(55 days)
Not Found
Not Found
No
The provided text describes a fluorescent immunoassay for detecting specific antibodies and does not mention any AI or ML components.
No.
The device is used to diagnose autoimmune vasculitides, not to treat them.
Yes
The device is described as aiding in the "diagnosis of the autoimmune vasculitides" by detecting specific antibodies.
No
The device is a fluorescent immunoassay, which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, based on the provided information, the QUANTA Plex™ ANCA Profile is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "semi-quantitative detection of anti-MPO and anti-PR3 antibodies in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence of specific antibodies related to autoimmune vasculitides).
- Purpose: The purpose is to "aid in the diagnosis of the autoimmune vasculitides," which is a diagnostic purpose.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QUANTA Plex™ ANCA Profile is a fluorescent immunoassay for the semi-quantitative detection of anti-MPO and anti-PR3 autoantibodies in human serum. The presence of these antibodies is to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of the autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis.
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
Prescription Use
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
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" arranged around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by flowing lines, suggesting movement and connection.
MAY 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers 9900 Old Grove Rd. San Diego, CA 92131-1638
Re: K050715
R050715
Trade/Device Name: QUANTA Plex™ ANCA Profile Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MOB Dated: March 17, 2005 Received: March 18, 2005
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 510(1) production is substantially equivalent (for the indications for referenced above and nave decemined the ences marketed in interstate commerce use stated in the encrosure) to regally manoletal Device Amendments, or to devices that prior to May 26, 1970, the chaomism aan the provisions of the Federal Food, Drug, and Cosmetic have been fectassified in accordance wif a premarket approval application (PMA). You may, Act (Act) that to the require approval othe general controls provisions of the Act. The general therefore, market the device, subject to an igent in the manual registration, listing of devices, good controls provisions of the rich and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aconvols. Existing major regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sourcerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that 1 Dr. I issualle ty our device complies with other requirements of the Act or that i Dria made a decemination administered by other Federal agencies. You must comply with ally Foural statutes and regarding and limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, moractires, offacturing practice requirements as set forth in the quality labeling (21 CFR Part 0017, good management of any if applicable, the electronic product radiation systems (QB) regalaters (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisions (Soctions 551 - 12 - 12 - 22 - 22 - 25 - 12 - 12 - 12 - 12 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 I ms letter will and w you to cogn mains of substantial equivalence of your device to legally
1
Page 2 – Mr. Brys C. Myers
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), please If you desire specific advice is 1 3 % (240) 276-0131. Also, please note the regulation entitled, Comace the Office of Octification" (21CFR Part 807.97). You may obtain other IMISoranding by reference to psystemsibilities under the Act from the Division of Small general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(201) +45-6597 of acts intludema/dsmamain.html
Sincerely yours,
Robert Mackay
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K050715
Device Name: QUANTA Plex™ ANCA Profile
Indications For Use:
The QUANTA Plex™ ANCA Profile is a fluorescent immunoassay for the semi-quantitative detection of anti-MPO and anti-PR3 ene Bear quarteration The presence of these antibodies aacountinounce in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of the autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis.
(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)
Mana Chan
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Satety
510(k) K050715