(81 days)
Not Found
No
The device description and performance studies focus on a clot-based assay using biological reagents and standard laboratory procedures, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for the quantitative determination of protein S activity, which helps diagnose protein S deficiency. It is not used for treating or modifying a disease state.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "cryocheck™ Clot S™ is used to diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism." This directly indicates a diagnostic purpose.
No
The device description clearly lists physical components (Protein S Deficient Plasma, Clot S Activator, Diluent) which are reagents used in a laboratory assay, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is a "clot-based assay intended for the quantitative determination of protein S activity in citrated human plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body).
- Purpose: The purpose is to "diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism." This diagnostic purpose is a key characteristic of IVDs.
- Device Description: The device consists of reagents (Protein S Deficient Plasma, Clot S Activator, Diluent) that are used to perform a test on a biological sample.
- Performance Studies: The performance studies involve testing "clinical samples from the target population for the assay," further indicating its use in a clinical diagnostic setting.
- Predicate Device: The mention of a "Predicate Device" (STA® - Staclot® Protein S) which is also an IVD, strongly suggests that cryocheck™ Clot S™ falls under the same regulatory category.
All of these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
CRYOcheck™ Clot S™ is a clot-based assay intended for the quantitative determination of protein S activity in citrated human plasma.
cryocheck™ Clot S™ is used to diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism. A deficiency in protein S may produce recurrent thrombotic episodes.
Congenital deficiencies of protein S are classified as three types:
- type I deficiencies correspond to reduced antigen levels of both total and free protein S .
- type II deficiencies are characterized by a reduced protein S activity but with normal . antigen levels of both total and free protein S
- type III deficiencies are defined by a reduced antigen level and activity of free protein S . but the antigen level of total protein S remains normal
Acquired protein S deficiencies are associated with several clinical states:
- oral anticoagulant therapy
- liver disease .
- disseminated intravascular coagulation .
- . oral contraceptives
- oestrogen therapy .
- acute phase inflammatory responses .
- pregnancy .
- newborns
Product codes (comma separated list FDA assigned to the subject device)
GGP
Device Description
CRYOcheck™ Clot S™ consists of:
• Protein S Deficient Plasma - contains citrated pooled normal human plasma that has been depleted of protein S by immunoadsorption, buffers and stabilizers.
• Clot S Activator - contains activated protein C, Russell's viper venom, heparin neutralizing agents, buffers and stabilizers.
• Precision BioLogic Clot C & S Diluent (available separately from Precision BioLogic).
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
Prescription Use
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)
cryocheck™ Clot S™ was compared to STA® - Staclot® Protein S using 115 clinical samples from the target population for the assay. A correlation of R = 0.880 was obtained.
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.
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
§ 864.7290 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).
0
MAR 1 8 2005
SECTION 6
510(K) Summary cryocheck™ Clot s™
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: _K04367 _______________________________________________________________________________________________________________________________________
| Submitters Name & Address: | Precision BioLogic Inc.
900 Windmill Road, Suite 100
Dartmouth, Nova Scotia B3B 1P7
Canada | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Name: | Stephen L. Duff - Director of New Business Development
Phone: 902-468-6422 ext. 224
Fax: 902-468-6421
Email: sduff@precisionbiologic.com | | |
| Preparation Date: | December 22, 2004 | | |
| Device Name & Classification: | CRYOcheck™ Clot S™
Common Name: Clot-based Protein S Assay
Classification Name: Test, Qualitative and Quantitative Factor Deficiency
Regulatory Class II | | |
| Predicate Device: | STA® - Staclot® Protein S (K913424)
Diagnostica Stago
9, rue des Frères Chausson
92600 ASNIERES (France) | | |
| Device Description: | CRYOcheck™ Clot S™ consists of:
• Protein S Deficient Plasma - contains citrated pooled normal
human plasma that has been depleted of protein S by
immunoadsorption, buffers and stabilizers.
• Clot S Activator - contains activated protein C, Russell's viper
venom, heparin neutralizing agents, buffers and stabilizers.
