(258 days)
Not Found
Not Found
No
The summary describes a laboratory test kit using an immunoturbidimetric assay, which is a standard biochemical method and does not mention any AI/ML components or image processing.
No
The device is a test kit for quantitative determination of a specific human component to aid in diagnosing immunological disorders, which is an in-vitro diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended for the quantitative determination of a specific human component (Cl4) which "aids in the diagnosing of immunological disorders," directly indicating a diagnostic purpose.
No
The device is described as a "Test Kit" and an "immunoturbidimetric assay," which are laboratory-based methods involving physical reagents and equipment, not solely software.
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 kit is for the "quantitative determination of human C4 (4th complement component) in human serum by immunoturbidimetric assay." This involves testing a biological sample (human serum) in vitro (outside the body) to obtain diagnostic information.
- Diagnostic Purpose: The intended use also states that the results "aid in the diagnosing of immunological disorders, especially the entile with complement deficiency disorders." This directly links the test results to the diagnosis of a disease or condition.
These are the key characteristics of an IVD. The other sections being "Not Found" or "Not Applicable" do not negate the fact that the intended use and purpose align with the definition of an IVD.
N/A
Intended Use / Indications for Use
The N-4ssay TIA Test Kit is intended to be used for the quantitative determination of human (4 (4th complement component) in human serum by immunoturbidimetric assay. Cl4 aids in the diagnosing of immunological disorders, especially the entile with complement deficiency disorders, with complement deficiency disorders.
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 (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
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Crestat Diagnostics, Inc. c/o Ms. Mary Rees Official Correspondent 374 Goodhill Road Weston, Connecticut 06883
JUL 1 4 1997
Re : K964297 / S3 Trade Name: N-Assay TIA C4 Test Kit Requlatory Class: II Product Code: DBI Dated: May 3, 1997 Received: May 12, 1997
Dear Ms. Rees:
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 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 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 regulation may result in requlatory 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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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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Page -್ರ (
510(k) Number (if known): ___K964297
N-Assay TIA C4 Test Kit Device Name:
Indications for Use:
The N-4ssay TIA Test Kit is intended to be used for the quantitative determination of human (4 (4th complement component) in human serum by immunoturbidimetric assay. Cl4 aids in the diagnosing of immunological disorders, especially the entile
with complement deficiency disorders, with complement deficiency disorders.
Peter E. Mauer
(Division Sign-Off) (Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Lise V
(Per 21 CFR 801.1091
OR
Over-The-Counter Use__
(Optional Format 1-2-96)