(907 days)
Orion Diagnostica QuikRead go CRP K142993
No
The description focuses on a standard immunoassay technology and does not mention any AI or ML components for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used to measure CRP levels, aiding in the evaluation of inflammatory disorders, rather than directly treating or mitigating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." This indicates that the device is intended to diagnose diseases or conditions. Also, the purpose of the assay is to aid in the evaluation of injury to body tissues and inflammatory disorders, which are diagnostic applications.
No
The device description explicitly mentions the "ProciseDx Analyzer" as the means by which the test is carried out, indicating a hardware component is required. The description also details a fluorescence immunoassay process involving labeled antibodies and antigens, which are physical reagents, not purely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Purpose: The device is designed to measure C-Reactive Protein (CRP) levels in human serum, which is a biological sample taken in vitro (outside the body).
- Clinical Context: The measurement of CRP is used to "aid in evaluation of injury to body tissues, inflammatory disorders," which are clinical conditions.
- Intended User and Setting: It is intended for use by "trained professionals in the clinical laboratory," a typical setting for IVD testing.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. The test is carried out by means of the ProciseDx Analyzer. Measurement of CRP aids in evaluation of injury to body tissues, 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.
Product codes
DCK
Device Description
The Procise CRP assay is a homogeneous sandwich immunoassay assay that uses a fluorescence resonance energy transfer (FRET) signal to detect and quantify CRP. FRET is a process in which a donor molecule, in an excited state, transfers excitation energy to an acceptor fluorophore when the two are brought into close proximity. Upon excitation at a characteristic wavelength the energy absorbed by the donor is transferred to the acceptor, which in turn emits light energy. The level of light emitted from the acceptor fluorophore is directly proportional to the degree of donor/acceptor complex formation.
The Procise CRP assay format is designed as a competitive format. A monoclonal anti-CRP antibody and exogenous CRP antigen are labeled with donor and acceptor fluorophores, respectively. The monoclonal antibody specific for CRP is labelled with the donor fluorophores and the CRP antigen is labelled with the acceptor fluorophore. Similar to other competitive assay formats, as the concentration of CRP increases a proportional decrease in the signal is observed.
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
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
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)
A Analytical Performance:
1. Precision/Reproducibility:
- Within-Laboratory Imprecision: Study conducted based on CLSI guideline EP05-A3. Six serum samples tested in duplicates per run, two runs per day for 20 days using two reagent lots on two analyzers (each lot per each analyzer). Total of 160 test results (2 replicates x 2 runs x 20 days x 2 lots = 160). Total SD and CV% calculation based on within-run, between-run, between-day, and between-lot data.
- Sample 1 (Mean 5.9 mg/L): Total SD 0.4, %CV 7.4
- Sample 2 (Mean 9.2 mg/L): Total SD 0.8, %CV 8.6
- Sample 3 (Mean 35.5 mg/L): Total SD 1.6, %CV 4.4
- Sample 4 (Mean 75.1 mg/L): Total SD 4.6, %CV 6.1
- Sample 5 (Mean 93.5 mg/L): Total SD 6.4, %CV 6.8
- Sample 6 (Mean 125.6 mg/L): Total SD 10.0, %CV 8.0
- Between-site imprecision: Study conducted at three different sites using five serum samples (3 patients and 2 QCs) with different CRP concentrations. Within-run, between-run, between-day, between-operator/instrument, between-site, and total SDs and %CVs calculated based on 180 determinations per sample performed with three replicates per run, two runs per day for five different days on two operators/instruments at three test sites using a single reagent lot (3 replicates x 2 runs x 5 days x 2 instruments x 3 sites = 180).
- Sample 1 (Mean 7.27 mg/L): Total SD 0.6, %CV 7.6
- Sample 2 (Mean 25.3 mg/L): Total SD 2.0, %CV 7.8
- Sample 3 (Mean 72.7 mg/L): Total SD 6.5, %CV 9.0
- QC1 (Mean 5.53 mg/L): Total SD 0.6, %CV 10.0
- QC2 (Mean 48.7 mg/L): Total SD 4.5, %CV 9.3
2. Linearity: Evaluated using 11 dilution levels of pooled human serum samples (3.6 to 161.0 mg/L). Each sample dilution measured in one run with three or four replicates. Linear regression analysis of expected value vs observed CRP value performed.
