(81 days)
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
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).
Here's an analysis of the provided information regarding the acceptance criteria and study for the CRYOcheck™ Clot S™ device:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria for the new device's performance in isolation. Instead, the "performance" presented is the correlation to the predicate.
| Feature/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Correlation | Strong correlation (R-value) with the predicate device. | R = 0.880 correlation with STA® - Staclot® Protein S. |
| Intended Use | Must align with the predicate device for protein S activity. | Same intended use: quantitative determination of protein S activity in citrated human plasma. |
| Basic Principles | Must be a clot-based assay, use protein S deficient plasma, and exogenous activated protein C. | Both are clot-based, use protein S deficient plasma, and exogenous activated protein C. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 115 clinical samples.
- Data Provenance: The samples were "clinical samples from the target population for the assay." The document does not specify the country of origin, whether they were retrospective or prospective, or other explicit demographic details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "ground truth" in this context is established by the predicate device (STA® - Staclot® Protein S) rather than human experts interpreting results. The comparison is between the new device's measurements and the predicate device's measurements on the same samples.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication as the comparison was made against a predicate device's quantitative outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of how much Human Readers Improve with AI vs. without AI Assistance
Not applicable. This is a medical device for quantitative laboratory analysis, not an AI-based diagnostic tool requiring human reader interpretation in an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not explicitly stated as a "standalone" study in the AI sense, but the device performance itself, i.e., the quantitative measurement of protein S activity, is a standalone function. The "study" presented here is the comparison of this standalone function's output to that of a predicate device. The 0.880 correlation is a standalone performance metric relative to the predicate.
7. The Type of Ground Truth Used
The "ground truth" for the comparison study was the measurements obtained from the predicate device (STA® - Staclot® Protein S).
8. The Sample Size for the Training Set
Not applicable. This device is a biochemical assay, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 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: | December 22, 2004 | ||
| Device Name & Classification: | CRYOcheck™ Clot S™Common Name: Clot-based Protein S AssayClassification Name: Test, Qualitative and Quantitative Factor DeficiencyRegulatory Class II | ||
| Predicate Device: | STA® - Staclot® Protein S (K913424)Diagnostica Stago9, rue des Frères Chausson92600 ASNIERES (France) | ||
| Device Description: | CRYOcheck™ Clot S™ consists of:• Protein S Deficient Plasma - contains citrated pooled normalhuman plasma that has been depleted of protein S byimmunoadsorption, buffers and stabilizers.• Clot S Activator - contains activated protein C, Russell's vipervenom, heparin neutralizing agents, buffers and stabilizers.• Precision BioLogic Clot C & S Diluent (available separately fromPrecision BioLogic). | ||
| Device Intended Use: | CRYOcheck™ Clot S™ is a clot-based assay intended for the quantitativedetermination of protein S activity in citrated human plasma. |
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Comparison to Predicate Device:
| Parameter | CRYOcheck™ Clot S™ | STA® - Staclot® Protein S (K913424) |
|---|---|---|
| Intended Use | CRYOcheck™ Clot S™ is a clot-based assayintended for use in the quantitativedetermination of protein S activity incitrated human plasma. | The STA® – Staclot® Protein S kit is intendedfor use with analyzers of the STA® brandname, for the quantitative measurement ofthe functional protein S level based on theprinciple of factor Va inhibition. |
| Format | Frozen | Lyophilized |
| Volume | • 5 x 3.0 mL Protein S Deficient Plasma• 5 x 3.0 mL Clot S ActivatorOR• 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.
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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 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.
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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
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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
§ 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).