(359 days)
HemosIL Factor VIII Deficient Plasma (K110237)
No
The device is a biological reagent (deficient plasma) used in a laboratory assay, not a software or hardware device that would typically incorporate AI/ML for analysis or interpretation. The description focuses on the biological composition and performance characteristics of the plasma itself.
No.
This device is an in vitro diagnostic (IVD) product used to determine Factor VIII activity to identify Factor VIII deficiency and aid in managing hemophilia A. It is not used to treat or cure a disease but rather to diagnose and monitor a condition.
Yes
The device is intended for clinical laboratory use to aid in the management of hemophilia A by identifying factor VIII deficiency in human plasma. This application directly supports medical diagnosis and patient management.
No
The device is a biological reagent (plasma) used in a laboratory assay, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use" and describes its use in a clinical laboratory setting for the quantitative determination of Factor VIII activity in human plasma. This is a classic definition of an in vitro diagnostic device.
- Device Description: The description details a reagent (plasma) used in a laboratory test.
- Intended User/Care Setting: It specifies "clinical laboratory use," which is where IVD tests are performed.
The entire context of the document, including the performance studies and predicate device information, further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use
Product codes (comma separated list FDA assigned to the subject device)
GJT
Device Description
CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and to which an exogenous source of human von Willebrand Factor (vWF) has been added and buffered with HEPES. Factor VIII has been assayed at less than 1% of normal activity levels and vWF antigen and activity are >50%. It will be provided to users frozen in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into boxes; these will be frozen during the manufacturing process and will be shipped and stored frozen until use to preserve the integrity of the components.
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
individuals aged 2 years and older.
Intended User / Care Setting
clinical laboratory 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)
Multi-Reagent Lot Precision: An internal precision study was performed using three (3) lots of cRYocheck Factor VIII Deficient Plasma with VWF in a modified APTT assay by two operators on an IL ACL TOP 700 CTS analyzer (K160276) in accordance with CLSI EP05-A3. The study quantified one normal and two abnormal reference controls and three patient plasma samples representing very low, and high levels of FVIII activity. Each sample was measured with each product lot in duplicate, twice a day for 20 days for a total of 80 replicates per sample per lot. The pooled results demonstrated a precision 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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September 13, 2023
Precision BioLogic Inc. Karen Black VP of Compliance and Product Development 140 Eileen Stubbs Avenue Dartmouth, Nova Scotia B3B 0A9 Canada
Re: K222831
Trade/Device Name: CRYOcheck Factor VIII Deficient Plasma with VWF Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GJT Dated: May 19, 2023 Received: May 19, 2023
Dear Karen Black:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Min Wu-S" in a large, sans-serif font. The text is black, and the background is white. The letters are evenly spaced and easy to read. There is a faint watermark in the background.
Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22831
Device Name
CRYOcheck Factor VIII Deficient Plasma with VWF
Indications for Use (Describe)
CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary cryocheck™ Factor VIII Deficient Plasma with VWF
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: K222831
| Submitter's | Precision BioLogic Inc. | |
|---|---|---|
| Information | 140 Eileen Stubbs Ave. | |
| Dartmouth, Nova Scotia B3B 0A9 | ||
| Canada | ||
| Contact Person | Karen M. Black, VP of Compliance & Product Development | |
| Phone: 902-468-6422, ext. 226, or 902-706-3125 | ||
| E-mail: kblack@precisionbiologic.com | ||
| Preparation Date | 25 August 2023 | |
| Device Trade Name | CRYOcheck™ Factor VIII Deficient Plasma with VWF | |
| Regulation Number and | 21 CFR 864.7290 | |
| Description | Factor Deficiency Test | |
| Regulatory | Classification | Class II |
| Information | Product Code | GJT, Plasma, Coagulation Factor |
| Deficient; 21 CFR 864.7290 | ||
| Classification Panel | Hematology | |
| Predicate Device | HemosIL Factor VIII Deficient Plasma (K110237) | |
| Indication for Use/ | ||
| Intended Use | CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical | |
| laboratory use as a deficient substrate in the quantitative | ||
| determination of Factor VIII activity in 3.2% citrated human plasma | ||
| based on the activated partial thromboplastin time (APTT) assay. It is | ||
| intended to be used in identifying factor VIII deficiency and as an aid in | ||
| the management of hemophilia A in individuals aged 2 years and | ||
| older. For in vitro diagnostic use | ||
| Device Description | CRYOcheck Factor VIII Deficient Plasma with VWF is normal human | |
