(103 days)
DPC hCG IRMA
DPC hCG IRMA
No
The device description details a traditional immunoassay method (IRMA) and the analysis of results using a gamma counter. There is no mention of AI, ML, or any computational analysis beyond basic proportional calculations. The performance studies involve linear regression and correlation, which are standard statistical methods, not indicative of AI/ML.
No
The device is an in vitro diagnostic (IVD) assay intended for the quantitative determination of I-hCG in human serum, used as an aid in the detection of pregnancy, and does not directly treat or diagnose a disease state.
Yes
The device is described as an "in vitro diagnostic use" assay and its purpose is to aid "in the detection of pregnancy" by quantitatively determining I-hCG in human serum, which directly falls under the definition of a diagnostic device.
No
The device description clearly outlines a hardware-based assay format (IRMA) involving test tubes, antibodies, radiolabelling, and a gamma counter. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy." This is the primary indicator of an IVD.
- Device Description: The description details a laboratory assay (IRMA) performed on a biological sample (human serum) to measure a specific analyte (I-hCG). This is characteristic of an in vitro diagnostic test.
- Intended User: The intended user is "professional laboratory personnel," which aligns with the use of a laboratory-based diagnostic test.
- Performance Studies: The document describes a study comparing the device to a reference device using patient samples, which is a standard practice for evaluating the performance of an IVD.
All these elements strongly indicate that the DSL I-hCG IRMA assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DSL I-hCG IRMA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy.
Product codes
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Device Description
The DSL 8300 I-hCG IRMA Kit was developed for the quantitative measurement of I-hCG 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 hCG is directly proportional to the concentration of the hCG present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional laboratory personnel
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
To demonstrate substantial equivalence between the two assays, patient samples (n=53) were collected and assayed using both methods. Samples were chosen based on expected hCG levels so that samples with low, intermediate and high levels would be evaluated.
Summary of Performance Studies
Substantial equivalence study: patient samples (n=53) were collected and assayed using both methods. Linear regression analysis of the results obtained for the comparison gave the equation Y=0.86(X) + 9.5 with a correlation coefficient of (r) = 0.96.
Key Metrics
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Predicate Device(s)
DPC hCG IRMA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Diagnontic Systems Unboratories, 445 Medical Center Box to Webster Texas 77598-421 / lel / 13.332 76. B Fax 713.554 4220
MAY - 7 1996
Customer Assistance Center Tel 800.231 79/0 Fax 713.338.1845
SUMMARY OF SAFETY AND EFFECTIVENESS
Name of Device: DSL 8300 I-hCG IRMA Kit Classification Name: Radioimmunoassay, Human Chorionic Gonadotropin Analyte Code and Name: Human Chorionic Gonadotropin Requiatory Class: =
- Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster. Texas 77598 Phone:713-332-9678
Date: January 24, 1996
The DSL I-hCG IRMA kit was developed for the quantitative measurement of I-hCG 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 hCG is directly proportional to the concentration of the hCG present in the sample.
The DSL I-hCG IRMA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy.
The DSL I-hCG IRMA is substantially equivalent to the DPC hCG IRMA.
To demonstrate substantial equivalence between the two assays, patient samples (n=53) were collected and assayed using both methods. Samples were chosen based on expected hCG 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=0.86(X) + 9.5 with a correlation coefficient of (r) = 0.96.