(334 days)
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No
The description focuses on standard immunoassay technology and does not mention AI or ML.
No
The device is described as a chemiluminescent immunoassay (CIA) used for the detection of autoantibodies to aid in diagnosis, not for treating any condition.
Yes
The text explicitly states that the device is "an aid in the diagnosis" of several conditions (granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and Goodpasture's Syndrome).
No
The device description clearly indicates it is a chemiluminescent immunoassay (CIA) kit, which involves chemical reagents and is run on a physical instrument (BIO-FLASH®). This is a hardware-based diagnostic test, 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 clearly states that the devices are for the "detection of IgG anti-proteinase 3 (PR3) autoantibodies in human serum," "detection of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum," and "detection of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum." These are all tests performed in vitro (outside the body) on human specimens (serum).
- Diagnostic Aid: The intended use also explicitly states that the devices are an "aid in the diagnosis of granulomatosis with polyangiitis (GPA)," "aid in the diagnosis of microscopic polyangiitis (MPA)," and "aid in the diagnosis of Goodpasture's Syndrome." This indicates their purpose is to provide information used in the diagnostic process.
- Laboratory Tests: The intended use mentions being used "in conjunction with clinical findings and other laboratory tests," further reinforcing their role as a laboratory diagnostic tool.
- Calibrators and Controls: The inclusion of calibrators and controls is typical for IVD assays, as they are necessary for ensuring the accuracy and reliability of the test results.
Therefore, the description aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QUANTA Flash PR3 is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-proteinase 3 (PR3) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash PR3 is an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash PR3 Calibrators are intended for use with the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.
The QUANTA Flash PR3 Controls are intended for quality control purposes of the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.
The QUANTA Flash MPO is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash MPO is an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash MPO Calibrators are intended for use with the QUANTA Flash MPO chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.
The QUANTA Flash MPO Controls are intended for quality control purposes of the QUANTA Flash MPO chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.
The QUANTA Flash GBM is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash GBM is an aid in the diagnosis of Goodpasture's Syndrome in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash GBM Calibrators are intended for use with the QUANTA Flash GBM chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.
The QUANTA Flash GBM Controls are intended for quality control purposes of the QUANTA Flash GBM chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.
Product codes (comma separated list FDA assigned to the subject device)
MOB, MVJ, JIX, JJX
Device Description
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling a stylized eagle or bird in flight, composed of flowing lines that also suggest human profiles.
10903 New Hampshire Avenue Silver Spring, MD 20993
Inova Diagnostics, Inc. c/o Rosanna Keivens 9900 Old Grove Rd. San Diego, California 92131-1638
Re: K112545
Trade/Device Name: QUANTA Flash® PR3 Reagents QUANTA Flash® PR3 Calibrators QUANTA Flash® PR3 Controls
QUANTA Flash® MPO Reagents QUANTA Flash® MPO Calibrators QUANTA Flash® MPO Controls
QUANTA Flash® GBM Reagents QUANTA Flash® GBM Calibrators QUANTA Flash® GBM Controls
Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MOB, MVJ, JIX, JJX Dated: June 20, 2012 Received: June 26, 2012
Dear Ms. Keivens:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21,
JUL 3 1 2012
1
Page 2 – Ms. Rosanna Keivens
Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
Con Maria M. Chan, Ph.D. Director
Division 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): K112545
Device Name: QUANTA Flash® PR3 Reagents
Indications for Use:
The QUANTA Flash PR3 is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-proteinase 3 (PR3) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash PR3 is an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with clinical findings and other laboratory tests.
Over-The-Counter Use Prescription Use × Prescription USC
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
510(k) K112545
3
510(k) Number (if known): K112545
Device Name: QUANTA Flash® PR3 Calibrators
Indications for Use:
The QUANTA Flash PR3 Calibrators are intended for use with the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.
Prescription Use × Frescription OSE _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) [K112545](https://510k.innolitics.com/search/K112545)
Page 1 of
**4**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® PR3 Controls
Indications for Use:
The QUANTA Flash PR3 Controls are intended for quality control purposes of the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.
Over-The-Counter Use Prescription Use × Prescription USE _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
510(k) [K112545](https://510k.innolitics.com/search/K112545)
**5**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® MPO Reagents
Indications for Use:
The QUANTA Flash MPO is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash MPO is an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with clinical findings and other laboratory tests.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
Over-The-Counter Use
Page 1 of _
し
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ff
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) [K112545](https://510k.innolitics.com/search/K112545).
**6**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® MPO Calibrators
Indications for Use:
The QUANTA Flash MPO Calibrators are intended for use with the QUANTA Flash MPO chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.
Over-The-Counter Use Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
510(k) [K112545](https://510k.innolitics.com/search/K112545)
**7**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® MPO Controls
Indications for Use:
The QUANTA Flash MPO Controls are intended for quality control purposes of the QUANTA Flash MPO chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.
Over-The-Counter Use Prescription Use X Presenption Ose --------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
510(k) [K112545](https://510k.innolitics.com/search/K112545)
**8**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® GBM Reagents
Indications for Use:
The QUANTA Flash GBM is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash GBM is an aid in the diagnosis of Goodpasture's Syndrome in conjunction with clinical findings and other laboratory tests.
Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
h
510(k) [K112545](https://510k.innolitics.com/search/K112545)
**9**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® GBM Calibrators
Indications for Use:
The QUANTA Flash GBM Calibrators are intended for use with the QUANTA Flash GBM chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.
Prescription Use Over-The-Counter Use X Prescription USC-201 Subpart D) AND/OR ( (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) [K112545](https://510k.innolitics.com/search/K112545)
Page 1 of _
**10**
510(k) Number (if known): [K112545](https://510k.innolitics.com/search/K112545)
Device Name: QUANTA Flash® GBM Controls
Indications for Use:
The QUANTA Flash GBM Controls are intended for quality control purposes of the QUANTA Flash GBM chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.
Over-The-Counter Use Prescription Use × Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
. '
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
hm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) [K112545](https://510k.innolitics.com/search/K112545)
Page 1 of