- Range (mg/L): 3.6 - 161.0
- Slope (95%CI): 0.99 (0.97 – 1.00)
- Intercept (95% CI): 0.05 (-0.94 – 1.05)
- R2: 1.00
3. Analytical Specificity/Interference: Three pooled human serum samples (12.3, 52.9, and 89.7 mg/L) spiked with potential interfering substances. CRP level measured in three replicates; recovery calculated relative to unspiked sample. Acceptance criterion:
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 4, 2022
Procise Diagnostics Kurtis Bray Senior Director of Clinical Development and Regulatory Affairs 9449 Carroll Park Drive San Diego, California 92121
Re: K201256
Trade/Device Name: Procise CRP Assay Kit, ProciseDx Instrument, ProciseDx Calibration Cartridge Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: August 4, 2022 Received: August 5, 2022
Dear Kurtis Bray:
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.
1
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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201256
Device Name Procise CRP
Indications for Use (Describe)
The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human scrum. The test is carried out by means of the ProciseDx Analyzer.
Measurement of CRP aids in evaluation of injury to body tissues, 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for ProciseDx. The logo consists of the word "ProciseDx" in a blue sans-serif font. To the right of the word is a stylized checkmark symbol that is split into two colors, blue and pink. The blue portion of the checkmark is on the bottom left, and the pink portion is on the top right.
510(k) Summarv
1. Submitter
ProciseDx, Inc. 9449 Carroll Park Drive San Diego, CA 92121 Telephone: (619) 354-2264 Contact Person: Kurtis Bray Date: October 24, 2022
2. Proprietary Names
ProciseDx Analyzer Procise C-Reactive Protein Procise CRP ProciseDx Calibration Cartridge
3. Predicate
Orion Diagnostica QuikRead go CRP K142993
4. Device Description
The Procise CRP assay is a homogeneous sandwich immunoassay assay that uses a fluorescence resonance energy transfer (FRET) signal to detect and quantify CRP. FRET is a process in which a donor molecule, in an excited state, transfers excitation energy to an acceptor fluorophore when the two are brought into close proximity. Upon excitation at a characteristic wavelength the energy absorbed by the donor is transferred to the acceptor, which in turn emits light energy. The level of light emitted from the acceptor fluorophore is directly proportional to the degree of donor/acceptor complex formation.
The Procise CRP assay format is designed as a competitive format. A monoclonal anti-CRP antibody and exogenous CRP antigen are labeled with donor and acceptor fluorophores, respectively. The monoclonal antibody specific for CRP is labelled with the donor fluorophores and the CRP antigen is labelled with the acceptor fluorophore. Similar to other competitive assay formats, as the concentration of CRP increases a proportional decrease in the signal is observed.
5. Intended Use
The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. The test is carried out by means of the ProciseDx Analyzer.
4
Measurement of CRP aids in evaluation of injury to body tissues, infection, 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.
