(333 days)
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No
The summary describes a standard turbidimetric immunoassay and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test for measuring C-Reactive Protein, which is used for detection and evaluation of conditions, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma." This clearly indicates its use in diagnosing or aiding in the diagnosis of various medical conditions.
No
The device description clearly states it is an in vitro diagnostic test method used on a clinical chemistry system and is based on a particle enhanced turbidimetric immunoassay technique, which involves physical reagents and a measurement system, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is an "in vitro diagnostic test". It also describes the purpose of the test (quantitative determination of CRP in human serum and plasma) and its clinical utility (detection and evaluation of infection, tissue injury, inflammatory disorders).
- Device Description: It describes a method (particle enhanced turbidimetric immunoassay) that analyzes a biological sample (serum and plasma) outside of the body to measure a specific analyte (C-Reactive Protein).
- Performance Studies: The document details various performance studies (Method Comparison, Linearity, Detection Capability, Precision, Specimen Equivalency, Interference) which are standard for demonstrating the analytical performance of an IVD.
- Expected Values: The inclusion of expected values and a reference interval is typical for an IVD, providing context for interpreting the test results.
- Predicate Device(s): The mention of a predicate device (K003419; RCRP Flex® reagent cartridge assay) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device.
All of these elements strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique. Synthetic particles coated with antibody to C-Reactive Protein (AbPR) aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
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)
Risk analysis was conducted according to ISO 14971:2012 standard, Medical Devices -Application of Risk Management to Medical Devices, to assess the impact of the modification. This risk analysis supports that the modification did not introduce any new risk to the performance of the modified RCRP Flex reagent cartridge assay.
Based on the risks analysis, verification testing was performed for updating the traceability from the IFCC CRM 470 reference material to the ERM-DA474/IFCC reference material. Method comparison, linearity, functional sensitivity/LoQ, and additional studies were conducted.
Method Comparison – Modified RCRP assay vs Predicate RCRP assay: Method comparison study was conducted in accordance with CLSI EP09-A3. Individual human native serum samples were tested on the Dimension RXL system. The serum samples were obtained from specimen vendors. The modified RCRP Flex reagent cartridge assay was calibrated with calibrator traceable to ERM-DA474/IFCC reference material. The predicate RCRP Flex reagent cartridge assay was calibrated with the calibrator traceable to IFCC CRM 470 reference material. A single replicate was processed for each sample on calibration conditions. Eighteen (18) out of 132 samples tested were within the range of 7.5 and 12.5 mg/L (14% of total samples). The slope, y-intercept, and correlation coefficient (r) results were generated using Deming regression.
Regression Equation: y = 0.99x - 0.5 mg/L
Sample Interval: 5.0 to 247.6 mg/L
Number of samples tested (Na): 132
Correlation coefficient (rb): 1.000
Slope: 0.99 (Acceptance Criteria: 1.00 ± 0.1), Pass
y-intercept: -0.5 mg/L (Acceptance Criteria: 0.0 ± 2.0 mg/L), Pass
Correlation Coefficient (r): 1.000 (Acceptance Criteria: >= 0.9600), Pass
Method Comparison - RCRP assay on Dimension RXL system vs N High Sensitivity CRP on the BNTM System: For the change in the analytical measurement range (AMR) from [0.5 - 250.0 mg/L] 0.05 -25.00 mg/dL to [5.0 - 250.0 mg/L] 0.50 - 25.00 mg/dL, the historical IFU data was re-analyzed and the IFU was updated with the summary of the results for the method comparison of the candidate RCRP assay on Dimension RXL clinical chemistry system versus the predicate N High Sensitivity CRP on the BNTM System.
Regression Equation: y = 0.95x - 1.6 mg/L (Sample Interval 5.3 to 241.3 mg/L, Na: 171, rb: 0.997)
Regression Equation: y = 0.86x - 0.2 mg/L (Sample Interval 5.3 to 20.2 mg/L, Na: 39, rb: 0.986)
Slope: 0.95 (Acceptance Criteria: 1.00 ± 0.10), Pass
y-intercept: -1.6 mg/L (Acceptance Criteria: 0.0 ± 2.0 mg/L), Pass
Correlation Coefficient (r): 0.997 (Acceptance Criteria: >= 0.9600), Pass
Linearity: Linearity study was conducted in accordance with CLSI EP06-ED2. The modified RCRP Flex reagent cartridge assay is linear for the analytical measurement range of 5.0 - 250.0 mg/L.
Detection Capability: Verification of the existing Analytical Sensitivity and Functional Sensitivity in the Instructions for Use (IFU/Pacakage Insert) was replaced with conducting Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies. Detection capability was determined in accordance with CLSI Document EP17-A2.
LoB: 0.6 mg/L (0.06 mg/dL)
LoD: 1.0 mg/L (0.10 mg/dL)
LoQ: 5.0 mg/L (0.50 mg/dL)
Precision: Precision was verified in accordance with CLSI Document EP05-A3. Samples at each level were analyzed N=10 replicates each day for 5 days.
Serum 1 (N=50): Mean 6.8 mg/L, Repeatability (CV) 1.2%, Within-Lab (CV) 1.8%
Serum 2 (N=50): Mean 9.1 mg/L, Repeatability (CV) 0.8%, Within-Lab (CV) 1.9%
Serum 3 (N=50): Mean 37.7 mg/L, Repeatability (CV) 0.8%, Within-Lab (CV) 1.1%
Serum 4 (N=50): Mean 108.4 mg/L, Repeatability (CV) 1.0%, Within-Lab (CV) 1.5%
Serum 5 (N=50): Mean 208.3 mg/L, Repeatability (CV) 1.6%, Within-Lab (CV) 2.3%
Serum 6 (N=50): Mean 233.4 mg/L, Repeatability (CV) 1.7%, Within-Lab (CV) 2.6%
Specimen Equivalency: Specimen equivalency was verified using the Deming regression model in accordance with CLSI EP09C-ED3.
