(112 days)
Not Found
No
The description details a quantitative immunoassay based on light scattering and comparison to a standard. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on a direct chemical reaction and measurement, not pattern recognition or learning algorithms.
No
This device is for in vitro diagnostic use, meaning it's used to analyze samples from the human body to diagnose conditions or assess risk, rather than providing direct therapeutic intervention to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use" and that measurements "may be used as an aid in identification of individuals at risk for future cardiovascular disease" and "as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes." This clearly indicates its diagnostic purpose.
No
The device is an in vitro diagnostic assay consisting of reagent packs and is used in conjunction with a physical analyzer (Atellica CH Analyzer). It involves chemical reactions and light scattering measurements, which are hardware-dependent processes.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is for in vitro diagnostic use". This is the most direct confirmation.
- Device Description: The description details a laboratory assay that analyzes human serum and plasma samples to measure the concentration of C-Reactive Protein. This is a typical function of an in vitro diagnostic device.
- Method of Operation: The description explains a process of mixing reagents with a patient sample and measuring the resulting reaction (light scattering). This is a common method used in in vitro diagnostic tests.
- Sample Type: The device is designed to analyze human serum and plasma, which are biological specimens collected from the human body for diagnostic purposes.
- Output: The device provides a quantitative determination of CRP concentration, which is a diagnostic result used in clinical evaluation.
- Regulatory Information: The "For Prescription Use Only" indicates it's a medical device intended for use in a healthcare setting under the direction of a healthcare professional, which is consistent with IVDs.
- Performance Studies: The inclusion of performance studies like detection capability, precision, reproducibility, assay comparison, and interference testing are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a predicate device (K212559; BN ProSpec System CardioPhase hsCRP) which is also an IVD, further supports the classification of this device as an IVD.
Based on the provided information, the Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay clearly meets the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin, sodium heparin or K2 EDTA) on the Atellica® CH Analyzer.
Measurements from Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) may be used as an aid in identification of individuals at risk for future cardiovascular disease. Measurement of hCRP2, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.
Product codes (comma separated list FDA assigned to the subject device)
NQD
Device Description
The Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is used for the quantitative determination of C-Reactive protein in human serum and plasma using the Atellica CH analyzer. This device is two ready-to-use reagent packs consisting of 23.1mL Phosphate buffer, polidocanol (1.9g/L), and sodium azide (0.1%) in Pack 1 and 12.3mL Mouse anti-CRP monoclonal antibodies (13mg/L), polystyrene particles (1g/L), human albumin (0.05%) and sodium azide ( 9.50 mg/L.
Expected Values:
- Study Type: Reference interval for healthy adults verified in accordance with CLSI Document EP28-A3c.
- Key Results:
- Low risk for cardiovascular disease prediction: 3.00 mg/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
0
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: 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" followed by the words "U.S. Food & Drug Administration".
January 18, 2024
Siemens HealthCare Diagnostics Inc. Anthony Calabro Regulatory Affairs Specialist 500 GBC Drive Newark, Delaware 19714
Re: K233242
Trade/Device Name: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: Class II Product Code: NQD Dated: October 20, 2023 Received: October 20, 2023
Dear Anthony Calabro:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
K233242 Device Name
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Indications for Use (Describe)
The Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin, sodium heparin or K2 EDTA) on the Atellica® CH Analyzer.
Measurements from Atellica® CH High Sensitivity C -Reactive Protein 2 (hCRP2) may be used as an aid in identification of individuals at risk for future cardiovascular disease. Measurement of hCRP2, when used in coniunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.
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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3
This 510(k) Summary of Safety and Effectiveness 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: K233242
1. Date Prepared
January 18, 2024
2. Applicant Information
| Contact: | Anthony Calabro
Regulatory Affairs Specialist |
|----------|-------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc
500 GBC Drive
Newark, DE 19714 |
| Email: | anthony_calabro@siemens-healthineers.com |
3. Regulatory Information
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay
Trade Name: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) Common Name: Cardiac C-Reactive Protein, Antiserum, and Control Classification Name: C-reactive protein immunological test system FDA Classification: Class II Review Panel: Immunology Product Code: NQD Regulation Number: 21 CFR 866.5270
4. Predicate Device Information
Predicate Device Name: BN ProSpec System CardioPhase hsCRP 510(k) Number: K212559
4
5. Intended Use / Indications For Use
The Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin, sodium heparin or K2 EDTA) on the Atellica® CH Analyzer.
Measurements from Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) may be used as an aid in identification of individuals at risk for future cardiovascular disease. Measurement of hCRP2, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.
Special Conditions for Use Statement: For Prescription Use Only
6. Device Description
The Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is used for the quantitative determination of C-Reactive protein in human serum and plasma using the Atellica CH analyzer. This device is two ready-to-use reagent packs consisting of 23.1mL Phosphate buffer, polidocanol (1.9g/L), and sodium azide (0.1%) in Pack 1 and 12.3mL Mouse anti-CRP monoclonal antibodies (13mg/L), polystyrene particles (1g/L), human albumin (0.05%) and sodium azide (for in vitro diagnostic use in the
quantitative determination of the
concentration of C-Reactive Protein
(CRP) in human serum and plasma
(lithium heparin, sodium heparin or
K2 EDTA) on the Atellica® CH
Analyzer.
Measurements from Atellica® CH
High Sensitivity C-Reactive Protein 2
(hCRP2) may be used as an aid in
identification of individuals at risk for
future cardiovascular disease.
