(104 days)
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No
The description details a standard ELISA assay with results based on optical density values compared to a cutoff, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is designed as an in vitro diagnostic kit to screen samples for the presence of alloantibodies to FVIII, rather than providing treatment or therapy.
Yes
The device is described as an "in vitro diagnostic kit" intended to "assist in screening samples for the presence of alloantibodies to epitopes on FVIII molecule," which directly relates to diagnosing a condition.
No
The device description clearly states it is an "ELISA platform" and an "in vitro diagnostic kit," which are hardware-based laboratory assays, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the product is "intended to be used as an in vitro diagnostic kit".
- Device Description: The description details how the assay is performed on "human plasma samples" to detect antibodies, which is a common characteristic of in vitro diagnostic tests.
- Performance Studies: The inclusion of performance studies comparing the device to a "Bethesda assay" (another diagnostic test) further supports its classification as an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K993553 GTI-PF4 ELISA) indicates that this device is being compared to a previously cleared diagnostic device, a standard process for IVD submissions.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FVIII Inhibitor Assay is a solid phase Enzyme-Linked Immunosorbent Assay (ELISA) which is used to detect IgG antibodies reactive with recombinant human FVIII.
GTI-FVIII Inhibitor Assay is designed as a solid phase Enzyme-Linked Immunosorbent Assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories providing factor VIII inhibitor assay to assist in screening samples for the presence of alloantibodies to epitopes on FVIII molecule.
Product codes (comma separated list FDA assigned to the subject device)
GGP
Device Description
FVIII Inhibitor Assay is an ELISA platform which is designed to detect IgG antibodies to human recombinant FVIII in human plasma samples. Recombinant human FVIII molecules are passively immobilized in microtiter wells. Patient plasma is tested against wells containing immobilized recombinant FVIII and compared to the reaction obtained from the negative control sera included in the kit. The results are obtained in optical density (OD) values. The patient samples having OD values greater than the cutoff value are regarded as being positive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hemostasis and other laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
GTI-FVIII Inhibitor Assay was compared to Bethesda assay in two independent clinical laboratories. Results indicated that GTI-FVIII Inhibitor Assay detects FVIII antibodies with a concordance of 89.6%, sensitivity of 98.9%, and negative predictive value of 98.8% as compared to Bethesda assay.
Lot-to-lot testing of GTI-FVIII Inhibitor Assay was comparable between three different lots.
Tech-to-tech testing of GTI-FVIII Inhibitor Assay showed good correlation of the results obtained by three different individuals.
Stability data carried out over a 27 month period indicated that GTI- FVIII Inhibitor Assay remains stable during the dating period.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
concordance of 89.6%, sensitivity of 98.9%, and negative predictive value of 98.8%
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.
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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.
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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).
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§ 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
1 2000 FEB
1 11 1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is | K993553 |
|---|---|
| Name: | FVIII Inhibitor |
| Equivalence: | PF4 ELISA |
| Description: | FVIII Inhibitor Assay is an ELISA platform which is designed to detect IgG antibodies to human recombinant FVIII in human plasma samples. Recombinant human FVIII molecules are passively immobilized in microtiter wells. Patient plasma is tested against wells containing immobilized recombinant FVIII and compared to the reaction obtained from the negative control sera included in the kit. The results are obtained in optical density (OD) values. The patient samples having OD values greater than the cutoff value are regarded as being positive. |
| Intended Use: | FVIII Inhibitor Assay is a solid phase Enzyme-Linked Immunosorbent Assay (ELISA) which is used to detect IgG antibodies reactive with recombinant human FVIII. |
Comparison of FVIII Inhibitor Assay to the predicate device:
The following table demonstrates the comparison:
| Feature/
Characteristic | GTI-PF4
ELISA | GTI-FVIII
Inhibitor Assay |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | Solid Phase ELISA for the
detection of heparin-
associated antibodies reactive
with PF4/PVS complexes. | Solid Phase ELISA for the
detection of antibodies
directed against epitopes on
recombinant human factor
VIII molecule |
| IMMUNOASSAY FORMAT | SOLID PHASE ELISA | |
| TYPE OF TEST | QUALITATIVE | |
1
| ANTIGEN SOURCE | Affinity purified
Human PF4 | Recombinant human FVIII |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| TARGET ANTIGEN
IMMOBILIZATION | PF4/PVS complex passively
adsorbed in microtiter wells | Recombinant human FVIII
Passively adsorbed in
microtiter wells |
| INTERPRETATION OF
TEST RESULTS | The OD for each microtiter
Well is compared to a cut off
value in order to determine the
positive & negative results | The OD for each microtiter
well is compared to a cutoff
value in order to determine the
positive & negative results |
| TYPE OF ANTIBODIES
DETECTED | Heparin-associated antibodies
Reactive with PF4/PVS
complexes | FVIII inhibitor antibodies
reactive with recombinant
human factor VIII |
Support of 510(k) with Clinical Data
GTI-FVIII Inhibitor Assay was compared to Bethesda assay in two independent clinical laboratories. Results indicated that GTI-FVIII Inhibitor Assay detects FVIII antibodies with a concordance of 89.6%, sensitivity of 98.9%, and negative predictive value of 98.8% as compared to Bethesda assay.
Support of 510(k) with Non-Clinical Data
Lot-to-lot testing of GTI-FVIII Inhibitor Assay was comparable between three different lots.
Tech-to-tech testing of GTI-FVIII Inhibitor Assay showed good correlation of the results obtained by three different individuals.
Stability data carried out over a 27 month period indicated that GTI- FVIII Inhibitor Assay remains stable during the dating period.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing snakes or streams.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 2000
Mr. Michael Moghaddam Director, Product Development Genetic Testing Institute 150 North Patrick Boulevard Brookfield, Wisconsin 53045-5837
Re: K993553 Trade Name: GTI-FVIII Inhibitor Assay Regulatory Class: II Product Code: GGP Dated: January 4, 2000 Received: January 5, 2000
Dear Mr. Moghaddam:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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Page 2
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 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
| Page _ | of _ |
|---|---|
| -------- | ------ |
510(k) Number (if known): K993553
Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE
GTI-FVIII Inhibitor Assay is designed as a solid phase Enzyme-Linked Immunosorbent Assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories providing factor VIII inhibitor assay to assist in screening samples for the presence of alloantibodies to epitopes on FVIII molecule.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suta E. Machi
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)