(287 days)
No
The summary describes a biological reagent (deficient plasma) used in a laboratory assay, with no mention of computational analysis, algorithms, or AI/ML terms.
No
This device is a diagnostic reagent, used as a substrate in clot-based Factor XII assays, not for treating a condition.
Yes
The device is used as a substrate in clot-based Factor XII assays, which are diagnostic tests used to evaluate a patient's coagulation system.
No
The device is a biological reagent (frozen human plasma) used as a substrate in a laboratory assay, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is "recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay." This describes a test performed in vitro (outside the body) on a sample (plasma) to diagnose or monitor a condition related to blood coagulation.
- Device Description: The description details a product derived from human plasma, processed to be deficient in a specific factor, and intended for use in a laboratory test.
- Predicate Device: The mention of a predicate device (K900412; Factor XII Deficient Plasma) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes for similar IVD products.
The information provided aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
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.
Product codes
81 GJT
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%.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
24 Hour Open Vial Stability: 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. The conclusion was that test results indicate that a claim of 8 hours open vial stability is acceptable.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 II |
| Hematology Panel | ||
| Product 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%.
1
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.
2
| 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.