| citrated plasma which has been immunodepleted of factor VIII and to | ||
| which an exogenous source of human von Willebrand Factor (vWF) has | ||
| been added and buffered with HEPES. Factor VIII has been assayed at | ||
| less than 1% of normal activity levels and vWF antigen and activity are |
50%. It will be provided to users frozen in small-volume aliquots (25
vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into
boxes; these will be frozen during the manufacturing process and will
be shipped and stored frozen until use to preserve the integrity of the
components |
| Comparison to Predicate | ||
|---|---|---|
| Item | Predicate | New Device |
| Proprietary and | ||
| Established Names | HemosIL Factor VIII Deficient | |
| Plasma | CRYOCheck Factor VIII Deficient | |
| plasma with VWF | ||
| Manufacturer | Instrumentation Laboratory | Precision BioLogic |
| Similarities | ||
| Measurand | Human Factor VIII | Same |
| Classification Product | ||
| Code | GJT, Plasma, Coagulation | |
| Factor Deficient | Same | |
| Regulation Section | 21 CFR 864.7290 | |
| Factor Deficiency Test | 21 CFR 864.7290 | |
| Factor Deficiency Test | ||
| Comparison to Predicate | ||
| Item | Predicate | New Device |
| Classification | Class II | Class II |
| Panel | 81 (Haematology) | 81 (Haematology) |
| Intended Use | HemosIL Factor VIII deficient | |
| plasma is human plasma | ||
| depleted for Factor VIII and | ||
| intended for the in vitro | ||
| diagnostic quantitative | ||
| determination of Factor VIII | ||
| activity in citrated plasma, | ||
| based on the activated partial | ||
| thromboplastin time (APTT) | ||
| assay, on the ACL TOP Family | ||
| analyzers. HemosIL Factor VIII | ||
| deficient plasma is indicated | ||
| for use on patients who are | ||
| suspected of congenital or | ||
| acquired deficiency based on | ||
| the activated partial | ||
| thromboplastin time (APTT) | ||
| assay results. | CRYOcheck Factor VIII Deficient | |
| Plasma with VWF is for clinical | ||
| laboratory use as a deficient | ||
| substrate in the quantitative | ||
| determination of Factor VIII | ||
| activity in 3.2% citrated human | ||
| plasma based on the activated | ||
| partial thromboplastin time | ||
| (APTT) assay. It is intended to | ||
| be used in identifying factor VIII | ||
| deficiency and as an aid in the | ||
| management of hemophilia A in | ||
| individuals aged 2 years and | ||
| older. For in vitro diagnostic | ||
| use. | ||
| Assay Type | Quantitative (clot-based | |
| measurement of FVIII) | Same | |
| Methodology | Factor VIII activity in a | |
| patient's plasma is determined | ||
| by performing a modified | ||
| activated partial | ||
| thromboplastin time test | ||
| (APTT). Patient plasma is | ||
| diluted and added to plasma | ||
| deficient in Factor VIII. | ||
| Correction of the clotting time | ||
| of the deficient plasma is | ||
| proportional to the | ||
| concentration (% activity) of | ||
| that factor in the patient | ||
| plasma interpolated from a | ||
| calibration curve. | Same | |
| Expression of results | Quantitative; results are | |
| expressed as percent activity. | ||
| interpreted relative to a | ||
| calibration curve. | Same | |
| Instrument(s) | ACL TOP Family/ACL TOP | |
| Family 50 Series | Same | |
| Differences | ||
| Item | Predicate | New Device |
| Device Description | The HemosIL Factor VIII deficient plasma kit contains 10 x 1 mL vials of lyophilized human plasma that has been artificially depleted of factor VIII containing buffer and stabilizers. The residual factor VIII activity is less than or equal to 1% whereas von Willebrand Factor and the remaining intrinsic pathway factor levels are normal. | CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and to which an exogenous source of human von Willebrand Factor (vWF) has been added and buffered with HEPES. Factor VIII has been assayed at less than 1% of normal activity levels and vWF antigen and activity are >50%. It will be provided to users frozen in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into boxes; these will be frozen during the manufacturing process and will be shipped and stored frozen until use to preserve the integrity of the components. |
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PrecisionBioLogic
5
Performance Summary:
All studies were performed using cRYocheck Factor VIII Deficient Plasma with VWF in a modified APTT assay with Instrumentation Laboratories' APTT SynthASil reagent to measure FVIII activity on Instrumentation Laboratories' ACL TOP Series or TOP 50 Series Instruments; the specific instrument(s) used for each study are indicated in the summary reports below.
Multi-Reagent Lot Precision
An internal precision study was performed using three (3) lots of cRYocheck Factor VIII Deficient Plasma with VWF in a modified APTT assay by two operators on an IL ACL TOP 700 CTS analyzer (K160276) in accordance with CLSI EP05-A3. The study quantified one normal and two abnormal reference controls and three patient plasma samples representing very low, and high levels of FVIII activity. Each sample was measured with each product lot in duplicate, twice a day for 20 days for a total of 80 replicates per sample per lot. The pooled results demonstrated a precision of