Measurement of hCRP2, when used
in conjunction with traditional clinical
laboratory evaluation of acute
coronary syndromes, may be useful
as an independent marker of
prognosis for recurrent events in
patients with stable coronary disease
or acute coronary syndromes. | CardioPhase® hsCRP is an in-vitro
diagnostic reagent for the quantitative
determination of C-reactive protein (CRP)
in human serum, and heparin and EDTA
plasma by means of particle enhanced
immunonephelometry using the BN II and
BN ProSpec® System. In acute phase
response, increased levels of a number of
plasma proteins, including C-reactive
protein, is observed. Measurement of CRP
is useful for the detection and evaluation
of infection, tissue injury, inflammatory
disorders and associated diseases*. High
sensitivity CRP (hsCRP) measurements
may be used as an independent risk
marker for the identification of individuals
at risk for future cardiovascular disease.
Measurements of hsCRP, when used in
conjunction with traditional clinical
laboratory evaluation of acute coronary
syndromes, may be useful as
an independent marker of prognosis for
recurrent events, in patients with stable
coronary disease or acute coronary
syndromes. |
| Sample Type | Human serum and plasma (lithium heparin,
sodium heparin, K2 EDTA) | Human Serum, and heparin and K2 EDTA
plasma |
| Units of Measure | mg/L | Same |
| Assay Range / Measuring
Interval | 0.16-9.50 mg/L | 0.155 – 9.95 mg/L
(calibrator lot dependent) |
| Expected Values | Risk for cardiovascular disease
prediction:
3.00 mg/L are high risk | Same |
| Feature | Candidate Device | Predicate Device |
| | Atellica® CH High Sensitivity C-Reactive
Protein 2 (hCRP2) | BN ProSpec CardioPhase hsCRP |
| Assay Principle | Particle enhanced immunonephelometry | Same |
| Standardization | ERM-DA474/IFCC | Same |
| Calibration | Multi-Level calibration | Same |
| Calibrators | Atellica CH Protein 2 Calibrator
(PROT2 CAL) | N Rheumatology Standard SL |
| Reagents | Two liquid reagents, ready to use | Same |
| Composition | Pack 1: 23.1 mL
Phosphate buffer; polidocanol (1.9
g/L); sodium azide (0.1%)
Pack 2: 12.3 mL
Mouse anti-CRP monoclonal antibodies (13
mg/L); polystyrene
particles (1 g/L); human albumin
(0.05%); sodium azide ( 10% is considered interference. Analyte results should not be corrected based on this bias.
Interference testing was performed in accordance with CLSI Document EP07. The following results were obtained:
| Substance | Substance Concentration
Conventional Units (SI
Units)(g/L) | Analyte Concentration
Conventional Units | Bias
% |
|------------------------|------------------------------------------------------------------|---------------------------------------------|-----------|
| Hemoglobin | 1000 mg/dL (10 g/L) | 0.94 mg/L | 4 |
| | 1000 mg/dL (10 g/L) | 2.30 mg/L | 0 |
| Bilirubin, conjugated | 40 mg/dL (684 $\mu$ mol/L) | 1.10 mg/L | -1 |
| | 40 mg/dL (684 $\mu$ mol/L) | 2.80 mg/L | -1 |
| Bilirubin unconjugated | 40 mg/dL (684 $\mu$ mol/L) | 1.10 mg/L | -1 |
| | 40 mg/dL (684 $\mu$ mol/L) | 2.82 mg/L | 0 |
| Lipemia (Intralipid®) | 3000 mg/dL (30 g/L) | 0.90 mg/L | -7 |
| | 3000 mg/dL (30 g/L) | 2.48 mg/L | -4 |
12
10.6.2 Non-interfering Substances
The following substances do not interfere with Atellica CH High Sensitivity C-Reactive Protein 2 assay when present in serum and plasma at the concentrations indicated in the table below. Bias due to these substances is ≤ 10%.
Interference testing was performed in accordance with CLSI Document EP07. The following results were obtained:
| Substance | Substance Concentration
Conventional Units | Analyte Concentration
Conventional Units | Bias
% |
|--------------------|-----------------------------------------------|---------------------------------------------|-----------|
| Rheumatoid factors | 500 IU/mL | 0.94mg/L | -1 |
| | 500 IU/mL | 2.81mg/L | 0 |
10.6.3 High-Dose Hook Effect / Antigen Excess
High C-reactive protein levels can cause a paradoxical decrease in signal as a result of the high-dose hook effect. In the Atellica CH hCRP2 assay, C-reactive protein levels as high as 1300.00 mg/L will read > 9.50 mg/L.
Clinical Study 11.
Not applicable
11.1 Expected Values
A reference interval for healthy adults was verified in accordance with CLSI Document EP28-A3c.
| Group | Specimen Type | Reference Interval
mg/L |
|----------------------------------------------------|---------------|----------------------------|
| Low risk for cardiovascular disease prediction | Serum/plasma | 3.00 |
Pearson TA, Mensah GA, Alexander RW, Anderson JL, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rfai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for heathcare professionals from the Centrol and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511
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Standardization 12.
The assay is traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference material ERM-DA474/IFCC.
Clinical Cut-off 13.
Not applicable
Conclusion 14.
The results from the performance studies support that the Candidate Device, Atellica CH High Sensitivity C-Reactive Protein 2 assay is substantially equivalent to the Predicate Device, BN ProSpec CardioPhase hsCRP assay (K212559)