(85 days)
Not Found
Not Found
No
The document describes calibrators for laboratory assays, which are chemical reagents used for calibration, not a device that processes data or images using AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is a calibrator for CRP assays and not intended for direct treatment or diagnosis of a disease or condition in a patient. Its purpose is to ensure the accuracy of other diagnostic tests.
No
Explanation: This device is a calibrator used to ensure the accuracy of C-Reactive Protein (CRP) assays, not a diagnostic device itself. It helps in the calibration of tests that diagnose conditions, but it does not directly diagnose.
No
The device is described as liquid calibrators containing human recombinant CRP in a stabilised protein matrix, which are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are "for use in the calibration of CRP assays." CRP assays are laboratory tests performed on biological samples (like blood) to measure the level of C-Reactive Protein, which is a marker of inflammation. This is a classic example of an in vitro diagnostic use.
- Device Description: The description reinforces the intended use by stating they are "liquid calibrators containing human recombinant CRP in a stabilised protein matrix" and are "developed for use in the calibration of CRP assays."
- Intended User/Care Setting: The intended users are "suitably qualified laboratory personnel under appropriate laboratory conditions." This indicates use in a laboratory setting, which is typical for IVDs.
The definition of an IVD generally includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, a disease or a congenital predisposition to a disease, or to monitor therapeutic measures.
This device fits squarely within this definition as a calibrator used in an in vitro test (CRP assay) to provide information about a physiological or pathological state (inflammation).
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels.
The Randox Laboratories Limited C-Reactive Protein Calibrators should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
JIS
Device Description
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels.
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
suitably qualified laboratory personnel under appropriate laboratory conditions.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows a logo with the words "MAN SERVICES USA" at the top and "DEPARTM" at the bottom. In the center of the logo is a stylized graphic that resembles a bird or a series of curved lines. The logo is black and white and appears to be a seal or emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Limited 55 Diamond Road Crumlin, County Antrim, United Kingdom BT29 4QY
5 2002 NOV
K022682 Re:
Trade/Device Name: C-Reactive Protein Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: August 5, 2002 Received: August 12, 2002
Dear Dr. Armstrong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
| 510(k) Number (if known) | NOT KNOWN |
|---|---|
| Device Name | C-REACTIVE PROTEIN CALIBRATOR |
Indications For Use :
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels.
The Randox Laboratories Limited C-Reactive Protein Calibrators should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use (Optional format 1-2-96)
(Liaison Sign-Off)
of Clinical Laboratory Devices 51 Ujk) Number -