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K Number
K984327
Device Name
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
Manufacturer
BIO-RAD
Date Cleared
1998-12-22

(19 days)

Product Code
JJX
Regulation Number
862.1660
Type
Traditional
Panel
CH
Reference & Predicate Devices
K950469
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Architect Total T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Total T3 assay on the Abbott Architect i System.

Device Description

Architect Total T3 MasterCheck Level 0 contains human serum.

Architect Total T3 MasterCheck Levels 1, 2, and 3 contain Total T3 prepared in human serum.

Preservative: Sodium Azide.

AI/ML Overview

I am sorry, but the provided text appears to be a 510(k) summary for a diagnostic control device (Architect Total T3 MasterCheck) and does not contain information about studies proving the device meets acceptance criteria in the way described by your request (e.g., performance metrics like accuracy, sensitivity, specificity, or studies involving human readers or ground truth established by experts).

The document is a regulatory submission outlining:

  • Device Name: Architect Total T3 MasterCheck
  • Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the Total T3 assay on the Abbott Architect i System.
  • Classification: Class I, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed).
  • Predicate Device: Casco Standards Document Serum Multi-Analyte Verification Test Set (K950469).
  • Technological Characteristics Comparison: A table comparing Architect Total T3 MasterCheck to the predicate device, highlighting similarities and some differences (like analytes and open vial claim).
  • FDA Clearance: A letter from the FDA confirming substantial equivalence to a legally marketed predicate device.

This type of submission for a Class I control device typically focuses on demonstrating similarity to an existing device, manufacturing controls, and intended use, rather than extensive clinical performance studies that would involve establishing ground truth from patient data or evaluating human reader performance.

Therefore, I cannot provide the requested information as it is not present in the given text.

§ 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.