(265 days)
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No
The description details a standard chemiluminescence immunoassay (CLIA) technology for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond basic signal processing and comparison to thresholds. The performance studies focus on traditional assay metrics like percent agreement and reproducibility.
No.
It is an in vitro diagnostic device used to aid in diagnosis, not to treat a condition.
Yes
The device is described as an "aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome," which indicates its role in identifying or characterizing a disease.
No
The device description clearly outlines a chemiluminescence immunoassay (CLIA) technology that utilizes magnetic particles, reagents, and a LIAISON Analyzer for performing the assay steps and measuring the light signal. This involves significant hardware components and chemical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum." This is a test performed in vitro (outside the body) on a biological sample (serum) to provide information about a patient's health status (presence of EBV antibodies).
- Device Description: The description details a "chemiluminescence immunoassay (CLIA)" method, which is a common technique used in in vitro diagnostic testing to detect specific substances in biological samples.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where in vitro diagnostic tests are typically performed.
- Performance Studies: The document describes clinical trials and reproducibility studies, which are standard requirements for demonstrating the performance of in vitro diagnostic devices.
- Predicate Device: The mention of a "Predicate Device" (K992191; DiaSorin ETI-EA-G Kit) 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 these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® EA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. When used in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EA IgG kit is used in conjunction with LIAISON® EA IgG immunoassay for monitoring substantial reagent failure.
The LIAISON® EA IgG assay and LIAISON® EA IgG Controls use chemiluniescent immunoassay (CLIA) technology on the LIAISON Analyzer for the qualitative determination of IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum. This assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM).
Product codes (comma separated list FDA assigned to the subject device)
LSE
Device Description
The method for qualititative determination of specific IgG to Epstein-Barr virus early antigen-diffuse (EA(D) recombinant polypeptide] is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EA(D) recombinant polypeptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, EA(D) antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with EA(D) antibodies that are already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle. 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) and is indicative of the presence of EA(D) IgG antibodies 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)
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external US laboratories and at DiaSorin. Testing was performed on repository and prospective samples as defined below. The samples were tested by LIAISON® EA IgG and comparison assay (DiaSorin ETI-EA-G ELISA Kit), at the trial sites per the manufacturers' instructions for use.
Prospective Samples: Subjects Sent to the Laboratory for EBV Testing:
Overall Percent Agreement: 92.2% (759/823) with a 95% confidence interval of 90.2 – 94.0%.
Retrospective Samples: VCA IgM-positive Samples
Overall Percent Agreement: 100.0% (70/70) with a 95% confidence interval of 94.9 - 100.0%.
REPRODUCIBILITY: Reproducibility studies were performed at 3 sites using a coded panel comprised of 9 frozen repository serum samples. The serum panel was prepared to represent from low- to mid-positive analyte level. The same coded panel was tested at all sites, in three replicates per run for ten runs. Results expressed in U/mL are summarized in the following table.
Overall %CV ranged from 9.43% to 15.36% across the 9 samples.
INTERFERENCE: Controlled studies of potentially interfering substances showed that the assay performance was not affected by hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin).
CROSS-REACTIVITY: The cross-reactivity studies for the LIAISON® EA IgG assay were designed to evaluate potential interference from IgG immunoglobulins directed against other Epstein-Barr virus antibodies (VCA, EBNA), closely-related members of the herpes virus family (HSV-1/2, HSV-2, VZV, CMV), from other organisms that may cause symptoms similar to EBV (Toxoplasma gondii, rubella virus) and from other conditions that may result from atypical immune system activity (rheumatoid factor (RF), antinuclear antibodies (ANA)). In addition, potential interference from human anti-mouse antibodies (HAMA) was evaluated.
15 out of 183 samples from the cross-reaction panel returned positive or equivocal results in the LIAISON® EA IgG assay. The highest rate of cross-reactivity was observed with Toxoplasma gondii IgG (4/17) and Rubella virus IgG (8/87).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Samples:
Positive Percent Agreement: 90.3% (297/329)
Negative Percent Agreement: 93.5% (462/494)
Retrospective Samples:
Positive Percent Agreement: 100.0% (70/70)
Negative Percent Agreement: N.C.* (0/0)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DiaSorin ETI-EA-G Kit (K992191)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).
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6.0 510(k) SUMMARY
OCT 1 8 2006
David M. Ikeda Requlatory Affairs/Quality Systems Manager DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5592 Fax (651) 351-5669 E-mail: david.ikeda@diasorin.com
LIAISON® EA IgG / LIAISON® Control EA IgG
Immunoassay for the detection of IgG antibodies to
NAME OF DEVICE: Trade Name:
SUBMITTED BY:
Common Names/Descriptions:
Classification Names:
Product Code:
PREDICATE DEVICE:
EBV early antigen-diffuse [EA(D)]
EPSTEIN-BARR VIRUS, OTHER
DiaSorin ETI-EA-G Kit (K992191)
DEVICE DESCRIPTION:
INTENDED USE: The DiaSorin LIAISON® EA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coll DH-1 cells. When used in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EA IgG kit is used in conjunction with LIAISON® EA IgG immunoassay for monitoring substantial reagent failure.
LSE
KIT DESCRIPTION: The method for qualititative determination of specific IgG to Epstein-Barr virus early antigen-diffuse (EA(D) recombinant polypeptide] is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EA(D) recombinant polypeptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, EA(D) antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with EA(D) antibodies that are already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle. 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
1
photomultiplier as relative light units (RLU) and is indicative of the presence of EA(D) IgG antibodies present in calibrators, samples or controls.
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external US laboratories and at DiaSorin. Testing was performed on repository and prospective samples as defined below. The samples were tested by LIAISON® EA IgG and comparison assay (DiaSorin ETI-EA-G ELISA Kit), at the trial sites per the manufacturers' instructions for use.
Prospective Samples: Subjects Sent to the Laboratory for EBV Testing:
| LIAISON®
| EA IgG | DiaSorin ETI-EA-G | Total | |
|---|---|---|---|
| Positive | Negative | ||
| Positive (≥11.0 U/mL) | 297 | 20 | 317 |
| Equivocal (9.0-10.9 U/mL) | 17 | 12 | 29 |
| Negative ( Trade/Device Name: DiaSorin LIAISON® EA IgG Assay Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus Serological Reagents Regulatory Class: Class I Product Code: LSE Dated: October 6, 2006 Received: October 13, 2006 |
Dear Mr. Kafader:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, istis 1.0.1 devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Begister.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, axtom
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060204
LIAISON® EA IgG Assay and LIAISON® EA IgG Controls Device Name:
Indications For Use: The LIAISON® EA IgG assay and LIAISON® EA IgG Controls use chemiluniescent immunoassay (CLIA) technology on the LIAISON Analyzer for the qualitative determination of IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum. This assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sali atta
Division Sign
Office of In Vitro Diagnostic D» Evaluation and S & J
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