(73 days)
Not Found
No
The document describes a standard immunoassay technology (CLIA) for detecting antibodies and associated controls. There is no mention of AI, ML, or any computational analysis beyond standard assay processing.
No
This device is an in-vitro diagnostic (IVD) assay used for the qualitative determination of specific antibodies for the diagnosis of Epstein-Barr Viral Syndrome, and not for direct therapeutic treatment.
Yes
The device is described as aiding in the "clinical laboratory diagnosis of Epstein-Barr Viral Syndrome." This explicitly states its role in diagnosis.
No
The device description clearly states that the device is an immunoassay kit and control set used on a specific hardware analyzer family (LIAISON® and LIAISON® XL). It involves chemical reactions and physical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the LIAISON® VCA IgG and LIAISON® EBNA IgG assays are for the "qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV)... in human serum." It also states that when used with other markers, they can be used as an "aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome." This clearly indicates the device is intended for use in vitro (outside the body) to examine specimens (human serum) to provide information for the diagnosis of a disease.
- Device Description: The description details how the assays work (chemiluminescent immunoassay) and what they measure (antibodies in human serum). It also describes the control sets, which are used to monitor the performance of the assays, further supporting their use in a diagnostic setting.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is a typical setting for IVD use.
The control sets are also considered IVDs as they are intended to monitor the performance of the diagnostic assays.
N/A
Intended Use / Indications for Use
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed 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.
The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed 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.
The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
Product codes
LSE, LLM, JJX
Device Description
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum.
The LIAISON® VCA IgG Serum Control Set (negative and positive) consists of liquid ready-touse controls in human serum/defibrinated plasma. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.
The controls are designed for use with DiaSorin LIAISON® VCA IgG assay on the LIAISON® Analyzer family.
The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum.
The LIAISON® EBNA IgG Serum Control Set (negative) consists of liquid ready-touse controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.
The controls are designed for use with DiaSorin LIAISON® EBNA IgG assay on the LIAISON® Analyzer family.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical verification and validation testing conducted with the LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:
Testing of the LIAISON® VCA IgG Serum Control Set to validate and verify:
- Commutability between samples and controls (matrix effect)
- Precison equivalence between samples and controls
- o 20 day precison
- Control value assignment
- Control range definition .
Real Time Stability testing conducted on the LIAISON® VCA IgG Serum Control Set to support the following product claims:
- Shelf-life of 12 months at (2-8°C) ●
- Eight (8) weeks open use stability when stored at 2-8°C between uses .
Based on the results from the validation and verification activities, the modifications to the LIAISON® VCA IgG Serum Control Set do not introduce any new risks to the performance of the device.
Non-clinical verification and validation testing conducted with the LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:
Testing of the LIAISON® EBNA IgG Serum Control Set to validate and verify:
- Commutability between samples and controls (Matrix Effect)
- Precison equivalence between samples and controls
- o 20 Day Precison
- Control value assignment
- Control range definition .
Real time stability testing conducted on the LIAISON® EBNA IgG Serum Control Set to support the following product claims:
- Shelf-life of 12 months at (2-8°C) ●
- Eight (8) weeks open use stability when stored at 2-8°C between uses .
Based on the results from the validation and verification activities, the modifications to the LIAISON® EBNA IgG Serum Control Set do not introduce any new risks to the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 LIAISON® VCA IgG (K040120), DiaSorin LIAISON® EBNA IgG (K040120)
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.
Not Found
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).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 05, 2017
DIASORIN INCORPORATED JOHN C. WALTER PRESIDENT 1951 NORTHWESTERN AVE. STILLWATER, MN 55082
Re: K162961
Trade/Device Name: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LSE, LLM, JJX Dated: October 21, 2016 Received: December 6, 2016
Dear Mr. Walter:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria I. Garcia -S 2017.01.05 10:28:34 -05'00'
For: Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162961
Device Name
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
Indications for Use (Describe)
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed 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.
The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K162961
Device Name
LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
Indications for Use (Describe)
The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed 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.
