(28 days)
No
The document describes a quality control set for an immunoassay, which is a standard laboratory reagent. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies focus on analytical performance metrics like commutability, precision, and stability, which are typical for control materials.
No
This device is a quality control sample used to monitor the performance of an in vitro diagnostic assay. It is not intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
Explanation: The device is described as a "Control Set" for monitoring the performance of an assay. It is used to ensure the accuracy of a diagnostic test, but it does not directly diagnose a patient's condition.
No
The device description clearly states the device consists of "liquid ready-to-use controls in human serum," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay". This indicates it's used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Device Description: The description confirms it consists of "liquid ready-to-use controls in human serum" and is designed for use with a specific diagnostic assay ("DiaSorin LIAISON® EBV IgM assay").
- Performance Studies: The performance studies focus on evaluating the characteristics of the controls themselves (commutability, precision, value assignment, stability) in the context of their use with the diagnostic assay.
- Predicate Device: The predicate device listed (K040120; LIAISON® Control EBV IgM) is also a control product for an IVD assay, further supporting the classification.
While the device itself is a control and not the primary diagnostic test, it is an essential component used in vitro to ensure the accuracy and reliability of an IVD assay. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The LIAISON® EBV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay on the LIAISON® Analyzer family.
Product codes
JJX
Device Description
The LIAISON® EBV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use 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® EBV IgM 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
Non-clinical verification and validation testing conducted with the LIAISON® EBV IgM 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:
- Commutability between Samples and Controls (Matrix Effect)
- Precision Equivalence between Samples and Controls
- Control Value Assignment
- Control Range Definition
Real Time Stability testing conducted on the LIAISON® EBV IgM Serum Control Set to support the following product claims:
- Shelf-life of 12 months at (2-8°C)
- Sixteen (16) weeks On-Board/Open Use Stability
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2016
DiaSorin Inc. Sandra Zimniewicz Regulatory Affairs Specialist 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285
Re: K161522
Trade/Device Name: LIAISON® EBV IgM Serum Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: I Product Code: JJX Dated: May 31, 2016 Received: June 02, 2016
Dear Ms. Zimniewicz:
This letter corrects our substantially equivalent letter of June 30, 2016.
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
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as set forth in the quality systems (OS) 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 regulations (21 CFR Parts 801 and 809), 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
LIAISON® EBV IgM Serum Control Set
Indications for Use (Describe)
The LIAISON® EBV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay on the LIAISON® Analyzer family.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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7.0 -510(k) SUMMARY
| SUBMITTED BY: | Sandra Zimniewicz
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Email: sandra.zimniewicz@diasorin.com |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | May 31, 2016 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® EBV IgM Serum Control Set |
| Common Names/Description: | EBV IgM Controls |
| Classification: | Quality Control Material: 21 CFR 862.1660 Class I, reserved; Microbiology (83) |
| Product Code: | JJX |
| PREDICATE DEVICE: | LIAISON® Control EBV IgM (K040120) |
DEVICE DESCRIPTION:
The LIAISON® EBV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use 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® EBV IgM assay on the LIAISON® analyzer family.
INTENDED USE:
The LIAISON® EBV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay on the LIAISON® Analyzer family.
COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):
Changes to the DiaSorin LIAISON® EBV IgM 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 EBV IgM and the modified device.
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| Summary of Similarities and Differences LIAISON EBV IgM Controls | |||
|---|---|---|---|
| Characteristic | Predicate Device | ||
| LIAISON® Control EBV IgM | |||
| K040290, cleared 06/01/2005 | Modified Device | ||
| LIAISON® EBV IgM Serum Control | |||
| Set | |||
| Intended Use | The LIAISON® EBV IgM controls | ||
| (negative and positive) are used for | |||
| monitoring substantial reagent failure of | |||
| the LIAISON® EBV IgM chemiluminescent | |||
| immunoassay (CLIA). The LIAISON® EBV | |||
| IgM quality control material contains only | |||
| a 5% serum matrix and may not | |||
| adequately control the DiaSorin LIAISON® | |||
| EBV IgM assay for serum specimens. | The LIAISON® EBV IgM Serum | ||
| Controls (negative and positive) is | |||
| intended for use as assayed quality | |||
| control samples to monitor the | |||
| performance of the LIAISON® EBV IgM | |||
| assay on the LIAISON® Analyzer | |||
| family. | |||
| Negative Control | 5% Human Serum/plasma not reactive for | ||
| VCA IgM antibodies, diluted in PBS | |||
| buffer, BSA, with ProClin® 300 as a | |||
| preservative. | Human Serum/plasma non-reactive for | ||
| VCA IgM antibodies, 0.1% ProClin® | |||
| 300 and 0.09% sodium azide. | |||
| Positive Control | 5% Human Serum/plasma reactive for | ||
| VCA IgM antibodies, diluted in PBS | |||
| buffer, BSA, with ProClin® 300 as a | |||
| preservative and an inert yellow dye. | Human Serum/plasma reactive for | ||
| VCA IgM 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 2-8ºC | Same | |
| Open Use Stability | Once opened controls are stable for four | ||
| (4) weeks when properly stored at 2-8ºC | |||
| between uses. | Once opened controls are stable for | ||
| sixteen (16) weeks when properly | |||
| stored at 2-8ºC between uses. |
SUMMARY OF PERFORMANCE DATA:
Non-clinical verification and validation testing conducted with the LIAISON® EBV IgM 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:
- Commutability between Samples and Controls (Matrix Effect) ●
- Precision Equivalence between Samples and Controls ●
- Control Value Assignment ●
- Control Range Definition
Real Time Stability testing conducted on the LIAISON® EBV IgM Serum Control Set to support the following product claims:
- . Shelf-life of 12 months at (2-8°C)
- Sixteen(16) weeks On-Board/Open Use Stability ●
Based on the findings from the validation and verification activities, the modifications to the LIAISON® EBV IgM Serum Control Set do not introduce any new risks to the performance of the device and do not alter safety and effectiveness.
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CONCLUSION:
Modifications 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 is as safe and effective as the predicate and does not raise new questions of safety and efficacy.
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.