K Number
K961911
Device Name
DSL ACTIVE I-HCG ELISA
Date Cleared
1996-06-28

(42 days)

Product Code
Regulation Number
862.1155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DSL I-hCG ELISA 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.
Device Description
The ELISA 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 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 hCG is directly proportional to the concentration of the hCG present in the sample.
More Information

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No
The description details a standard ELISA assay, a biochemical method for detecting and quantifying substances. There is no mention of AI, ML, or any computational analysis beyond basic spectrophotometry and linear regression for performance comparison.

No
The device is an in vitro diagnostic assay used for the quantitative determination of I-hCG in human serum, intended as an aid in the detection of pregnancy. It is explicitly stated for "in vitro diagnostic use" and does not directly treat or prevent a disease or condition in a patient.

Yes
The "Intended Use" section explicitly states that the device is intended for "in vitro diagnostic use".

No

The device is an ELISA assay, which is a laboratory test involving physical reagents and a spectrophotometer, 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 test (ELISA) performed on a human sample (serum) to measure a substance (I-hCG) for diagnostic purposes.
  • Intended User / Care Setting: The intended user is "professional laboratory personnel," which is typical for IVDs.
  • Performance Studies: The document describes performance studies comparing the device to a predicate device using patient samples, a common requirement for demonstrating the performance of an IVD.

N/A

Intended Use / Indications for Use

The DSL I-hCG ELISA 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 I-hCG ELISA kit was developed for the quantitative measurement of I-hCG in human serum. The ELISA 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 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 hCG is directly proportional to the concentration of the hCG 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

human serum

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

To demonstrate substantial equivalence between the two assays, patient samples (n =54) 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=0.92(X) + 16.5 with a correlation coefficient of (r) = 0.98.

Key Metrics

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Predicate Device(s)

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Reference Device(s)

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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.

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K961911

i liagnostic Systems Laboratories, 445 Medical Center Boulevan Webster Texas 77598-4217 US Tel 713.332.96/ Fax 713.554.422

Customer Assistance Cente Tel 800.231.791 Fax 713.338.189 .

JUN 2 8 1996

SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 10-8300 I-hCG ELISA Kit Classification Name: Enzymeimmunoassay, Human Chorionic Gonadotropin Analyte Code and Name: Human Chorionic Gonadotropin Requlatory Class: 11

Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678

Date: May 15, 1996

The DSL I-hCG ELISA kit was developed for the quantitative measurement of I-hCG in human serum. The ELISA 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 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 hCG is directly proportional to the concentration of the hCG present in the sample.

The DSL I-hCG ELISA 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 ELISA is substantially equivalent to the DSL I-hCG IRMA.

To demonstrate substantial equivalence between the two assays, patient samples (n =54) 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=0.92(X) + 16.5 with a correlation coefficient of (r) = 0.98.