(45 days)
DSL IGF-I IRMA
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No
The device description details a standard immunoassay (IRMA) kit which relies on antibody binding and radioactive detection, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used for quantitative determination of IGF-II in human serum or plasma to evaluate growth status; it does not provide any therapeutic benefit or treatment.
Yes
The "Intended Use / Indications for Use" states, "The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status." This explicitly identifies the device's diagnostic purpose.
No
The device description clearly outlines a physical kit with antibodies, test tubes, and the need for a gamma counter, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says "For In Vitro Diagnostic Use in the evaluation of growth status." This is the primary indicator that the device is intended for diagnostic purposes outside of a living organism.
- Device Description: The description details a laboratory assay (IRMA) performed on human serum or plasma samples to measure a specific analyte (IGF-II). This is characteristic of an in vitro diagnostic test.
- Analyte Measurement: The device measures the concentration of IGF-II in biological samples, which is a common practice in diagnostic testing to assess physiological conditions (in this case, growth status).
N/A
Intended Use / Indications for Use
The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.
Product codes
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Device Description
The DSL 9100 IGF-II IRMA Kit is an immunoradiometric assay (IRMA) for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay where the analyte (IGF-II) is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube. The second antibody, mouse monoclonal anti-IGF-II, is radiolabelled for detection. The analyte present binds to both antibodies to form a "sandwiched" complex. Unbound materials are removed by decanting and washing the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of bound IGF-II is directly proportional to the concentration of the IGF-II 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
DSL IGF-I IRMA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1370 Human growth hormone test system.
(a)
Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.(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 logo with two stylized letters, 'd' and 'u', in a bold, sans-serif font. The letters are connected, with the 'd' on the left and the 'u' on the right. The logo is black against a white background, and the image quality is somewhat grainy.
AUG 30 1996
Diagnostic Systems Laboratories 445 Medical Center Epuleware Webster Texas 77598.4217 LSA Tel 713.332.9578 Fax 713.554.- 220
Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895
SUMMARY OF SAFETY AND EFFECTIVENESS
Name of Device: DSL 9100 IGF-II IRMA Kit Olassification Name: Immunoradiometric Assay, IGF-II Analyte Code and Name: Insulin Like Growth Factor-II Regulatory Class:
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678
Date: July 12, 1996
The DSL IGF-II IRMA kit was developed for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube, the other antibody, mouse monoclonal anti-IGF-II is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound IGF-II is directly proportional to the concentration of the IGF-II present in the sample.
The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.
The DSL IGF-II IRMA is substantially equivalent to the DSL IGF-I IRMA.
Both assays are used in the evaluation of growth status with human serum or plasma samples.