(180 days)
Not Found
No
The device description and intended use clearly define the product as frozen plasma calibrators and controls for coagulation assays. There is no mention of any computational or analytical components that would suggest the use of AI or ML.
No
The device is described as a calibrator and control plasma for in vitro diagnostic assays, not a device used to treat or cure a disease.
No
This device is described as a calibrator and control plasma for laboratory assays, used in the calibration and quality control of coagulation and fibrinolysis assays. It is not used for diagnosing patients directly.
No
The device description clearly states that the device is a frozen plasma product, which is a biological material, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the products are intended for use in the calibration and quality control of coagulation and fibrinolysis assays. These assays are performed in vitro (outside the body) on biological samples (plasma) to obtain information about a patient's health.
- Device Description: The description details the composition of the products as plasma, which is a biological sample used in in vitro testing.
- Predicate Devices: The listed predicate devices (K952622, K023141, K013708, K952624) are all known IVD products used for similar purposes (calibration and control of coagulation assays).
The core function of these products is to provide known standards and controls for in vitro diagnostic tests, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The VisuCal-F Frozen Calibrator Plasma is intended for use in the calibration of coagulation and fibrinolysis assays.
The VisuCon-F Frozen Normal Control Plasma is intended for use in the quality control of coagulation assays in the normal range.
The VisuCon-F Frozen Abnormal Control Plasma is intended for the quality control of coagulation assays in the borderline pathological range.
The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coaqulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coaqulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor.
The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
Product codes (comma separated list FDA assigned to the subject device)
GGN, JIX
Device Description
The VisuCal-F Frozen Calibrator Plasma 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 Normal Control Plasma 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 Abnormal Control Plasma 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.
Cryocheck Normal Reference Plasma, K952622, Standard Human Plasma, K023141
Reference Control Normal (Reference Check), K013708
Cryocheck Abnormal 1 Reference Control, K952624
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
K09128y
510(k) Summary for VisuCal-F Frozen Calibrator 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.
1395 Sandhill Drive
Ancaster, ON
Canada, L9G 4V5
Phone: 905-304-9896
Fax: 905-304-9897 | OCT 2 8 2009 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Denise Foulon, Scientific Director
Phone: 905-304-9896
Fax: 905-304-9897 | |
| Summary Prepared: | October 20, 2009 | |
| Name of the Device: | VisuCal-F Frozen Calibrator Plasma
Common Name: Plasma Calibrator | |
| Classification of Device: | Class II
21 CFR 864.5425, Multipurpose Systems for In Vitro Coagulation Studies
Subpart H, Hematology Kits and Packages
Product Code: GGN | |
| Predicate Devices: | Cryocheck Normal Reference Plasma, K952622
Precision Biologic
and
Standard Human Plasma, K023141
Dade Behring Inc. | |
| Device Description: | The VisuCal-F Frozen Calibrator Plasma 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 VisuCal-F Frozen Calibrator Plasma is intended for use in the calibration of coagulation and fibrinolysis assays. | |
Comparison to Predicate Device:
A technical comparison of the proposed device and the predicate devices is illustrated in the following table:
ら hogil links and the state of the state of
1
| | VisuCal-F Frozen
Calibrator Plasma
(Proposed Device) | Precision Biologic
Cryocheck Normal
Reference Plasma
(Predicate Device) | Dade Behring Standard
Human Plasma
(Predicate Device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the calibration of
coagulation and fibrinolysis
assays | For use in the in vitro
quantification of hemostatic
parameters in human
plasma | For the calibration of
coagulation and fibrinolysis
tests |
| Analytes | Fibrinogen, Coagulation
factors II, V, VII, VIII, IX, X,
XI, XII, von Willebrand
Factor antigen, Ristocetin
Cofactor, Protein S activity
Protein S Total antigen,
Protein C activity, Protein C
antigen, antithrombin
activity, a2-antiplasmin,
plasminogen | Fibrinogen, Coagulation
factors II, V, VII, VIII, IX, X,
XI, XII, von Willebrand
Factor antigen, Ristocetin
Cofactor, Protein S activity,
Protein S Total antigen,
Protein C activity, Protein C
antigen, antithrombin
activity, a-2-antiplasmin
(also known as plasmin
inhibitor), plasminogen,
Factor XIII, Free Protein S
antigen, antithrombin
antigen | Prothrombin Time (PT),
Fibrinogen, Coagulation
factors II, V, VII, VIII, IX, X,
XI, XII, von Willebrand
Factor antigen, Ristocetin
Cofactor, Protein S activity,
Protein C activity,
antithrombin activity, a2-
antiplasmin, plasminogen,
C-1 inhibitor, Total
Complement Activity |
| Traceability
of Calibrator
Plasma | Value assignments
traceable to SSC/ISTH
Secondary Coagulation
Standard, where available,
which is calibrated against
WHO International
Standards | Value assignments
traceable to SSC/ISTH
Secondary Coagulation
Standard, where available,
which is calibrated against
WHO International
Standards | Value assignments
traceable to WHO
International Standards,
where available |
| Matrix | Citrated human plasma | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen | Lyophilized |
| Open-Vial
Stability | 8 hours at 2-8°C except
Protein S which is stable
for 4 hours at 2-8°C | 8 hours at 2-8°C | 4 hours at +15 to +25°C
4 weeks at -20°C |
Conclusion: The VisuCal-F Frozen Calibrator Plasma is substantially equivalent to the Precision Biologic Cryocheck Normal Reference Plasma and Dade Behring Standard Human Plasma based on similar intended use, product matrix and performance. To our knowledge, any differences, including analytes tested in the predicate devices but not in the proposed device, do not affect the safety and effectiveness of the proposed device.
:・・・
・・・・
.