Lithium heparin plasma (y) vs Serum (x): y = 0.99x + 0.1 mg/L, Sample Interval: 5.2 to 243.2, Na: 73, rb: 1.00
Interference: For the change in the analytical measurement range (AMR) from [0.5 - 250.0 mg/L] 0.05 -25.00 mg/dL to [5.0 - 250.0 mg/L] 0.50 - 25.00 mg/dL, the hemolysis, icterus, and lipemia (HIL) interference study was repeated using sample with CRP analyte level within the new range. The modified assay was evaluated for interference from hemolysis, icterus and lipemia according to EP07-ED3. Bias exceeding 10% is considered "interference".
Hemoglobin: 500 mg/dL, Analyte Concentration 11.6 mg/L, Bias 0%
Bilirubin (Unconjugated): 40 mg/dL, Analyte Concentration 11.7 mg/L, Bias 2%
Lipemia (Intralipid): 250 mg/dL, Analyte Concentration 11.8 mg/L, Bias -9%
Lipemia (Triglyceride Fraction): 750 mg/dL, Analyte Concentration 11.1 mg/L, Bias -7%
Expected Values: The reference interval was verified in accordance with CLSI EP28-A3c. The reference interval was verified as
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 17, 2023
Siemens Healthcare Diagnostics Inc. Ian Thompson Regulatory Affairs Professional 511 Benedict Avenue Tarrytown, New York 10591
Re: K221119
Trade/Device Name: RCRP Flex reagent cartridge Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: Class II Product Code: DCN Dated: January 20, 2023 Received: January 23, 2023
Dear Ian Thompson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221119
Device Name RCRP Flex® reagent cartridge
Indications for Use (Describe)
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K221119
1. Date Prepared
January 20, 2023
2. Applicant Information
| Contact: | Ian Thompson
Regulatory Affairs Professional |
|----------|-------------------------------------------------|
| Address: | 511 Benedict Avenue
Tarrytown, NY 10591-5097 |
Email: ian_thompson@siemens-healthineers.com
3. Regulatory Information
Dimension RCRP Flex® reagent cartridge assay
| Trade Name: | RCRP Flex® reagent cartridge |
|---|---|
| Common Name: | System, Test, C-Reactive Protein |
| Classification Name: | C-reactive protein immunological test system |
| FDA Classification: | Class II |
| Review Panel: | Immunology |
| Product Code: | DCN |
| Regulation Number: | 21 CFR 866.5270 |
Predicate Device Information 4.
Predicate Device Name: RCRP Flex® reagent cartridge assay
510(k) Number: K003419
5. Intended Use / Indications For Use
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Special Conditions for Use Statement(s): For Prescription Use Only.
6. Device Description
The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique.
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Synthetic particles coated with antibody to C-Reactive Protein (AbPR) aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration.
Purpose of Submission 7.
The purpose of this submission is a special 510(k) premarket notification for a modified device: RCRP Flex® reagent cartridge assay. This device was modified by updating the traceability from the IFCC CRM 470 reference material to the ERM-DA474/IFCC reference material.
A Special 510(k) Premarket Notification is the requested pathway because of the following:
- The change is to the manufacturer's own legally marketed device. .
- There is no change to the intended use or indications for use. .
- There is no change in the fundamental scientific technology.
- There is no change to the principle of operation. ●
- There is no change to the formulation.
- . There is no change to the instrument parameters related to sample volume, reagent volume, mix speed, wavelengths, or read times.
8. Comparison of Candidate Device and Predicate Device
The table below describes the similarities and difference between the modified RCRP Flex reagent cartridge assay (Candidate Device) and RCRP Flex reagent cartridge assay (Predicate Device cleared under K003419). The Candidate Device and Predicate Device employ the same prepackaged reagents for use on an automated test system. The Intended Use / Indications for Use, assay principle, and reagent formulations are the same.
The Instructions for Use (IFU)/Package Insert for the Dimension Revised C-Reactive Protein Calibrator (RCRP CAL) was updated for this change.
| Feature | Candidate Device | Predicate Device |
|---|---|---|
| RCRP Flex reagent cartridge | RCRP Flex reagent cartridge | |
| Intended Use | The C-Reactive Protein Extended | |
| Range (RCRP) method used on the | ||
| Dimension® clinical chemistry system is | ||
| an in vitro diagnostic test intended for | ||
| the quantitative determination of CRP | ||
| in human serum and plasma (lithium | ||
| heparin). | Same | |
| Indications for Use | Measurement of C-Reactive Protein is | |
| useful for the detection and evaluation | ||
| of infection, tissue injury, inflammatory | ||
| disorders and associated diseases. | Same |
The method comparison study between the Candidate Device and the Predicate Device demonstrated acceptable correlation.
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| Feature | Candidate Device | Predicate Device |
|---|---|---|
| RCRP Flex reagent cartridge | RCRP Flex reagent cartridge | |
| Sample Type | serum and plasma (lithium heparin) | Same |
| Units of Measure | mg/L | Same |
| Analytical | ||
| Measurement Range | 5.0 - 250.0 mg/L | 0.5 - 250.0 mg/L |
| Expected Values |