(287 days)
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No
The summary describes a biological reagent (deficient plasma) used in a laboratory assay, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is used as a substrate in assays to measure Factor XI levels, not for treating a condition.
No
This device is a reagent (Factor XI Deficient Plasma) used as a substrate in clot-based Factor XI assays, not a diagnostic device itself.
No
The device is a biological reagent (frozen human plasma) used as a substrate in laboratory assays, not a software program.
Based on the provided information, 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 XI assays using the activated partial thromboplastin time (APTT)." This describes a test performed in vitro (outside the body) on a biological sample (plasma) to provide information about a patient's health status (Factor XI levels).
- Device Description: The description details a product derived from human plasma, specifically designed to be deficient in a particular coagulation factor for use in laboratory testing.
- Performance Studies: The summary of performance studies describes testing performed on the device in vitro to assess its stability and suitability for use in Factor XI assays.
- Predicate Device: The mention of a predicate device with a K number (K900411) and the name "Factor XI Deficient Plasma" strongly indicates that this device is being submitted for regulatory clearance as an IVD, likely through the 510(k) pathway.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes
81 GJT
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.
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 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. Test results indicate that a claim of 8 hours open vial stability is acceptable.
Key Metrics
| 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 |
Predicate Device(s)
Reference Device(s)
Not Found
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
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 II |
| Hematology Panel | ||
| Product 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
1
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.
2
| 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.