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510(k) K161951

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay by Kronus, Inc. — Product Code PNI

K161951 is an FDA 510(k) premarket notification submitted by Kronus, Inc. for the device "KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay". The FDA issued a decision of Substantially Equivalent on July 22, 2016. The device falls under product code PNI (Aquaporin-4 Autoantibody), a Class II device regulated under 21 CFR 866.5665. Kronus, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2016
Date Received
July 15, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aquaporin-4 Autoantibody
Device Class
Class II
Regulation Number
866.5665
Review Panel
IM
Submission Type

For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings.

Other clearances by Kronus, Inc.

  • K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (August 24, 2023)
  • K180607 — Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit (November 23, 2018)
  • K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (January 19, 2018)
  • DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (April 25, 2016)
  • K915428 — KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT (March 30, 1992)
  • K915429 — KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT (March 30, 1992)
  • K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (July 25, 1989)
  • K894203 — ANTI-THYROGLOBULIN TEST KIT (July 25, 1989)

Other clearances for product code PNI

  • DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (April 25, 2016)

FDA data resources