(31 days)
DSL 2800 IGF-I IRIMA
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No
The description details a standard ELISA assay kit, which is a biochemical method for measuring substances. There is no mention of AI, ML, or any computational analysis beyond basic statistical correlation.
No
The device is an in vitro diagnostic (IVD) assay used for the quantitative determination of IGF-1 in human serum, acting as a diagnostic aid rather than directly treating or preventing a disease.
Yes
The intended use explicitly states, "The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders." This indicates its role in diagnosis.
No
The device description clearly describes a physical ELISA kit with antibodies immobilized on microtitration wells, indicating it is a hardware-based assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of IGF-1 in human serum" and is used as a "diagnostic aid in the evaluation of growth-related disorders." This clearly indicates it's used to analyze a sample from the human body to provide information for diagnosis.
- Device Description: The description details a laboratory test (ELISA) performed on human serum samples.
- Performance Studies: The performance studies involve testing patient samples and comparing the results to a predicate device, which is typical for IVD submissions.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.
Product codes
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Device Description
The DSL Active IGF-1 ELISA kit was developed for the quantitative measuremer t of Insulin-like Growth Factor-I in human serum. This ELISA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the microtitration wells. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the anti-IGF-I antibody conjugated to the enzyme horseradish peroxidase.
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
Patient samples (n = 319) 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 =0.60(X) +0.73 with a correlation coefficient of (r) = 0.82.
Key Metrics
Correlation coefficient (r) = 0.82
Predicate Device(s)
DSL 2800 IGF-I IRIMA
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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D. S. L USA
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Diganoslic System's laboratories, Inc. 445 Medic il ' Sen or Boulevard Wabster Texa . 77598-4217 1JSA Tel 281.332.94.70 a: 281.554.4220
Customer Assistance Center
Tel 800.231.7970
Fax 281.338.1895
Email niktgi@dslabs.com
SUMMARY OF SAFETY AND EFFECTIVENESS
Name of Device: Classification Name: Analyte Name: Regulatory Class:
DSL 10-2800 IGF-I ELISA Kit Enzyme Linked Immunosorbent Assay, IGF-I Insulin-like Growth Factor-l -
MAY 1 2 1997
- Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678
May 7, 1997 Date:
The DSL Active IGF-1 ELISA kit was developed for the quantitative measuremer t of Insulin-like Growth Factor-I in human serum. This ELISA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the microtitration wells. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the anti-IGF-I antibody conjugated to the enzyme horseradish peroxidase.
The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.
The DSL 10-2800 IGF-I ELISA is substantially equivalent to the DSL 2800 IGF-I IRIMA. These kits have the same intended use.
To demonstrate substantial equivalence between the two assays, patient samples (n = 319) 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 =0.60(X) +0.73 with a correlation coefficient of (r) = 0.82.