..
2
510(k) Summary for VisuCon-F Frozen Normal 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.
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: | September 9, 2009 |
| Name of the Device: | VisuCon-F Frozen Normal Control Plasma
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: | Reference Control Normal (Reference Check), K013708
Precision Biologic |
| Device Description: | The VisuCon-F Frozen Normal Control Plasma 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 Normal Control Plasma is intended for use in the
quality control of coagulation assays in the normal range. |
Comparison to Predicate Device:
A technical comparison of the proposed device and the predicate device is illustrated in the following table:
| | VisuCon-F Frozen Normal
Control Plasma
(Proposed Device) | Precision Biologic Reference
Control Normal
(Predicate Device) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quality control of
coagulation assays in the normal
range | For controlling the accuracy of
quantitative hemostasis assays in
the normal range |
| Analytes | Fibrinogen, Coagulation factors II,
V, VII,VIII, IX, X, XI, XII, Protein S
activity, Protein C activity,
antithrombin activity | Fibrinogen, Coagulation factors II,
V, VII,VIII, IX, X, XI, XII, XIII, von
Willebrand Factor antigen,
Ristocetin Cofactor, Prekallikrein,
Protein S (activity, total antigen, |
3
| free antigen), Protein C (activity, antigen), antithrombin (activity, antigen), α2-antiplasmin, plasminogen | ||
|---|---|---|
| Traceability of | ||
| Calibrator Plasma | Value assignments traceable to | |
| SSC/ISTH Secondary Coagulation | ||
| Standard, where available, which is | ||
| calibrated against WHO | ||
| International Standards | Value assignments traceable to | |
| SSC/ISTH Secondary Coagulation | ||
| Standard, where available, which | ||
| is calibrated against WHO | ||
| International Standards | ||
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen |
| Open-Vial Stability | 8 hours at 2-8°C | 8 hours at 2-8°C |
Conclusion: The VisuCon-F Frozen Normal Control Plasma is substantially equivalent to its predicate device, Precision Biologic Reference Control Normal, based on similar intended use, product matrix and performance. To our knowledge, any differences, such as analytes tested, do not affect the safety and effectiveness of the proposed device.
4
510(k) Summary for VisuCon-F Frozen Abnormal 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.
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: | September 9, 2009 |
| Name of the Device: | VisuCon-F Frozen Abnormal 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 Abnormal 1 Reference Control, K952624
Precision Biologic |
| Device Description: | The VisuCon-F Frozen Abnormal Control Plasma 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 Abnormal Control Plasma is intended for the
quality control of coagulation assays in the borderline pathological range. |
Comparison to Predicate Device:
A technical comparison of the proposed device and the predicate device is illustrated in the following table:
| | VisuCon-F Frozen Abnormal
Control Plasma
(Proposed Device) | Precision Biologic Abnormal
1 Reference Control
(Predicate Device) |
|--------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | For the quality control of
coagulation assays in the borderline
pathological range | For controlling the accuracy of
quantitative assays in the
borderline pathological range |
| Analytes | Fibrinogen, Coagulation factors II, | Fibrinogen, Coagulation factors II, |
5
| V, VII, VIII, IX, X, XI, XII, Protein S activity, Protein C activity, antithrombin activity | V, VII, VIII, IX, X, XI, XII, XIII, von Willebrand Factor antigen, Ristocetin Cofactor, Prekallikrein, Protein S (activity, total antigen, free antigen), Protein C (activity, antigen), antithrombin (activity, antigen), α2-antiplasmin, plasminogen | |
|---|---|---|
| Traceability of | ||
| Calibrator Plasma | Value assignments traceable to SSC/ISTH Secondary Coagulation Standard, where available, which is calibrated against WHO International Standards | Value assignments traceable to SSC/ISTH Secondary Coagulation Standard, where available, which is calibrated against WHO International Standards |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen |
| Open-Vial Stability | 8 hours at 2-8°C | 8 hours at 2-8°C |
Conclusion: The VisuCon-F Frozen Abnormal Control Plasma is substantially equivalent to the predicate device, Precision Biologic Cryocheck Abnormal 1 Reference Control, based on similar intended use, product matrix and performance. To our knowledge, any differences, such as analytes tested, do not affect the safety and effectiveness of the proposed devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Affinity Biologicals Inc. Ms. Denise Foulon Scientific Director 1395 Sandhill Drive Ancaster, ON Canada, L9G 4V5
OCT 2 8 2009
Re: K091284
Trade/Device Name: VisuCal-F frozen calibrator, VisuCon-F frozen normal control and VisuCon-F frozen abnormal control plasmas Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose systems for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN, JIX Dated: September 9, 2009 Received: September 10, 2009
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 either class II (Special Controls) or class III (PMA), 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
7
Page 2 - Ms. Denise Foulon
medical device-related adverse events) (21 CFR 803); and good manufacturing practice 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/RcportaProblem/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 yours.
im Chan
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
8
Indications For Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VisuCal-F Frozen Calibrator Plasma
Indications for Use:
The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coaqulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coaqulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor.
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)
Division Sign-Off
ce of In Vitro Diagnostic Device Evaluation and Safety
091284
510(k)
9
Indications For Use Statement
510(k) Number (if known): K091284
Device Name: VisuCon-F Frozen Abnormal Control Plasma
Indications for Use:
The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
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)
Division Sign-Off
Office of In Vitro Diagne Device Evaluation and Safety
510(k) 091284
10
Indications For Use Statement
510(k) Number (if known): K091284
Device Name: VisuCon-F Frozen Normal Control Plasma
Indications for Use:
The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
Prescription Use イ (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)
Division Sign-Off
se of In Vitro Diagne Evaluation and
510(k) 09/284-