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510(k) K183088

ADVIA Centaur Erythropoietin (EPO) assay by Axis-Shield Diagnostics Limited — Product Code GGT

K183088 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics Limited for the device "ADVIA Centaur Erythropoietin (EPO) assay". The FDA issued a decision of Substantially Equivalent on August 2, 2019. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. Axis-Shield Diagnostics Limited has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2019
Date Received
November 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Erythropoietin
Device Class
Class II
Regulation Number
864.7250
Review Panel
HE
Submission Type

Other clearances by Axis-Shield Diagnostics Limited

  • K182012 — ADVIA Centaur Calcitonin (CALCT) assay (December 21, 2018)
  • K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Qual (August 4, 2016)
  • K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active- (July 26, 2016)

Other clearances for product code GGT

  • K240182 — Access EPO (April 22, 2024)
  • K052223 — ACCESS EPO ASSAY (October 6, 2006)
  • K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (June 7, 2000)
  • K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (July 12, 1999)
  • K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (March 23, 1999)
  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K954898 — PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (February 5, 1996)
  • K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (July 19, 1994)
  • K931756 — QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (April 21, 1994)
  • K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT (March 11, 1994)

FDA data resources