(35 days)
Abbott IMx® hCG
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No
The device description details a standard immunoassay method based on chemical reactions and optical measurements, with no mention of AI or ML components. The performance studies describe a comparison to a predicate device using traditional statistical metrics.
No
This device is used for quantitative measurement of hCG for early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device quantitatively measures intact hCG in serum and plasma for the early detection of pregnancy, which is a diagnostic purpose to identify a physiological state.
No
The device description clearly outlines a chemical assay method involving reagents, particles, magnetic separation, and color change measurement at a specific wavelength (577nm). This indicates a physical, hardware-based system (the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module) is required to perform the test, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "quantitatively measure intact hCG in serum and plasma, for the early detection of pregnancy." This involves testing biological samples (serum and plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a laboratory-based immunoassay method that analyzes chemical reactions within the sample to determine the concentration of hCG. This is a hallmark of IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes
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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 ß-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-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.
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
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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
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.
Key Metrics
Correlation coefficient of 0.986, slope of 1.270, and an intercept of 2.87 mIU/mL.
Predicate Device(s)
Abbott IMx® hCG
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.
0
MAR 1 0 1997
Chemistry Systems
P.O. Box 6101
Newark, DE 19714
DA!
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 ß-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-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.
1
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
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 1/31/97