(64 days)
Not Found
Not Found
No
The summary describes an in vitro diagnostic test for detecting autoantibodies, which is a standard laboratory assay and does not mention any AI/ML components or image processing.
No
The device is described as an "in vitro diagnostic product" intended for "detection and measurement of autoantibodies in human serum" to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies." It also mentions that the measurement "aids in the diagnosis of microscopic polyangiitis" and "aids in the diagnosis of Wegener's granulomatosis," all of which point to a diagnostic purpose.
No
The device is described as an in vitro diagnostic test for detecting and measuring autoantibodies in human serum. This implies the use of laboratory reagents and equipment, which are hardware components, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the tests are "intended for use in clinical laboratories as in vitro diagnostic tests".
- Purpose: The tests are designed to detect and measure autoantibodies in human serum, which is a biological sample taken from the body, and the analysis is performed outside of the body ("in vitro").
- Clinical Context: The results of the tests are intended to "aid in the diagnosis" of specific medical conditions (microscopic polyangiitis and Wegener's granulomatosis), indicating a clinical purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TheraTest EL-ANCA™: anti-MPO- and EL- ANCA™: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.
TheraTest EL- ANCA™: anti-MPO is intended for use in clinical laboratories as in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis.
TheraTest EL- ANCA™: anti-PR3 is intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil proteinase 3. Measurement of anti-PR3 aids in the diagnosis of 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
clinical laboratories
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 features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 20 2006
TheraTest Laboratories, Inc. c/o Dr. Marius Teodorescu President and CEO 1111 N. Main St. Lombard, IL 60148
Re: K061376
Trade/Device Name: TheraTest EL-ANCA™: anti-MPO TheraTest EL-ANCA™: anti-PR3 TheraTest EL-ANCA™: anti-MPO and anti-PR3 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Antibodies Immunological Test System Regulatory Class: Class II Product Code: MOB Dated: May 10, 2006 Received: May 17, 2006
Dear Dr. Teodorescu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert K. Beckerf
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Attachment 2a
Indications for Use Statement
TheraTest EL-ANCA™: anti-MPO and anti-PR3;
K061376. 510(k)Number
TheraTest EL-ANCA™: anti-MPO; Device Name TheraTest EL-ANCA™: anti-PR3; TheraTest EL-ANCATM: anti-MPO and anti-PR3;
Indications for Use. TheraTest EL- ANCATM: anti-MPO- and EL- ANCA™: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.
Prescription use X AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of in vitro Diagnostic devices (OIVD)
Mana Chen
ton Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
3
Attachment 2b
Indications for Use Statement
TheraTest EL-ANCA™: anti-MPO
K061376. 510(k)Number
TheraTest EL-ANCA™: anti-MPO Device Name:
Indications for Use. TheraTest EL- ANCATM: anti-MPO is intended for use in clinical laboratories as in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis.
Prescription use
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of in vitro Diagnostic devices (OIVD)
Maria ekan
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(k) K061376
4
Attachment 2c
Indications for Use Statement
TheraTest EL-ANCA™: anti-PR3;
K061376. 510(k)Number
TheraTest EL-ANCATM: anti-PR3 Device Name
Indications for Use. TheraTest EL- ANCA™: anti-PR3 is intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil proteinase 3. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.
Prescription use______________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of in vitro Diagnostic devices (OIVD)
Maria Chan
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagn Device Evaluation and Safety
510(k) K061376