(90 days)
Not Found
No
The summary describes a kit of reagents for a laboratory assay and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is an in vitro diagnostic (IVD) kit used to determine a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A. It does not treat or cure a disease but rather provides diagnostic information.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use." The device is designed to determine a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A, which is a diagnostic purpose.
No
The device description clearly lists physical components (Imidazole Buffered Pooled Normal Plasma, Imidazole Buffered Bovine Serum Albumin, Negative Factor VIII Inhibitor Control, Positive Factor VIII Inhibitor Control) which are reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
Furthermore, the intended use describes the device's purpose in a clinical laboratory setting to perform a test on human plasma to aid in the clinical management of a specific condition (congenital hemophilia A), which is a characteristic of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a Factor VIII activity assay to enable the performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years or older. For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
GGP, GGN
Device Description
The FVIII Inhibitor Kit is used in the CDC modification of the Nijmegen-Bethesda assay and contains the following components:
Imidazole Buffered Pooled Normal Plasma (IB-PNP): Pooled normal plasma from a minimum of twenty donors with a factor VIII activity value of 95-113% and buffered with imidazole to a pH of 7.3 – 7.5.
Imidazole Buffered Bovine Serum Albumin (IB-BSA): A 4% BSA solution buffered with imidazole to a pH of 7.3-7.5.
Negative Factor VIII Inhibitor Control: Pooled normal plasma from a minimum of five donors buffered with HERES to a pH of 6.2-8.2.
Positive Factor VIII Inhibitor Control: HEPES buffered (pH 6.2-8.2) immunodepleted FVIII deficient plasma to which anti-human FVIII antibodies have been added.
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
2 years or 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
Study type: Internal precision study
Sample size: 80 replicates per sample per lot tested across 3 lots for a total of 240 replicates per sample.
Key results: Pooled precision of 8 % CV for the positive samples and 0.1 BU/mL SD for the negative sample.
Multi-Reagent Lot Site to Site Reproducibility
Study type: Reproducibility study
Sample size: 30 replicates per sample per site across 3 sites for a total of 90 replicates per sample.
Key results: Pooled reproducibility of ≤16% CV for the positive samples and 0.1 BU/mL SD for the negative plasma sample.
Linearity/Assay Reportable Range
Study type: Linearity study
Key results:
Linearity Range: 0.2 to 1402.9 BU/mL
Stability
Shelf Life Stability
Study type: Shelf life stability study
Key results: Supports a 12-month shelf-life stability claim.
In-Use Stability
Study type: In-use stability study
Key results: Supports a 4-hour in-use stability of the product when maintained at room temperature or at 2-8 °C post thaw.
Detection Limit
Limit of Blank (LoB)
Study type: LoB determination study
Key results: LoB was determined to be 0.1 BU/mL.
Limit of Detection (LoD)
Study type: LoD determination study
Key results: LoD was determined to be 0.2 BU/mL.
Limit of Quantitation (LoQ)
Study type: LoQ determination study
Key results: LoQ was determined to be 0.2 BU/mL.
Interferences
Study type: Interference studies
Key results: Hemoglobin (≤ 500mg/dL), Bilirubin (≤ 500mg/dL), Intralipid (≤ 29mg/dL), vWF (≤ 20 µg/mL) showed no interference. Lupus anticoagulant autoantibodies may interfere with the quantification of low titer FVIII inhibitors. Rheumatoid Factor at ≥ 82 IU/mL showed interference.
Method Comparison Studies
Study type: Method comparison study
Sample size: N=210 human plasma samples from individuals with congenital hemophilia A
Key results: Positive agreement of 100% (95% Cl, 97-100%) and negative agreement of 99% (95% CI, 93-100%). Regression statistics show that the cRYOcheck FVIII Inhibitor Kit performed equivalently to the comparator method. Overall Pearson Correlation Coefficient = 0.970 (r^2 =0.940).
Sample Integrity
Study type: Sample integrity studies
Key results: Demonstrated robustness of FVIII measurements in fresh and frozen plasma samples including after multiple freeze/thaw cycles. Demonstrated sample stability of 12 months when stored frozen at
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name written out as "U.S. Food & Drug Administration".
