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.

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.

AI/ML Overview

The provided text describes two devices, VisuCon-F Frozen Coag Screen N (Normal) and VisuCon-F Frozen Coag Screen ABN (Abnormal), and their substantial equivalence to predicate devices, not a study performing a traditional acceptance criteria evaluation with a test set of data. The document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with a specific set of acceptance criteria and associated results.

Therefore, many of the requested sections (sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth) are not applicable to this type of submission.

However, I can extract the "acceptance criteria" in the context of what the device is intended to do and how it compares to its predicate, which serves as the "study" for its claims of substantial equivalence.

Here's the breakdown based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device, as the submission aims to demonstrate substantial equivalence. The "reported device performance" is the device's ability to meet these very similar characteristics.

VisuCon-F Frozen Coag Screen N (Normal Control Plasma)

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (VisuCon-F Frozen Coag Screen N)
Intended Use: Quality control of coagulation assays in the normal range.	Intended Use: Quality control of quantitative coagulation assays, including PT, APTT, and fibrinogen, in the normal range.
Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT), Fibrinogen.	Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT), Fibrinogen.
Matrix: Citrated human plasma.	Matrix: Citrated human plasma.
Open-Vial Stability: 8 hours at 2-8°C.	Open-Vial Stability: 8 hours at 2-8°C or on-board coagulation instrument (15-22°C).
Format: (Predicate is Lyophilized)	Format: Frozen.

VisuCon-F Frozen Coag Screen ABN (Abnormal Control Plasma)

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (VisuCon-F Frozen Coag Screen ABN)
Intended Use: Quality control of coagulation assays in the low abnormal range.	Intended Use: Quality control of quantitative coagulation assays, including PT and APTT, in the mid-level abnormal range.
Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT).	Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT).
Matrix: Citrated human plasma.	Matrix: Citrated human plasma.
Open-Vial Stability: 8 hours at 2-8°C.	Open-Vial Stability: 8 hours at 2-8°C or on-board coagulation instrument (15-22°C).
Format: (Predicate is Lyophilized)	Format: Frozen.

Study Details (As applicable to a 510(k) Substantial Equivalence Submission)

Sample size used for the test set and the data provenance:
- Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a performance study with a specific test set of cases or data. The device itself is a control plasma used in studies, not a diagnostic device being evaluated on patient samples. The device description mentions that the plasmas are collected from a minimum of 20 donors, but this is for the composition of the device, not a test set for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "test set" in the context of diagnostic performance evaluation requiring expert ground truth in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set requiring adjudication is described or performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a quality control plasma for coagulation assays, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a quality control reagent, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for these control plasmas is established by their formulation (e.g., normal vs. abnormal range, specific analytes) and performance against recognized reference methods during their manufacturing and validation. The 510(k) focuses on demonstrating that these formulations and expected performance are substantially equivalent to existing, legally marketed controls.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set.

Summary

{0}------------------------------------------------

OCT 20 **

K110432

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 DriveAncaster, ONCanada, L9G 4V5Phone: 905-304-9896Fax: 905-304-9897
Contact Person:	Denise Foulon, Scientific DirectorPhone: 905-304-9896Fax: 905-304-9897
Summary Prepared:	October 11, 2011
Name of the Device:	VisuCon-F Frozen Coag Screen NCommon Name: Normal Control Plasma
Classification of Device:	Class II21 CFR 864.5425Subpart H, Hematology Kits and PackagesProduct Code: GGN
Predicate Device:	HemosIL Routine Control Level 1, K082859Instrumentation Laboratory
Device Description:	The VisuCon-F Frozen Coag Screen N is a pool of normalcitrated human plasma collected from a minimum of 20donors, buffered with 0.02 M HEPES buffer, dispensed andrapidly frozen.
Device Intended Use:	The VisuCon-F Frozen Coag Screen N plasma is anassayed normal control plasma intended for use in thequality control of quantitative coagulation assays, includingProthrombin Time (PT), Activated partial thromboplastintime (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 CoagScreen N(Proposed Device)	HemosIL Routine ControlLevel 1,(Predicate Device)
Intended Use	For the quality control ofcoagulation assays in thenormal range	For the quality control ofcoagulation assays in thenormal range
Analytes	Prothrombin time (PT), Activatedpartial thromboplastin time(APTT), Fibrinogen	Prothrombin time (PT),Activated partial thromboplastintime (APTT), Fibrinogen
Matrix	Citrated human plasma	Citrated human plasma
Format	Frozen	Lyophilized
Open-VialStability	8 hours at 2-8°C or on-boardcoagulation 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

K110432

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 DriveAncaster, ONCanada, L9G 4V5Phone: 905-304-9896Fax: 905-304-9897
Contact Person:	Denise Foulon, Scientific DirectorPhone: 905-304-9896Fax: 905-304-9897
Summary Prepared:	October 11, 2011
Name of the Device:	VisuCon-F Frozen Coag Screen ABNCommon Name: Abnormal Control Plasma
Classification of Device:	Class II21 CFR 864.5425Subpart H, Hematology Kits and PackagesProduct Code: GGN
Predicate Device:	HemosIL Routine Control Level 2, K082859Instrumentation Laboratory
Device Description:	The VisuCon-F Frozen Coag Screen ABN is a pool ofnormal citrated human plasma collected from a minimum of20 donors, diluted to defined concentrations, buffered with0.02 M HEPES buffer, dispensed and rapidly frozen.
Device Intended Use:	The VisuCon-F Frozen Coag Screen ABN plasma is anassayed abnormal control plasma intended for use in thequality control of quantitative coagulation assays, includingProthrombin Time (PT) and Activated partialthromboplastin time (APTT), in the mid-level abnormalrange. The VisuCon-F Frozen Coag Screen ABN plasmamay be used with mechanical and photo-opticalcoagulation instruments in conjunction with appropriatecommercial 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 CoagScreen ABN(Proposed Device)	HemosIL Routine ControlLevel 2,(Predicate Device)
Intended Use	For the quality control ofcoagulation assays in the mid-level abnormal range	For the quality control ofcoagulation assays in the lowabnormal range
Analytes	Prothrombin time (PT), Activatedpartial thromboplastin time(APTT),	Prothrombin time (PT),Activated partial thromboplastintime (APTT)
Matrix	Citrated human plasma	Citrated human plasma
Format	Frozen	Lyophilized
Open-VialStability	8 hours at 2-8°C or on-boardcoagulation 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:

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:

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

Regulation Number and Section

§ 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.