(29 days)
DSL 5600 IGF-I IRMA
No
The description details a laboratory assay kit based on radioimmunoassay (IRMA) technology, which is a traditional biochemical method and does not involve AI or ML.
No
The device is described as an IRMA kit intended for the quantitative measurement of IGF-I in human serum and plasma to aid in the diagnosis of growth status disorders, not for treating them.
Yes
The "Intended Use / Indications for Use" section states, "The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders."
No
The device description clearly outlines a physical kit containing coated test tubes, antibodies, and radioactive labeling (Iodine-125), indicating it is a hardware-based assay kit, not 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 measurement of Insulin-like Growth Factor-I in human serum and plasma" and is used as a "diagnostic aid in the evaluation of growth status disorders." This clearly indicates it's used to test samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test method (IRMA - Immunoradiometric Assay) that uses reagents (antibodies labeled with Iodine-125) to measure a substance (IGF-I) in biological samples (serum and plasma). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The summary of performance studies describes testing patient samples with the device and comparing the results to a predicate device. This type of testing is required for IVD devices to demonstrate their performance characteristics.
N/A
Intended Use / Indications for Use
The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders.
Product codes
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Device Description
The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with lodine-125.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
To demonstrate substantial equivalence between the two assays, patient samples (n=146) were collected and assayed simultaneously by both methods. Samples were chosen based on expected IGF-I levels so that samples with low, intermediate and high levels of IGF-I 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 with the IGF-1 assay gave the equation Y = 1.19(X) -22.07 with a correlation coefficient of (r) = 0.98.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The DSL IGF-I IRMA is substantially equivalent to the DSL 5600 IGF-I IRMA.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 the letters 'dsl' in a stylized, interconnected design. The letters are bold and black, with the 'd' and 'l' connected by a curved line that forms the 's'. To the right of the logo, there is a small, abstract shape that resembles a star or asterisk. The background is white, providing a stark contrast to the black elements.
K96//172
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SUMMARY OF SAFETY AND EFFECTIVENESS
Name of Device: Classification Name: Analyte Name: Requiatory Class:
DSL 2800 IGF-I IRMA Kit Immunoradiometric, IGF-I Insulin-like Growth Factor-I
- Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
March 22, 1996 Date:
The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with lodine-125.
The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders.
The DSL IGF-I IRMA is substantially equivalent to the DSL 5600 IGF-I IRMA. These kits have the same intended use.
To demonstrate substantial equivalence between the two assays, patient samples (n=146) were collected and assayed simultaneously by both methods. Samples were chosen based on expected IGF-I levels so that samples with low, intermediate and high levels of IGF-I would be evaluated. Linear regression analysis of the results obtained for the comparison with the IGF-1 assay gave the equation Y = 1.19(X) -22.07 with a correlation coefficient of (r) = 0.98.