(96 days)
Not Found
No
The summary describes a chemical reagent-based clotting assay and does not mention any AI or ML components.
No
This device is a diagnostic assay intended to screen for a genetic mutation, not to treat a condition.
Yes
The device is a clotting assay intended to screen for resistance to activated protein C in human plasma, which is a diagnostic purpose to identify individuals with the factor V Leiden mutation.
No
The device description explicitly lists physical reagents (Activator Reagent and Russell's Viper Venom Reagent) as components of the device, indicating it is a chemical assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "clotting assay intended to screen for resistance to activated protein C in citrated human plasma". This involves testing a sample taken from the human body (in vitro) to provide information about a medical condition (resistance to activated protein C).
- Device Description: The description lists reagents used to perform the assay on the plasma sample.
- Performance Studies: The document describes clinical tests performed on "clinical samples from the target population for the assay," further indicating it's used for diagnostic purposes.
- Predicate Device: The mention of a predicate device (GradiLeiden V) with a K number (K992456) strongly suggests this device is undergoing regulatory review as an IVD.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CRYOCheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in plasma from individuals with the factor VLeiden mutation.
Product codes (comma separated list FDA assigned to the subject device)
GGW
Device Description
cryocheck Clot APCR consists of:
- 5 x 2.0 mL Activator Reagent (APC-AR) .
- 5 x 4.0 mL Russell's Viper Venom Reagent (APC-RV)
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
Not Found
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)
Non-clinical tests were performed in-house to determine precision, interferences, and stability. cryocheck Clot APCR showed comparable precision to that of the predicate, GradiLeiden V. Both devices demonstrated identical results when challenged with interfering substances and factor deficiencies. Storage stability is reflected in product labeling.
Clinical tests were performed at Precision BioLogic and a US university hospital-based clinical coagulation laboratory. cRYocheck Clot APCR and the predicate device exhibited identical sensitivity and specificity.
cryocheck Clot APCR was compared to GradiLeiden V using 207 clinical samples from the target population for the assay. A correlation of R = 0.960 was obtained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Identical sensitivity and specificity (compared to predicate).
Correlation of R = 0.960.
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
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
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510(K) Summary cryocheck™ Clot APCR™
MAY 10 2006
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: HOLO2 8
Part A
-
- Submitter's name, address, telephone, contact person, and the date the summary was prepared
| Submitter's Name: | Precision BioLogic Inc. |
|---|---|
| Submitter's Address: | 900 Windmill Road, Suite 100 |
| Dartmouth, Nova Scotia B3B 1P7 | |
| Canada | |
| Submitter's Telephone Number: | 902-468-6422 |
| Submitter's Contact Name: | Stephen L. Duff - Director of New Business Development |
| Phone: 902-468-6422 ext. 224 | |
| Fax: 902-468-6421 | |
| Email: sduff@precisionbiologic.com | |
| Date of 510(k) Preparation: | February 2, 2006 |
-
- Name of the device, including the trade or proprietary name, the common or usual name and the classification name
| Device Name & Classification: | CRYOcheck Clot APCR |
|---|---|
| Common Name: | Activated Protein C Resistance (APCR) Screening Assay |
| Classification Name: | Hematology; Test, Time, Partial Thromboplastin |
| Regulatory Class II |
-
- Identification of the legally marketed device to which the submitter claims substantial equivalence
| Predicate Device Name: | GradiLeiden V |
|---|---|
| 510(k) number: K992456 | |
| Regulation Number: 864.7925 | |
| Regulatory Class: II | |
| Life Therapeutics Ltd.(formerly Gradipore Ltd.) | |
| 22 Rodborough Road | |
| Frenchs Forest, NSW | |
| 2086 Australia |
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4. Description of the device
Device Description:
cryocheck Clot APCR consists of:
- 5 x 2.0 mL Activator Reagent (APC-AR) .
- 5 x 4.0 mL Russell's Viper Venom Reagent (APC-RV)
5. Statement of the intended use of the device
| Device Intended Use: | CRYOCheck Clot APCR is a clotting assay intended to screen for resistance
to activated protein C in plasma from individuals with the factor VLeiden mutation. |
| ---------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device
Comparison to Predicate Device:
| Parameter | CRYO check Clot APCR | GradiLeiden V - (K992456) |
|---|---|---|
| Intended Use | CRYOcheck Clot APCR is a clotting assay | |
| intended to screen for resistance to | ||
| activated protein C in plasma from | ||
| individuals with the factor VLeiden mutation. | GradiLeiden V is a simple, functional test | |
| system intended for screening of resistance to | ||
| activated protein C in plasma from individuals | ||
| with the factor VLeiden defect. | ||
| Format | Frozen | Lyophilized |
| Volume | • 5 x 2.0 mL Activator Reagent (APC-AR) | |
| • 5 x 4.0 mL Russell's Viper Venom Reagent | ||
| (APC-RV) | • 5 x 2.0 mL Activator Reagent | |
| • 5 x 4.0 mL PR3V Reagent |
Comments on Substantial Equivalence:
It is the opinion of Precision BioLogic Inc. that cxrocheck Clot APCR is substantially equivalent to GradiLeiden V, manufactured by Life Therapeutics (formerly Gradipore Ltd. Australia), and currently marketed in the United States by Rainbow Scientific. This opinion is based on the following:
- Both products are clot-based assays, �
- . Both products are intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden defect.
- Both methods rely on the activation of endogenous protein C. .
- Both methods perform a dilute Russell's viper venom time (dRVVT) on the plasma with . saline and with activator to obtain a ratio which is used for interpretation of a diagnosis.
- . Both products can be automated in 2 stage clotting test systems with similar activation and acquisition times.
- . Both cryocheck Clot APCR and GradiLeiden V tests can be used with the same patient groups.
- Both methods do not require the addition of factor V deficient plasma. .
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Part B
1. Brief discussion of the non-clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Non-clinical tests were performed in-house to determine precision, interferences, and stability. cryocheck Clot APCR showed comparable precision to that of the predicate, GradiLeiden V. Both devices demonstrated identical results when challenged with interfering substances and factor deficiencies. Storage stability is reflected in product labeling.
2. Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Clinical tests were performed at Precision BioLogic and a US university hospital-based clinical coagulation laboratory. cRYocheck Clot APCR and the predicate device exhibited identical sensitivity and specificity.
3. Conclusions drawn from the non-clinical and clinical tests that demonstrate that the device is as safe, as effective, and as well or better than the legally marketed device identified in Part A (3)
cryocheck Clot APCR and GradiLeiden V have the same intended use and can be used with the same patient groups. Precision BioLogic considers cryocheck Clot APCR to be substantially equivalent to GradiLeiden V in terms of intended use, method comparison, and overall performance characteristics. cryocheck Clot APCR was compared to GradiLeiden V using 207 clinical samples from the target population for the assay. A correlation of R = 0.960 was obtained.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the logo.
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
MAY 1 0 2006
Re: K060284
Trade/Device Name: CryoCheckTM Clot APCRTM Regulation Number: 21 CFR § 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: II Product Code: GGW Dated: April 28, 2006 Received: May 2, 2006
Dear Mr. Duff:
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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PA. 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 4
Indications for Use
кобраз 8
510(k) Number:
cryocheck™ Clot APCR™ Device Name:
Indications for Use:
cryocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden mutation.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060284
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