(511 days)
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No
The document describes a standard immunoturbidimetric assay and instrument for measuring CRP. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the chemical assay and the instrument's ability to measure the results.
No
The device is described as an "in vitro diagnostic test system" and is used for quantitative determination of C-reactive protein, which aids in evaluation of injury and inflammatory disorders, not for treating them.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system" and "Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders." This confirms its diagnostic purpose.
No
The device description explicitly mentions a "QuikRead go® instrument," which is a hardware component used to perform the immunoturbidimetric assay. The software is part of a larger system that includes hardware and reagents.
Yes, all of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statements: The intended use sections for the QuikRead go® CRP, QuikRead go® CRP Control Set, QuikRead go® CRP Verification Set, and QuikRead go® Instrument all explicitly state "For in vitro diagnostic use" or "is an in vitro diagnostic test system."
- Definition of IVD: An IVD is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. The descriptions clearly indicate that these devices are used to analyze human samples (blood, plasma, serum) to measure CRP, which is used to aid in the evaluation of injury and inflammatory disorders.
- Components of an IVD System: The descriptions show that these are components of a system designed for in vitro diagnostic testing. The instrument is designed to work with the reagent kits (QuikRead go® CRP) and the control and verification sets are used to ensure the performance of the assay.
Therefore, based on the provided information, all listed devices are IVDs.
N/A
Intended Use / Indications for Use
Indications for Use (Describe)
QuikRead go® CRP:
QuikRead goThe QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma and in serum samples. The test is carried out by means of the QuikRead go® instrument.
Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use.
QuikRead go® CRP Control Set:
The QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go® CRP assay with the QuikRead go® Instrument. For in vitro diagnostic use.
QuikRead go® CRP Verification Set:
The QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. This assayed verification material is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. For in vitro diagnostic use.
QuikRead go® Instrument:
The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system. The QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. Not for point-of-care use.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JJX, JJQ
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
trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use.
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): 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.
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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.
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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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§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
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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 stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
ORION DIAGNOSTICA OY MS. ANJA KONTIO REGULATORY AFFAIRS MANAGER KIVIHARJUNTIE 11 4B OULU, 90220, FINLAND
Re: K142993
Trade/Device Name: QuikRead go® CRP
QuikRead go® CRP Verification Set OuikRead go® CRP Control Set QuikRead go® Instrument Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: II Product Code: DCK, JJX, JJQ Dated: March 02, 2016 Received: March 07, 2016
Dear Ms. Kontio:
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. 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.
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
1
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 regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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.
Kelly Oliner -S
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) 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) K142993
Device Name
QuikRead go® CRP, QuikRead go® CRP Control Set, QuikRead go® CRP Verification Set, QuikRead go® Instrument
Indications for Use (Describe)
QuikRead go® CRP:
QuikRead goThe QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma and in serum samples. The test is carried out by means of the QuikRead go® instrument.
Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use.
QuikRead go® CRP Control Set:
The QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go® CRP assay with the QuikRead go® Instrument. For in vitro diagnostic use.
QuikRead go® CRP Verification Set:
The QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. This assayed verification material is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. For in vitro diagnostic use.
QuikRead go® Instrument:
The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system. The QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. Not for point-of-care use.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------- | --------------------------------------------- |
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