(149 days)
Not Found
Not Found
No
The 510(k) summary describes a traditional immunofluorescence kit for detecting antibodies and does not mention any AI or ML components.
No
This device is an immunofluorescence kit used for screening and titration of antibodies, which helps in diagnosis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is used for "screening and titration of circulating anti-neutrophil cytoplasmic antibodies (ANCA). These antibodies are markers for the diagnosis..." which indicates its role in identifying specific biological markers for diagnostic purposes.
No
The device is described as an "indirect immunofluorescence kit" with "ethanol and formalin fixed human neutrophils as a substrate," which are physical components, indicating it is not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "screening and titration of circulating anti-neutrophil cytoplasmic antibodies (ANCA)." This process is performed in vitro (outside the body) on biological samples (presumably blood or serum) to provide information for the diagnosis of systemic vasculitides. This aligns perfectly with the definition of an IVD.
The other sections being "Not Found" do not negate the clear indication in the "Intended Use / Indications for Use" section that this device is used for diagnostic purposes on biological samples.
N/A
Intended Use / Indications for Use
This indirect immunofluorescence kit, with ethanol and formalin This indirect Inmundiruorescence has substrate is in the fixed numan neutrophils as a subberies anti-neutrophil cytoplasmic screening and Citracion of Circuiae are markers for the diagnosis antibodies (ANCA). These antibodies are in and other systemic antibodies (ANCA). These antiboures and other systemic vasculitides.
Product codes
MOB
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): 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.
Not Found
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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY
MAY 2 1 1997
The Binding Site, Limited c/o Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K965133/S1 Trade Name: ANCA Combi Diagnostic Test Kit Regulatory Class: II Product Code: MOB Dated: April 8, 1997 Received: April 11, 1997
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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.
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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 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
2
1:04 child
K965133//A'
2002
1-15-9.
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
ANCA Cmobi Diagnostic Test Kit Device Name:
Indications For Use:
This indirect immunofluorescence kit, with ethanol and formalin This indirect Inmundiruorescence has substrate is in the fixed numan neutrophils as a subberies anti-neutrophil cytoplasmic screening and Citracion of Circuiae are markers for the diagnosis
antibodies (ANCA). These antibodies are in and other systemic antibodies (ANCA). These antiboures and other systemic vasculitides.
Peter E. Maher
(Division Sign-Off) Division of Clinical Laboratory D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
SK=19