| Device & Predicate
| Device(s): | K201256 | K142993 |
|---|---|---|
| Device Trade Name | Procise CRP | QuikRead Go CRP |
| General Device | ||
| Characteristic Similarities | ||
| Intended Use/Indications | ||
| For Use | The Procise CRP assay | |
| is a time-resolved | ||
| fluorescence energy | ||
| transfer immunoassay | ||
| for the quantitative | ||
| determination of C- | ||
| Reactive Protein (CRP) | ||
| levels in human serum. | ||
| The test is carried out | ||
| by means of the | ||
| ProciseDx Analyzer. | ||
| Measurement of CRP | ||
| aids in evaluation of | ||
| injury to body tissues, | ||
| infection, 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. | The 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 | ||
| infection 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. | ||
| Product Code | DCK | Same |
| Assay Type | Quantitative | Same |
| Sample Volume | 20 µL | Same |
| Limit of Quantitation | 5 mg/L | Same |
| Calibrators | The reagents are pre- | |
| calibrated. | Same | |
| Traceability | ERM® -DA474/IFCC | Same |
| Assay principle | Immunoassay | Same |
| Assay Controls | Two (2) Levels, ready | |
| to use | Same | |
| General Device | ||
| Characteristic Differences | ||
| Sample Type | Serum | Serum |
| Venous whole blood | ||
| (K2-EDTA) | ||
| Venous whole blood | ||
| (Li-Heparin) | ||
| Plasma | ||
| Technology | Fluorescence resonance | |
| energy transfer (FRET) | Immunoturbidimetry | |
| Instrument | ProciseDx Analyzer | QuikRead go Analyzer |
| Antibody | Fab' anti-human CRP | |
| antibody | Anti-human CRP | |
| F(ab)2 fragment | ||
| Reagent Storage | Ambient (15-30°C) | Refrigerated (2-8°C) |
| Assay Range | 5.0-150 mg/L (serum) | 5-200 mg/L (plasma |
| and serum) | ||
| 5-150 mg/L (whole | ||
| blood) |
6. Comparison
5
7. Standard/Special Control/Guidance Documents Referenced
- ANSI Standard "HL7 Messaging Standard Version 2.7.1, An Application Protocol for . Electronic Data Exchange in Healthcare Environments - 2012
- CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures- Third ● Edition - October 2014
- CLSI EP06-A: Evaluation of the Linearity of Quantitative measurement Procedures A ● Statistical Approach - First Edition - April 2003
- CLSI EP07-3rd Edition Interference Testing in Clinical Chemistry April 2018 ●
- CLSI EP09c Measurement Procedure Comparison and Bias Estimation Using Patient . Samples. Third edition - June, 2018
- . CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures - Second Edition - June 2012
- CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic reagents- First Edition-. September 2009
- . CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory- Third Edition - November 2008
6
- Electrical Safety IEC 61010-1:2010 (third edition), Safety requirements for electrical . equipment for measurement, control, and laboratory use - Part 1: General requirements
- EN ISO 13485: Medical devices Ouality management systems Requirements for . regulatory purposes
- EN ISO 14971: Medical devices Application of risk management to medical devices ●
- EN ISO 15223-1: Medical devices Symbols to be used with medical device labels, ● labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)
- EN ISO 18113-1: In vitro diagnostic medical devices Information supplied by the . manufacturer (labelling). Part 1: Terms, definitions and general requirements
- EN ISO 18113-3: In vitro diagnostic medical devices Information supplied by the ● manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
- EN 61326-1; 2013/IEC 61326-1:2012, Electrical equipment for measurement, control ● and laboratory use - EMC requirements - Part 1: General requirements
- EN 62366-1: Application of usability engineering to medical devices ●
- General Principles of Software Validation Guidance for Industry and FDA Staff. January ● - 2002
- . Guidance for Industry - Review Criteria for Assessment of C - Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices Guidance for Industry and FDA Staff. May - 2005
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover ● Human Specimens that are Not Individually Identifiable, April 2006
- IEC 62304 Medical device software Software life cycle processes ●
- ISTA Procedure 2A: Partial simulation testing of individual packaged-products weighing ● 150 lb (68kg) or less when prepared for shipment
- Off-The-Shelf Software Use in Medical Devices. Guidance for Industry and Food and Drug Administration Staff - September 2019
8. Performance Characteristics
A Analytical Performance:
-
- Precision/Reproducibility:
- Within-Laboratory Imprecision: a.
The study was conducted based on CLSI guideline EP05-A3, where six serum samples were tested in duplicates per run, two runs per day for 20 days using two reagent lots on two analyzers (each lot per each analyzer). Each sample was tested to generate a total of 160 test results (2 replicates x 2 runs x 20 days x 2 lots = 160). The total SD and CV% calculation was based on the within-run, between-run, between-day, and between-lot data. The results are shown in the table below.
