(46 days)
Not found
Not Found
No
The summary describes a standard in vitro diagnostic test kit for quantitative determination of transferrin using immunoprecipitin analysis. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on substantial equivalence to a predicate device, which is common for traditional IVD kits.
No
The device is described as "FOR IN VITRO DIAGNOSTIC USE" and is designed for the quantitative determination of transferrin in human serum, which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "FOR IN VITRO DIAGNOSTIC USE." and describes the device as being "designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis," which is a diagnostic purpose.
No
The device is described as an "Immunological Test Kit" and "ANTIBODY REAGENT SET," which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first line explicitly states "FOR IN VITRO DIAGNOSTIC USE."
- Device Description: It is described as an "Immunological Test Kit," which is a common type of IVD.
- Intended User / Care Setting: It reiterates "FOR IN VITRO DIAGNOSTIC USE."
- Purpose: The intended use is for the "quantitative determination of transferrin in human serum by immunoprecipitin analysis," which is a laboratory test performed on a biological sample (serum) outside of the body to diagnose or monitor a condition.
All of these points strongly indicate that this device is intended for use in a laboratory setting to perform diagnostic tests on biological samples, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FOR IN VITRO DIAGNOSTIC USE. The Transferrin SPQ™ III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.
Product codes (comma separated list FDA assigned to the subject device)
DDG
Device Description
Transferrin (TRF) Immunological Test Kit
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
Not Found
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)
Nonclinical testing demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device. Clinical testing demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device.
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.
SPQ™ Antibody Reagent Set II for Transferrin
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
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).
0
DEC 18 1998
11983880
Special 510(k): Device Modification: Transferrin SPQ™ III Antibody Reagent Set
10 510(k) Summary
October 30, 1998
. .
| Submitted By: | Judith J. Smith
DiaSorin, Inc.
9175 Guilford Rd. Suite 100
Columbia, MD 21046 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name Of Device:
Trade Name: | Transferrin SPQ™ III Antibody Reagent Set |
| Common Name: | Transferrin (TRF) Immunological Test Kit |
| Classification Name: | Transferrin, antigen, antiserum, Control (82 DDG) |
| Device Classification | Class II |
| Predicate Device: | SPQ™ Antibody Reagent Set II for Transferrin |
| Device Description: | Transferrin (TRF) Immunological Test Kit |
| Intended Use: | FOR IN VITRO DIAGNOSTIC USE.
The Transferrin SPQ™ III ANTIBODY REAGENT SET is designed
for the quantitative determination of transferrin in human serum by
immunoprecipitin analysis. |
| Technological
Comparison: | The modified device has the same technological basis as the
predicate device. |
| Labeling Comparison: | The labeling of the modified assay is substantially equivalent to that
of the predicate device. Changes in labeling directly reflect the
device modification (higher titer primary antibody, elimination of
patient sample diluent). |
| Nonclinical Testing: | Nonclinical testing demonstrated that the performance
characteristics of the modified device were substantially equivalent
to those of the predicate device. |
| Clinical Testing: | Clinical testing demonstrated that the performance characteristics
of the modified device were substantially equivalent to those of the
predicate device. |
| Conclusions from
Testing: | The modified device is substantially equivalent to the predicate
device. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 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 a stylized symbol of three human profiles facing right, stacked on top of each other.
DEC 1 8 1998 Ms. Judith J. Smith Corporate Director Worldwide Requlatory Affairs And Ouality Systems DiaSorin, Inc. 9175 Guilford Road, Suite 100 Columbia, Maryland 21046
Re: K983880 Trade Name: Transferrin SPQ™ III Antibody Reagent Set Requlatory Class: II Product Code: DDG Dated: October 30, 1998 November 2, 1998 Received:
Dear Ms. Smith:
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 aqainst 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 A substantially equivalent determination assumes compliance to 895. 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2
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 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 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
3
Indications for Use 3
510(k) Number: _ K 983880
Device Name: Transferrin SPQ™ III Antibody Reagent Set
Indications For Use:
FOR IN VITRO DIAGNOSTIC USE.
The Transferrin SPQTM III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | f983880 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)