(234 days)
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No
The description details a standard immunoassay with electrochemiluminescence detection and a quantitative measurement based on light intensity. There is no mention of AI, ML, or any complex algorithms beyond basic signal processing for quantification.
No.
The device is an in vitro diagnostic (IVD) device used to measure CRP levels to aid in the evaluation of infection, tissue injury, and inflammatory disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum." Additionally, it mentions that "Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders," directly linking its function to diagnosis.
No
The device is an in-vitro diagnostic assay kit and an instrument, which are hardware components used to perform a quantitative measurement. While software is likely involved in the instrument's operation and data analysis, the core device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the MSD CRP Kit is "intended for in vitro diagnostic use".
- Purpose: The kit is used for the "quantitative determination of C-reactive protein (CRP) in human serum", which is a measurement performed outside of the body on a biological sample to aid in diagnosis or evaluation of medical conditions.
- Setting and User: The test is performed in a "hospital or clinical laboratory setting by trained laboratory personnel", which is typical for IVD tests.
- Device Description: The "Device Description" further clarifies that it is a "quantitative in-vitro diagnostic assay".
- Regulatory Context: The comparison study mentions a "predicate device", which is a common requirement for regulatory submissions of new IVD devices.
All of these points strongly indicate that the MSD CRP Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO® SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings.
The SECTOR S 700 instrument is intended for the in-vitro determination of analytes in bodily fluids. This instrument is not intended for Point-of-Care use.
Product codes (comma separated list FDA assigned to the subject device)
DCK, DCN
Device Description
The MSD CRP Assay Kit is a quantitative in-vitro diagnostic assay for conventional measurement of C-reactive protein in human serum. The CRP Assay Kit is designed for use with the MESO SECTOR® S 700 Instrument. The kit components include the 96-well CRP assay plate, CRP calibrator, CRP detection antibody, CRP diluent and CRP read buffer. The assay in the MSD CRP Kit is a sandwich immunoassay employing electrochemiluminescence (ECL) detection. In the instrument, a voltage is applied to the plate electrodes causing the captured labels to emit light. The instrument measures the intensity of emitted light from each spot to provide a quantitative measure of analyte in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Adults.
Intended User / Care Setting
hospital or clinical laboratory setting by trained laboratory personnel.
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)
- Analytical performance: All results for analytical performance met the sponsor's predetermined acceptance criteria for each study.
- Precision/Reproducibility: Five serum samples containing various concentrations of CRP were tested in duplicate, two runs per day, for 20 days with one assay kit lot at three testing sites (n = 240 replicates per sample). Total %CV ranged from 7.1% to 12.6%.
- Linearity/Assay reportable range: Linearity was evaluated according to CLSI guideline EP06-A. "Low" and "High" CRP serum pools were created by mixing individual samples. Materials from the High and Low CRP pools were combined to create a total of eleven (11) serial dilutions. A total of four (4) replicate runs were performed on each dilution sample using a single MSD CRP Assay Kit lot. The assay is linear from 3 - 160 mg/L.
- Hook effect: The assay was tested for prozone or hook effect up to a CRP concentration of 800 mg/L. No prozone effect was observed within the linear range of the assay.
- Traceability, Stability, Expected values (controls, calibrators, or methods):
- Traceability: The calibrators used to calibrate the assay are traceable to the CRM474 reference material.
- Stability: The real-time stability for un-opened components supports a kit shelf life of 7 months.
- Detection limit:
- Limit of Blank (LoB): 0.02 mg/L for all tested kit lots. Determined by testing one hundred twenty (120) blank replicates.
- Limit of Detection (LoD): 0.039, 0.048 and 0.049 mg/L for each of the tested kit lots. Determined by testing one hundred twenty (120) low-level CRP samples.
- Limit of Quantification (LoQ): 3 mg/L. Validated by testing eight (8) replicates of six (6) low-level CRP pools.
- Analytical specificity: Five serum samples spiked with potential endogenous interferents or drugs were tested. The average % difference (n=15) for all substances was less than 10%, indicating no significant interference.
