(267 days)
For in vitro diagnostic use only. The RDI Extended Range hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.
Not Found
This FDA 510(k) clearance letter and associated documents for the "RDI Extended Range hs CRP Kit" primarily focus on the regulatory approval process and device's "intended use." It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the detailed study information generally required to describe acceptance criteria and how a device meets them in the context of AI/ML or complex diagnostic performance.
The document specifically describes a C-reactive protein immunological test system, which is a laboratory assay. The information requested in your prompt (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone performance) is typically relevant for AI/ML-based diagnostic devices, image analysis software, or devices that rely on complex algorithms and human interpretation. This document deals with a quantitative chemical assay.
Therefore, many of the requested fields cannot be directly answered from the provided text because they are not applicable to the type of device described or the information is simply not present in a 510(k) clearance letter.
However, I can extract what is available and clarify what is missing or not applicable:
Device Name: RDI Extended Range hs CRP Kit (C-reactive protein)
Regulation Number: 21 CFR 866.5270
Regulation Name: C-reactive protein immunological test system
Regulatory Class: Class II
Product Code: DCK
Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative "acceptance criteria" (e.g., sensitivity, specificity, accuracy thresholds) or provide detailed "reported device performance" in a table as would be expected for a study demonstrating analytical or clinical performance of a diagnostic test.
For a C-reactive protein kit, acceptance criteria would typically involve analytical performance characteristics like:
- Accuracy: Agreement with a reference method.
- Precision (Repeatability/Reproducibility): How consistent the results are.
- Linearity/Measuring Range: The range over which the test provides accurate results.
- Limit of Detection (LoD): The lowest concentration that can be reliably detected.
- Limit of Quantitation (LoQ): The lowest concentration at which analyte can be accurately quantified.
- Interferences: Effects of various substances on the test.
The 510(k) clearance indicates that the device has been found "substantially equivalent" to a legally marketed predicate device. This implies that the device's performance (analytical and, if applicable, clinical) has been demonstrated to be comparable to that predicate. However, the specific data demonstrating this is not provided in this regulatory letter.
Study Details (Based on available information and general understanding of 510(k)s for this type of device)
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided documents. Would typically reflect analytical performance goals (e.g., % bias vs. predicate, %CV for precision, linearity range).
- Reported Device Performance: Not explicitly stated in the provided documents. Would typically include data on accuracy, precision, linearity, LoD, LoQ, and interference.
Example (Hypothetical, as not provided in text):
Performance Metric Acceptance Criteria (e.g., vs. Predicate) Reported Device Performance Accuracy (Bias) ≤ 10% bias for concentrations X-Y X% bias Precision (CV) ≤ 10% CV at low/medium/high conc Y% CV Linearity Range 0.2 - 200 mg/L 0.2 - 200 mg/L Limit of Detection (LoD) ≤ 0.2 mg/L 0.15 mg/L -
Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. Clinical laboratory device validation studies typically use a range of patient samples (e.g., 50-100+ samples spanning the measuring range and including various clinical conditions).
- Data Provenance: Not specified. For 510(k)s, studies are typically conducted by the manufacturer, often internally or at external research sites, and would be prospective in nature for validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. For a C-reactive protein immunoassay, the "ground truth" is typically established by comparative analysis against a well-characterized reference method or a legally marketed predicate device, rather than expert interpretation.
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Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are relevant for subjective interpretations (e.g., imaging reads). For a quantitative assay, results are numerical. Data might be statistically analyzed against a comparison method.
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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:
- No. This is not applicable to a quantitative C-reactive protein assay kit. MRMC studies are used for devices that involve human interpretation, often in conjunction with AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. A C-reactive protein kit, as described, is a standalone diagnostic test (an in vitro diagnostic device or IVD). Its performance is evaluated on its own analytical capabilities to measure CRP in a sample. It doesn't typically involve an "algorithm only" in the sense of AI/ML, but rather a biochemical reaction and detection system.
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The type of ground truth used:
- Comparative method / Predicate device results. For this type of IVD, the "ground truth" would be established by comparing the device's results to a recognized reference method (e.g., gravimetric method if available, or another FDA-cleared predicate CRP assay known for its accuracy).
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. Development of the assay components and optimization of the reagents would involve extensive internal testing and formulation work, but not a "training set" of data for an algorithm.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
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SEP 3 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Joseph Lawlor, Ph.D. Reference Diagnostics, Inc. 19 Crosby Drive – Suite 30 Bedford, MA 01730
Re: K030044
Trade/Device Name: RDI Extended Range hs CRP Kit (C-reactive protein) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: July 7, 2003 Received: July 8, 2003
Dear Dr. Lawlor:
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 Sutman
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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REFERENCE DIAGNOSTICS, INC.
19 Crosby Drive, Suite 30 Bedford, Massachusetts 01730 Tel 781 276-9000 Fax 781 276-9002
Statement of Intended Use
Page 1 of 1
510(k) Number (if known): K030044
RDI Extended Range hs CRP Kit (C-reactive protein) Device Name:
Indications For Use:
For in vitro diagnostic use only. The RDI Extended Range hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.
Summary and Explanation of the Test:
Measurement of CRP helps in detecting and evaluating infection, tissue injury, inflammatory disorders, and associated diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number K030544
§ 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).