(409 days)
Cryocheck Low Fibrinogen Control Plasma
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No
The document describes a control plasma for laboratory testing and does not mention any AI or ML components.
No
The device is a control plasma used for quality control of fibrinogen assays, not for directly treating a patient. It is explicitly labeled "For In Vitro Diagnostic Use".
Yes
The device is described as "intended 'For In Vitro Diagnostic Use'" and is used in the "quality control of quantitative fibrinogen assays," which are diagnostic tests.
No
The device description clearly states it is a plasma product, which is a biological material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This plasma is intended 'For In Vitro Diagnostic Use'".
- Intended Use: The device is intended for "quality control of quantitative fibrinogen assays in the low abnormal range" and for "determining fibrinogen levels in plasma by the clotting method of Clauss". These are laboratory tests performed on biological samples (plasma) outside of the body, which is the definition of in vitro diagnostics.
- Device Description: The device is a "pool of de-fibrinated citrated human plasma", a biological material used in laboratory testing.
- Intended User: The intended users are "trained laboratory personnel working in clinical laboratories", which is consistent with the use of IVD devices.
N/A
Intended Use / Indications for Use
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
Product codes
GGN
Device Description
The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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
The intended users of the VisuCon-F Low Fibringen Control Plasma are trained laboratory personnel working in clinical laboratories.
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
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Key Metrics
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Predicate Device(s)
Cryocheck Low Fibrinogen Control Plasma
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2016
Affinity Biologicals Inc. Denise Foulon Scientific Director 1348 Sandhill Drive Ancaster, ON Canada, L9G 4V5
Re: K150144
Trade/Device Name: VisuCon-F Low Fibrinogen Control Plasma Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: February 1, 2016 Received: February 2, 2016
Dear Ms. Foulon:
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
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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 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 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/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 vours.
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150144
Device Name
VisuCon-F Low Fibrinogen Control Plasma
Indications for Use (Describe)
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuOon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
The intended users of the VisuCon-F Low Fibringen Control Plasma are trained laboratory personnel working in clinical laboratories.
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)
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510(k) Summary for VisuCon-F Low Fibrinogen Control Plasma (Summary of Safety and Effectiveness)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitted By: | Affinity Biologicals Inc.
1348 Sandhill Drive
Ancaster, ON
Canada, L9G 4V5
Phone: 905-304-9896
Fax: 905-304-9897 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Denise Foulon, Scientific Director
Phone: 905-304-9896
Fax: 905-304-9897 |
| Summary Prepared: | January 29, 2016 |
| Name of the Device: | VisuCon-F Low Fibrinogen Control Plasma
Common Name: Abnormal Control Plasma |
| Classification of Device: | Class II
21 CFR 864.5425
Subpart H, Hematology Kits and Packages
Product Code: GGN |
| Predicate Device: | Cryocheck Low Fibrinogen Control Plasma
Precison Biologic Inc. |
| Device Description: | The VisuCon-F Low Fibrinogen Control plasma is a pool of de-
fibrinated citrated human plasma buffered with 0.02 M HEPES
buffer, dispensed and rapidly frozen. |
| Device Intended Use: | The VisuCon-F Low Fibrinogen Control Plasma is an assayed
control plasma prepared from de-fibrinated human plasma
intended for use in the quality control of quantitative fibrinogen
assays in the low abnormal range. The VisuCon-F Low
Fibrinogen Control Plasma may be used with mechanical
instruments in conjunction with appropriate commercial reagents
for determining fibrinogen levels in plasma by the clotting method
of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
The intended users of the VisuCon-F Low Fibrinogen Control
Plasma are trained laboratory personnel working in clinical |
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Comparison to Predicate Device:
A technical comparison of the proposed device and the predicate device is illustrated in the following table:
| | VisuCon-F Low Fibrinogen
Control Plasma
(Proposed Device) | Cryocheck Low Fibrinogen
Control Plasma
(Predicate Device) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | An assayed control plasma
prepared from de-fibrinated
human plasma intended for use
in the quality control of
quantitative fibrinogen assays in
the low abnormal range | Recommended for use as an
abnormal control in quantitative
fibrinogen assays |
| Analytes | Fibrinogen | Fibrinogen |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen |
| Open-Vial
Stability | 72 hours at 2-8°C or 8 hours on-
board instrument (19-22°C) | 72 hours at 2-8°C |
| Precision
(% Coefficient of
Variation (CV)) | Within Run = 3.15%
Between Day = 0.54%
Between Run = 0%
Within Device = 8.44% | 2.8 - 3.7% (n = 36) |
Conclusion: The VisuCon-F Low Fibrinogen Control plasma is substantially equivalent to its predicate device, Cryocheck Low Fibrinogen Control plasma, based on similar intended use, product matrix, stability and performance characteristics (precision).