(41 days)
No
The summary describes a biological reagent (factor deficient plasma) used in a standard clotting assay, with no mention of computational analysis, algorithms, or learning processes.
No
This device is an in vitro diagnostic (IVD) product used for the quantitative determination of specific factor levels, not for treating a disease or condition. Its purpose is diagnostic, as indicated by its "Intended Use" 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."
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency." This clearly indicates a diagnostic purpose. Additionally, the "Device Description" section states it is for "in vitro diagnostic use."
No
The device description clearly states "Factor deficient plasma," indicating a biological product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for 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 is a diagnostic purpose performed in vitro (outside the body).
- Device Description: The description mentions "in vitro diagnostic use."
- Intended User/Care Setting: It's intended for "Clinical laboratories," which are typical settings for IVD testing.
- Performance Studies: The summary mentions comparing the assay to a "known sample," which is a common practice for validating the performance of an IVD.
- Predicate Device: The presence of a predicate device (K843310 - Sigma - Factor X) further supports its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
All these points strongly indicate that this device is designed and intended for use in diagnosing a medical condition (factor deficiency) using a sample of human origin (plasma) outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated use - Factor deficient plasma, Factor - X is a human plasma immunodepleted of the specific factor 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 X 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/0 description: The image shows a world map projection. The map is divided into several lobes, each representing a different region of the world. The map is also covered with a grid of lines, which are used to show the latitude and longitude of different locations. The map appears to be a type of interrupted projection, which is designed to minimize distortion.
UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
DEC 1 8 1996
Non-Confidential Summary of Safety and Effectiveness
November 1, 1996
page 1 of 2
Universal Reagents, Inc.
2858 N. Pennsylvania St.
Indianapolis, IN 46205
Tel - (317) 926-0006
Fax - (317) 926-0014
| Official contact: | Jorge Miller, Director, Coagulation Products |
|---|---|
| Proprietary or Trade Name: | Factor deficient coagulation plasma - X |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - X |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - X |
| Predicate devices: | Sigma - K843310 - Factor X |
| Device description: | Factor deficient plasma to be free of antigen of Factor X utilized in in vitro diagnostic use. |
Intended use:
Indicated use - Factor deficient plasma, Factor - X is a human plasma immunodepleted of the specific factor 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 | Sigma |
|---|---|---|
| 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 |
1
Non-Confidential Summary of Safety and Effectiveness (continued)
November 1, 1996
page 2 of 2
Comparison to predicate devices: (continued)
| Attribute | Intended products | Sigma |
|---|---|---|
| Design | ||
| 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 |
| 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 |
| Donor criteria | ||
| 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.