- Comparison studies:
- Method comparison with predicate device: A total of 120 serum samples were tested with the MSD CRP Assay Kit and MESO SECTOR S 700 Instrument and the predicate Roche Diagnostics C-Reactive Protein (Latex) Assay and Roche Diagnostics Cobas Integra 800 Analyzer. Passing-Bablok regression analysis yielded a slope of 1.094 (95% CI: 1.077-1.120), an intercept of 0.088 (-0.548-0.736), and an R-squared of 0.988 for the range 3.7-179.0 mg/L.
- Clinical studies:
- Clinical Sensitivity and Clinical Specificity: Not applicable.
- Expected values/Reference range: The reference range in the normal population was verified by testing 120 apparently healthy individuals per CLSI EP28-A3c. The median CRP value was 1.01 mg/L, and the central 95% interval was 0.100 - 12.9 mg/L.
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.
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).
Not Found
§ 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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January 17, 2018 Meso Scale Diagnostics, LLC Lillian Quintero Vice President, QA/RA 1601 Research Boulevard Rockville, Maryland 20850
Re: K171498
Trade/Device Name: MSD CRP Assay Kit and MESO SECTOR S 700 Instrument Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN, DCK Dated: November 30, 2017 Received: December 1, 2017
Dear Lillian Quintero:
This letter corrects our substantially equivalent letter of January 12, 2018.
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kelly Oliner -S
For. Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171498
Device Name MSD® CRP Assay Kit
Indications for Use (Describe)
The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO® SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Meso Scale Diagnostics, LLC. The logo consists of three circles, each containing a letter: M, S, and D. The letter S is red, while the other two are black. Below the logo, the text "Meso Scale Diagnostics, LLC." is displayed, followed by the text "510(k) Summary".
| Date Prepared: | January 8, 2018 |
|---|---|
| 510(k) Number: | K171498 |
| Sponsor Name: | Meso Scale Diagnostics, LLC. |
| Address: | 1601 Research Boulevard |
| Rockville, Maryland 20850-3173 | |
| Contact Person: | Lillian Quintero, VP Quality Assurance/Regulatory Affairs |
| Telephone Number: | 1-240-314-2600 |
| Fax Number: | 1-240-632-2219 |
| Device Trade Name: | MSD® CRP Assay Kit and MESO® SECTOR S 700 Instrument |
| Common/Usual Name: | CRP Assay System |
| Product Code: | DCK, DCN |
| Classification Name: | C-reactive protein immunological test system |
| 21 CFR 866.5270; Class II | |
| Predicate Device: | Roche Diagnostics C-Reactive Protein (Latex) Assay and Roche |
| Diagnostics Cobas Integra 800 Analyzer | |
| Common/Usual Name: | CRP Assay System |
| Product Code: | DCK, DCN |
| Classification Name: | C-reactive protein immunological test system |
| 21 CFR 866.5270; Class II | |
| Premarket Notification: | K073277 |
| Purpose for Submission: | New Device |
| Measurand: | C-Reactive Protein |
| Type of Test: | Electrochemiluminescence, Quantitative |
Intended Use
MSD CRP Assay Kit
The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings.
1601 Research Boulevard, Rockville, MO 20850-3126 . Phone: 240.314.2600 . Fax: 240.632.2219
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MESO SECTOR S 700 Instrument
The SECTOR S 700 instrument is intended for the in-vitro determination of analytes in bodily fluids. This instrument is not intended for Point-of-Care use.
Indication for use: Same as Intended Use
Special Conditions for Use Statement: For prescription use only
Special instrument requirements: The MESO SECTOR S 700
Device Description
The MSD CRP Assay Kit is a quantitative in-vitro diagnostic assay for conventional measurement of C-reactive protein in human serum. The CRP Assay Kit is designed for use with the MESO SECTOR® S 700 Instrument. The kit components include the 96-well CRP assay plate, CRP calibrator, CRP detection antibody, CRP diluent and CRP read buffer. The assay in the MSD CRP Kit is a sandwich immunoassay employing electrochemiluminescence (ECL) detection. In the instrument, a voltage is applied to the plate electrodes causing the captured labels to emit light. The instrument measures the intensity of emitted light from each spot to provide a quantitative measure of analyte in the sample.