The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
| SUBMITTED BY: | DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285 |
|---------------------------|-----------------------------------------------------------------------------------------|
| CONTACT: | Gagan Gill
Regulatory Affairs Associate
Email: gagan.gill@diasorin.com |
| DATE OF PREPARATION: | October 21, 2016 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® VCA IgG
LIAISON® VCA IgG Serum Control Set |
| Common Names/Description: | Immunoassay for the detection of IgG antibodies to
EBV viral capsid antigens (VCA) |
| Classification: | Epstein-Barr Virus, serological reagents; 21 CFR
866.3235; Class I, Microbiology(83) |
| Product Code: | LSE, JJX |
| PREDICATE DEVICE: | DiaSorin LIAISON® VCA IgG (K040120) |
DEVICE DESCRIPTION:
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum.
The LIAISON® VCA IgG Serum Control Set (negative and positive) consists of liquid ready-touse controls in human serum/defibrinated plasma. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.
The controls are designed for use with DiaSorin LIAISON® VCA IgG assay on the LIAISON® Analyzer family.
INTENDED USE:
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed 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.
The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not
5
been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):
The following table provides a summary of the FDA cleared LIAISON® VCA IgG assay.
| LIAISON® VCA IgG assay | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® VCA IgG | ||
| K040120, Cleared 06/01/2005 | DiaSorin LIAISON® VCA IgG | |
| Intended | ||
| Use/Indications for | ||
| Use | The LIAISON® VCA IgG assay uses | |
| chemiluminescent immunoassay (CLIA) technology | ||
| on the LIAISON® Analyzer family* for the qualitative | ||
| determination of specific IgG antibodies to Epstein- | ||
| Barr virus (EBV) viral capsid antigen (VCA) p18 | ||
| synthetic peptide in human serum. When | ||
| performed in conjunction with other EBV markers, | ||
| this assay can be used as an aid in the clinincal | ||
| laboratory diagnosis of Epstein-Barr Viral | ||
| Syndrome in patients with signs and symptoms of | ||
| EBV infection such as infectious mononucleosis. | ||
| *(LIAISON® and LIAISON® XL). | No Change | |
| Technology/ | ||
| Assay Principle | Chemiluminescent Immunoassay (CLIA) | No Change |
| Sample | ||
| Handling/Assay | ||
| Processing | Automated | No Change |
| Storage | Store at 2-8° C until ready to use | No Change |
| Measured Analyte | IgG antibodies to Epstein-Barr virus (EBV) viral | |
| capsid antigen | No Change | |
| Assay Performance | ||
| Characteristics | No Change | No Change |
| Labeling (IFU) | References buffer based controls | References serum based |
| controls | ||
| Controls | Provided Separately | No Change |
6
Changes to the DiaSorin LIAISON® VCA IgG Serum Control Set include a 100% serum/defibrinated plasma based matrix and the extension of the open use stability claim.
The following tables provide a summary of the similarities and differences between the FDA cleared LIAISON® Control VCA IgG and the modified device, LIAISON® VCA IgG Serum Control Set.
| Summary of Similarities and Differences LIAISON® VCA IgG Control Set | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® Control VCA IgG | ||
| K040120, Cleared 06/01/2005 | Modified Device | |
| DiaSorin LIAISON® VCA IgG Serum | ||
| Control Set | ||
| Intended Use | The LIAISON® VCA IgG Controls | |
| (negative, positive) are used for | ||
| monitoring substantial reagent failure | ||
| of the LIAISON® VCA IgG | ||
| chemiluminescent immunoassay | ||
| (CLIA). The LIAISON® VCA IgG quality | ||
| control material contains a 5% serum | ||
| matrix and may not adequately control | ||
| the DiaSorin LIAISON® VCA IgG assay | ||
| for serum specimens. The | ||
| performance of the LIAISON® VCA | ||
| IgG Controls has not been established | ||
| with any other EBV assay or | ||
| instrument platforms different from | ||
| LIAISON® and LIAISON® XL. | The DiaSorin LIAISON® VCA IgG | |
| Serum Control Set is intended for use | ||
| as assayed quality control samples to | ||
| monitor the performance of the | ||
| LIAISON® VCA IgG assay on the | ||
| LIAISON® Analyzer family*. The | ||
| performance characteristics of the | ||
| LIAISON® VCA IgG controls have not | ||
| been established for any other assay or | ||
| instrument platforms different from the | ||
| LIAISON® and LIAISON® XL. | ||
| *(LIAISON® and LIAISON® XL). | ||
| Negative Control | 5% Human serum/defibrinated plasma | |
| not reactive for VCA IgG antibodies, | ||
| diluted in PBS buffer, BSA, with | ||
| ProClin® 300 as a preservative. | Human serum/defibrinatedplasma non- | |
| reactive for VCA IgG antibodies, 0.1% | ||
| ProClin® 300 and 0.09% sodium azide. | ||
| Positive Control | 5% Human serum/defibrinated plasma | |
| reactive for VCA IgG antibodies, diluted in | ||
| PBS buffer, BSA, with ProClin® 300 as a | ||
| preservative and an inert yellow dye. | Human serum/defibrinated plasma | |
| reactive for VCA IgG antibodies, 0.1% | ||
| ProClin® 300 and 0.09% sodium azide. | ||
| Reagent | ||
| Configuration | 2 vials each level (negative and positive) | |
| 0.9 mL/vial, ready to use. | Same | |
| Storage | Store at 2-8°C | Same |
| Open Use | ||
| Stability | Once opened controls are stable for four | |
| (4) weeks when properly stored at 2-8°C | ||
| between uses. | Once opened controls are stable for | |
| eight (8) weeks when properly stored at | ||
| 2-8°C between uses. |
ProClin® is a trademark of the Dow Chemical Company (Dow) or an affiliated company of Dow.
