HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · Dade Chemistry Systems, Inc. · DHA · Mar 10, 1997 · Clinical Chemistry
Device Facts
| Record ID | K970387 |
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| Device Name | HUMAN CHORIONIC GONADOTROPIN METHOD |
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| Applicant | Dade Chemistry Systems, Inc. |
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| Product Code | DHA · Clinical Chemistry |
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| Decision Date | Mar 10, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 862.1155 |
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| Device Class | Class 2 |
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Intended Use
The HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure intact hCG in serum and plasma, for the early detection of pregnancy.
Device Story
Dimension® RxL system HCG method; two-step enzyme immunoassay; sandwich principle. Input: patient serum or plasma. Process: sample incubated with monoclonal antibody-coated chromium dioxide particles; magnetic separation; incubation with β-galactosidase-labeled monoclonal antibody conjugate; magnetic separation/wash; addition of chromogenic substrate chlorophenol red-β-d-galactopyranoside (CPRG). Output: rate of color change measured at 577nm via hydrolysis of CPRG to chlorophenol red (CPR). Used in clinical laboratory settings by trained personnel. Output provides quantitative hCG concentration to assist clinicians in pregnancy diagnosis.
Clinical Evidence
Split-sample comparison of 134 clinical patient samples (range 0-984 mIU/mL) between Dimension® RxL HCG and Abbott IMx® hCG. Results: correlation coefficient 0.986, slope 1.270, intercept 2.87 mIU/mL.
Technological Characteristics
Two-step enzyme immunoassay; sandwich format. Reagents: monoclonal antibodies, chromium dioxide particles, β-galactosidase conjugate, chlorophenol red-β-d-galactopyranoside (CPRG) substrate. Detection: colorimetric rate measurement at 577nm. System: Dimension® RxL clinical chemistry analyzer with heterogeneous immunoassay module.
Indications for Use
Indicated for quantitative measurement of intact hCG in serum and plasma for early pregnancy detection.
Regulatory Classification
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. 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.
Predicate Devices
Related Devices
- K131037 — LIAISON XL HCG · DiaSorin, Inc. · Sep 6, 2013
- K221990 — Access Total ßhCG (5th IS) · Beckman Coulter, Inc. · Dec 27, 2022
- K072264 — FASTPACK HCG IMMUNOASSAY · Qualigen, Inc. · Dec 6, 2007
Submission Summary (Full Text)
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DADE
K970387
MAR 10 1997
Chemistry Systems
P.O. Box 6101
Newark, DE 19714
# Summary of Safety and Effectiveness Information
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.
## Submitter's Name:
Rebecca S. Ayash
Dade International Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101
## Date of Preparation:
1/31/97
## Name of Product:
Human Chorionic Gonadotropin Method
## FDA Classification Name:
HCG Test System
## Predicate Device:
Abbott IMx® hCG
## Device Description:
The HCG method for the Dimension® RxL system with the heterogeneous immunoassay module is a two-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for the hCG alpha subunit to form a particle/hCG complex. Particles are separated magnetically and the supernatant removed. The particle/hCG complex is incubated with conjugate reagent (β-galactosidase labeled monoclonal antibodies specific for the hCG beta subunit) to form a particle/hCG/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound β-galactosidase is combined with the chromogenic substrate chlorophenol red-β-d-galactopyranoside (CPRG) and catalyzes the hydrolysis of CPRG to the chromophore chlorophenol red (CPR). The concentration of hCG in the patient sample is directly proportional to the rate of color change measured at 577nm due to formation of CPR.
## Intended Use:
The HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure intact hCG in serum and plasma, for the early detection of pregnancy.
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Printed on recycled paper
with 25% post-consumer fiber
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Comparison to Predicate
Device:
| Item | Dimension® RxL HCG Method | Abbott IMx® hCG |
| --- | --- | --- |
| Technology | Sandwich format monoclonal antibody immunoassay | Sandwich format monoclonal/polyclonal antibody immunoassay |
| Detection | Colorimetric rate measurement at 577nm and 700nm | Fluorometric endpoint measurement |
Comments on Substantial
Equivalence: Split sample comparison between the HCG method for the Dimension® RxL system and the Abbott IMx® hCG assay gave a correlation coefficient of 0.986, slope of 1.270, and an intercept of 2.87 mIU/mL when tested with 134 clinical patient samples ranging from 0 - 984 mIU/mL.
Conclusion: The HCG Method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Abbott IMx® hCG Assay based on the split sample comparison summarized above.
Rebecca S. Ayash
Regulatory Affairs and
Compliance Manager
Date: 1/31/97
