(16 days)
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No
The device description details a standard immunoassay technique (IRMA) and the performance studies describe a linear regression analysis for comparison, neither of which inherently involve AI or ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
The device is described as an "assay" and "kit" used for "quantitative determination of LH in human serum" and as a "diagnostic aid," which are characteristics of an in vitro diagnostic device, not a therapeutic device.
Yes
The intended use explicitly states that "The measurement of LH is used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction."
No
The device description clearly outlines a physical kit with test tubes, immobilized antibodies, radiolabelled antibodies, and the need for 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 "quantitative determination of LH in human serum" and "used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction." This clearly indicates the device is intended to be used in vitro (outside the body) to analyze a human sample (serum) for diagnostic purposes.
- Device Description: The description details a laboratory assay (IRMA) performed on a human sample (serum) to measure an analyte (LH). This is consistent with the nature of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" which is another LH IRMA assay further supports that this device falls under the category of IVDs, as predicate devices are used for comparison in regulatory submissions for new IVDs.
N/A
Intended Use / Indications for Use
The DSL LH IRMA assay is intended for the quantitative determination of LH in human serum. The measurement of LH is used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction.
Product codes
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Device Description
The DSL LH IRMA kit was developed for the quantitative measurement of LH 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 inside wall of the test 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 tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound LH is directly proportional to the concentration of the LH 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
To demonstrate substantial equivalence between the two assays, patient samples (n=41) were collected and assayed using both methods. Samples were chosen based on expected LH 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=1.71(X) + 3.81 with a correlation coefficient of (r) = 0.95.
Key Metrics
correlation coefficient of (r) = 0.95
Predicate Device(s)
DPC LH IRMA.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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
AFR - 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Name of Device: DSL 4600 LH IRMA Kit Classification Name: Immunoradiometric Assay, LH Analyte Code and Name: Luteinizing Hormone Regulatory Class: -
- Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
March 19, 1996 Date:
The DSL LH IRMA kit was developed for the quantitative measurement of LH 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 inside wall of the test 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 tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound LH is directly proportional to the concentration of the LH present in the sample.
The DSL LH IRMA assay is intended for the quantitative determination of LH in human serum. The measurement of LH is used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction.
The DSL LH IRMA is substantially equivalent to the DPC LH IRMA.
To demonstrate substantial equivalence between the two assays, patient samples (n=41) were collected and assayed using both methods. Samples were chosen based on expected LH 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=1.71(X) + 3.81 with a correlation coefficient of (r) = 0.95.