7
SUMMARY OF PERFORMANCE DATA:
Non-clinical verification and validation testing conducted with the LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:
Testing of the LIAISON® VCA IgG Serum Control Set to validate and verify:
- Commutability between samples and controls (matrix effect)
- . Precison equivalence between samples and controls
- o 20 day precison
- . Control value assignment
- Control range definition .
Real Time Stability testing conducted on the LIAISON® VCA IgG Serum Control Set to support the following product claims:
- Shelf-life of 12 months at (2-8°C) ●
- Eight (8) weeks open use stability when stored at 2-8°C between uses .
Based on the results from the validation and verification activities, the modifications to the LIAISON® VCA IgG Serum Control Set do not introduce any new risks to the performance of the device.
CONCLUSION:
As summarized, LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set is substantially equivalent to the originally cleared device. The changes to the device do not constitute new intended/indications for use, or changes to the fundamental scientific technology. Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of design specifications. The device was determined to be substantially equivalent to the previously cleared device.
The material submitted in this Special 510(k) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.
8
510(k) SUMMARY
| SUBMITTED BY: | DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285 |
|---------------------------|-----------------------------------------------------------------------------------------|
| CONTACT: | Gagan Gill
Regulatory Affairs Associate
Email: gagan.gill@diasorin.com |
| DATE OF PREPARATION: | October 21, 2016 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® EBNA IgG
LIAISON® EBNA IgG Serum Control Set |
| Common Names/Description: | Immunoassay for the detection of IgG antibodies to
EBV Nuclear Antigen (EBNA) |
| Classification: | Epstein-Barr Virus, serological reagents; 21 CFR
866.3235; Class I, Microbiology(83) |
| Product Code: | LLM, JJX |
| PREDICATE DEVICE: | DiaSorin LIAISON® EBNA IgG (K040120) |
DEVICE DESCRIPTION:
The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum.
The LIAISON® EBNA IgG Serum Control Set (negative) consists of liquid ready-touse controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.
The controls are designed for use with DiaSorin LIAISON® EBNA IgG assay on the LIAISON® Analyzer family.
INTENDED USE:
The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinincal laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.
The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not
9
been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL)
COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):
The following table provides a summary of the FDA cleared LIAISON® EBNA IgG assay.
| LIAISON® EBNA IgG assay | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® EBNA IgG | ||
| K040120, cleared 06/01/2005 | DiaSorin LIAISON® EBNA IgG | |
| Intended | ||
| Use/Indications for | ||
| Use | The LIAISON® EBNA IgG assay uses | |
| chemiluminescent immunoassay (CLIA) | ||
| technology on the LIAISON® Analyzer family* | ||
| for the qualitative determination of specific | ||
| IgG antibodies to Epstein-Barr virus (EBV) | ||
| nuclear antigen synthetic peptide (EBNA-1) in | ||
| human serum. When performed 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. | ||
| *(LIAISON® and LIAISON® XL). | No Change | |
| Technology/ | ||
| Assay Principle | Chemiluminescent Immunoassay (CLIA) | No Change |
| Sample | ||
| Handling/Assay | ||
| Processing | Automated | No Change |
| Storage | Store at 2-8° C until ready to use | No Change |
| Measured Analyte | IgG antibodies to Epstein-Barr virus (EBV) | |
| nuclear antigen | No Change | |
| Assay Performance | ||
| Characteristics | No Change | No Change |
| Labeling (IFU) | References buffer based controls | References serum based controls |
| Controls | Provided Separately | No Change |
Changes to the DiaSorin LIAISON® EBNA IgG Serum Control Set include a 100% serum/defibrinated plasma based matrix and the extension of the open use stability claim.
