Acetaminophen-Sl Assay

• • Terminated Z-1902-2012 FDA Class II ·initiated 29 May 2012

  Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

• • Terminated Z-1233-2007 FDA Unclassified (pre-2012) ·initiated 1 Jun 2007

  Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

510(k) Number

K042330 ↗

FDA Product Code

LDP

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Unsaturated Iron Binding Capacity (Uibc) Assay

  Class I

  FDA 510(k) K963116 Active Cleared 20 Aug 1996

• Creatine Kinase-Sl Assay, Catalogue Number 326-10, 326-30

  Class II

  FDA 510(k) K973999 Active Cleared 11 Mar 1998

• Alkaline Phosphatase-Sl Assay Catalogue Number 309-10, 309-30

  Class II

  FDA 510(k) K980316 Active Cleared 12 Feb 1998

• Hdl/Ldl-Advance Calibrator, Cat. No. Se-278

  Class II

  FDA 510(k) K041926 Active Cleared 23 Nov 2004

• Urea-L3K Assay, Catalogue Number 283-17/10/30/50

  Class II

  FDA 510(k) K993178 Active Cleared 18 Oct 1999

• Y-Glutamyltransferase-Sl Assay, Cataloge Number 324-10, 324-30

  Class I

  FDA 510(k) K974000 Active Cleared 4 Nov 1997

See all devices from Diagnostic Chemicals, Ltd. →