(146 days)
Not Found
No
The summary describes an in vitro diagnostic reagent (factor deficient plasma) used in clotting assays, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for performing in vitro diagnostic tests to determine factor levels, not for treating a condition.
Yes
This device, "Factor deficient plasma," is used 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 aligns with the definition of a diagnostic device as it helps identify and measure specific medical conditions. Its intended use in "in vitro diagnostic use" further supports this classification.
No
The device description clearly states it is "Factor deficient plasma," which is a biological material, 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 to provide information about a medical condition.
- Device Description: The description mentions it is "utilized in in vitro diagnostic use."
- Performance Studies: The performance studies involve comparing the assay to known samples and testing for the presence of viruses, which are typical evaluations for IVD devices.
- Predicate Devices: The listed predicate devices are also described as "Factor Deficient Plasmas," which are known types of IVD reagents used in coagulation testing.
All of these points strongly indicate that this device is designed and intended for use in an in vitro diagnostic setting.
N/A
Intended Use / Indications for Use
Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, 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. Factor VIII is human plasma and bovine material.
Product codes
Not Found
Device Description
Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XI, XII, respectively, 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
Hospital, 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)
K924394, K924396, K924400, K893523, K893524, K893525, K893533, K893534, K893535, K893536, K900133
Reference Device(s)
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 is a black and white drawing of a world map. The map is drawn in a unique projection, where the continents are stretched and distorted. The map is also overlaid with a grid of lines, which may represent latitude and longitude. The continents of North America, South America, Africa, Europe, Asia, and Australia are all visible in the image.
UNIVERSAL REAGENTS, INC.
2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
OCT 1 0 1996
Non-Confidential Summary of Safety and Effectiveness
May 15, 1996
page 1 of 3
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 - II, V, VII, VIII, IX, X, XI, XII | ||
| Common/Usual Name: | Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII | ||
| Classification Name: | Factor deficient coagulation plasma | ||
| Intended device: | Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII | ||
| Predicate devices: | Behring Factor Deficient Plasmas - | ||
| K924394 - Factor V, K924396 - Factor VIII, IX, XI, XII | |||
| K924400 - Factor II, VII, X | |||
| and | |||
| Medical Diagnostics Technologies - | |||
| K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, | |||
| K893533 - Factor V, K893534 - Factor XII, K893535 - Factor VII, | |||
| K893536 - Factor XI, K900133 - Factor II. | |||
| Device description: | Factor deficient plasma to be free of antigen of Factor II, V, VII, | ||
| VIII, IX, X, XI, XII, respectively, utilized in in vitro diagnostic use. | |||
| Intended use |
Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, 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. Factor VIII is human plasma and bovine material.
Environment of use - Hospital, laboratories
page 3 of 25
1
Non-Confidential Summary of Safety and Effectiveness (continued)
May 15, 1996
page 2 of 3
Comparison to predicate devices: (continued)
| Attribute | Intended
products | Behring | Medical Diagnostics
Technologies |
|-----------------------------------------------------------------------------------------|----------------------|---------|-------------------------------------|
| Use | | | |
| Indicated for use in determination
of coagulation of plasma | Yes | Yes | Yes |
| In vitro diagnostic use | Yes | Yes | Yes |
| Used as a quantitative assay | Yes | Yes | Yes |
| Design | | | |
| Factor deficient plasmas offered -
II, V, VII, VIII, IX, X, XI, XII | Yes | Yes | Yes |
| Packaging either -
Frozen or Dry / lyophilized | Yes | Yes | Yes |
| Can be used with different
instruments and reagents per
manufacturer instructions | Yes | Yes | Yes |
| Materials | | | |
| Donor human plasma | Yes | Yes | Yes |
| Bovine enhanced factor VIII | Yes | Yes | Yes |
| Various buffers | Yes | Yes | Yes |
| Performance Testing | | | |
| Compare assay to known sample | Yes | Yes | Yes |
| Negative by FDA approved test for
HIV 1/2 and HBsAG | Yes | Yes | Yes |
page 4 of 25
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2
Non-Confidential Summary of Safety and Effectiveness (continued)
May 15, 1996
page 3 of 3
Comparison to predicate devices: (continued)
| Attribute | Intended
products | Behring | Medical Diagnostic
Technologies |
|------------------------------------------------------|----------------------|-----------|------------------------------------|
| Performance Testing (continued) | | | |
| Negative by FDA approved test for
HCV and HIV-1ag | Yes | not known | not known |
| Donor criteria | | | |
| Deficiency of relevant factor
less than 1% | Yes | not known | Yes |
| Negative for HIV and HBSAG | Yes | Yes | Yes |
| Negative for HCV, HIV-1ag | Yes | not known | not known |
| No inhibitor present | Yes | not known | Yes |
B. Differences
(
The only difference is that the intended products are claimed to be negative for HCV and HIV-1ag by an FDA approved test.
Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.
page 5 of 25
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