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K Number
K083412
Device Name
PATHFAST HSCRP
Manufacturer
MITSUBISHI KAGAKU IATRON
Date Cleared
2009-03-09

(111 days)

Product Code
DCN,JIT
Regulation Number
866.5270
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PATHFAST® hsCRP test, for use with PATHFAST® analyzer, is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum, as an aid in the detection and evaluation of the infection, tissue injury, inflammatory disorders, and associated disorders. This method is for use in clinical laboratory or point of care (POC) settings.

PATHFAST® hsCRP Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the PATHFAST® System.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information or acceptance criteria requested.

The letter confirms that the PATHFAST hsCRP test is substantially equivalent to legally marketed predicate devices. To provide the requested information, I would need to analyze the actual 510(k) submission document (K083412), which is not provided here.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes and data provenance for the test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth was established for the training set.

The provided document is merely the FDA's clearance letter acknowledging the 510(k) submission and its determination of substantial equivalence. The actual performance data and study details would be in the submission itself.

§ 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).