(579 days)
Not Found
Not Found
No
The summary describes a laboratory assay for measuring a specific protein (C4) using an analyzer, which is a standard laboratory technique and does not mention any AI/ML components.
No
The device is described as an "assay ... for the in vitro measurement of human C4 in serum ... as an aid in the diagnosis of abnormal C4 metabolism," which indicates a diagnostic rather than a therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" states that the assay is designed as an "aid in the diagnosis of abnormal C4 metabolism." This directly indicates its role in diagnosis.
No
The summary describes an "assay" for the "in vitro measurement of human C4 in serum using the MININEPH analyzer." This strongly suggests a laboratory test involving reagents and a physical analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism."
The phrase "in vitro" is the key indicator that this device is intended for use outside of a living organism, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.
Product codes
DBI
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle, following its curvature.
Public Health Service
DEC 2 0 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site C/O Mr. Jay Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K981785 Trade Name: C4 Minineph Antiserum Regulatory Class: II Product Code: DBI Dated: October 14, 1999 Received: October 15, 1999
Dear Mr. Geller:
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 (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.
1
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 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/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
2
INDICATIONS FOR USE STATEMENT
Minineph C4 Antiserum Device Name:
This assay is designed for the in_vitro Indications for Use: measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.
Peter E. Mafeni
(Division Sign-Off) Division of Clinical Laboratory "cvices 510(k) Number J
/ Prescription