(27 days)
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No
The summary describes a standard ELISA kit for measuring human growth hormone, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No.
This device is designed for quantitative measurement of human growth hormone, serving as a diagnostic aid, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurement of growth hormone by this kit "is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly."
No
The device description clearly describes a physical ELISA kit with antibodies immobilized on a microtiter plate, indicating it is a hardware-based diagnostic assay, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative measurement of human growth hormone in human serum" and that this measurement is used as a "diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly." This clearly indicates the device is intended for use in the diagnosis of disease or other conditions.
- Device Description: The description details a laboratory test method (ELISA) that analyzes a biological sample (human serum) to detect and quantify a specific analyte (human growth hormone). This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The performance study involves testing patient samples to demonstrate the device's performance in a clinical context, further supporting its diagnostic purpose.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. This device fits that definition perfectly.
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Intended Use / Indications for Use
The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme.
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)
To demonstrate substantial equivalence between the two assays, 41 patient samples were collected and assayed simultaneously by both methods. Samples were chosen with low medium and high levels of hGH. Linear regression analysis of the results obtained for the comparison yield the following results: V= 1.06x + 0.25 with a correlation coefficient of 0.99.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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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 that appears to be an abstract design. The logo is composed of thick, black lines forming shapes that resemble stylized letters. The overall design is compact and has a modern, minimalist aesthetic.
Diagnostic Systems Laborotones 145 Medical Center Boulevil 1/etister lexas 77508 1217 116 Tel 713.332.967 Fox 713.554.429
Customer Assistonce Cer Tel 800.231.79 Fax 713.338.189
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-1900 hGH ELISA Kit. Name of Device: Enzyme-Linked Immunosorbent Assay, hGH. Classification Name: Analyte Name: Human Growth Hormone. Regulatory Class: l
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd. Webster. Texas 77598 Phone: (713) 332-9678
Date: February 7, 1996
The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme.
The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
The DSL hGH ELISA is substantially equivalent to the Nichols Institute hGH IRMA. These kits have the same intended use.
To demonstrate substantial equivalence between the two assays, 41 patient samples were collected and assayed simultaneously by both methods. Samples were chosen with low medium and high levels of hGH. Linear regression analysis of the results obtained for the comparison yield the following results: V= 1.06x + 0.25 with a correlation coefficient of 0.99.