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K Number
K111938
Device Name
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
Manufacturer
IMMUNODIAGNOSTIC SYSTEMS LTD.
Date Cleared
2012-02-14

(221 days)

Product Code
JJX
Regulation Number
862.1660
Type
Abbreviated
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IDS-iSYS IGFBP-3 Control Set is intended for medical purposes for use in the IDS-iSYS IGFBP-3 Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 Assay.
The IDS-iSYS IGFBP-3 Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS IGFBP-3 Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
The IDS-iSYS hGH Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the hGH Assay (IDS-iSYS hGH) when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, indicating that the devices listed are substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily addresses the regulatory approval process and includes "Indications for Use" for three specific devices:

  • IDS-iSYS IGFBP-3 Control Set: Intended for medical purposes to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
  • IDS-iSYS IGFBP-3 Calibration Verifiers: Intended for medical purposes for quantitative verification of calibration of the IDS-iSYS IGFBP-3 Assay on the IDS-iSYS Multi-Discipline Automated Analyzer.
  • IDS-iSYS hGH Calibration Verifiers: Intended for medical purposes for quantitative verification of calibration of the hGH Assay (IDS-iSYS hGH) on the IDS-iSYS Multi-Discipline Automated Analyzer.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than performance studies.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.