Substantial Equivalence
Comparison with predicate:
| Item | Device | Predicate |
|---|---|---|
| MSD CRP Assay Kit and MESO | Roche Diagnostics C-Reactive Protein | |
| SECTOR S 700 Instrument | (Latex) Assay and Roche Diagnostics | |
| Cobas Integra 800 Analyzer | ||
| Intended | The MSD CRP Kit is intended for in | Measurements of C-reactive protein aids in |
| Use/Indication for | vitro diagnostic use in the quantitative | evaluation of the amount of injury to body |
| Use | determination of C-reactive protein | tissues |
| (CRP) in human serum using the MESO | ||
| SECTOR S 700 instrument. | ||
| Measurement of CRP aids in the | ||
| evaluation of infection, tissue injury, | ||
| and inflammatory disorders. This test | ||
| will be performed in a hospital or | ||
| clinical laboratory setting by trained | ||
| laboratory personnel. The target patient | ||
| population for the MSD CRP Assay is | ||
| symptomatic adults. Clinicians should | ||
| utilize the results of the MSD CRP | ||
| Assay for diagnosis of inflammatory | ||
| diseases in conjunction with other | ||
| clinical and laboratory findings. | ||
| Measurement | Quantitative | Same |
| Sample Type | Serum | Serum and Plasma |
1601 Research Boulevard, Rockville, MO 20850-3126 . Phone: 240.314.2600 . Fax: 240.632.2219
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| Item | Device | Predicate |
|---|---|---|
| MSD CRP Assay Kit and MESO | ||
| SECTOR S 700 Instrument | Roche Diagnostics C-Reactive Protein | |
| (Latex) Assay and Roche Diagnostics | ||
| Cobas Integra 800 Analyzer | ||
| Method | Sandwich-type | |
| electrochemiluminescence | ||
| immunoassay | Particle-enhanced turbidimetric assay | |
| Calibration | MSD CRP Calibrator | CRP T Control N |
| Precinorm Protein (K012371) | ||
| Precipath Protein (K012371) | ||
| Antibody | Mouse monoclonal anti-human CRP | |
| antibodies | Same | |
| Assay Measuring | ||
| Range (AMR) | 3 – 160 mg/L | 1 – 200 mg/L |
| Traceability | CRM474 | CRM470 |
Standard/Guidance Document Referenced (if applicable):
- Guidance for Industry and FDA Staff Review Criteria for Assessment of C-● Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays, September 22, 2005
- CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition
- CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: ● A Statistical Approach; Approved Guideline
- CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline -Second Edition
- CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using . Patient Samples; Approved Guideline - Third Edition
- CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory . Measurement Procedures: Approved Guideline - Second Edition
- CLSI EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in . The Clinical Laboratory; Approved Guideline - Third Edition
Test Principle:
The assay in the MSD CRP Kit is a sandwich immunoassay employing electrochemiluminescence (ECL) detection. This assay is carried out in a 96-well plate consumable that has integrated carbon ink electrodes screen-printed on the bottom of each well. The plate is provided pre-coated with capture antibody on a single, welldefined region of the electrode surface. The user adds the calibrator or sample and a solution containing detection antibody conjugated with electrochemiluminescent labels over the course of two incubation periods. Analyte in the sample binds to the capture antibodies immobilized on the electrode surface; recruitment of the detection antibodies by the bound analyte completes the sandwich. The user adds a buffer that creates the appropriate chemical environment for the electrochemiluminescent signal and loads the plate into an MSD MESO SECTOR S 700 instrument. In the instrument, a voltage is applied to the plate electrodes causing the captured labels to emit light. The instrument
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measures the intensity of emitted light to provide a quantitative measure of analyte in the sample.
Performance Characteristics:
-
- Analytical performance: All results for analytical performance met the sponsor's predetermined acceptance criteria for each study.
