(108 days)
CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2 % citrated human plasma. 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.
CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components:
- Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizer.
- Reagent 2: Human FIIa, bovine FIXa, calcium chloride and phospholipids.
- Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor.
- Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.
In the first stage of the chromogenic assay, test plasma (containing an unknown amount of functional FVIII) is added to a reaction mixture comprised of calcium, phospholipids, human purified thrombin and FIXa, and bovine FX (Reagent 1 and Reagent 2). This mixture swiftly activates FVIII to FVIIIa, which works in concert with FIXa to activate FX. When the reaction is stopped, FXa production is assumed to be proportional to the amount of functional FVIII present in the sample. The second stage of the assay is to measure FXa through cleavage of a FXa-specific peptide nitroanilide substrate (FXa Substrate). P-nitroaniline is produced, giving a color that can be measured spectrophotometrically by absorbance at 405 nm.
Based on the provided FDA 510(k) Clearance Letter, the device in question is the CRYOcheck Chromogenic Factor VIII. This document details the clearance of a modified version of an existing device, emphasizing the differences from the previous version regarding interference claims and recovery of Factor VIII replacement therapies.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance claim in a quantified manner (e.g., "Interference must be less than X%"). Instead, it reports the limits of non-interference found in their studies, implying these served as the de facto acceptance criteria. For the Factor VIII replacement therapy recovery, the acceptance criterion appears to be "accurate evaluation" across a range of concentrations, with specific over/under recovery noted.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Interference: | ||
| Hemoglobin | Must show no interference up to the concentration indicated. | No interference observed up to ≤1000 mg/dL (increased from ≤500 mg/dL) |
| Intralipid | Must show no interference up to the concentration indicated. | No interference observed up to ≤830 mg/dL (increased from ≤500 mg/dL) |
| Bilirubin (unconjugated) | Must show no interference up to the concentration indicated. | No interference observed up to ≤40 mg/dL (increased from ≤29 mg/dL) |
| Bilirubin (conjugated) | Must show no interference up to the concentration indicated. | No interference observed up to ≤11 mg/dL (increased from ≤2 mg/dL) |
| von Willebrand factor | Must show no interference up to the concentration indicated. | No interference observed up to ≤20 µg/mL (same) |
| Unfractionated heparin | Must show no interference up to the concentration indicated. | No interference observed up to ≤3.3 IU/mL (increased from ≤2 IU/mL) |
| Low molecular weight heparin | Must show no interference up to the concentration indicated. | No interference observed up to ≤5 IU/mL (increased from ≤2 IU/mL) |
| Fondaparinux | Must show no interference up to the concentration indicated. | No interference observed up to ≤0.2 mg/L (decreased from ≤1.25 mg/L) |
| Lupus Anticoagulant | Must show no interference up to the concentration indicated. | No interference observed up to ≤1.8 dRVVT ratio (same) |
| Emicizumab | Must show no interference up to the concentration indicated. | No interference observed up to ≤150 µg/mL (new claim) |
| Mim8 | Must show no interference up to the concentration indicated. | No interference observed up to ≤8 µg/mL (new claim) |
| Warfarin | Must show no interference up to the concentration indicated. | No interference observed up to INR ≤7 (new claim) |
| Rivaroxaban | Must not interfere. | Interfered with quantification of FVIII activity. |
| Dabigatran | Must not interfere. | Interfered with quantification of FVIII activity. |
| Recovery of FVIII Replacement Therapy: | Must accurately evaluate potency. | Accurately evaluated potency for ADVATE, ADYNOVATE, AFSTYLA, ALTUVIIO, ESPEROCT, HUMATE-P, JIVI, KOVALTRY, Novoeight, Nuwiq, and wilate at 0.05-1.0 IU/mL; ELOCTATE, and XYNTHA at 0.05-0.6 IU/mL (with over recovery at 0.8 & 1.0 IU/mL); Underestimation for OBIZUR. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Interference Studies: Plasma samples were "spiked with possible interferents," and "10 replicates were tested alongside 10 replicates of the corresponding blank matrix control." The total number of individual patient samples from which this plasma was derived is not specified, nor is the country of origin. The study design implies a prospective spiking experiment in a laboratory setting.
