CryoCheck Clot C consists of: Protein C Deficient Plasma - contains citrated pooled normal human plasma that has been depleted of protein C by immunoadsorption. Clot C Activator - Contains protein isolated from the venom of Agkistrodon contortrix capable of activating protein C in human plasma, Russell's viper venom, phospholipids, heparin neutralizing agents, buffers and stabilizers. CS Diluent (provided separately by Precision BioLogic).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CryoCheck Clot C device, extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Quantitative determination of protein C activity in citrated human plasma.	CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma. (Matches predicate)
Correlation with Predicate Device	Substantial equivalence demonstrated by a strong correlation (R value).	R = 0.9142 when compared to STA - Staclot Protein C.
Assay Format	Not explicitly stated as a numerical criterion, but expected to be effective.	Frozen
Volume	Not explicitly stated as a numerical criterion.	• 5 x 3.0 mL Protein C Deficient Plasma• 5 x 3.0 mL Clot C ActivatorOR• 5 x 1.0 mL Protein C Deficient Plasma• 5 x 1.0 mL Clot C Activator

Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria with numerical performance thresholds. The "acceptance criteria" are therefore inferred from the comparison study's objective to show equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 119 clinical samples.
Data Provenance: The document states "clinical samples," implying human patient samples, but does not specify the country of origin or whether they were retrospective (previously collected) or prospective (collected specifically for the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish ground truth for the test set. The comparison is made against a predicate device, implying the predicate device's results serve as the reference or "ground truth" for correlation.

4. Adjudication Method for the Test Set:

Not applicable. The study is a direct comparison to a predicate device, not an expert-driven adjudication process.

5. 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 clot-based assay (an in-vitro diagnostic test measuring a protein in plasma), not an AI-powered imaging or diagnostic tool requiring human reader interpretation. Therefore, an MRMC study or AI assistance is not relevant to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is an assay performed in a laboratory, not an algorithm. The "standalone" performance is effectively the performance of the assay itself as described in the correlation study.

7. The Type of Ground Truth Used:

The ground truth for the comparison study was the results obtained from the STA - Staclot Protein C (K861079) predicate device. The study correlated the CryoCheck Clot C results with those of the predicate device using clinical samples.

8. The Sample Size for the Training Set:

Not applicable. This is an in-vitro diagnostic assay, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Summary

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SECTION 6

510(K) Summary CryoCheck Clot C

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.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Submitters Name & Address:	Precision BioLogic Inc.900 Windmill Road, Suite 100Dartmouth, Nova Scotia B3B 1P7Canada
Contact Name:	Stephen L. Duff - Director of New Business DevelopmentPhone: 902-468-6422 ext. 224Fax: 902-468-6421Email: sduff@precisionbiologic.com
Preparation Date:	April 13, 2004
Device Name & Classification:	CryoCheck Clot CTMCommon Name: Clot-based Protein C AssayClassification Name: Test, Qualitative and Quantitative Factor DeficiencyRegulatory Class II
Predicate Device:	STA - Staclot Protein C (K861079)Diagnostica Stago9, rue des Frères Chausson92600 ASNIERES-SUR-SEINE (France)
Device Description:	CryoCheck Clot C consists of:Protein C Deficient Plasma - contains citrated pooled normal human plasma that has been depleted of protein C by immunoadsorption. Clot C Activator - Contains protein isolated from the venom of Agkistrodon contortrix capable of activating protein C in human plasma, Russell's viper venom, phospholipids, heparin neutralizing agents, buffers and stabilizers. CS Diluent (provided separately by Precision BioLogic).
Device Intended Use:	CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma.

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Comparison to Predicate Device:

Parameter	CryoCheck Clot C	STA - Staclot Protein C (K861079)
Intended Use	CryoCheck Clot C is a clot-based assayintended for use in the quantitativedetermination of protein C activity incitrated human plasma.	The STA - Staclot Protein C kit is intended foruse with analyzers of the STA brand name, foquantitative measurement of the functionalprotein C level based on the prolongation ofthe activated partial thromboplastin time(APTT).
Format	Frozen	Lyophilized
Volume	• 5 x 3.0 mL Protein C Deficient Plasma• 5 x 3.0 mL Clot C ActivatorOR• 5 x 1.0 mL Protein C Deficient Plasma• 5 x 1.0 mL Clot C Activator	• 3 x 1mL vials of Reagent 1(Protein C Deficient Plasma)• 3 x 1mL vials of Reagent 2(PC-Activator).

Correlation with Predicate Device:

CryoCheck Clot C was compared to STA - Staclot Protein C using 119 clinical samples from the target population for the assay. A correlation of R = 0.9142 was obtained.

Comments on Substantial Equivalence:

It is the opinion of Precision BioLogic Inc. that CryoCheck Clot C is substantially equivalent to STA - Staclot Protein C, manufactured by Diagnostica Stago (France), and currently marketed in the United States by Diagnostica Stago Inc. This opinion is based on the following:

Both products are clot-based assays. .
Both products are intended for use in the quantitative measurement of functional Protein C in . citrated human plasma.
Both products use an extract from the venom of Agkistrodon contortrix (Protac®) to activate Protein . C in test samples.
Both products provide all coagulation factors in excess by the use of protein C deficient plasma. .

Conclusion:

CryoCheck Clot C is substantially equivalent to STA - Staclot Protein C.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen L. Duff Director of New Business Development Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth, Nova Scotia Canada B3B 1P7

JUN 1 8 2004

K040987 Re: Trade/Device Name: CryoCheck Clot C Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency test Regulatory Class: II

Product Code: GGP Dated: April 13, 2004 Received: April 15, 2004

Dear Mr. Duff:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to that 2011 2011 31 de rices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ateres, since of the Act include requirements for annual registration, listing of general volta on anufacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it It your device 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 r reaso oe acrised a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I 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); and good manufacturing practice Of it Part 807), accember (QS) regulation (21 CFR Part 820). This letter requirences as beegin marketing your device as described in your Section 510(k) premarket motification. The FDA finding of substantial equivalence of your device to a legally marketed nonticate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2

If you desire specific information about the application of labeling requirements to your device, of In If you desire specific information access the appear device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the VITO Dagnostic Dorto Development by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misoranaming of Pricen on your responsibilities under the Act from the You may online of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. 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

510(k) Number (if known): K040987

Device Name: CryoCheck Clot C

Indications For Use:

CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma.

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, Qffice of In Yitro Diagnostic Devices (OIVD)

Stephine Bautter
Division Sign-Off

Division Sign/Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

10(k) K 04098

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).