(144 days)
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No
The description focuses on standard immunoassay technology and the analyzer's automated steps, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an immunoassay system designed for the quantitative determination of human chorionic gonadotropin (hCG) in human serum for early detection of pregnancy. This is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device quantitatively determines total human chorionic gonadotropin (hCG) in human serum for early detection of pregnancy, which provides information used to diagnose a medical condition (pregnancy).
No
The device description clearly outlines a physical analyzer (LIAISON® XL Analyzer) that performs the assay steps, including incubations, addition of reagents, and measurement of light signals. This indicates a hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy." This involves testing a biological sample (human serum) outside of the body to provide information about a physiological state (pregnancy).
- Device Description: The description details a "sandwich chemiluminescence immunoassay" that uses antibodies and reagents to measure a substance (hCG) in a sample. This is a classic method used in in vitro diagnostics.
- Performance Studies: The document describes various performance studies (Method Comparison, Reference Range/Expected Values, Reproducibility/Precision, Dilution Linearity, LoB/LoD/LoQ, Recovery, Interfering Substances) that are standard for evaluating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K003178; Roche ELECSYS® HCG +Beta Test) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.
Product codes (comma separated list FDA assigned to the subject device)
DHA
Device Description
The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: One hundred sixty-three (163) serum samples, that spanned the reportable range of the assay, were tested and analyzed by Weighted Deming Regression. The method comparison study was performed according to CLSI EP9-A2 guideline.
Results: Weighted Deming Regression analysis was performed on the results across the range of LIAISON® XL HCG assay yielding agreement of y= 0.973x &0.2233; R2 = 0.9933.
Reference Range/Expected Values: The reference range study was performed according to CLSI Approved Guideline C28-A3. Human serum samples from apparently healthy non-pregnant premenopausal and postmenopausal subjects were tested to determine the reference range for the LIAISON® XL HCG assay. The results are listed below:
In a study performed on 74 healthy, non-pregnant premenopausal women (
§ 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
DiaSorin LIAISON® XL HCG Premarket Notification
5.0 510(k) SUMMARY
SUBMITTED BY:
Mari Mever Director, Regulatory Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 439-9710 Fax (651) 351-5669 Email: mari.meyer@diasorin.com
SEP
06
2013
NAME OF DEVICE:
Trade Name:
Common Names/Descriptions:
Classification Names:
LIAISON® XL HCG
Human Chorionic Gonadotropin (hCG)
Human Chorionic Gonadotropin (hCG) test system
Product Code:
DHA
PREDICATE DEVICE:
Roche ELECSYS® HCG +Beta Test Reference K003178
DEVICE DESCRIPTION:
INTENDED USE:
The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.
KIT DESCRIPTION:
The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody
1
conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.
COMPARISON TO PREDICATE DEVICE:
The DiaSorin LIAISON XL HCG assay is substantially equivalent in principle and performance to the Roche Elecsys® HCG +Beta Test (K003178) which was FDA cleared December 14, 2002.
| Table 1: Table of Similarities | ||
|---|---|---|
| Characteristic | New Device | |
| LIAISON® XL HCG | Predicate Device | |
| Roche ELECSYS® HCG + Beta | ||
| Test System (K003178) | ||
| Intended Use | In-vitro assay for the quantitative | |
| determination of total human | ||
| chorionic gonadotropin (hCG and | ||
| βhCG) in human serum for early | ||
| detection of pregnancy using the | ||
| LIAISON® XL Analyzer. | Immunoassay for the in-vitro | |
| quantitative determination of the sum | ||
| of human chorionic gonadotropin | ||
| (hCG) plus the hCG Beta subunit in | ||
| human serum and plasma. | ||
| Indications for | ||
| Use | For the early detection of | |
| pregnancy. | For the early detection of pregnancy. | |
| Measured | ||
| Analyte | human chorionic gonadotropin | |
| (hCG) plus the hCG Beta subunit | human chorionic gonadotropin (hCG) | |
| plus the hCG Beta subunit | ||
| Assay Type | Chemiluminescent Immunoassay | Electrochemiluminescent |
| Immunoassay | ||
| Test principle | Sandwich chemiluminescent | |
| Immunoassay | Sandwich chemiluminescent | |
| Immunoassay | ||
| Solid Support | Paramagnetic particles coated with | |
| recombinant hCG | Paramagnetic particles coated with | |
| streptavidin and coupled to | ||
| biotinylated monoclonal hCG-specific | ||
| antibodies | ||
| Reagent Integral | ||
| Storage | On-board or in refrigerator@ 2-8°C | On-board or in refrigerator@ 2-8°C |
| Sample | ||
| Handling/Process | ||
| ing | Automated | Automated |
| Unit of Measure | mlU/mL | mlU/mL |
| Traceability | 3rd WHO reference standard IS | |
| 75/537. | 3rd WHO reference standard IS | |
| 75/537. |
2
| Table 2 : Table of Differences | ||
|---|---|---|
| Characteristic | New Device | |
| LIAISON® HCG | Predicate Device | |
| Roche ELECSYS® HCG + Beta | ||
| Test System (K003178) | ||
| Instrument | LIAISON® XL Analyzer | Roche Elecsys® Immunoassay |
| analyzer | ||
| Calibration | Two-point calibrator verification of | |
| stored master curve. | ||
| Included with the kit. | Two-point calibrator verification of | |
| stored master curve. Not included | ||
| with the kit. | ||
| Measuring range | 1.5 - 10,000 mIU/mL | 0.100 - 10,000 mIU/mL |
| Sample Matrix | Human serum | Human serum and plasma |
| Sample size | 30 μL | 10 μL |
| Conjugate | ||
| Antibody | Anti-hCG antibodies (mouse) | |
| labeled with isoluminol | Biotinylated monoclonal anti-hCG | |
| antibodies (mouse) | ||
| Open storage | ||
| 2-8°C | 4 weeks | 12 weeks |
| Controls | No Controls Provided | 2 Levels |
PERFORMANCE DATA:
Method Comparison:
One hundred sixty-three (163) serum samples, that spanned the reportable range of the assay, were tested and analyzed by Weighted Deming Regression. The method comparison study was performed according to CLSI EP9-A2 guideline.
Results:
Weighted Deming Regression analysis was performed on the results across the range of LIAISON® XL HCG assay yielding agreement of y= 0.973x _0.2233; R2 = 0.9933.
Reference Range/Expected Values:
The reference range study was performed according to CLSI Approved Guideline C28-A3. Human serum samples from apparently healthy non-pregnant premenopausal and postmenopausal subjects were tested to determine the reference range for the LIAISON® XL HCG assay. The results are listed below:
· In a study performed on 74 healthy, non-pregnant premenopausal women (