(71 days)
Not Found
Not Found
No
The summary describes a qualitative blood test kit and does not mention any AI or ML components or processes.
No
The device is a diagnostic tool used to determine the need for RhIg administration, not to directly treat a condition.
Yes
This device is a qualitative test used to indicate the need for further quantitative testing to determine if more RhIg is needed to protect a D negative mother from sensitization after delivering a D positive infant. This process of identifying a medical condition or its predisposition (D sensitization) fulfills the definition of a diagnostic device.
No
The device is described as a "Fetal D Tection Kit" which is used to test blood samples. This strongly implies the use of physical components (reagents, test strips, etc.) for the assay, not just software. The description focuses on a laboratory test procedure, not a software application.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "test blood samples drawn from D negative mothers". This involves testing biological samples in vitro (outside the body).
- Device Description (Implied): While the description is "Not Found", the intended use describes a "Kit" used for testing blood samples. This strongly suggests a collection of reagents, materials, or instruments designed for laboratory analysis of biological specimens.
- Anatomical Site: The anatomical site is "blood samples", which are biological specimens tested in vitro.
- Intended User / Care Setting: The intended user is a "Clinical Laboratory", which is the typical setting for performing in vitro diagnostic tests.
The core function of the device is to analyze a biological sample (blood) outside the body to provide information about a patient's condition (presence of D antigen in the infant's blood, indicating potential sensitization risk for the mother). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.
Product codes
LIM
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7455 Fetal hemoglobin assay.
(a)
Identification. A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.(b)
Classification. Class II (special controls). A fetal hemoglobin stain intended for use with a fetal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 8 1998
Mr. Peter L. Minetti, CQA, CQE, CQMgr (ASQ) Manager, QA, QC & Regulatory Affairs Biopool International, Inc. 1230 Wilson Drive West Chester, Pennsylvania 19380
Re : K980314 Trade Name: Fetal D Tection Kit Regulatory Class: II Product Code: LIM Dated: January 26, 1998 Received: January 27, 1998
Dear Mr. Minetti:
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 of the Act. The qeneral 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 requirement, 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 requlation may result in regulatory 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.
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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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
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of I Page -
510(k) Number (if known): $980314
Device Name: Fetal D Tection Kit
Indications For Use:
The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Stur E. Meier
(Division Sign-
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
O