10
The following table provides a summary of the similarities and differences between the FDA cleared LIAISON® Control EBNA IgG and the modified device, LIAISON® EBNA IgG Serum Control Set.
| Summary of Similarities and Differences LIAISON® EBNA IgG Control Set | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® Control EBNA IgG | ||
| K040120, cleared 06/01/2005 | Modified Device | |
| DiaSorin LIAISON® EBNA IgG Serum | ||
| Control Set | ||
| Intended Use | The LIAISON® EBNA IgG Serum Controls | |
| (negative, positive) are used for monitoring | ||
| substantial reagent failure of the LIAISON® | ||
| EBNA IgG chemiluminescent | ||
| immunoassay (CLIA). The LIAISON® | ||
| EBNA IgG quality control material contains | ||
| a 5% serum matrix and may not | ||
| adequately control the DiaSorin LIAISON® | ||
| EBNA IgG assay for serum specimens. | ||
| The performance of the LIAISON® EBNA | ||
| IgG Controls has not been established with | ||
| any other EBV assay or instrument | ||
| platforms different from LIAISON® and | ||
| LIAISON® XL. | The DiaSorin LIAISON® EBNA IgG | |
| Serum Control Set is intended for use | ||
| as assayed quality control samples to | ||
| monitor the performance of the | ||
| LIAISON® EBNA IgG assay on the | ||
| LIAISON® Analyzer family*. The | ||
| performance characteristics of the | ||
| LIAISON® EBNA IgG controls have not | ||
| been established for any other assay | ||
| or instrument platforms different from | ||
| the LIAISON® and LIAISON® XL. | ||
| *(LIAISON® and LIAISON® XL). | ||
| Negative Control | 5% Human serum/ defibrinated plasma not | |
| reactive for EBNA IgG antibodies, diluted | ||
| in PBS buffer, BSA, with ProClin® 300 as | ||
| a preservative. | Human serum/defibrinated plasma | |
| non-reactive for EBNA IgG antibodies, | ||
| 0.1% ProClin® 300 and 0.09% sodium | ||
| azide. | ||
| Positive Control | 5% Human serum/defibrinated plasma | |
| reactive for EBNA IgG antibodies, diluted | ||
| in PBS buffer, BSA, with ProClin® 300 as a | ||
| preservative and an inert yellow dye. | Human Serum/defibrinated plasma | |
| reactive for EBNA IgG antibodies, | ||
| 0.1% ProClin® 300 and 0.09% sodium | ||
| azide. | ||
| Reagent | ||
| Configuration | 2 vials each level (negative and positive) | |
| 0.9 mL/vial, ready to use. | Same | |
| Storage | Store at 2-8°C | Same |
| Open Use Stability | Once opened controls are stable for four | |
| (4) weeks when properly stored at 2-8°C | ||
| between uses. | Once opened controls are stable for | |
| eight (8) weeks when properly stored | ||
| at 2-8°C between uses. |
ProClin® is a trademark of the Dow Chemical Company (Dow) or an affiliated company of Dow.
11
SUMMARY OF PERFORMANCE DATA:
Non-clinical verification and validation testing conducted with the LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:
Testing of the LIAISON® EBNA IgG Serum Control Set to validate and verify:
- . Commutability between samples and controls (Matrix Effect)
- . Precison equivalence between samples and controls
- o 20 Day Precison
- . Control value assignment
- Control range definition .
Real time stability testing conducted on the LIAISON® EBNA IgG Serum Control Set to support the following product claims:
- Shelf-life of 12 months at (2-8°C) ●
- Eight (8) weeks open use stability when stored at 2-8°C between uses .
Based on the results from the validation and verification activities, the modifications to the LIAISON® EBNA IgG Serum Control Set do not introduce any new risks to the performance of the device.
CONCLUSION:
As summarized, LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set is substantially equivalent to the originally cleared device. The changes to the device do not constitute new intended/indications for use, or changes to the fundamental scientific technology. Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of design specifications. The device was determined to be substantially equivalent to the previously cleared device.
The material submitted in this Special 510(k) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.