(287 days)
Cryov Check™ Factor XI Deficient Plasma is recommended for use as a substrate in clot-based Factor XI assays using the activated partial thromboplastin time (APTT).
Cryo Check™ Factor XI Deficient Plasma is frozen human plasma deficient in the Factor XI coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XI by immunoadsorption. Activity levels of Factor XI are assayed at less than 1% normal levels while all other coagulation factors are within normal ranges.
The provided text describes the 510(k) summary for CryoCheck™ Factor XI Deficient Plasma, focusing on its non-clinical performance data for open vial stability.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (Summary Statistics) |
|---|---|---|
| Mean % Recovery of Factor XI | Mean (+/-) 5% of reference value | 0 Hours: 97.2%, 24 Hours: 96.2%, Average: 96.7% |
| Coefficient of Variation (C.V.%) | < 5% | 0 Hours: 1.53%, 24 Hours: 2.37%, Average: 1.95% |
| Open Vial Stability Duration (Claim) | Acceptable based on meeting the above criteria | 8 hours |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 5 samples at 0 hours and 5 samples at 24 hours (total of 10 measurements for summary statistics).
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. However, it's a non-clinical performance test conducted by the manufacturer, Precision Biologicals Incorporated, located in Dartmouth, Nova Scotia, Canada. The study appears to be prospective as it involves specifically testing the device's stability over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The "ground truth" here is the "known reference plasma" to which the Factor XI assays are compared, but details about its establishment or expert involvement are absent. The test is comparing the device's performance to a "known reference plasma," implying an established standard, but no human expert consensus process is described for this specific test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable to this type of non-clinical performance study. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies among evaluators need to be resolved. This study focuses on objective measurements of Factor XI recovery.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable. This is a non-clinical performance study for an in vitro diagnostic reagent, not an AI-assisted diagnostic tool involving human readers or interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This device is a reagent for laboratory testing; it does not involve algorithms or AI in the way implied by "standalone performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for this test is a known reference plasma. The Factor XI assays were performed on this reference plasma, and the "recovered factor XI values" using the CryoCheck™ Factor XI Deficient Plasma as a substrate were compared to it. The "reference value" is also implied as the basis for the acceptance criteria "Mean (+/-) 5% of reference value."
8. The sample size for the training set
- This information is not applicable. The device is a diagnostic reagent, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- This information is not applicable for the same reasons as point 8.
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LG81173
JAN 1 3 1999
510(k) Summary for Cryov Check™ Factor XI Deficient Plasma
- Submitter's Address and Contact Information 1.
- Precision Biologicals Incorporated a) 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: pbi@fox.nstn.ca
- Date Prepared: March 09, 1998 c)
- Device Name 2.
| a) | Proprietary (trade) name: | Cryo✓Check™ Factor XI Deficient Plasma |
|---|---|---|
| b) | Common name: | Factor XI Deficient Plasma (human) |
| c) | Classification name: | Coagulation Factor Deficient Plasma |
| d) | Classification information: | Regulatory Class IIHematology PanelProduct Code - 81 GJT |
3. Device Description:
Cryo Check™ Factor XI Deficient Plasma is frozen human plasma deficient in the Factor XI coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XI by immunoadsorption. Activity levels of Factor XI are assayed at less than 1% normal levels while all other coagulation factors are within normal ranges.
V - 1
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Intended Use 4.
b)
Cryov Check™ Factor XI Deficient Plasma is recommended for use as a substrate in clot-based Factor XI assays using the activated partial thromboplastin time (APTT).
- Substantially Equivalent Device న్.
- a) 510(k) number: K900411
- Factor XI Deficient Plasma Trade Name: c)
- d) Manufacturer: Sigma
- Substantial Equivalence Comparison e)
Cryo Check™ Factor XI 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 XI Deficient Plasma differs from the predicate device in that it is a frozen liquid preparation and not a lyophillized Additionally, CryovCheck™ Factor XI Deficient Plasma is product. prepared from normal human plasma from which Factor XI has been immunoadsorbed, while the predicate device is derived from human donors with a congenital Factor XI 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:
- i) Factor XI assays were performed on a known reference plasma using vials of Cryo Check™ Factor XI Deficient Plasma as a substrate. Recovered factor XI values were measured at 0 hours and 24 hours. (see table for results)
- b) Conclusions:
- a) Testing Performed:
Test results indicate that a claim of 8 hours open vial stability is acceptable.
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| Table S1 | |||
|---|---|---|---|
| Open Vial Stability of Cryo✓Check™ | |||
| Factor XI Deficient Plasma | |||
| Summary Statistics (% Recovery) | |||
| 0 Hours | 24 Hours | Average | |
| MEAN | 97.2 | 96.2 | 96.7 |
| MAXIMUM | 99 | 99 | 99 |
| MINIMUM | 95 | 93 | 93 |
| S.D. | 1.48 | 2.28 | 1.89 |
| 2 S.D. | 2.97 | 4.56 | 3.78 |
| SAMPLE SIZE | 5 | 5 | 10 |
| C.V.% | 1.53 | 2.37 | 1.95 |
Note: Reference Value =
.
Acceptable values are: Mean (+/-) 5% of reference value; and %C.V. < 5%
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JAN 1 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Sandy Morrison Manager, Technical Operations Precision Biologicals Incorporated 900 Windmill Road Unit # 100 Dartmouth, Nova Scotia CANADA B3B 1P7
Re: K981173
Trade Name: Cryo Check™ Factor XI Deficient Plasma Regulatory Class: II Product Code: GJT Dated: March 27, 1998 Received: April 1, 1998
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: KG81173
Device Name: CryovCheck™ Factor XII Deficient Plasma
Indications for Use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor XII (also known as Hageman factor) is a serine protease located in the "intrinsic coagulation pathway". Patients with Factor XII deficiency generally do not have significant bleeding tendencies. Factor XII deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT).
CryovCheck™ Factor XII Deficient Plasma is human plasma deficient in the Factor XII coagulation protein while having all other coagulation factors greater than 50%. It is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT).
Peter E. Marki
(Division Sign-Off)
Division of Clinical Laboratory Devices K451173
510(k) Number
Recyphoi
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).