- Recovery of Factor VIII Replacement Therapy: "Congenital FVIII deficient plasma was spiked with 14 FVIII replacement therapies at seven concentrations." The number of individual patient plasma units or lots of deficient plasma used is not specified. The study design implies a prospective spiking experiment in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an in vitro diagnostic device for quantitative determination of factor VIII activity, not an AI/imaging device requiring expert human readers for ground truth generation. The ground truth for these studies is established by the known concentrations of spiked interferents or FVIII replacement therapies, and the intrinsic properties of the FVIII deficient plasma.
4. Adjudication Method for the Test Set
N/A. As this is a quantitative in vitro diagnostic device, an adjudication method in the context of human expert review of imaging or clinical data is not applicable. The results are measured spectrophotometrically.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is relevant for AI imaging devices where human readers interpret medical images with and without AI assistance. This document describes an in vitro diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, this entire submission describes the standalone performance of the CRYOcheck Chromogenic Factor VIII assay. The device itself performs the quantitative determination of FVIII activity, entirely without a "human-in-the-loop" once the sample is loaded and the assay run according to protocol.
7. The Type of Ground Truth Used
- Interference Studies: The ground truth was the known concentration of the spiked interferent (e.g., Hemoglobin, Intralipid, Bilirubin, etc.) added to plasma samples, and the corresponding blank matrix control.
- Recovery of Factor VIII Replacement Therapy: The ground truth was the known concentration of the spiked FVIII replacement therapy added to congenital FVIII deficient plasma at various concentrations.
8. The Sample Size for the Training Set
N/A. This document describes an in vitro diagnostic assay based on chromogenic principles, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's components (reagents, diluent buffer) and their interaction define the assay, which is then validated through performance studies.
9. How the Ground Truth for the Training Set was Established
N/A. See point 8. The "ground truth" for developing and optimizing such a chromogenic assay would stem from extensive biochemical research, characterization of reagents, and titrations against known standards, which is inherent in the development of any diagnostic assay, but not referred to as a "training set" or "ground truth establishment" in the AI/ML context.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 25, 2025
Precision BioLogic Inc.
Karen Black
VP of Compliance and Product Development
140 Eileen Stubbs Avenue
Dartmouth, NS B3B0A9
Canada
Re: K251440
Trade/Device Name: CRYOcheck Chromogenic Factor VIII
Regulation Number: 21 CFR 864.7290
Regulation Name: Factor deficiency test
Regulatory Class: Class II
Product Code: GGP
Dated: May 27, 2025
Received: May 27, 2025
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 (the 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 available 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.
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K251440 - Karen Black Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K251440 - Karen Black Page 3
assistance/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,
Takeesha Taylor-bell -S
Takeesha Taylor-Bell
Deputy Director
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251440
Device Name
CRYOcheck Chromogenic Factor VIII
Indications for Use (Describe)
CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2 % citrated human plasma. 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Executive Summary
Proprietary Name: CRYOcheck™ Chromogenic Factor VIII
Common Name: Chromogenic Factor VIII Assay
Classification: Class II
Product Code: GGP; Test, Qualitative and Quantitative Factor Deficiency; 21 CFR 864.7290
Device Description: CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components:
- Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizer.
- Reagent 2: Human FIIa, bovine FIXa, calcium chloride and phospholipids.
- Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor.
- Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.
In the first stage of the chromogenic assay, test plasma (containing an unknown amount of functional FVIII) is added to a reaction mixture comprised of calcium, phospholipids, human purified thrombin and FIXa, and bovine FX (Reagent 1 and Reagent 2). This mixture swiftly activates FVIII to FVIIIa, which works in concert with FIXa to activate FX. When the reaction is stopped, FXa production is assumed to be proportional to the amount of functional FVIII present in the sample. The second stage of the assay is to measure FXa through cleavage of a FXa-specific peptide nitroanilide substrate (FXa Substrate). P-nitroaniline is produced, giving a color that can be measured spectrophotometrically by absorbance at 405 nm.
Device Intended Use: CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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.