March 12, 2019
Precision BioLogic Inc. Karen Black VP of Compliance & Product Development 140 Eileen Stubbs Avenue Dartmouth, Nova Scotia B3B 0A9 Canada
Re: K183440
Trade/Device Name: CRYOcheck FVIII Inhibitor Kit Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: December 10, 2018 Received: December 12, 2018
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183440
Device Name CRYOcheck FVIII Inhibitor Kit
Indications for Use (Describe)
The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a Factor VIII activity assay to enable the performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years or 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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3
510(k) Summary cryocheck FVIII Inhibitor Kit
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: ___K183440
| Submitter's
Information | Precision BioLogic Inc.
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 | December 10, 2018 | |
| Device Trade Name | CRYOcheck™ Factor VIII Inhibitor Kit | |
| Regulatory
Information | Regulation Number and
Description | 21 CFR 864.7290
Factor Deficiency Test
21 CFR 864.5425
Multipurpose system for in vitro
coagulation studies |
| | Classification | Class II |
| | Product Code | GGP; Test, Qualitative and Quantitative
Factor Deficiency; 21 CFR 864.7290;
GGN; Plasma, Coagulation Control; 21 CFR 864.5425 |
| | Classification Panel | Hematology |
| | Predicate Device | Immucor FVIII Antibody Screen Assay (K082205) |
| Indication for Use/
Intended Use | The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in
conjunction with a Factor VIII activity assay to enable performance of a
modified Nijmegen-Bethesda assay using 3.2% citrated human plasma.
It enables the determination of a functional FVIII inhibitor titer to aid in
the clinical management of congenital hemophilia A in individuals aged
2 years or older. For in vitro diagnostic use. | |
| Device Description | The FVIII Inhibitor Kit is used in the CDC modification of the Nijmegen-
Bethesda assay and contains the following components:
Imidazole Buffered Pooled Normal Plasma (IB-PNP) : Pooled normal
plasma from a minimum of twenty donors with a factor VIII activity
value of 95-113% and buffered with imidazole to a pH of 7.3 – 7.5.
Imidazole Buffered Bovine Serum Albumin (IB-BSA) : A 4% BSA solution
buffered with imidazole to a pH of 7.3-7.5.
Negative Factor VIII Inhibitor Control : Pooled normal plasma from a
minimum of five donors buffered with HERES to a pH of 6.2-8.2 | |
| Positive Factor VIII Inhibitor Control: HEPES buffered (pH 6.2-8.2) | | |
| immunodepleted FVIII deficient plasma to which anti-human FVIII antibodies have been added. | | |
| Comparison to Predicate | | |
| Item | Predicate | New Device |
| Proprietary and Established Names | Factor VIII Antibody Screen,
Immucor FVIII Antibody Screen Assay | CRYOCheck FVIII Inhibitor Kit |
| Manufacturer | Genetic Testing Institute, Inc.
(original applicant) | Precision BioLogic |
| Similarities | | |
| Measurand | Antibodies to human Factor VIII | Factor VIII Inhibitor |
| Product Code | GGP
Test, Qualitative and Quantitative Factor Deficiency | GGP
Test, Qualitative and
Quantitative Factor Deficiency
GGN
Plasma, Coagulation Control |
| Regulation Section | 21 CFR 864.7290
Factor Deficiency Test | 21 CFR 864.7290
Factor Deficiency Test
21 CFR 864.5425
Multipurpose system for in vitro
coagulation studies |
| Classification | Class II | Class II |
| Panel | 81 (Haematology) | 81 (Haematology) |
| Intended Use | The Factor VIII Antibody Screen is a
qualitative solid phase enzyme
linked immunosorbent assay (ELISA)
designed to detect IgG antibodies
reactive with recombinant human
VIII (FVIII) in human serum and
plasma. | The CRYOcheck FVIII Inhibitor Kit
is for clinical laboratory use in
conjunction with a Factor VIII
activity assay to enable
performance of a modified
Nijmegen-Bethesda assay using
3.2% citrated human plasma. It
enables the determination of a
functional FVIII inhibitor titer to
aid in the clinical management of
congenital hemophilia A in
individuals aged 2 years or older.
For in vitro diagnostic use. |
| Differences | | |
| Assay Type | ELISA
(Qualitative) | Quantitative |
| Device Description | The Factor VIII Antibody Screen
assay is an ELISA with a colorimetric
endpoint. The assay kit is made of a
96 welled microwell plate (in 1 X 8 | The FVIII Inhibitor Kit is used in
the CDC modification of the
Nijmegen-Bethesda assay and |
| | strips), alkaline phosphatase
conjugated goat antibody to human
immunoglobulin G, p-nitrophenyl
phosphate substrate, positive and
negative control, Stop Solution,
diluents, buffers, wash solutions,
and plate sealers. | contains the following
components:
Imidazole Buffered Pooled
Normal Plasma (IB-PNP): Pooled
normal plasma from a minimum
of twenty donors with a factor
VIII activity value of 95-113% and
buffered with imidazole to a pH
of 7.3 – 7.5.
Imidazole Buffered Bovine Serum
Albumin (IB-BSA): A 4% BSA
solution buffered with imidazole
to a pH of 7.3-7.5.
Negative Factor VIII Inhibitor
Control: Pooled normal plasma
from a minimum of five donors
buffered with HEPES to a pH of
6.2-8.2.
Positive Factor VIII Inhibitor
Control: HEPES buffered (pH 6.2-
8.2) immunodepleted FVIII
deficient plasma to which anti-
human FVIII antibodies have
been added. |
| Methodology | Diluted patient sample is added to
microwells coated with
recombinant FVIII, and antibody, if
present will bind. Unbound material
is washed away, and an alkaline
phosphatase labeled anti-human
immunoglobulin reagent (anti IgG)
is added to the wells and incubated.
Unbound anti-IgG is washed away
and then PNPP (p-nitrophenyl
phosphate) substrate is added.
After a 30 minute incubation
period, the reaction is stopped, and
the optical density of the color that
develops is measured at 405nm. | Diluted heat inactivated patient
plasma is mixed with an
exogenous source of FVIII (IB-
PNP) and prepared alongside a
control mix, consisting of a
diluent (IB-BSA) and IB-PNP.
Following a 2 hour incubation,
the FVIII activity of the test
plasma relative to the control
mix is determined and used to
calculate FVIII inhibitor activity
expressed as Bethesda units per
milliliter. |
| Expression of results | Qualitative; results are reported as
positive or negative. | Quantitative; results are
expressed in Bethesda units per
milliliter. |
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5
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Performance Summary:
All studies were performed using the cRYOcheck FVIII Inhibitor Kit in conjunction with the Siemens FVIII chromogenic assay (K884544, original applicant Baxter Healthcare Corporation) on Siemens BCS XP instrument(s) (K970431, original applicant Behring Diagnostics Inc).
Multi-Reagent Lot Precision
An internal precision study was performed using three (3) different lots of cRYocheck FVIII Inhibitor Kit by one operator on a Siemens BCS XP analyzer in accordance with CLSI EPO5-A3. The study quantified the kit's Positive and Negative Control as well as four plasma samples from congenital hemophilia A patients representing negative, low, mid and high levels of FVIII inhibitor. 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 results demonstrated a pooled precision of 8 % CV for the positive samples and 0.1 BU/mL SD for the negative sample as summarized below.
| Lot 1 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | Within-Run | Between- Run | Between-Day | Within-Lot | |||||
| Sample | (BU/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Kit Negative Control | 0.0 | 0.0 | 189.7 | 0.0 | 178.9 | 0.0 | 156.4 | 0.1 | 304.1 |
| Kit Positive Control | 1.8 | 0.1 | 7.9 | 0.1 | 5.2 | 0.0 | 0.0 | 0.2 | 9.4 |
| Negative Plasma Sample | 0.3 | 0.1 | 22.2 | 0.0 | 10.1 | 0.0 | 0.0 | 0.1 | 24.4 |
| Low Plasma Sample | 1.4 | 0.1 | 7.9 | 0.0 | 0.0 | 0.0 | 2.2 | 0.1 | 8.2 |
| Mid Plasma Sample | 5.6 | 0.5 | 8.8 | 0.2 | 3.5 | 0.2 | 3.1 | 0.6 | 9.9 |
