(88 days)
Not Found
No
The device is a biological reagent (deficient plasma) used as a substrate in laboratory assays. The description and performance studies focus on the biological properties and analytical performance of the plasma, with no mention of AI or ML algorithms for data analysis, interpretation, or device function.
No
This device is a substrate used in diagnostic assays to measure Factor II levels, not a device used for therapy.
No
Cryov Check™ Factor 2 Deficient Plasma is a reagent used as a substrate in clot-based Factor II assays, not a device that directly diagnoses a medical condition.
No
The device description clearly states it is "frozen human plasma deficient in the Factor II coagulation protein," indicating it is a biological reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is "recommended for use as a substrate in clot-based factor II assays using the one stage prothrombin time (PT) assay." This indicates it is used in vitro (outside the body) to analyze a sample (plasma) for diagnostic purposes (determining Factor II levels).
- Device Description: It is described as "frozen human plasma deficient in the Factor II coagulation protein," which is a reagent used in laboratory testing.
- Performance Studies: The performance studies describe testing performed on the device itself to demonstrate its suitability for use in Factor II assays, including stability, reproducibility, and correlation with a predicate device. These are typical studies for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K900906) and name ("Factor II Deficient Plasma") strongly suggests that this device is being compared to a previously cleared IVD device, which is a common pathway for regulatory clearance of IVDs.
Therefore, the Cryov Check™ Factor 2 Deficient Plasma fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CryovCheck™ Factor 2 Deficient Plasma is recommended for use as a substrate in clot-based factor II assays using the one stage prothrombin time (PT) assay.
Cryov Check™ Factor 2 Deficient Plasma is human plasma deficient in the Factor II coagulation protein while having all other coagulation factors within normal limits. It is recommended for use as a substrate in clot-based Factor II assays using the one stage prothrombin time (PT).
Product codes
81 GJT
Device Description
CryovCheck™ Factor 2 Deficient Plasma is frozen human plasma deficient in the Factor II coagulation protein. It is prepared from citrated pooled normal human plasma which has been depleted of Factor II by immunoadsorption. Activity levels of Factor II are assayed at less than 1% normal levels while all other coagulation factors are within normal levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Testing Performed:
i) Prothrombin Time (PT) assays and Activated Partial Thromboplastin Time (APTT) assays were performed on vials of Cryo Check™ Factor 2 Deficient Plasma at 0 hours, 8 Hours and 24 hours. No anomalous results were detected.
ii) Factor II assays were performed on a known reference plasma using vials of Cryor Check™ Factor 2 Deficient Plasma as a substrate. Recovered Factor II values were measured at 0 hours, 8 Hours and 24 Hours. (see table S1 for results)
iii) Inter- and intra-lot reproducibility testing on normal and abnormal samples using two lot numbers of factor II deficient plasma. (see tables S2 for results)
iv) Correlation study with a predicate device using samples with factor II levels in the normal, borderline, and pathological ranges. (see table S3 for results)
v) Normal donor study using healthy male and female donors. (see table S4 for results)
Conclusions:
i) Factor II level for Cryo Check™ Factor 2 Deficient Plasma is less than 1%
ii) All other coagulation factors are within normal limits
iii) No anomalous results for PT and APTT assays were observed during a 24 hour open vial stability study
iv) Factor II values were within expected levels following factor II assays over a 24 hour open vial stability study
v) Inter and intra-lot CV's of
§ 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).
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7 1999 JUN
510(k) Summary for Cryov Check™ Factor 2 Deficient Plasma
Submitter's Address and Contact Information 1.
- a) Address Precision BioLogic Incorporated 900 Windmill Rd. Unit # 100 Dartmouth, Nova Scotia Canada B3B 1P7
b) Contact …
Mr. Sandy Morrison Manager, Technical Operations Phone: (902) 468-6422 (902) 468-6421 Fax: E-mail: smorrison@precisionbiologic.com
Date Prepared: February 16, 1999 c)
2. Device Name
- Cryov Check™ Factor 2 Deficient Plasma Proprietary (trade) name: a)
Factor II (2) Deficient Plasma (human) b) Common name:
Classification name: Coagulation Factor Deficient Plasma c)
- Classification information : Regulatory Class II d) Hematology Panel Product Code - 81 GJT
3. Device Description:
CryovCheck™ Factor 2 Deficient Plasma is frozen human plasma deficient in the Factor II coagulation protein. It is prepared from citrated pooled normal human plasma which has been depleted of Factor II by immunoadsorption. Activity levels of Factor II are assayed at less than 1% normal levels while all other coagulation factors are within normal levels.
V - 1
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Intended Use 4.
CryovCheck™ Factor 2 Deficient Plasma is recommended for use as a substrate in clot-based factor II assays using the one stage prothrombin time (PT) assay.
Substantially Equivalent Device న.
- 510(k) number: K900906 a)
- Factor II Deficient Plasma b) Trade Name:
- Manufacturer: Sigma c)
- Substantial Equivalence Comparison d)
Cryo / Check™ Factor 2 Deficient Plasma is similar to the predicate device in that they both have the same "indications for use", target population, and are both made from human plasma.
Cryo Check™ Factor 2 Deficient Plasma differs from the predicate device in that it is a frozen liquid preparation and not a lyophillized product. Additionally, Cryo Check™ Factor 2 Deficient Plasma is prepared from normal human plasma from which Factor II has been immunoadsorbed, while the predicate device is derived from human donors with a congenital Factor II deficiency.
To our knowledge, these differences do not affect the intended use or performance of the device.
- Non-Clinical Performance Data 24 Hour Open Vial Stability : 6.
- a) Testing Performed:
- Prothrombin Time (PT) assays and Activated Partial Thromboplastin i) Time (APTT) assays were performed on vials of Cryo Check™ Factor 2 Deficient Plasma at 0 hours, 8 Hours and 24 hours. No anomalous results were detected.
- ii) Factor II assays were performed on a known reference plasma using vials of Cryor Check™ Factor 2 Deficient Plasma as a substrate. Recovered Factor II values were measured at 0 hours, 8 Hours and 24 hours. (see table S1 for results)
- iii) Inter- and intra-lot reproducibility testing on normal and abnormal samples using two lot numbers of factor II deficient plasma. (see tables S2 for results)
- a) Testing Performed:
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- Correlation study with a predicate device using samples with factor II iv) levels in the normal, borderline, and pathological ranges. (see table S3 for results)
- Normal donor study using healthy male and female donors. (see table S4 v) for results)
- Conclusions: b)
- Factor II level for Cryo Check™ Factor 2 Deficient Plasma is less i) than 1%
- ii) All other coagulation factors are within normal limits
- iii) No anomalous results for PT and APTT assays were observed during a 24 hour open vial stability study
- Factor II values were within expected levels following factor II iv) assays over a 24 hour open vial stability study
- Inter and intra-lot CV's of Trade Name: Cryov Check™ Factor 2 Deficient Plasma Regulatory Class: II Product Code: GJT Dated: May 6, 1999 Received: May 13, 1999
Dear Mr. Morrison:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K 990814
Device Name: Cryo Check™ Factor 2 Deficient Plasma
Indications for Use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor II (also known as prothrombin) is a serine protease located in the "common coagulation pathway" and is essential to normal hemostasis. Factor II deficiency is commonly diagnosed in vitro through the use of a modified prothrombin time (PT) assay.
Cryov Check™ Factor 2 Deficient Plasma is human plasma deficient in the Factor II coagulation protein while having all other coagulation factors within normal limits. It is recommended for use as a substrate in clot-based Factor II assays using the one stage prothrombin time (PT).
Peter E. Mafem
Prescription