Comparison to Predicate Device:
Similarities
| Parameter | Current CRYOcheck Chromogenic Factor VIII | Changed CRYOcheck Chromogenic Factor VIII |
|---|---|---|
| 510(k) Number | K193204 | K251440 |
| Measurand | Human Factor VIII activity | Same |
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510(k) Executive Summary
CRYOcheck Chromogenic Factor VIII
Page 2 of 5
| Parameter | Current CRYOcheck Chromogenic Factor VIII | Changed CRYOcheck Chromogenic Factor VIII |
|---|---|---|
| Applicant | Precision BioLogic Inc. | Same |
| Proprietary and Established Names | CRYOcheck Chromogenic Factor VIII | Same |
| Regulation Number | 21 CFR 864.7290 Factor Deficiency Test | Same |
| Classification | Class II | Same |
| Product Code | GGP Test, Qualitative and Quantitative Factor Deficiency | Same |
| Panel | 81 (Hematology) | Same |
| Intended Use | CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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. | Same |
| Indications for Use | N/A – same as Intended Use | Same |
| Type of Test | Quantitative | Same |
| Test Principle | In the first stage of the chromogenic assay, test plasma (containing an unknown amount of functional FVIII) is added to a reaction mixture comprised of calcium, phospholipids, human purified thrombin and FIXa and bovine FX (Reagent 1 and Reagent 2). This mixture swiftly activates FVIII to FVIIIa, which works in concert with FIXa to activate FX. When the reaction is stopped, FXa production is assumed to be proportional to the amount of functional FVIII present in the sample. The second stage of the assay is to measure FXa through cleavage of a FXa-specific peptide nitroanilide substrate (FXa Substrate). P-nitroaniline is produced, giving a color that can be measured spectrophotometrically by absorbance at 405 nm. | Same |
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510(k) Executive Summary
CRYOcheck Chromogenic Factor VIII
Page 3 of 5
| Parameter | Current CRYOcheck Chromogenic Factor VIII | Changed CRYOcheck Chromogenic Factor VIII |
|---|---|---|
| Expression of Results | Quantitative; results are expressed as percent activity interpreted relative to a calibration curve. | Same |
| Instrument | IL ACL TOP CTS Series and ACL TOP 50 CTS Series | Same |
Differences
| Parameter | Current CRYOcheck Chromogenic FVIII Claim | Modified CRYOcheck Chromogenic FVIII Claim |
|---|---|---|
| Device Description | CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components: Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizers. Reagent 2: Human FIIa, human FIXa, calcium chloride and phospholipids Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor. Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist. | CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components: Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizers. Reagent 2: Human FIIa, bovine FIXa, calcium chloride and phospholipids Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor. Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist. |
| Interferences | Hemoglobin: ≤500 mg/dL Intralipid: ≤500 mg/dL Bilirubin (unconjugated): ≤29 mg/dL Bilirubin (conjugated): ≤2 mg/dL von Willebrand factor: ≤20 µg/mL Unfractionated heparin: ≤2 IU/mL Low molecular weight heparin: ≤2 IU/mL Fondaparinux: ≤1.25 mg/L Lupus Anticoagulant: ≤1.8 dRVVT ratio Dabigatran and Rivaroxaban interfere with the quantification of FVIII activity. | Hemoglobin: ≤1000 mg/dL Intralipid: ≤830 mg/dL Bilirubin (unconjugated): ≤40 mg/dL Bilirubin (conjugated): ≤11 mg/dL von Willebrand factor: ≤20 µg/mL Unfractionated heparin: ≤3.3 IU/mL Low molecular weight heparin: ≤5 IU/mL Fondaparinux: ≤0.2 mg/L Lupus Anticoagulant: ≤1.8 dRVVT ratio Dabigatran and Rivaroxaban interfere with the quantification of FVIII activity. Emicizumab: ≤150 µg/mL Mim8: ≤8 µg/mL Warfarin: INR ≤7 |
Page 8
510(k) Executive Summary
CRYOcheck Chromogenic Factor VIII
Page 4 of 5
| Parameter | Current CRYOcheck Chromogenic FVIII Claim | Modified CRYOcheck Chromogenic FVIII Claim |
|---|---|---|
| Recovery of FVIII Replacement Therapies | The performance of this device has not been established in evaluating the potency of FVIII concentrates. | CRYOcheck Chromogenic Factor VIII accurately evaluated the potency of FVIII replacement products including ADVATE, ADYNOVATE, AFSTYLA, ALTUVIIO, ESPEROCT, HUMATE-P, JIVI, KOVALTRY, Novoeight, Nuwiq, and wilate at concentrations ranging from 0.05 to 1.0 IU/mL. It also accurately evaluated the potency of ELOCTATE, and XYNTHA from 0.05 to 0.6 IU/mL, with an over recovery observed at 0.8 and 1.0 IU/mL. There was an underestimation of OBIZUR. |
Summary of Performance Testing
All studies were performed using the changed CRYOcheck Chromogenic Factor VIII on Instrumentation Laboratory ACL TOP CTS Series or TOP 50 CTS Series instruments. Precision, reproducibility, accuracy (method comparison), reference interval, shelf-life stability, in-use stability, linearity, and detection capability performance characteristics are all substantially equivalent to the current device.
