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K Number
K992311
Device Name
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-09-13

(66 days)

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

The K-ASSAY CRP (I) Assay is intended to be used for the quantitative determination of C-Reactive Protein (CRP) in serum by a latex enhanced immunoturbidimetric method. Measurement of CRP is useful as an aid in the detection and evaluation of inflammatory conditions and tissue injury. CRP is an acute phase reactant protein that is elevated in the presence of inflammatory processes, infection, and tissue injury. Measurement of CRP is useful as an aid in the detection and evaluation of inflammatory conditions and tissue injury.

The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (I) Assay.

The K-ASSAY CRP Multi-Calibrator C is intended to be used for the calibration of the K-ASSAY CRP (I) Assay.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the K-ASSAY CRP (I), K-ASSAY CRP Multi-Calibrator A, and K-ASSAY CRP Multi-Calibrator C. It states that the devices are substantially equivalent to legally marketed predicate devices. The "Indications for Use Statement" describes the intended use of the K-ASSAY CRP (I) Assay for quantitative determination of C-Reactive Protein (CRP) in human serum, with the calibrators intended for calibration of the assay.

However, the document does not contain the detailed acceptance criteria and study information requested in the prompt. Specifically, it lacks:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts and their qualifications for ground truth.
  4. Adjudication method.
  5. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
  6. Information on standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The 510(k) letter confirms clearance based on substantial equivalence to a predicate device, which usually implies that the new device performs similarly to an already approved device. The specifics of the performance studies that supported this equivalence are typically found within the full 510(k) submission, not in the final clearance letter 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).