(54 days)
Not Found
No
The 510(k) summary describes a laboratory reagent (factor deficient plasma) used in a clotting assay, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used for in vitro diagnostic testing to determine factor levels, not for treating or preventing disease in a patient.
Yes
The device is intended for the "quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein," which is a diagnostic purpose to identify or assess a medical condition.
No
The device description clearly states "Factor deficient plasma," indicating a biological reagent, not software.
Based on the provided information, 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 classic example of an in vitro diagnostic test used to analyze a sample (plasma) from a patient to diagnose or monitor a medical condition.
- Device Description: The description mentions "in vitro diagnostic use."
- Environment of Use: It's intended for use in "Clinical laboratories," which are the typical settings for IVD testing.
- Predicate Device: The mention of a predicate device (K792507 - Helena - Factor V) which is also a Factor V product, strongly suggests that this device falls under the same regulatory category, which for these types of products is IVD.
The other sections (image processing, AI/ML, anatomical site, etc.) are not relevant to determining if a device is an IVD. The core definition of an IVD is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
Indicated use - Factor deficient plasma, Factor - V 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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Factor deficient plasma to be free of antigen of Factor V 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)
Performance Testing:
- Compare assay to known sample: Yes
- Negative by FDA approved test for HIV 1/2 and HBsAG: Yes
- Negative by FDA approved test for HCV and HIV-1ag: Yes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Helena - K792507 - Factor V
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 sections, each representing a portion of the Earth's surface. The projection appears to be a type of interrupted projection, where the map is split to reduce distortion. Continents and oceans are visible, with grid lines indicating latitude and longitude.
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
October 17, 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 - V |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - V |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - V |
| Predicate devices: | Helena - K792507 - Factor V |
| Device description: | Factor deficient plasma to be free of antigen of Factor V utilized
in in vitro diagnostic use |
Intended use:
Indicated use - Factor deficient plasma, Factor - V 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 | Helena |
|---|---|---|
| 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 V deficient plasmas offered | Yes | Yes |
1
Non-Confidential Summary of Safety and Effectiveness (continued)
October 17, 1996
page 2 of 2
Comparison to predicate devices: (continued)
| Attribute | Intended
products | Helena |
|-----------------------------------------------------------------------------------------|----------------------|-----------|
| Packaging either -
Frozen or Dry / Iyophilized | 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.