• Precision BioLogic Clot C & S Diluent (available separately from
Precision BioLogic). | | |
| Device Intended Use: | CRYOcheck™ Clot S™ is a clot-based assay intended for the quantitative
determination of protein S activity in citrated human plasma. | | |
1
Comparison to Predicate Device:
| Parameter | CRYOcheck™ Clot S™ | STA® - Staclot® Protein S (K913424) |
|---|---|---|
| Intended Use | CRYOcheck™ Clot S™ is a clot-based assay | |
| intended for use in the quantitative | ||
| determination of protein S activity in | ||
| citrated human plasma. | The STA® – Staclot® Protein S kit is intended | |
| for use with analyzers of the STA® brand | ||
| name, for the quantitative measurement of | ||
| the functional protein S level based on the | ||
| principle of factor Va inhibition. | ||
| Format | Frozen | Lyophilized |
| Volume | • 5 x 3.0 mL Protein S Deficient Plasma | |
| • 5 x 3.0 mL Clot S Activator | ||
| OR | ||
| • 5 x 1.5 mL Protein S Deficient Plasma | ||
| • 5 x 1.5 mL Clot S Activator | • 2 x 1 mL vials of Reagent 1 | |
| (Protein S Deficient Plasma) | ||
| • 2 x 1 mL vials of Reagent 2 | ||
| (Human Activated Protein C) | ||
| • 2 x 1 mL vials of Reagent 3 | ||
| (Preparation Containing Bovine Factor Va) |
Correlation with Predicate Device:
cryocheck™ Clot S™ was compared to STA® - Staclot® Protein S using 115 clinical samples from the target population for the assay. A correlation of R = 0.880 was obtained.
Comments on Substantial Equivalence:
It is the opinion of Precision BioLogic Inc. that CRYOcheck™ Clot S™ is substantially equivalent to STA® -Staclot® Protein S, 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 S in . citrated human plasma.
- Both products provide all coagulation factors in excess by the use of protein S deficient plasma. .
- Both products use exogenous activated protein C. .
Conclusion:
CRYOcheck™ Clot S™ is substantially equivalent to STA® - Staclot® Protein S.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
MAR 1 8 2005
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
K043571 Re:
Trade/Device Name: CryoCheck™ Clot STM Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency test Regulatory Class: II Product Code: GGP Dated: February 14, 2005 Received: February 15, 2005
Dear Mr. Duff:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected. B ready personally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to connine.co proc to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, de rices that 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, mereleve, missus of the Act include requirements for annual registration, listing of general oontrold provision 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 rr 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 hat 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 or any I edetar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 8077, last forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as begin marketing your device as described in your Section 510(k) premarket with and in to 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.
3
Page 2 -
If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Vido Diagnostic Dortes Lranding by reference to premarket notification" (21CFR Part 807.97). regulation chitted, "Misoranaing of responsibilities under the Act from the Tou inay 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/industry/support/index.html
Sincerely yours,
lobatz Beckeyh
Robert L. Becker, Jr., MD, PJ.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
SECTION 5
Indications for Use
510(k) Number: K043571
cryocheck™ Clot S™ Device Name:
Indications for Use:
cryocheck™ Clot S™ is a clot-based assay intended for the quantitative determination of protein S activity in citrated human plasma.
cryocheck™ Clot S™ is used to diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism. A deficiency in protein S may produce recurrent thrombotic episodes.
Congenital deficiencies of protein S are classified as three types:
- type I deficiencies correspond to reduced antigen levels of both total and free protein S .
- type II deficiencies are characterized by a reduced protein S activity but with normal . antigen levels of both total and free protein S
- type III deficiencies are defined by a reduced antigen level and activity of free protein S . but the antigen level of total protein S remains normal
Acquired protein S deficiencies are associated with several clinical states:
- oral anticoagulant therapy ●
- liver disease .
- disseminated intravascular coagulation .
- . oral contraceptives
- oestrogen therapy .
- acute phase inflammatory responses .
- pregnancy .
- newborns
| 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)
| Division Sign-Off | |
|---|---|
| ------------------- | -- |
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ffice of In Vitro Diagnostic Device Evaluation and Sa
510(k) K043571