(34 days)
K# unknown
Not Found
No
The summary describes a laboratory reagent for measuring coagulation factor levels and does not mention any computational or algorithmic components indicative of AI/ML.
No.
This device is an in vitro diagnostic (IVD) product used for quantitative determination of factor levels in patient samples, not for treating or preventing disease.
Yes
This device is described as being "for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII," which indicates it is used to identify a medical condition. It also states "utilized in in vitro diagnostic use."
No
The device description clearly states it is "Factor deficient plasma," which is a biological reagent, not software. The intended use also describes a laboratory test using this plasma.
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 factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII." This is a diagnostic purpose performed in vitro (outside the body) on a biological sample (plasma).
- Device Description: The description confirms it's "utilized in in vitro diagnostic use."
- Intended User / Care Setting: It's intended for "Clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
- Performance Studies: The summary of performance studies describes comparisons to known samples and testing for infectious agents, which are standard procedures for evaluating the performance and safety of in vitro diagnostic reagents derived from human plasma.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (even if unknown) and a name like "Pacific Hemostasis Factor XII" strongly suggests this device is being compared to a previously cleared or approved IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated use - Factor deficient plasma, Factor - XII is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the 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 factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII.
Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
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 XII 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
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 XII - 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
Image /page/0/Picture/0 description: This image shows a world map projection. The map is divided into several sections, each representing a different part of the world. The continents are outlined in black, and the grid lines are also black. The map appears to be a type of interrupted projection, possibly designed to minimize distortion of landmasses.
UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
SEP 2 5 1997
Non-Confidential Summary of Safety and Effectiveness August 21, 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 - XII |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - XII |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - XII |
| Predicate devices: | Pacific Hemostasis Factor XII - K# unknown |
| Device description: | Factor deficient plasma to be free of antigen of Factor XII |
| utilized in in vitro diagnostic use. |
Intended use:
Indicated use - Factor deficient plasma, Factor - XII is a human plasma immunodepleted of the
specific factor and intended for use in the quantitative determination of the 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 XII deficient plasma offered | Yes | Yes |
| page 3 of 36 |
1
Non-Confidential Summary of Safety and Effectiveness
August 21, 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
r
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
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 5 1997
Jorge Miller Director, Coaqulation Products Universal Reagents, Inc. 2858 North Pennsylvania Street Indianapolis, Indiana 46205
Re : K973143 URI Factor XII Requlatory Class: II GJT, GGP Product Code: September 8, 1997 Dated: Received: September 15, 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 reqistration, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation 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 regulations.
3
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 premarket notification" (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
4
Section # 3
Labeling (continued)
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 - XII (12) | |
| Indications for Use: | |
| Indicated use - | This product is intended for use in the quantitative determination of |
| factor levels in patients suspected of congenital or acquired deficiency | |
| of this coagulation protein or factor, XII. | |
| Factor immunodeficient plasma XII 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
510(k) Number. 197343
Prescription Use (Per 21 CFR 801.109)
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