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K Number
K984319
Device Name
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
Manufacturer
BIO-RAD
Date Cleared
1998-12-22

(19 days)

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

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

Device Description

Architect Free T3 MasterCheck Level 0 contains human serum. Architect Free T3 MasterCheck Levels 1, 2 and 3 contain Free T3 prepared in human serum. Preservative: Sodium Azide.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the "Architect Free T3 MasterCheck" device, primarily focused on establishing its substantial equivalence to a predicate device.

It details:

  • The device's intended use.
  • A comparison of technological characteristics with a predicate device.
  • Confirmation from the FDA regarding its classification and clearance.

However, there is no mention of:

  1. Specific acceptance criteria (like accuracy, precision, sensitivity, specificity thresholds).
  2. Any performance study involving a test set, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
  3. Standalone algorithm performance or multi-reader multi-case studies, as this device is a control/calibrator, not an AI-driven diagnostic.
  4. Training set information, as it's not an AI/machine learning device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study from the given input.

§ 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.