(113 days)
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No
The description details a standard immunoturbidimetric assay for CRP, which relies on chemical reactions and light measurement, not AI/ML algorithms for analysis or interpretation. There is no mention of AI, ML, or related concepts in the document.
No
This device is an in vitro diagnostic assay used for the quantitative determination of C-Reactive Protein (CRP), which aids in detecting and evaluating infection, tissue disorder, and inflammatory disorders. It does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases." This indicates that the device provides information used to aid in the diagnosis of various medical conditions, classifying it as a diagnostic device.
No
The device is a latex particle enhanced immunoturbidimetric assay, which is a chemical reagent kit used on clinical chemistry systems. This involves physical components (reagents, controls, standards) and a physical process (agglutination measured by light transmission), not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of C-Reactive Protein (CRP) in human serum". This is a test performed on a biological sample (serum) outside of the body to provide information about a person's health.
- Device Description: The description details a "latex particle enhanced immunoturbidimetric assay" which is a laboratory method used to measure substances in biological fluids. It also mentions the use of "human serum" as the sample.
- Components: The device includes reagents (Latex Reagent, Reaction Buffer), standards for calibration, and controls for quality monitoring, all typical components of an IVD assay kit.
- Performance Studies: The performance studies describe method comparison and precision testing, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (K991385 N High Sensitivity CRP) indicates that this device is being compared to another device that is already classified as an IVD.
All these factors strongly indicate that the Quantex CRP High Sensitivity device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
Product codes
DCK, JIS, JIS, JJX
Device Description
Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
When a sample containing CRP is mixed with the Latex Reagent and the Reaction Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
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)
Method Comparison:
- Evaluated 156 samples with CRP levels ranging from 0.18 to 283 mg/L on an ILab 900/1800.
- Slope: 0.948
- Intercept: -0.105
- r: 0.9969
- Evaluated 55 samples ranging from 0.20 to 283 mg/L on an ILab 600.
- Slope: 0.957
- Intercept: -0.074
- r: 0.9989
Precision:
- Within run precision assessed over multiple runs using two levels of control.
- ILab 900/1800:
- quantex CRP High Sensitivity control 1: Mean 2.39 mg/L CRP, Within run CV% 1.25, Total CV% 3.32
- quantex CRP High Sensitivity control 2: Mean 5.87 mg/L CRP, Within run CV% 0.88, Total CV% 1.50
- ILab 600:
- quantex CRP High Sensitivity control 1: Mean 2.32 mg/dL CRP, Within run CV% 2.11, Total CV% 2.50
- quantex CRP High Sensitivity control 2: Mean 5.82 mg/dL CRP, Within run CV% 1.96, Total CV% 2.09
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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103266 Section 3 quantex CRP High Sensitivity
510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
August 27, 2003
Name of the Device:
quantex CRP High Sensitivity quantex CRP High Sensitivity standard multipoint quantex CRP High Sensitivity controls 1/2
Classification Name(s):
| 866.5270 | C-Reactive Protein Immunological Test System | Class II |
|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, and Control |
Identification of predicate device(s):
K991385 N High Sensitivity CRP
Description of the device/intended use(s):
Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
When a sample containing CRP is mixed with the Latex Reagent and the Reaction Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
quantex CRP High Sensitivity is substantially equivalent to the commercially available predicate device (N High Sensitivity CRP) in performance and intended use.
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Section 3 (Cont.) quantex CRP High Sensitivity 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating 156 samples with CRP levels ranging from 0.18 to 283 mg/L on an ILab 900/1800 and 55 samples ranging from 0.20 to 283 mg/L on an ILab 600, the slope and correlation coefficient (r) for quantex CRP High Sensitivity versus the predicate device are shown below:
| IL System | Slope | Intercept | r |
|---|---|---|---|
| ILab 900/1800 | 0.948 | -0.105 | 0.9969 |
| ILab 600 | 0.957 | -0.074 | 0.9989 |
Precision
Within run precision assessed over multiple runs using two levels of control with the following results:
| ILab 900/1800 | Mean
mg/L CRP | Within run
CV% | Total
CV% |
|----------------------------------------|------------------|-------------------|--------------|
| quantex CRP High Sensitivity control 1 | 2.39 | 1.25 | 3.32 |
| quantex CRP High Sensitivity control 2 | 5.87 | 0.88 | 1.50 |
| | Mean | Within run | Total |
| ILab 600 | mg/dL CRP | CV% | CV% |
| quantex CRP High Sensitivity control 1 | 2.32 | 2.11 | 2.50 |
| quantex CRP High Sensitivity control 2 | 5.82 | 1.96 | 2.09 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three curved lines forming the body and head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2003
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421-3125
K032663 Trade/Device Name: quantex CRP High Sensitivity Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK: JIS; JIS; JJX Dated: November 21, 2003 Received: November 24, 2003
Dear Ms. Marble:
Re:
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 Title 21, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K032663
Device Name: quantex CRP High Sensitivity
Indications for Use:
Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K032663 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.019) | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | -------------------------------------------------------------------- | ---- | ---------------------- |