(180 days)
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.
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.
The provided document describes three devices: VisuCal-F Frozen Calibrator Plasma, VisuCon-F Frozen Normal Control Plasma, and VisuCon-F Frozen Abnormal Control Plasma. However, the document does not contain an acceptance criteria table or performance study results for any of these devices. Instead, it provides a comparison of the proposed devices to predicate devices to establish substantial equivalence based on similar intended use, product matrix, and performance characteristics.
Therefore, I cannot fulfill your request for an acceptance criteria table or details of a study that proves the device meets specific acceptance criteria. The document focuses on establishing substantial equivalence for regulatory purposes rather than presenting detailed performance data against predefined acceptance criteria.
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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 DriveAncaster, ONCanada, L9G 4V5Phone: 905-304-9896Fax: 905-304-9897 | OCT 2 8 2009 |
|---|---|---|
| Contact Person: | Denise Foulon, Scientific DirectorPhone: 905-304-9896Fax: 905-304-9897 | |
| Summary Prepared: | October 20, 2009 | |
| Name of the Device: | VisuCal-F Frozen Calibrator PlasmaCommon Name: Plasma Calibrator | |
| Classification of Device: | Class II21 CFR 864.5425, Multipurpose Systems for In Vitro Coagulation StudiesSubpart H, Hematology Kits and PackagesProduct Code: GGN | |
| Predicate Devices: | Cryocheck Normal Reference Plasma, K952622Precision BiologicandStandard Human Plasma, K023141Dade 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
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| VisuCal-F FrozenCalibrator Plasma(Proposed Device) | Precision BiologicCryocheck NormalReference Plasma(Predicate Device) | Dade Behring StandardHuman Plasma(Predicate Device) | |
|---|---|---|---|
| Intended Use | For use in the calibration ofcoagulation and fibrinolysisassays | For use in the in vitroquantification of hemostaticparameters in humanplasma | For the calibration ofcoagulation and fibrinolysistests |
| Analytes | Fibrinogen, Coagulationfactors II, V, VII, VIII, IX, X,XI, XII, von WillebrandFactor antigen, RistocetinCofactor, Protein S activityProtein S Total antigen,Protein C activity, Protein Cantigen, antithrombinactivity, a2-antiplasmin,plasminogen | Fibrinogen, Coagulationfactors II, V, VII, VIII, IX, X,XI, XII, von WillebrandFactor antigen, RistocetinCofactor, Protein S activity,Protein S Total antigen,Protein C activity, Protein Cantigen, antithrombinactivity, a-2-antiplasmin(also known as plasmininhibitor), plasminogen,Factor XIII, Free Protein Santigen, antithrombinantigen | Prothrombin Time (PT),Fibrinogen, Coagulationfactors II, V, VII, VIII, IX, X,XI, XII, von WillebrandFactor antigen, RistocetinCofactor, Protein S activity,Protein C activity,antithrombin activity, a2-antiplasmin, plasminogen,C-1 inhibitor, TotalComplement Activity |
| Traceabilityof CalibratorPlasma | Value assignmentstraceable to SSC/ISTHSecondary CoagulationStandard, where available,which is calibrated againstWHO InternationalStandards | Value assignmentstraceable to SSC/ISTHSecondary CoagulationStandard, where available,which is calibrated againstWHO InternationalStandards | Value assignmentstraceable to WHOInternational Standards,where available |
| Matrix | Citrated human plasma | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen | Lyophilized |
| Open-VialStability | 8 hours at 2-8°C exceptProtein S which is stablefor 4 hours at 2-8°C | 8 hours at 2-8°C | 4 hours at +15 to +25°C4 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.
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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 DriveAncaster, ONCanada, L9G 4V5Phone: 905-304-9896Fax: 905-304-9897 |
|---|---|
| Contact Person: | Denise Foulon, Scientific DirectorPhone: 905-304-9896Fax: 905-304-9897 |
| Summary Prepared: | September 9, 2009 |
| Name of the Device: | VisuCon-F Frozen Normal Control PlasmaCommon Name: Normal Control Plasma |
| Classification of Device: | Class II21 CFR 864.5425Subpart H, Hematology Kits and PackagesProduct Code: GGN |
| Predicate Device: | Reference Control Normal (Reference Check), K013708Precision Biologic |
| Device Description: | The VisuCon-F Frozen Normal Control Plasma is a pool of normalcitrated human plasma collected from a minimum of 20 donors, bufferedwith 0.02 M HEPES buffer, dispensed and rapidly frozen. |
| Device Intended Use: | The VisuCon-F Frozen Normal Control Plasma is intended for use in thequality 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 NormalControl Plasma(Proposed Device) | Precision Biologic ReferenceControl Normal(Predicate Device) | |
|---|---|---|
| Intended Use | For the quality control ofcoagulation assays in the normalrange | For controlling the accuracy ofquantitative hemostasis assays inthe normal range |
| Analytes | Fibrinogen, Coagulation factors II,V, VII,VIII, IX, X, XI, XII, Protein Sactivity, Protein C activity,antithrombin activity | Fibrinogen, Coagulation factors II,V, VII,VIII, IX, X, XI, XII, XIII, vonWillebrand Factor antigen,Ristocetin Cofactor, Prekallikrein,Protein S (activity, total antigen, |
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| free antigen), Protein C (activity, antigen), antithrombin (activity, antigen), α2-antiplasmin, plasminogen | ||
|---|---|---|
| Traceability ofCalibrator Plasma | Value assignments traceable toSSC/ISTH Secondary CoagulationStandard, where available, which iscalibrated against WHOInternational Standards | Value assignments traceable toSSC/ISTH Secondary CoagulationStandard, where available, whichis calibrated against WHOInternational 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.
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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 DriveAncaster, ONCanada, L9G 4V5Phone: 905-304-9896Fax: 905-304-9897 |
|---|---|
| Contact Person: | Denise Foulon, Scientific DirectorPhone: 905-304-9896Fax: 905-304-9897 |
| Summary Prepared: | September 9, 2009 |
| Name of the Device: | VisuCon-F Frozen Abnormal Control PlasmaCommon Name: Abnormal Control Plasma |
| Classification of Device: | Class II21 CFR 864.5425Subpart H, Hematology Kits and PackagesProduct Code: GGN |
| Predicate Device: | Cryocheck Abnormal 1 Reference Control, K952624Precision Biologic |
| Device Description: | The VisuCon-F Frozen Abnormal Control Plasma is a pool of normalcitrated human plasma collected from a minimum of 20 donors, diluted todefined concentrations, buffered with 0.02 M HEPES buffer, dispensedand rapidly frozen. |
| Device Intended Use: | The VisuCon-F Frozen Abnormal Control Plasma is intended for thequality 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 AbnormalControl Plasma(Proposed Device) | Precision Biologic Abnormal1 Reference Control(Predicate Device) | |
|---|---|---|
| Intended Use | For the quality control ofcoagulation assays in the borderlinepathological range | For controlling the accuracy ofquantitative assays in theborderline pathological range |
| Analytes | Fibrinogen, Coagulation factors II, | Fibrinogen, Coagulation factors II, |
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| 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 ofCalibrator 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.
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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
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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
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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)
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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
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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-
§ 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.