- a. Precision/Reproducibility:
The precision and reproducibility of the assay were calculated by testing five serum samples containing various concentrations of CRP. Each sample was run in duplicate, two runs per day, for 20 days with one assay kit lot at three testing sites (n = 240 replicates per sample). The results are summarized in the two tables below.
| Level | Concentration (mg/L) | Within-run %CV | Total %CV |
|---|---|---|---|
| Level 1 | 4.49 | 10.1 | 12.6 |
| Level 2 | 8.47 | 2.9 | 8.2 |
| Level 3 | 10.80 | 2.8 | 7.3 |
| Level 4 | 57.18 | 3.2 | 7.2 |
| Level 5 | 214.11 | 3.3 | 11.8 |
Precision Testing Results - All Data
| Precision Testing Results - Outliers Removed* | |
|---|---|
| -- | ----------------------------------------------- |
| Level | Concentration (mg/L) | Within-run %CV | Total %CV | ||
|---|---|---|---|---|---|
| Level 1 | 4.45 | 3.0 | 7.3 | ||
| Level 2 | 8.47 | 2.9 | 8.2 | ||
| Level 3 | 10.81 | 2.7 | 7.1 | ||
| Level 4 | 57.18 | 3.2 | 7.2 | ||
| Level 5 | 215.8 | 3.3 | 8.3 |
*5 Outliers (from a total of 1199 measurements) were removed in accordance with CLSI EP05-A3
b. Linearity/assay reportable range:
Linearity: Linearity was evaluated according to CLSI guideline EP06-A. "Low" and "High" CRP serum pools were created by mixing individual samples. Materials from the High and Low CRP pools were combined to create a total of eleven (11) serial dilutions. A total of four (4) replicate runs were performed on each dilution sample using a single MSD CRP Assay Kit lot. The results of the regression analysis are summarized as follows:
| Test Range
| (mg/L) | Slope (95% CI) | Intercept (95% CI) | R2 | % Recovery |
|---|---|---|---|---|
| 0.627 — 201 | 0.942 (0.926 — 0.958) | 0.0296 (-0.0389 — 0.0982) | 0.997 | -8.9% — 0.0% |
The assay is linear from 3 - 160 mg/L.
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Hook effect: The assay was tested for prozone or hook effect up to a CRP concentration of 800 mg/L. No prozone effect was observed within the linear range of the assay.
- c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability: The calibrators used to calibrate the assay are traceable to the CRM474 reference material.
Value assignment: A reference lot is created by diluting bulk calibration material. It is assigned using 4 dilutions across the quantitation range; CRM474 is utilized as the calibration standard. Production lots of kit calibrator are created by diluting the bulk calibration material in CRP Diluent to the nominal highest calibration level used in the assay. The concentration of each lot of kit calibrator is assigned using 4 dilutions across the quantitation range, using the reference lot as the calibration standard.
Stability: The real-time stability for un-opened components was performed using multiple kit lots. The results support a kit shelf life of 7 months. Storage temperatures for each kit component are found on the component labels and in the product insert.
d. Detection limit:
Limit of Blank (LoB) was determined by testing one hundred twenty (120) blank replicates created using MSD CRP Diluent without addition of the MSD CRP Calibrator. Samples were run on multiple kit lots and the statistical method for determining LoB for each kit lot was based on whether the data distribution was Non-Gaussian or Gaussian in accordance with CLSI guideline EP17-A2. The LoB was determined to be 0.02 mg/L for all tested kit lots.
Limit of Detection (LoD) was determined by testing one hundred twenty (120) low-level CRP samples created by testing twenty (20) replicates of six (6) lowlevel serum pools prepared by mixing MSD CRP Calibrator and MSD CRP Diluent in varying proportions. Samples were run on multiple kit lots and the LoD was calculated according to CLSI guideline EP17-A2 to be 0.039, 0.048 and 0.049 mg/L for each of the tested kit lots.
Limit of Quantification (LoQ) was validated by testing eight (8) replicates of six (6) low-level CRP pools that were prepared by mixing the MSD CRP Calibrator and the MSD CRP Diluent in varying proportions close to the lower limit of the reportable range. CLSI guideline EP17-A2 defines LoQ as the lowest concentration of the analyte that can be reported with a Total Error (TE)