(101 days)
K/DEN number: Not Found
No
The device description details a standard immunoassay technique (IRMA) and analysis using a gamma counter, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is described as a diagnostic aid for quantitative determination of FSH, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders," indicating its use for diagnostic purposes.
No
The device description clearly outlines a hardware-based assay format involving test tubes, antibodies, radiolabelling, and a gamma counter. This is a physical laboratory test, 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 FSH in human serum" and "used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders." This clearly indicates the device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis.
- Device Description: The description details a laboratory assay (IRMA) performed on a human sample (serum) to measure an analyte (FSH). This is a typical description of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing "patient samples" to compare the results of this assay with a predicate device. This further supports its use in a diagnostic context.
N/A
Intended Use / Indications for Use
The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders.
Product codes
Not Found
Device Description
The DSL FSH IRMA kit was developed for the quantitative measurement of FSH 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 FSH is directly proportional to the concentration of the FSH present in the sample.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence between the two assays, patient samples (n=81) were collected and assayed using both methods. Samples were chosen based on expected FSH 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 =0.66(X) + 1.26 with a correlation coefficient of (r) = 0.98.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The DSL FSH IRMA is substantially equivalent to the DPC FSH IMMULITE.
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
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(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
Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220
SEP - 9 1996
Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895
SUMMARY OF SAFETY AND EFFECTIVENESS
Name of Device: DSL 4700 FSH IRMA Kit Classification Name: Immunoradiometric Assav. FSH Analyte Code and Name: Follicle Stimulating Hormone Requiatory Class: -
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
May 29, 1996 Date:
The DSL FSH IRMA kit was developed for the quantitative measurement of FSH 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 FSH is directly proportional to the concentration of the FSH present in the sample.
The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders.
The DSL FSH IRMA is substantially equivalent to the DPC FSH IMMULITE.
To demonstrate substantial equivalence between the two assays, patient samples (n=81) were collected and assayed using both methods. Samples were chosen based on expected FSH 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 =0.66(X) + 1.26 with a correlation coefficient of (r) = 0.98.