CRYOCHECK CLOT C

K040987 · Precision Biologic, Inc. · GGP · Jun 18, 2004 · Hematology

Device Facts

• Record ID: K040987
• Device Name: CRYOCHECK CLOT C
• Applicant: Precision Biologic, Inc.
• Product Code: GGP · Hematology
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

The Precision Biologic Cro Check C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma.

Device Story

CryoCheck Clot C is a clot-based in vitro diagnostic assay used to measure functional protein C activity in citrated human plasma. The device utilizes protein C deficient plasma and a Clot C Activator containing Agkistrodon contortrix venom (which activates protein C), Russell's viper venom, phospholipids, and heparin neutralizing agents. The assay is performed in a clinical laboratory setting. The activator initiates the coagulation process in the patient sample; the resulting clotting time is measured to determine protein C activity levels. Healthcare providers use these quantitative results to assess protein C deficiency, aiding in the diagnosis and management of coagulation disorders. The device is provided in a frozen format.

Clinical Evidence

Clinical performance was evaluated by comparing CryoCheck Clot C to the predicate device (STA - Staclot Protein C) using 119 clinical samples. The study demonstrated a correlation coefficient of R = 0.9142.

Technological Characteristics

Clot-based coagulation assay. Reagents include protein C deficient plasma and Agkistrodon contortrix venom-based activator. Frozen format. Quantitative measurement principle based on clotting time prolongation. No electronic or software components; manual or automated coagulation analyzer-based testing.

Indications for Use

Indicated for the quantitative determination of protein C activity in citrated human plasma for patients requiring assessment of protein C levels.

Predicate Devices

• STA - Staclot Protein C (K861079)

Submission Summary (Full Text)

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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.<br>900 Windmill Road, Suite 100<br>Dartmouth, Nova Scotia B3B 1P7<br>Canada |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Stephen L. Duff - Director of New Business Development<br>Phone: [phone] ext. 224<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | April 13, 2004 |
| Device Name & Classification: | CryoCheck Clot CTM<br>Common Name: Clot-based Protein C Assay<br>Classification Name: Test, Qualitative and Quantitative Factor Deficiency<br>Regulatory Class II |
| Predicate Device: | STA - Staclot Protein C (K861079)<br>Diagnostica Stago<br>9, rue des Frères Chausson<br>92600 ASNIERES-SUR-SEINE (France) |
| Device Description: | CryoCheck Clot C consists of:<br>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 assay<br>intended for use in the quantitative<br>determination of protein C activity in<br>citrated human plasma. | The STA - Staclot Protein C kit is intended for<br>use with analyzers of the STA brand name, fo<br>quantitative measurement of the functional<br>protein C level based on the prolongation of<br>the activated partial thromboplastin time<br>(APTT). |
| Format | Frozen | Lyophilized |
| Volume | • 5 x 3.0 mL Protein C Deficient Plasma<br>• 5 x 3.0 mL Clot C Activator<br>OR<br>• 5 x 1.0 mL Protein C Deficient Plasma<br>• 5 x 1.0 mL Clot C Activator | • 3 x 1mL vials of Reagent 1<br>(Protein C Deficient Plasma)<br>• 3 x 1mL vials of Reagent 2<br>(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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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 [phone]. 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 [phone] or [phone] 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

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10(k) K 04098