(45 days)
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No
The device description and performance studies detail a standard ELISA assay and statistical analysis (linear regression, correlation coefficient) of the results, with no mention of AI or ML algorithms for data processing, interpretation, or prediction.
No.
The device is an in vitro diagnostic (IVD) test intended to aid in the detection of pregnancy by measuring Free ß-hCG in serum, not to treat or cure a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy."
No
The device is an in vitro diagnostic (IVD) kit that uses chemical reagents and a physical assay method (ELISA) to measure a substance in serum. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy." This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The DSL-10-8500 ACTIVE™ Free ß-hCG ELISA assay is intended for the quantitative determination of Free ß-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-10-8500 ACTIVE™ Free ß-hCG Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in serum. This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. Human chorionic gonadotropin (hCG) is a glycoprotein secreted by the trophoblastic cells of the placenta. hCG is composed of two dissimilar non-covalently linked polypeptides known as the or- and ßsubunits [1].
The DSL ACTIVE® Free B-hCG ELISA is a two-site ELISA assay in which the free ß-hCG to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound Free B-hCG is directly proportional to the concentration of the Free ß-hCG present in the sample. The antibodies were raised against sterically remote epitopes on the beta subunit of hCG, such that in intact hCG molecules, these antibody recognition sites are not available. The DSL ACTIVE® Free M-RCG ELISA is very specific for free ß-hCG without cross-reactivity or interference due to LH, FSH, AFP, TSH or prolactin.
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
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
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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, pregnant patient samples (n=98) 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: DSL-10-8500 = 0.007(DSL-8300) - 2.7, with a correlation coefficient of r = 0.82 and p
§ 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
Image /page/0/Picture/0 description: The image shows the date "MAR 1 2002" in bold, sans-serif font. The month is abbreviated to "MAR", followed by the number "1", and then the year "2002". The text is black against a white background.
Image /page/0/Picture/1 description: The image shows a logo with the letters "dsl" in white against a black circular background. The letters are stylized and connected, with the "d" and "l" appearing to be mirror images of each other. There is a small registered trademark symbol located between the "s" and "l".
SUMMARY OF SAFETY AND EFFECTIVENESS 4.0
Submitter: Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678 FDA Registration # 1628193
Contact: Carroll Potts Manager of Regulatory Affairs Office: (281) 332-9678 Fax: (281) 338-1895 cpotts@dslabs.com
| Date of Summary: | December 31, 2001 |
|---|---|
| Device Trade Name: | DSL ACTIVE™ Free β-hCG ELISA Kit |
| Classification Name: | Enzymeimmunoassay, Human Chorionic Gonadotropin |
| Analyte Code and Name: | Human Chorionic Gonadotropin (hCG) |
| Regulatory Class: | II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
Test Description:
The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. Human chorionic gonadotropin (hCG) is a glycoprotein secreted by the trophoblastic cells of the placenta. hCG is composed of two dissimilar non-covalently linked polypeptides known as the or- and ßsubunits [1]. The or-subunit is very similar to the ox-chain of lutropin (hLH), follitropin (hFSH), and thyrotropin (hTSH). The ß-subunit is responsible for the biological activity of this hormone [1,2].
The primary utility of hCG measurement is for the early detection and monitoring of pregnancy, and pregnancy related disorders. Healthy, non-pregnant individuals have low (