(344 days)
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No
The provided text describes a fully automated chemiluminescent immunoassay for measuring specific antibodies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the context of medical devices. The description focuses on the assay method and its intended use for diagnosis.
No
The device is an immunoassay intended for in vitro diagnostic purposes, specifically for the semi-quantitative measurement of antibodies as an aid in diagnosing thrombotic disorders. It does not directly treat or prevent a disease.
Yes
The device is described as "an aid in the diagnosis of thrombotic disorders," which directly indicates its diagnostic purpose.
No
The device description is not available, but the intended use clearly describes a "fully automated chemiluminescent immunoassay" performed on a "BIO-FLASH® instrument." This indicates a hardware-based laboratory instrument and associated reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "In Vitro Diagnostic" Definition: IVDs are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Evidence in the Text: The provided text explicitly states the intended use of the devices:
- "Fully automated chemiluminescent immunoassay for the semiquantitative measurement of anti-cardiolipin (aCL) In human citrated plasma and serum..."
- "...as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings."
- "Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 ((S2GP1) IgA antibodies in human citrated plasma and serum..."
- "...as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings."
These statements clearly indicate that the devices are used to analyze human specimens (plasma and serum) to aid in the diagnosis of a medical condition (thrombotic disorders related to APS). This aligns perfectly with the definition of an IVD.
N/A
Intended Use / Indications for Use
QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semiquantitative measurement of anti-cardiolipin (aCL) In human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings.
QUANTA Flash aCL IgA Controls: The QUANTA Flash aCL IgA Controls are intended for quality control purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument.
QUANTA Flash B2GP1 IgA: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 (B2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings.
QUANTA Flash B2GP1 IgA Controls: The QUANTA Flash B2GP1 IgA Controls are intended for the quality control purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.
Product codes
MID, MSV, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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).
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§ 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31. 2013
INOVA DIAGNOSTICS, INC. C/O MS. ROSANNA KEIVENS DIRECTOR OF QUALITY SYSTEMS 9900 OLD GROVE ROAD SAN DIEGO, CA 92131
Re: K120817
Trade/Device Name: OUANTA Flash™ B2GP1 IgA OUANTA Flash™ aCL IgA OUANTA Flash™ B2GP] IgA Controls OUANTA Flash™ aCL IgA Controls Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID, MSV, JJX Dated: February 20, 2013 Received: February 21, 2013
Dear Ms. Keivens:
This letter corrects our substantially equivalent letter of February 26, 2013.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Ms. Rosanna Keivens
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2 I 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Reena Philip -S
for Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K120817
QUANTA Flash™ aCL IgA Device Name:
Indications For Use:
QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semiquantitative measurement of anti-cardiolipin (aCL) In human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings.
QUANTA Flash™ aCL IgA Controls Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The QUANTA Flash aCL IgA Controls are intended for quality control purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Page 1 of 1
Reena Philip -S 2013.03.04 12:24:33 -05'00'
3
Indications for Use
510(k) Number (if known): K120817
QUANTA Flash™ B2GP1 IgA Device Name:
Indications For Use:
Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 ((S2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings.
QUANTA Flash™ B2GP1 IgA Controls Device Name: Indications For Use: The QUANTA Flash $2GP1 IgA Controls are intended for the quality control purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Reena Philip -S 2013.03.04 12:25:36 -05'00' Page 1 of ____________________________________________________________________________________________________________________________________________________________________