(66 days)
Not Found
No
The summary describes a diagnostic reagent (plasma) used in a clotting assay, with no mention of AI/ML terms, image processing, or data training/testing.
No
The device is described as "Factor deficient plasma" used for "quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay," which indicates it is an in vitro diagnostic (IVD) device, not a therapeutic one.
Yes
The device is described as "intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency... and is performed by clotting assay," which clearly indicates a diagnostic purpose. The "in vitro diagnostic use" in the Device Description further supports this.
No
The device description clearly states it is "Factor deficient plasma," which is a biological material used in in vitro diagnostic testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay." This describes a test performed on a sample taken from the human body (plasma) to diagnose or monitor a medical condition (factor deficiency).
- Device Description: The description mentions "in vitro diagnostic use."
- Care Setting: The intended user is "Clinical laboratories," which is a typical setting for IVD testing.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated use - Factor deficient plasma, Factor - VIII is a human plasma immunodepleted of the indication and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Product codes
Not Found
Device Description
Factor deficient plasma to be free of antigen of Factor VIII utilized in in vitro diagnostic use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Compare assay to known sample
Negative by FDA approved test for HIV 1/2 and HBSAG
Negative by FDA approved test for HCV and HIV-1ag
Deficiency of relevant factor less than 1%
Negative for HIV and HBSAG
Negative for HCV, HIV-1ag
No inhibitor present
Key Metrics
Not Found
Predicate Device(s)
OTC Factor VIII - K823453
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
Image /page/0/Picture/0 description: The image is a black and white illustration of a world map projection. The map is presented in a distorted, segmented format, with the continents outlined in white against a background of grid lines. The grid lines are curved and distorted, reflecting the unusual projection method used to represent the Earth's surface.
Universal Reagents, Inc.
2858 N. Pennsylvania St. Indianapolis, IN 46205
UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
PR 25 1997
Non-Confidential Summary of Safety and Effectiveness February 17, 1997 page 1 of 2
Tel - (317) 926-0006 Fax - (317) 926-0014
| Official contact: | Jorge Miller, Director, Coagulation Products |
|---|---|
| Proprietary or Trade Name: | Factor deficient coagulation plasma - VIII |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - VIII |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - VIII |
| Predicate devices: | OTC Factor VIII - K823453 |
| Device description: | Factor deficient plasma to be free of antigen of Factor VIII |
| utilized in in vitro diagnostic use. |
Intended use:
Indicated use - Factor deficient plasma, Factor - VIII is a human plasma immunodepleted of the indication and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Environment of use: Clinical laboratories
Comparison to predicate devices:
| Attribute | Intended product | OTC |
|---|---|---|
| Use | ||
| Indicated for use in determination | ||
| of coagulation of plasma | Yes | Yes |
| In vitro diagnostic use | Yes | Yes |
| Used as a quantitative assay | Yes | Yes |
| Design | ||
| Factor VIII deficient plasma offered | Yes | Yes |
1
Non-Confidential Summary of Safety and Effectiveness (continued)
February 17, 1997
page 2 of 2
Comparison to predicate devices: (continued)
| Attribute | Intended products | OTC |
|---|---|---|
| Packaging either - | ||
| Frozen or Dry / lyophilized | Yes | Yes |
| Can be used with different | ||
| instruments and reagents per | ||
| manufacturer instructions | Yes | Yes |
| Materials | ||
| Donor human plasma | Yes | Yes |
| Enhanced bovine factor V | Yes | Yes |
| Various buffers | Yes | Yes |
| Performance Testing | ||
| Compare assay to known sample | Yes | Yes |
| Negative by FDA approved test for | ||
| HIV 1/2 and HBSAG | Yes | Yes |
| Negative by FDA approved test for | ||
| HCV and HIV-1ag | Yes | not known |
| Deficiency of relevant factor | ||
| less than 1% | Yes | not known |
| Negative for HIV and HBSAG | Yes | Yes |
| Negative for HCV, HIV-1ag | Yes | not known |
| No inhibitor present | Yes | not known |
Differences
The only difference is that the intended product is claimed to be negative for HCV and HIV-1ag by an FDA approved test.
Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device.