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510(k) K043242

TRIAGE TOX DRUG SCREEN by Biosite Incorporated — Product Code LDP

K043242 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE TOX DRUG SCREEN". The FDA issued a decision of Substantially Equivalent on February 28, 2005. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Biosite Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2005
Date Received
November 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Acetaminophen
Device Class
Class II
Regulation Number
862.3030
Review Panel
TX
Submission Type

Other clearances by Biosite Incorporated

  • K092987 — INRATIO/INRATIO2 TEST STRIPS (June 11, 2010)
  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (April 19, 2010)
  • K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (November 13, 2009)
  • K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (June 6, 2008)
  • K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (December 7, 2007)
  • K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (March 1, 2007)
  • K062530 — TRIAGE PROTEIN C TEST (January 29, 2007)
  • K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (July 10, 2006)
  • K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400 (June 22, 2006)
  • K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (January 23, 2006)

Other clearances for product code LDP

  • K202644 — Acetaminophen (February 18, 2022)
  • K180835 — SEKURE Acetaminophen L3K Assay (February 8, 2019)
  • K110726 — ROCHE ACETAMINOPHEN ASSAY (December 23, 2011)
  • K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (August 2, 2010)
  • K081938 — ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 (May 1, 2009)
  • K061655 — DIMENSION VISTA FLEX REAGENT CARTRIDGES (July 10, 2006)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K020792 — ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 11, 2002)
  • K013757 — ROCHE ACETAMINOPHEN (January 8, 2002)
  • K011465 — SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (June 8, 2001)

FDA data resources