(260 days)
Not Found
No
The summary describes a traditional in vitro diagnostic (IVD) kit for measuring CRP concentration using reagents and an analyzer. There is no mention of AI/ML in the device description, intended use, performance studies, or any other section.
No.
The device is intended for quantitative in vitro determination of C-reactive protein in serum to aid in evaluation, not for treating any condition.
Yes
The device is intended for the "quantitative in vitro determination of C-reactive protein (CRP) concentration in serum," which "aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders." This clearly indicates its use in aiding diagnosis.
No
The device is a kit comprised of reagents for use on an analyzer, indicating it is a hardware-based in vitro diagnostic device, not software-only.
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 kit is for the "quantitative in vitro determination of C-reactive protein (CRP) concentration in serum." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes "serum," which is a biological sample taken from the body.
- Purpose: The purpose is to measure a substance (CRP) in the sample to aid in the "evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders." This is a diagnostic purpose.
- Device Description: The description lists reagents used to perform a test on a biological sample.
- Performance Studies: The document details analytical and comparison studies, which are typical for demonstrating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K083444; Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared IVD.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
The C-Reactive Protein Kit for use on SPAPLUS is comprised of the following reagents:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The concentration given on the quality control certificate has been obtained by comparison with the international reference standard ERM-DA474.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
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 (Part 21 CFR 801 Subpart D)
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-A2, where 4 sera samples (targeted to 6.025mg/L, 8.643mg/L, 21.342mg/L and 65.165mg/L) were tested in 2 runs per day (each of the 2 runs in duplicate) over 21 days using 1 reagent lot on 3 analysers. Results met the acceptance criteria for total precision (%CV
§ 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
The Binding Site Group Ltd Ms. Kirsty Samuels Regulatory Affairs Officer 8 Calthorpe Road, Edgbaston Birmingham, West Midlands, B15 1QT UK
Re: K161982
Trade/Device Name: C-Reactive Protein Kit for Use on SPAPlus Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein Immunological Test System Regulatory Class: II Product Code: DCN Dated: March 9, 2017 Received: March 10, 2017
Dear Ms. Samuels:
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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kelly Oliner -S
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161982
Device Name
C-Reactive Protein Kit for use on SPAPLUS
Indications for Use (Describe)
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subnart 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
C-Reactive Protein kit for use on SPAPLUS 510(k) Summary
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
F. Proprietary and Established Names:
C-Reactive Protein Kit for use on SPAPLUS®
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:
4
H. Intended use:
1. Intended use(s):
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum.
2. Indication(s) for use:
Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.
3. Special conditions for use statement(s):
Prescription use only
4. Special instrument requirements:
The Binding Site SPAPLUS analyser
l. Device Description:
The C-Reactive Protein Kit for use on SPAPLUS is comprised of the following reagents:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The concentration given on the quality control certificate has been obtained by comparison with the international reference standard ERM-DA474.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
J. Substantial equivalence information:
1. Predicate device name(s) and 510(k) number(s):
Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3 (K083444)
5
2. Comparison with predicate:
Similarities
| Item | Device | Predicate |
|---|---|---|
| Intended use | Quantitative in vitro determination of | |
| C-reactive protein (CRP). | Same. | |
| Method | Turbidimetry | Same. |
| Reference Interval |