Updated claims include interferences updates, and factor VIII replacement therapy recovery.
Interferences
Interference studies were conducted according to CLSI EP07-A3 using a single lot of CRYOcheck Chromogenic Factor VIII on an IL ACL TOP CTS instrument (K160276). Plasma samples were spiked with possible interferents, and 10 replicates were tested alongside 10 replicates of the corresponding blank matrix control. The following substances showed no interference up to the concentrations indicated.
| Possible Interferent | Concentration |
|---|---|
| Hemoglobin | ≤1000 mg/dL |
| Intralipid | ≤830 mg/dL |
| Bilirubin (unconjugated) | ≤40 mg/dL |
| Bilirubin (conjugated) | ≤11 mg/dL |
| von Willebrand factor | ≤20 µg/mL |
| Unfractionated heparin | ≤3.3 IU/mL |
| Low molecular weight heparin | ≤5 IU/mL |
| Fondaparinux | ≤0.2 mg/L |
| Lupus Anticoagulant | ≤1.8 dRVVT ratio |
| Emicizumab | ≤150 µg/mL |
| Mim8 | ≤8 µg/mL |
| Warfarin | INR ≤7 |
Rivaroxaban and dabigatran interfered with the quantification of FVIII activity.
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510(k) Executive Summary
CRYOcheck Chromogenic Factor VIII
Page 5 of 5
Recovery of Factor VIII Replacement Therapy
A recovery study was conducted using a single lot of CRYOcheck Chromogenic Factor VIII on an IL ACL TOP 550 CTS instrument (K150877). Congenital FVIII deficient plasma was spiked with 14 FVIII replacement therapies at seven concentrations and percent recovery was determined. CRYOcheck Chromogenic Factor VIII accurately evaluated the potency of FVIII concentrates including ADVATE, ADYNOVATE, AFSTYLA, ALTUVIIO, ESPEROCT, HUMATE-P, JIVI, KOVALTRY, Novoeight, Nuwiq, and wilate at concentrations ranging from 0.05 to 1.0 IU/mL. It also accurately evaluated the potency of ELOCTATE, and XYNTHA from 0.05 to 0.6 IU/mL, with an over recovery observed at 0.8 and 1.0 IU/mL. There was an underestimation of OBIZUR.
| Product | Mean Percent Recovery (%) |
|---|---|
| ADVATE® | 90.3 |
| ADYNOVATE® | 97.7 |
| AFSTYLA® | 89.8 |
| ALTUVIIIO® | 96.2* |
| ELOCTATE® | 116.3 |
| ESPEROCT® | 93.2 |
| HUMATE-P® | 95.0 |
| JIVI® | 98.5 |
| KOVALTRY® | 92.0 |
| Novoeight® | 115.6 |
| Nuwiq® | 90.2 |
| OBIZUR® | 49.5 |
| wilate® | 95.2 |
| XYNTHA® | 114.7 |
*Per the manufacturer's recommendations, the mean percent recovery value includes dividing by a correction factor of 2.5 for chromogenic measurement.
Conclusion
The performance testing results demonstrate that the changed CRYOcheck Chromogenic Factor VIII is substantially equivalent to the predicate device, CRYOcheck Chromogenic Factor VIII (K193204), and that the assay is effective for its labeled intended use.
§ 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).