(94 days)
No
The device description and performance studies focus on standard immunoturbidimetric assay principles and statistical analysis, with no mention of AI or ML algorithms.
No
This device is an in vitro diagnostic (IVD) assay designed to measure C-reactive protein levels, which is useful in the detection and evaluation of infection, tissue injury, and inflammatory disorders. It is not used to treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The CRP Vario assay [CRPVa] is for in vitro diagnostic use."
No
The device is an in vitro diagnostic assay kit containing reagents and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma..."
This statement clearly indicates that the device is intended to be used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.
CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR): CRP Calibrators are intended to be used for the CRP Vario for the quantitative determination of C reactive protein in human serum or plasma samples.
Product codes (comma separated list FDA assigned to the subject device)
DCK
Device Description
The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma.
It is supplied as a two-reagent kit which contains 2 reagents composed as follow:
Reactive Ingredients
Reagent 1: Glycine buffer (pH 7.0) (1.28%)
Reagent 2: Anti-CRP polyclonal antibodies (rabbit) adsorbed on latex particles (0.2%)
Inactive Ingredients:
Reagent 1: contains bovine albumin (≤ 1%) and sodium azide (
§ 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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
November 8, 2019
Sentinel CH, Spa Patricia Dupe Head of Quality System Via Robert Koch, 2 Milano, 20152 It
Re: K192118
Trade/Device Name: CRP Vario Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: Class II Product Code: DCK Dated: August 1, 2019 Received: August 6, 2019
Dear Patricia Dupe:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Douglas Jeffery, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192118
Device Name CRP Vario
Indications for Use (Describe)
CRP Vario
The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.
CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR): CRP Calibrators are intended to be used for the CRP Vario for the quantitative determination of C reactive protein in human serum or plasma samples.
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 15: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807,92.
In accordance with 21 CFR 807.87, SENTINEL CH. hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification Special 510(k).
The purpose of this Special 510(k) Premarket Notification is to inform FDA of the proposed modifications to the CRP Vario labeling and provide sufficient detail to support a determination of substantial equivalence.
The primary change in the candidate device, CRP Vario, from the predicated device is the modification in the traceability of the assay from CRM 470 to ERM-DA472/IFCC.
Other changes that will also be addressed are the removal of the EDTA as tube type used for the specimen storage and the revision of the specimen from 3 years to 1 year when stored at -20°C.
Moreover, other changes to the device labeling implemented since the product initially cleared in 2005 were evaluated per the FDA Guidance document "Deciding When to Submit a 510(k)". Per the quidance document these changes required documentation only, and they did not present any new risks. The labeling changes are listed below:
- revision of the interference data for Bilirubin which was also separated into ● Conjugated and Unconjugated Bilirubin
- . revision of the High Sensitivity method precision
Note: There were no prior submissions for this device for which FDA provided feedback related to the data or information needed to support substantial equivalence.
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| Submitter Name | SENTINEL CH. SpA |
|---|---|
| Address | Via Robert Koch,2 |
| Milano (MI) | |
| 20152, Italy | |
| Contact | Primary: |
| Patricia Dupé | |
| +39 02 345 514 496 | |
| +39 02 345 514 64 | |
| patriciadupe@sentinel.it | |
| Date prepared | November 08, 2019 |
| Proprietary Name | CRP Vario |
| Common name | C-Reactive Protein, Antigen, Antiserum, and Control |
| Classification Name | C-Reactive Protein, Antigen, Antiserum, and Control |
| Device, (21CFR 866.5270, Class 2 device) | |
| Product Code | DCK |
| Predicate Devices | The candidate device is a modification of the predicate |
| device. The device name, CRP Vario, is unchanged from | |
| how it was cleared in 510(k) K050836 on August 8th, 2005 | |
| and CLIA categorized on October 1st,2008 | |
| Establishment | |
| Registration | The Establishment Registration number for SENTINEL CH. |
| SpA is 9681753 |
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1. DEVICE DESCRIPTION
The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma.
It is supplied as a two-reagent kit which contains 2 reagents composed as follow:
| Reactive Ingredients | Concentration |
|---|---|
| Reagent 1: Glycine buffer (pH 7.0) | 1.28% |
| Reagent 2: Anti-CRP polyclonal antibodies | |
| (rabbit) adsorbed on latex particles | 0.2% |
Inactive Ingredients:
Reagent 1: contains bovine albumin (≤ 1%) and sodium azide (Mean Beckman vs 1st rep c8000
Slope 0.969 (0.964 – 0.974)
Intercept 0.019 (0.001 – 0.036) mg/dL
r 1.000
n 111
range: (0.01 – 15.71) mg/dL |
| Standard
Method | Slope
R
n | 0.95 – 1.05
≥ 0.975
≥ 100 | Mean Beckman vs 1st rep c8000
Slope 0.956 (0.925 – 0.997)
Intercept -0.008 (-0.015 – -0.003) mg/dL
r 1.000
n 119
range: (0.01 – 27.74) mg/dL |
| Wide Range
Method | Slope
R
n | 0.95 – 1.05
≥ 0.975
≥ 100 | Mean Beckman vs 1st rep c8000
Slope 0.976 (0.944 – 0.993)
Intercept -0.012 (-0.022 – -0.007) mg/dL
r 1.000
n 119
range: (0.02 – 43.31) mg/dL |
| Table 15-3: Results of the Method Comparison between the Candidate Sentinel device |
|---|
| CRP Vario (LN. 6K26) and Beckman Coulter CRP Latex (REF. OSR6199). |
Limit of Quantitation
A study was conducted to assess the sensitivity of CRP Vario High Sensitivity (HS), Standard (Std) and Wide Range (WR) methods.
The LoQ study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2. The LOQ was determined using low-level analyte samples prepared at target levels concentrations of 0.08, 0.06, 0.05, 0.04. 0.03, 0.02, 0.01, and 0.005 mg/dL by diluting serum pool with SeraSub (a synthetic serum). Testing occurred over a minimum of 3 days, on 1 ARCHITECT c8000 System. Each sample was tested in a minimum of 10 replicates per run with 2 runs per day over 3 days, for a total of 60 replicates per sample.
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At a minimum the limit of quantitation shall be ≤ 0.03 mg/dL for hsCRP and ≤ 0.05 mg/dL for standard and Wide Range methods. The LOQ results are consistent with the original submission.
- CONCLUSIONS
The differences between predicate and candidate do not impact the indications for use or technological characteristics.
The conclusions drawn from the nonclinical tests (discussed above) demonstrate the modified CRP Vario are as safe and effective as the predicate device.
The information submitted in the premarket notification is complete and supports a substantial equivalence decision.