(247 days)
Not Found
No
The 510(k) summary describes a frozen plasma control for coagulation assays. There is no mention of AI, ML, or any computational analysis beyond standard laboratory procedures. The device description focuses on the biological composition and processing of the plasma.
No
This device is described as an assayed normal and abnormal control plasma intended for use in the quality control of quantitative coagulation assays, not for direct therapeutic treatment or diagnosis of patients.
No
The device is described as a "control plasma" intended for "quality control of quantitative coagulation assays," not for directly diagnosing medical conditions in patients. It is used to ensure the accuracy of other diagnostic tests.
No
The device description clearly states it is a pool of frozen human plasma, which is a biological material, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended for use in the quality control of quantitative coagulation assays...". Quality control materials used in laboratory tests performed on samples taken from the human body are a key category of IVDs.
- Device Description: The device is described as a "pool of normal citrated human plasma" and "a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations". These are materials derived from human specimens and used in laboratory testing.
- Predicate Devices: The mention of predicate devices (HemosIL Routine Control Level 1 and Level 2) which are also control plasmas used in coagulation testing further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
The device fits the definition of an IVD as it is a reagent or material intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes (in this case, ensuring the accuracy of coagulation assays used for diagnosis).
N/A
Intended Use / Indications for Use
The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
The VisuCon-F Frozen Coag Screen N is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The VisuCon-F Frozen Coag Screen ABN is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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)
Not Found
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.
HemosIL Routine Control Level 1, K082859, HemosIL Routine Control Level 2, K082859
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
§ 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.
0
OCT 20 **
510(k) Summary for VisuCon-F Frozen Coag Screen N (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.
1395 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: | October 11, 2011 |
| Name of the Device: | VisuCon-F Frozen Coag Screen N
Common Name: Normal Control Plasma |
| Classification of Device: | Class II
21 CFR 864.5425
Subpart H, Hematology Kits and Packages
Product Code: GGN |
| Predicate Device: | HemosIL Routine Control Level 1, K082859
Instrumentation Laboratory |
| Device Description: | The VisuCon-F Frozen Coag Screen N is a pool of normal
citrated human plasma collected from a minimum of 20
donors, buffered with 0.02 M HEPES buffer, dispensed and
rapidly frozen. |
| Device Intended Use: | The VisuCon-F Frozen Coag Screen N plasma is an
assayed normal control plasma intended for use in the
quality control of quantitative coagulation assays, including
Prothrombin Time (PT), Activated partial thromboplastin
time (APTT) and fibrinogen in the normal range.
The |
VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments
in conjunction with appropriate commercial reagents.
1
Comparison to Predicate Device:
.
A technical comparison of the proposed device and the predicate device is illustrated in the following table:
| | VisuCon-F Frozen Coag
Screen N
(Proposed Device) | HemosIL Routine Control
Level 1,
(Predicate Device) |
|------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended Use | For the quality control of
coagulation assays in the
normal range | For the quality control of
coagulation assays in the
normal range |
| Analytes | Prothrombin time (PT), Activated
partial thromboplastin time
(APTT), Fibrinogen | Prothrombin time (PT),
Activated partial thromboplastin
time (APTT), Fibrinogen |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Lyophilized |
| Open-Vial
Stability | 8 hours at 2-8°C or on-board
coagulation instrument
(15-22°C) | 8 hours at 2-8°C |
Conclusion: The VisuCon-F Frozen Coag Screen N is substantially equivalent to its predicate device, HemosIL Routine Control Level 1, based on similar intended use, product matrix and stability. To our knowledge, any differences, such as product format (frozen versus lyophilized), do not affect the safety and effectiveness of the proposed device.
2
OCT 2 0 2011
510(k) Summary for VisuCon-F Frozen Coag Screen ABN (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.
1395 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: | October 11, 2011 |
| Name of the Device: | VisuCon-F Frozen Coag Screen ABN
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: | HemosIL Routine Control Level 2, K082859
Instrumentation Laboratory |
| Device Description: | The VisuCon-F Frozen Coag Screen ABN is a pool of
normal citrated human plasma collected from a minimum of
20 donors, diluted to defined concentrations, buffered with
0.02 M HEPES buffer, dispensed and rapidly frozen. |
| Device Intended Use: | The VisuCon-F Frozen Coag Screen ABN plasma is an
assayed abnormal control plasma intended for use in the
quality control of quantitative coagulation assays, including
Prothrombin Time (PT) and Activated partial
thromboplastin time (APTT), in the mid-level abnormal
range. The VisuCon-F Frozen Coag Screen ABN plasma
may be used with mechanical and photo-optical
coagulation instruments in conjunction with appropriate
commercial reagents. |
3
Comparison to Predicate Device:
A technical comparison of the proposed device and the predicate device is illustrated in the following table:
| | VisuCon-F Frozen Coag
Screen ABN
(Proposed Device) | HemosIL Routine Control
Level 2,
(Predicate Device) |
|------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended Use | For the quality control of
coagulation assays in the mid-
level abnormal range | For the quality control of
coagulation assays in the low
abnormal range |
| Analytes | Prothrombin time (PT), Activated
partial thromboplastin time
(APTT), | Prothrombin time (PT),
Activated partial thromboplastin
time (APTT) |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Lyophilized |
| Open-Vial
Stability | 8 hours at 2-8°C or on-board
coagulation instrument
(15 - 22°C) | 8 hours at 2-8°C |
Conclusion: The VisuCon-F Frozen Coag Screen ABN is substantially equivalent to the predicate device, HemosIL Routine Control Level 2, based on similar intended use, product matrix and stability. To our knowledge, any differences, such as product format (frozen versus lyophilized), do not affect the safety and effectiveness of the proposed device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Affinity Biologicals Inc. c/o Ms. Denise Foulon 1395 Sandhill Dr. Ancaster, Ontario Canada L9G 4V5
Trade/Device Name:
Re: K110432
VisuCon-F Frozen Coag Screen N VisuCon-F Frozen Coag Screen ABN
OCT 2 0 2011
Regulation Number: 21 CFR 864.5425
Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: October 11, 2011 Received: October 12, 2011
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.
If your device is classified (see above) into class II (Special Controls), 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 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); and good manufacturing practice
5
Page 2 – Ms. Denise Foulon
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Fog
Reena Philip
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications For Use Statement
510(k) Number (if known): K110432
Device Name: VisuCon-F Frozen Coag Screen N
Indications for Use:
The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen, in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Qara Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and !
510K K110432
7
Indications For Use Statement
510(k) Number (if known): K110432
Device Name: VisuCon-F Frozen Coag Screen ABN
Indications for Use:
The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rera Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110432