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K Number
K980331
Device Name
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
Manufacturer
MORE DIAGNOSTICS
Date Cleared
1998-03-16

(47 days)

Product Code
DIF,MKW
Regulation Number
862.3280
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviation that may arise from reagent or analytical instrument in the measurement of cyclosporin A and tacrolimus.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding an 'Immunosuppressant (Whole Blood) Control' device, it does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter confirms that the device is "substantially equivalent" to previously marketed devices and permits it to be marketed. However, it does not include:

  1. A table of acceptance criteria and reported device performance: This information would typically be found in the applicant's submission, not in the FDA's decision letter.
  2. Sample size used for the test set and data provenance: Not present.
  3. Number of experts used to establish ground truth and their qualifications: Not present.
  4. Adjudication method for the test set: Not present.
  5. MRMC comparative effectiveness study details: Not applicable as this is a control material, not an AI-assisted diagnostic device for human readers.
  6. Standalone algorithm performance: Not applicable.
  7. Type of ground truth used: Not present.
  8. Sample size for the training set: Not applicable (this is not an AI algorithm requiring a training set).
  9. How ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory approval based on substantial equivalence, and indicates the "Indications For Use" as: "The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviation that may arise from reagent or analytical instrument for quantification of cyclosporin A and tacrolimus."

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.