| High Plasma Sample | 9.6 | 0.6 | 6.1 | 0.2 | 2.0 | 0.2 | 2.0 | 0.6 | 6.7 |
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| Lot 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | Mean | ||||||||
| (BU/mL) | Within-Run | Between- Run | Between-Day | Within-Lot | |||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||
| Kit Negative Control | 0.0 | 0.1 | 209.8 | 0.0 | 161.2 | 0.0 | 0.0 | 0.1 | 264.6 |
| Kit Positive Control | 1.5 | 0.1 | 8.4 | 0.1 | 4.2 | 0.1 | 5.5 | 0.2 | 10.9 |
| Negative Plasma Sample | 0.3 | 0.1 | 23.9 | 0.0 | 8.4 | 0.0 | 12.8 | 0.1 | 28.4 |
| Low Plasma Sample | 1.1 | 0.1 | 6.7 | 0.0 | 4.3 | 0.0 | 2.3 | 0.1 | 8.2 |
| Mid Plasma Sample | 5.3 | 0.3 | 6.0 | 0.2 | 3.8 | 0.1 | 1.3 | 0.4 | 7.2 |
| High Plasma Sample | 8.4 | 0.6 | 7.6 | 0.4 | 4.5 | 0.1 | 0.6 | 0.7 | 8.9 |
Aggregated Data (Lots 1, 2 and 3)
| Sample | Mean
(BU/mL) | Within-Laboratory | |
|------------------------|-----------------|-------------------|------|
| | | SD | %CV |
| Negative Plasma Sample | 0.3 | 0.1 | 29.0 |
| Low Plasma Sample | 1.2 | 0.1 | 8.2 |
| Mid Plasma Sample | 5.3 | 0.4 | 8.3 |
| High Plasma Sample | 8.6 | 0.7 | 8.4 |
Multi-Reagent Lot Site to Site Reproducibility
Reproducibility studies were conducted at three sites (one internal and two external) by three different operators on three different Siemens BCS XP analyzers using a single lot of cRYocheck FVIII Inhibitor Kit in accordance with CLSI EP05-A3. The study quantified the kit's Positive and Negative Control as well as four plasma samples from congenital hemophilia A patients representing negative, low, mid and high levels of FVIII inhibitor. Each sample was measured in triplicate, twice a day for 5 days for a total of 30 replicates per sample per site. The data across three sites demonstrated a pooled reproducibility of ≤16% CV for the positive samples and 0.1 BU/mL SD for the negative plasma sample as summarized below.
| Pooled 3-Site Data | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | Within-Run | Between- Run | Between-Day | Between-Site | Across-Site | ||||||
| Sample | (BU/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Kit Negative Control | 0.0 | 0.1 | 399.4 | 0.0 | 138.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 422.7 |
| Kit Positive Control | 1.8 | 0.2 | 8.9 | 0.1 | 3.3 | 0.1 | 3.4 | 0.2 | 12.4 | 0.3 | 16.0 |
| Negative Plasma Sample | 0.3 | 0.1 | 26.9 | 0.0 | 0.0 | 0.0 | 9.0 | 0.0 | 2.2 | 0.1 | 28.4 |
| Low Plasma Sample | 1.4 | 0.1 | 10.2 | 0.0 | 0.0 | 0.0 | 2.9 | 0.0 | 0.0 | 0.1 | 10.6 |
| Mid Plasma Sample | 5.5 | 0.4 | 7.8 | 0.1 | 1.9 | 0.1 | 2.2 | 0.0 | 0.0 | 0.5 | 8.3 |
| High Plasma Sample | 9.6 | 0.7 | 7.8 | 0.4 | 4.0 | 0.3 | 3.4 | 0.9 | 9.2 | 1.3 | 13.2 |
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Linearity/Assay Reportable Range
A linearity study was conducted in accordance with CLSI EP06-A using one lot of cRYOcheck FVIII Inhibitor Kit. Factor VIII inhibitor positive plasma from a congenital hemophilia A patient was combined with congenital hemophilia A patient plasma containing no FVIII inhibitor to create twelve sample dilutions with estimated titers in the range of 0 to 100 BU/mL. The results support the linearity claim described below.
An expanded linearity study was also conducted using one lot of cRYOcheck FVIII Inhibitor Kit. A series of eighteen sample dilutions spanning a range of 0 to 1402.9 BU/mL was created by diluting a high titer contrived sample (FVIII inhibitor titer of 1402.9 BU/mL, comprised of FVIII monoclonal antibody in immunodepleted FVIII deficient plasma) with immunodepleted FVIII deficient plasma. The results support the linearity claim described below.
Linearity Range: 0.2 to 1402.9 BU/mL
Stability
Shelf Life Stability
A shelf life stability study was conducted in accordance with CLSI EP25-A. Three lots of cRYocheck FVIII Inhibitor Kit were stored at