(35 days)
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DSL 10-1900
No
The device description details a standard immunoassay (IRMA) which relies on chemical reactions and radioactive detection, not computational algorithms like AI/ML. The summary also explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks descriptions of training or test sets which are typical for AI/ML devices.
No.
The device is an in-vitro diagnostic assay used for quantitative determination of hGH in human serum to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly." This indicates that the device assists in diagnosing medical conditions.
No
The device description clearly outlines a physical kit with reagents, coated tubes, and a radiolabelled antibody, requiring analysis in a gamma counter. This indicates a hardware-based assay, not a software-only device.
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 hGH in human serum" and is used as a "diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly." 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 assay (IRMA) that measures an analyte (hGH) in a biological sample (human serum). This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The performance study involves testing human serum samples to demonstrate the device's performance in a diagnostic context.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, urine, or tissue, from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
Product codes
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Device Description
The DSL 1900 hGH IRMA kit was developed for the quantitative measurement of hGH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody 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 tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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, human serum samples (n=68) were collected and assayed using both methods. Samples were chosen based on expected hGH 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 =0.93(DSL 10-1900) - 0.19 with a correlation coefficient of (r) = 0.97.
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.
The DSL 1900 hGH IRMA is substantially equivalent to the DSL 10-1900 hGH ELISA.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows a logo that appears to be an abstract design. It features interconnected shapes resembling stylized letters, possibly 'd', 's', and 'l'. The logo is presented in solid black against a white background, creating a strong contrast.
Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 281,332,9678 Fax 281.554.4220
Customer Assistance Center
Tel 800.231.7970
Fax 281.338.1895
Email mktg@dslabs.com
APR -2 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 1900 hGH IRMA Kit Name of Device: Immunoradiometric Assay for hGH Classification Name: Analyte Code and Name: hGH Requiatory Class: -
- John Willis Submitter: Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster. Texas 77598 Phone:281-332-9678
February 25, 1997 Date:
The DSL hGH IRMA kit was developed for the quantitative measurement of hGH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody 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 tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample.
The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
The DSL 1900 hGH IRMA is substantially equivalent to the DSL 10-1900 hGH ELISA.
To demonstrate substantial equivalence between the two assays, human serum samples (n=68) were collected and assayed using both methods. Samples were chosen based on expected hGH 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 =0.93(DSL 10-1900) - 0.19 with a correlation coefficient of (r) = 0.97.