RDI EXTENDED RANGE CRP CALIBRATOR SET by REFERENCE DIAGNOSTICS, INC.

The RDI Extended Range CRP Calibrator Set is intended for medical purposes for use with the RDI Extended Range hsCRP Kit, to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device called "RDI Extended Range CRP Calibrator Set."

Based on the provided text, the document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/software devices.

Here's why and what information is available:

Device Type: This device is a "Calibrator" (specifically, an "Extended Range CRP Calibrator Set"). Calibrators are used to establish reference points for assays (like a C-reactive protein assay). They are not typically "devices" in the sense of AI algorithms that perform an analysis or make a diagnosis.
Regulatory Pathway: This is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device. This pathway often focuses on demonstrating that the new device is as safe and effective as an existing one, rather than novel performance studies with acceptance criteria as you've described for AI.
Content of the Document: The letter is an official notification of clearance from the FDA. It confirms that the device can be marketed. It discusses general controls, regulations, and labeling, but it does not present a detailed study report or performance data.

Therefore, I cannot fill out the requested table or answer most of your questions as the information is not present in the provided text.

Here is what can be extracted to answer some parts, and explanations for why other parts cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not contain acceptance criteria or performance data for the calibrator in the way you've outlined. The FDA's substantial equivalence determination implies that the device performs comparably to a predicate, but the specific performance metrics and acceptance thresholds are not detailed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No study data (test set size, provenance) is included in this regulatory clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. This is not relevant for a calibrator's regulatory clearance and no such information is in the document. Ground truth for a calibrator would typically relate to its manufactured concentration values and traceability to international standards, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Not applicable or available in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This relates to AI/software performance with human readers, which is not what this device is.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. This device is a calibrator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a calibrator, the "ground truth" is its manufactured, certified value. The document mentions: "The accuracy of the CRP measurement is insured by using calibrators that are traceable to the international reference preparation (CRM470)." This indicates that the ground truth for the calibrator's values comes from its traceability to an internationally recognized standard.

8. The sample size for the training set

Cannot be provided. Not applicable for this type of device and no such information is in the document.

9. How the ground truth for the training set was established

Cannot be provided. Not applicable for this type of device and no such information is in the document.

In summary, the provided text is an FDA 510(k) clearance letter for a calibrator, which is a different type of medical device than an AI-driven diagnostic tool. Therefore, most of the questions, which are tailored to AI/software performance studies, cannot be answered from this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the serpent entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 1 2003

Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford, MA 01730

K030772 Trade/Device Name: RDI Extended Range CRP Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: March 10, 2003 Received: March 11, 2003

Dear Dr. Lawlor:

Re:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use

Page-1 of 1

1030772 510(k) Number (if known):

Device Name:

RDI Extended Range CRP Calibrator Set

Indications For Use:

For in vitro diagnostic use only.

Summary and Explanation of the Test:

Measurement of CRP helps in detecting and evaluating infection, tissue injury, inflammatory disorders, and associated diseases. The accuracy of the CRP measurement is insured by using calibrators that are traceable to the international reference preparation (CRM470).

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A Reeves for J. Bautista

Division of Clinical Laboratory Devices
510(k) Number K030772
Prescription Use OR Over-The Counter Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.