7
| Sample | N | Mean (mg/L) | Within-run | Between-run | Between-day | Between-lot | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| 1 | 160 | 5.9 | 0.4 | 6.2 | 0.0 | 0.0 | 0.1 | 1.2 | 0.2 | 3.8 | 0.4 | 7.4 |
| 2 | 160 | 9.2 | 0.6 | 6.4 | 0.0 | 0.0 | 0.1 | 0.7 | 0.5 | 5.7 | 0.8 | 8.6 |
| 3 | 160 | 35.5 | 1.4 | 3.9 | 0.7 | 2.0 | 0.0 | 0.0 | 0.3 | 0.8 | 1.6 | 4.4 |
| 4 | 160 | 75.1 | 2.8 | 3.7 | 0.8 | 1.1 | 0.9 | 1.2 | 3.4 | 4.6 | 4.6 | 6.1 |
| 5 | 160 | 93.5 | 4.3 | 4.6 | 0.0 | 0.0 | 2.3 | 2.5 | 4.2 | 4.5 | 6.4 | 6.8 |
| 6 | 160 | 125.6 | 6.8 | 5.4 | 0.0 | 0.0 | 2.3 | 1.9 | 7.0 | 5.5 | 10.0 | 8.0 |
b. Between-site imprecision:
The study was conducted at three different sites using five serum samples (3 patients and 2 QCs) with different CRP concentrations across the measuring interval. Within-run, between-run, between-day, between-operator/instrument, between-site, and total SDs and %CVs were calculated based on 180 determinations per sample performed with three replicates per run, two runs per day for five different days on two operators/instruments at three test sites using a single reagent lot (3 replicates x 2 runs x 5 days x 2 instruments x 3 sites = 180). The results are shown in the table below.
| Sample | N* | Mean
(mg/L) | Within-run | | Between-run | | Between-day | | Between-instrument | | Between-site | | Total | |
|--------|-----|----------------|------------|-----|-------------|-----|-------------|-----|--------------------|-----|--------------|-----|-------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 179 | 7.27 | 0.5 | 6.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 1.6 | 0.2 | 2.1 | 0.6 | 7.6 |
| 2 | 179 | 25.3 | 1.7 | 6.8 | 0.0 | 0.0 | 0.3 | 1.3 | 0.0 | 0.0 | 0.7 | 2.7 | 2.0 | 7.8 |
| 3 | 177 | 72.7 | 6.2 | 8.5 | 0.0 | 0.0 | 0.7 | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 6.5 | 9.0 |
| QC1 | 179 | 5.53 | 0.5 | 8.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.8 | 0.3 | 4.6 | 0.6 | 10.0 |
| QC2 | 178 | 48.7 | 4.2 | 8.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.8 | 3.7 | 4.5 | 9.3 |
- 98.3% (177/180) to 99.4% (179/180) of the test results were included in analysis.
2. Linearity:
The linearity was evaluated using a series of pooled human serum samples at 11 dilution levels prepared to evenly cover the CRP concentration range of 3.6 to 161.0 mg/L. Each sample dilution was measured in one run with three or four replicates; the mean of the three replicates or four replicates was calculated for each sample. Linear regression analysis of . expected value vs observed CRP value was performed to determine whether the sample set exhibits linearity. The linear regression results for nine samples within the measuring interval are shown in the table below.
| Range (mg/L) | Slope
(95%CI) | Intercept
(95% CI) | R2 |
|--------------|------------------|-----------------------|------|
| 3.6 - 161.0 | 0.99 | 0.05 | 1.00 |
8
| Range (mg/L) | Slope
(95%CI) | Intercept
(95% CI) | R2 |
|--------------|------------------|-----------------------|----|
| | (0.97 – 1.00) | (-0.94 – 1.05) | |
3. Analytical Specificity/Interference:
To investigate the test performance with presence of potential endogenous and exogenous interferents, three pooled human serum samples with various CRP concentrations (12.3, 52.9, and 89.7 mg/L) were prepared and spiked with potential interfering substances. The CRP level in the test samples was measured in three replicates and the recovery in relation to the unspiked sample without interferent was calculated. The acceptance criterion was 30, https://www.cdc.gov/obesity/aboutobesity/index.html) were excluded in the analysis. A total of 170 samples (88 males at 18-72 years and 82 females at 21-69 years) were included in the analysis. Of 170 tested samples, 150 samples (150/170, 88.2%) had concentrations within the consensus reference interval at 5 mg/L taken from the literature reference*. The 95th percentile was 8.2 mg/L. Each laboratory should establish its own reference range.
*The expected value in the normal population aged 20 to 60 years is