outside the body) on a biological sample (serum).
- Purpose: The measurement is used "in the diagnosis and treatment of females with excessive levels of androgen production." This clearly indicates a diagnostic purpose.
- Device Description: The description details a laboratory assay (EIA format, competitive binding protein assay) performed on a sample. This is characteristic of an in vitro diagnostic test.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DSL. Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.
Product codes
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Device Description
The DSL. Androstenedione EIA kit was developed for the quantitative measurement of Androstenedione in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled androstenedione competes with un-labeled androstenedione in the serum sample for binding sites to the androstenedione antibody coated to the microtitration well provided with the kit. Separation of free from bound androstenedione is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzymelabeled androstenedione bound to the antibody is inversely proportional to the concentration of the androstenedione 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=80) were collected and assayed using both methods. Samples were chosen based on expected Androstenedione 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 = 1.07(X) + 0.02 with a correlation coefficient of (r) = 0.85.
Key Metrics
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Predicate Device(s)
DSL 3800 Androstenedione RIA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1075 Androstenedione test system.
(a)
Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.(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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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 10-3800 Androstenedione EIA Kit Name of Device: Enzymeimmunoassay, Androstenedione Classification Name: Analyte Code and Name: Androstenedione Requiatory Class:
AUG / 6 1996
John Willis Submitter: Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
July 31, 1996 Date:
The DSL. Androstenedione EIA kit was developed for the quantitative measurement of Androstenedione in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled androstenedione competes with un-labeled androstenedione in the serum sample for binding sites to the androstenedione antibody coated to the microtitration well provided with the kit. Separation of free from bound androstenedione is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzymelabeled androstenedione bound to the antibody is inversely proportional to the concentration of the androstenedione present in the sample.
The DSL. Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.
The DSL 10-3800 Androstenedione EIA is substantially equivalent to the DSL 3800 Androstenedione RIA. Both kits have the same intended use.
To demonstrate substantial equivalence between the two assays, patient samples (n=80) were collected and assayed using both methods. Samples were chosen based on expected Androstenedione 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 = 1.07(X) + 0.02 with a correlation coefficient of (r) = 0.85.