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K Number
K012422
Device Name
K-ASSAY D-DIMER CONTROLS
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
2001-08-21

(22 days)

Product Code
GGC
Regulation Number
864.5425
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.

Device Description

Not Found

AI/ML Overview

This is an FDA K-number document. The information provided does not include the details to fill out the table of acceptance criteria and the study that proves the device meets the acceptance criteria. This document primarily focuses on the FDA's decision regarding the substantial equivalence of the K-ASSAY D-Dimer Controls to a legally marketed predicate device, allowing it to proceed to market.

Here's why the requested information cannot be extracted from this document:

  • Acceptance Criteria and Reported Device Performance: This document states the device is being cleared for marketing based on substantial equivalence. It does not contain details about specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) or the acceptance criteria established for those metrics. These would typically be found in the actual 510(k) submission, which is not fully provided here.
  • Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, Standalone, Ground Truth type, Training set info): The document summarizes the regulatory decision. It doesn't present the detailed study design, results, or methodologies (like sample sizes, experts, adjudication, or training data) that would be part of the technical data submitted by the manufacturer to the FDA. The "K012422" is the submission number, not a report of the study details itself.

In summary, this document is a regulatory approval letter, not a scientific study report describing the performance evaluation of the device.

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.