(74 days)
Not Found
No
The summary describes a standard immunoassay and control set for detecting CMV antibodies. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) assay designed to detect antibodies to human cytomegalovirus, used as an aid in determining serological status, rather than for direct treatment or therapy.
Yes.
The device is intended to be used "as an aid in the determination of serological status to CMV," which provides information for diagnostic purposes.
No
The device is an in vitro diagnostic (IVD) assay and control set, which are physical reagents and materials used with a hardware analyzer. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the device is for the "qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum." This is a test performed on a sample taken from the human body (serum) to provide information about a person's health status (presence of CMV antibodies).
- Device Description: It describes the assay and the control set as being used with human serum/defibrinated plasma.
- Performance Studies: The performance studies focus on the characteristics of the assay and controls when used with samples, which is typical for IVDs.
- Predicate Device: The predicate devices listed are also IVDs (LIAISON® CMV IgG and LIAISON® Control CMV IgG).
The core function of the device is to analyze a biological sample (human serum) outside of the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.
The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON® Analyzer family *. The performance characteristics of the LIAISON® CMV IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
Product codes
LFZ, JJX
Device Description
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum.
The LIAISON® CMV 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® CMV 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® CMV IgG and LIAISON® CMV 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® CMV 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® CMV 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® CMV 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)
DiaSorin LIAISON® CMV IgG (K040290)
Reference Device(s)
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
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The image is surrounded 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 6, 2017
DIASORIN INCORPORATED JOHN C. WALTER PRESIDENT 1951 NORTHWESTERN AVE. STILLWATER, MN 55082
Re: K162969
Trade/Device Name: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LFZ, JJX Dated: October 21, 2016 Received: December 8, 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 as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
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,
Stephen J. Lovell -S 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) K162969
Device Name LIAISON® CMV IgG LIAISON® CMV IgG Serum Control Set
Indications for Use (Describe)
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
See PRA Statement below.
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.
The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON® Analyzer family *. The performance characteristics of the LIAISON® CMV 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.
3
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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
DiaSorin LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set Special 510(k): Device Modification
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® CMV IgG
LIAISON® CMV IgG Serum Control Set |
| Common Names/Description: | Immunoassay for the detection of IgG antibodies to
human Cytomegalovirus (hCMV) |
| Classification: | Cytomegalovirus serological reagents, 21 CF
866.3175 Class II (performance standards)
Micorobiology (83) |
| Product Code: | LFZ, JJX |
| PREDICATE DEVICE: | DiaSorin LIAISON® CMV IgG (K040290) |
DEVICE DESCRIPTION:
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum.
The LIAISON® CMV 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® CMV IgG assay on the LIAISON® Analyzer family.
INTENDED USE:
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomeqalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.
The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON®
5
Analyzer family*. The performance characteristics of the LIAISON® CMV IgG controls have not 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® CMV IgG assay.
| LIAISON® CMV IgG assay | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® CMV IgG | ||
| K040290, cleared 06/01/2005 | LIAISON® CMV IgG | |
| Intended | ||
| Use/Indications for | ||
| Use | The LIAISON® CMV IgG assay uses | |
| chemiluminescent immunoassay (CLIA) | ||
| technology on the LIAISON® Analyzer family* for | ||
| the qualitative determination of IgG antibodies to | ||
| human cytomegalovirus (hCMV) in human serum. | ||
| It is intended to be used as an aid in the | ||
| determination of serological status to CMV. | ||
| *(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 human cytomegalovirus (hCMV) | 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® CMV IgG Serum Control Set include a 100% human serum/defibrinated plasma based matrix and the extension of the open use stability claim.
The following table provides a summary of the similarities and differences between the FDA cleared LIAISON® Control CMV IgG and the modified device, LIAISON® CMV IgG Serum Control Set.
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| Summary of Similarities and Differences LIAISON® CMV IgG Serum Control Set | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® Control CMV IgG | ||
| K040290, cleared 06/01/2005 | Modified Device | |
| DiaSorin LIAISON® CMV IgG Serum | ||
| Control Set | ||
| Intended Use | The LIAISON® CMV IgG Controls | |
| (negative, positive) are used for | ||
| monitoring substantial reagent failure of | ||
| the LIAISON® CMV IgG | ||
| chemiluminescent immunoassay (CLIA). | ||
| The LIAISON® CMV IgG quality control | ||
| material contains only a 5% serum matrix | ||
| and may not adequately control the | ||
| DiaSorin LIAISON® CMV IgG assay for | ||
| serum specimens. The performance of | ||
| the LIAISON® CMV IgG Controls has not | ||
| been established with any other CMV | ||
| assay or instrument platforms different | ||
| from LIAISON® and LIAISON® XL. | The DiaSorin LIAISON® CMV IgG | |
| Serum Control Set is intended for use | ||
| as assayed quality control samples to | ||
| monitor the performance of the | ||
| LIAISON® CMV IgG assay on the | ||
| LIAISON® Analyzer family*. The | ||
| performance characteristics of the | ||
| LIAISON® CMV 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/plasma not reactive for | |
| CMV IgG antibodies, diluted in PBS | ||
| buffer, BSA, with ProClin® 300 as a | ||
| preservative. | Human serum/plasma non-reactive for | |
| CMV IgG antibodies, 0.1% ProClin® | ||
| 300 and 0.09% sodium azide. | ||
| Positive Control | 5% Human serum/plasma reactive for | |
| CMV IgG antibodies, diluted in PBS | ||
| buffer, BSA, with ProClin® 300 as a | ||
| preservative and an inert yellow dye. | Human serum/plasma reactive for | |
| CMV IgG antibodies, 0.1% ProClin® | ||
| 300 and 0.09% sodium azide. | ||
| Reagent | ||
| Configuration | 2 vials each level (negative and positive) | |
| 0.7 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.
SUMMARY OF PERFORMANCE DATA:
Non-clinical verification and validation testing conducted with the LIAISON® CMV IgG and LIAISON® CMV 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® CMV 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 ●
7
Real time stability testing conducted on the LIAISON® CMV 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® CMV IgG Serum Control Set do not introduce any new risks to the performance of the device.
CONCLUSION:
As summarized, LIAISON® CMV IgG and LIAISON® CMV Serum Control Set is substantially equivalent to the originally cleared device. 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.