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510(k) K042411

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY by Axis-Shield , Ltd. — Product Code NRP

K042411 is an FDA 510(k) premarket notification submitted by Axis-Shield , Ltd. for the device "ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on April 7, 2005. The device falls under product code NRP (Sirolimus Test System), a Class II device regulated under 21 CFR 862.3840. Axis-Shield , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2005
Date Received
September 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sirolimus Test System
Device Class
Class II
Regulation Number
862.3840
Review Panel
TX
Submission Type

Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.

Other clearances by Axis-Shield , Ltd.

  • K001981 — DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 (August 21, 2000)
  • K001574 — DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 (June 9, 2000)

Other clearances for product code NRP

  • K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND (March 30, 2009)
  • K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS (October 30, 2008)
  • K070822 — ARCHITECT SIROLIMUS ASSAY (September 28, 2007)
  • DEN040008 — CEDIA SIROLIMUS ASSAY (July 28, 2004)

FDA data resources