(287 days)
CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.
Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.
Acceptance Criteria and Study Details for Cryo✓Check™ Factor XII Deficient Plasma
The device's performance was evaluated through an "Open Vial Stability" study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (24 Hours) |
|---|---|
| Mean (+/-) 5% of reference value | 93 (within 5% of reference value, as 92.9% is the overall average) |
| %C.V. < 5% | 3.4% (for 24 hours) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 5
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that Precision Biologicals Incorporated is located in Dartmouth, Nova Scotia, Canada, it is likely the study was conducted in Canada. The nature of stability testing suggests it was a prospective study.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This study focuses on the stability of a diagnostic reagent, not on interpreting images or clinical cases that would require expert consensus for ground truth. The "ground truth" reference value would be established by the assay's own internal standards.
4. Adjudication Method
Not applicable. The study involved quantitative measurements of factor XII activity, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study comparing human readers with and without AI assistance. It's a stability study for a diagnostic reagent.
6. Standalone Performance
The study primarily evaluates the standalone performance of the Cryo✓Check™ Factor XII Deficient Plasma in terms of its ability to maintain its reference value over time.
7. Type of Ground Truth Used
The ground truth used is a reference value established by the assay itself. The document states "Reference Value =" and implies the reported mean, maximum, and minimum values are compared against this reference. The specific method for determining this absolute reference value is not detailed, but it would typically involve calibrating against known standards.
8. Sample Size for Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable. No training set was used.
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JAN 1 3 1999
510(k) Summary for Cryo✓Check™ Factor XII 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 10, 1998 c)
- Device Name 2.
| a) | Proprietary (trade) name: | Cryo✓Check™ Factor XII Deficient Plasma |
|---|---|---|
| b) | Common name: | Factor 12 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 XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.
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Intended Use 4.
CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.
- Substantially Equivalent Device 5.
- 510(k) number: K900412 a)
- Trade Name: Factor XII Deficient Plasma b)
- Manufacturer: Sigma c)
- d) Substantial Equivalence Comparison
Cryo Check™ Factor XII 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 XII Deficient Plasma differs from the predicate device in that it is a frozen liquid preparation and not a lyophillized Additionally, Cryo Check™ Factor XII Deficient Plasma is product. prepared from normal human plasma from which Factor XII has been immunoadsorbed, while the predicate device is derived from human donors with a congenital Factor XII 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 XII assays were performed on a known reference plasma using vials of Cryor Check™ Factor XII Deficient Plasma as a substrate. Recovered factor XII 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 XII Deficient Plasma | |||
| Summary Statistics (% Recovery) | |||
| 0 Hours | 24 Hours | Average | |
| MEAN | 92.8 | 93 | 92.9 |
| MAXIMUM | 96 | 97 | 97 |
| MINIMUM | 90 | 89 | 89 |
| S.D. | 2.17 | 3.16 | 2.56 |
| 2 S.D. | 4.34 | 6.32 | 5.12 |
| SAMPLE SIZE | 5 | 5 | 10 |
| C.V.% | 2.34 | 3.4 | 2.75 |
Note: Reference Value =
Acceptable values are: Mean (+/-) 5% of reference value; and %C.V. < 5%
§ 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).