(25 days)
K# unknown
Not Found
No
The summary describes a laboratory reagent (factor deficient plasma) for in vitro diagnostic use and does not mention any AI or ML components or functionalities.
No
This device is an in vitro diagnostic (IVD) product used to measure factor levels in patient samples, not to treat a medical condition.
Yes
Explanation: The device is intended for the "quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI," which is a diagnostic purpose to identify or confirm a medical condition. It is also explicitly stated as "in vitro diagnostic use."
No
The device description clearly states it is "Factor deficient plasma," which is a biological reagent, 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 Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI." This is a diagnostic purpose performed in vitro (outside the body).
- Device Description: The description mentions "in vitro diagnostic use" and that the product is "made from human plasma that has been artificially depleted." This further confirms its use in laboratory testing.
- Intended User / Care Setting: The intended user is "Clinical laboratories," which is a typical setting for IVD testing.
The information provided clearly indicates that this product is designed to be used in a laboratory setting to diagnose or assess a medical condition (Factor XI deficiency) by testing a sample taken from the human body. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated use - Factor deficient plasma, Factor - XI 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.
This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.
Product codes (comma separated list FDA assigned to the subject device)
GJT, GGP
Device Description
Factor deficient plasma to be free of antigen of Factor XI utilized in in vitro diagnostic use.
Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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
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 (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.
Pacific Hemostasis Factor XI - K# unknown
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
JUL 14 1997
Safety and Effectiveness Summary and Premarket Notification Truthful and Accurate Statement
Safety and effectiveness summary:
Section # 2
The Non-confidential Summary of Safety and Effectiveness follows.
Premarket Notification Truthful and Accurate Statement:
As recommended, this statement has been placed on company letterhead and follows.
1
Image /page/1/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 are recognizable, but their shapes are not accurate.
UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
- . . . .
Non-Confidential Summary of Safety and Effectiveness June 18, 1997 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 - XI |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - XI |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - XI |
| Predicate devices: | Pacific Hemostasis Factor XI - K# unknown |
| Device description: | Factor deficient plasma to be free of antigen of Factor XI
utilized in in vitro diagnostic use. |
Intended use:
Indicated use - Factor deficient plasma, Factor - XI 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 | Pacific Hemostasis |
|---|---|---|
| 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 XI deficient plasma offered | Yes | Yes |
| page 3 of 30 |
2
Non-Confidential Summary of Safety and Effectiveness
June 18, 1997
page 2 of 2
Comparison to predicate devices: (continued)
| Attribute | Intended
product | Pacific Hemostasis |
|-----------------------------------------------------------------------------------------|---------------------|--------------------|
| 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 |
| 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.
page 4 of 36
2n
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
JUL 1 4 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jorge Miller Director, Coagulation Products Universal Reagents, Inc..... ..... 2858 North Pennsylvania Street Indianapolis, Indiana 46205
K972286 Re : URI Factor XI Requlatory Class: II Product Code: GJT, GGP Dated: June 18, 1997 Received: June 19, 1997
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
4
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one roganieren one instion" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section # 3 Labeling (continued)
page 1 of 1
C. Indications for Use Statement
Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is per that request.
510(k) Number: (to be assigned)
Device Name:
、
Factor Deficient Coagulation Plasma Factor - XI (11)
Indications for Use:
This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.
Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
Claims -Negative per FDA approved test for HIV 1/2, HBsAG, HCV, HIV-1ag · Packaging -Frozen
Freeze dried - Lyophilized
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices
510(k) Number 7-60-92
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
page 7 of 36
Section # 4
Section #
crons # 6,
ttachments