(269 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on standard laboratory assay methods.
No.
This device is an in vitro diagnostic (IVD) test kit used for measuring C-Reactive Protein, which helps in the evaluation of inflammation. It is not intended for the treatment, prevention, or mitigation of disease, which are functions of a therapeutic device.
Yes
The device is an in vitro diagnostic (IVD) measurement kit for C-Reactive Protein, used to evaluate conditions associated with inflammation, which is a diagnostic purpose.
No
The device description explicitly states it is comprised of physical components (latex reagent, calibrator, controls, reaction buffer) in liquid form, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is for "quantitative in vitro measurement of C-Reactive Protein in serum". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details the components of a kit used for laboratory testing (latex reagent, calibrator, controls, buffer). These are typical components of an IVD kit.
- Performance Studies: The document describes analytical performance studies (Precision, Linearity, Detection Limit, Analytical Specificity, Method Comparison) which are required for the validation of IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K053603) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory process for IVDs.
All these elements strongly point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
The Optilite High Sensitivity C-Reactive Protein Kit is comprised of latex reagent, single calibrator, controls (high and low) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.
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
Prescription use only
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)
Precision/Reproducibility: The studies were based on CLSI EP5-A3, where 5 sera samples (targeted at 1mg/L, 1-3mg/L, 3mg/L, 5mg/L, and 9mg/L) were tested in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 3 reagent lots on 3 analysers. Results met the acceptance criteria for total precision (%CV3mg/L. Each sample was spiked with interfering substances and tested. For non-interference to be claimed, the mean results from the spiked samples must be within 10% of the mean of the control samples.
Haemoglobin and Bilirubin results: The data demonstrated that the assay was not affected by high levels of the following substances: haemoglobin (5g/L), conjugated bilirubin (200mg/L) unconjugated bilirubin (200mg/L) and rheumatoid factor (25lU/mL).
Intralipid and Triglyceride results: The data demonstrated that the assay was not affected by triglyceride (1000mg/dL), and intralipid (2000mg/dL).
Drug Interference results: The data demonstrated that the assay was not affected by the 6 therapeutic drugs tested at the concentrations given below.
Method comparison with predicate device: A total of 391 serum samples, 302 of which reported results within the measuring range, were assayed in singlicate by both the Optilite High Sensitivity C-Reactive Protein Kit and the C-Reactive Protein High Sensitive Test System for Cobas Integra. The samples included 87 normal donors and 304 clinical samples.
Regression statistics are based on the balance of the paired results.
Passing & Bablok: y = 0.99x + 0.09, 95% CI Slope 0.97 to 1.01, 95% CI Intercept 0.05 to 0.11, PASS
Weighted Deming: y = 0.97x + 0.10, 95% CI Slope 0.94 to 0.99, 95% CI Intercept 0.07 to 0.13
Weighted Linear: y = 0.95x + 0.12, 95% CI Slope 0.93 to 0.98, 95% CI Intercept 0.10 to 0.15
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 contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2018
The Binding Site Group Ltd Andrea Thomas, Regulatory Affairs Manager 8 Calthorpe Road Edgbaston Birmingham B15 10T UK
Re: K180099
Trade/Device Name: Optilite High Sensitivity C-Reactive Protein Kit Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: August 29, 2018 Received: September 4, 2018
Dear Andrea Thomas:
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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 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,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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) K180099
Device Name
Optilite High Sensitivity C-Reactive Protein Kit
Indications for Use (Describe)
The Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.
| 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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Optilite High Sensitivity C-Reactive Protein Kit 510(k) Summary
Date prepared: 11th October 2018
A. 510(k) Number:
B. Purpose for Submission:
New device
C. Measurand:
C-Reactive Protein
D. Type of Test:
Quantitative immunoturbidimetry
E. Applicant:
The Binding Site Group, Ltd. Contact person: Andrea Thomas Address: 8 Calthorpe Road, Birmingham, B15 1QT, United Kingdom Contact number: +44(0)121 456 9500
F. Proprietary and Established Names:
Optilite® High Sensitivity C-Reactive Protein Kit
G. Regulatory Information:
-
- Regulation section:
21 CFR 866.5270, C-reactive protein immunological test system.
- Regulation section:
-
- Classification:
Class II
- Classification:
-
- Product code:
DCN, System, Test, C-Reactive Protein
- Product code:
-
- Panel:
Immunology (82)
- Panel:
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H. Intended use:
1. Intended use(s):
The Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.
2. Indication(s) for use:
Same as Intended use(s).
3. Special conditions for use statement(s):
Prescription use only
4. Special instrument requirements:
The Binding Site Optilite analyser
l. Device Description:
The Optilite High Sensitivity C-Reactive Protein Kit is comprised of latex reagent, single calibrator, controls (high and low) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.
J. Substantial equivalence information:
1. Predicate device name(s) and 510(k) number(s):
C-Reactive Protein High Sensitive Test System for Cobas Integra Instruments (K053603)
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2. Comparison with predicate:
Similarities
| ltem | Device | Predicate |
|---|---|---|
| Intended use | Quantitative in vitro measurement of | |
| C-reactive protein (CRP) | Same | |
| Reference Interval | 3mg/L. Each sample was spiked with interfering substances and tested. For non-interference to be claimed, the mean results from the spiked samples must be within 10% of the mean of the control samples. |
Haemoglobin and Bilirubin results: The data demonstrated that the assay was not affected by high levels of the following substances: haemoglobin (5g/L), conjugated bilirubin (200mg/L) unconjugated bilirubin (200mg/L) and rheumatoid factor (25lU/mL).
8
Intralipid and Triglyceride results: The data demonstrated that the assay was not affected by triglyceride (1000mg/dL), and intralipid (2000mg/dL).
Drug Interference results: The data demonstrated that the assay was not affected by the 6 therapeutic drugs tested at the concentrations given below.
| Drug | Concentration tested |
|---|---|
| Acetaminophen | 1324µmol/L |
| Acetylsalicylic Acid | 3.62mmol/L |
| Caffeine | 308µmol/L |
| Enalapril Maleate | 0.86µmol/L |
| Ibuprofen | 2425µmol/L |
| Warfarin | 32.5µmol/L |
f. Assay cut-off:
Refer to Expected Values.
2. Comparison studies:
- a. Method comparison with predicate device:
A total of 391 serum samples, 302 of which reported results within the measuring range, were assayed in singlicate by both the Optilite High Sensitivity C-Reactive Protein Kit and the C-Reactive Protein High Sensitive Test System for Cobas Integra. The samples included 87 normal donors and 304 clinical samples.
Regression statistics are based on the balance of the paired results.
| Results (n = 302) | ||||
|---|---|---|---|---|
| Analysis | Result | 95% CI Slope | 95% CI Intercept | Pass/Fail |
| Passing & Bablok | y = 0.99x + 0.09 | 0.97 to 1.01 | 0.05 to 0.11 | PASS |
| Weighted Deming | y = 0.97x + 0.10 | 0.94 to 0.99 | 0.07 to 0.13 | |
| Weighted Linear | y = 0.95x + 0.12 | 0.93 to 0.98 | 0.10 to 0.15 |
b. Matrix comparison:
None
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3. Clinical studies:
-
a. Clinical Sensitivity:
Not applicable -
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The reference interval was verified by testing 50 adult donor samples.
Consensus reference interval for adults: