Kallestad Florescent ANA/AMA/ASMA Test

• • Terminated Z-2430-2008 FDA Unclassified (pre-2012) ·initiated 29 Jul 2008

  The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

510(k) Number

K792610 ↗

FDA Product Code

DBL

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Kallestad Laboratories, Inc. →

• What is the Kallestad Florescent ANA/AMA/ASMA Test used for?

  It is used to detect antinuclear antibodies (ANA), anti-mitochondrial antibodies (AMA), and anti-smooth muscle antibodies (ASMA) in patient samples using an indirect immunofluorescence assay, which helps identify autoimmune conditions by visualizing antibody binding to specific antigens.

• How is the Kallestad Florescent ANA/AMA/ASMA Test supplied and what is its intended use environment?

  The device is supplied as a complete test system for laboratory use only, designed to be used in clinical immunology settings to perform autoantibody screening via fluorescence microscopy, and is not intended for point-of-care or home use.

• Is the Kallestad Florescent ANA/AMA/ASMA Test a single-use or reusable device?

  The test system includes reagent controls and antigens that are intended for single-use per test run to prevent cross-contamination and ensure assay accuracy; reusable components such as slides or equipment are not part of the device itself and depend on laboratory protocols.

• What regulatory pathway was used for the Kallestad Florescent ANA/AMA/ASMA Test and when was it cleared?

  The device received FDA 510(k) clearance through a traditional review process on February 22, 1980, under submission number K792610, demonstrating substantial equivalence to a legally marketed predicate device.

• What are the key identifiers for the Kallestad Florescent ANA/AMA/ASMA Test in regulatory databases?

  The device is classified as Class II under regulation 866.5660 with product code DBL, and its FDA listing includes the device name 'Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control' and FEI numbers associated with Kallestad Laboratories, Inc.