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510(k) K043303

ONLINE DAT PROPOXYPHENE PLUS by Roche Diagnostics Corp. — Product Code JXN

K043303 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONLINE DAT PROPOXYPHENE PLUS". The FDA issued a decision of Substantially Equivalent on March 11, 2005. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2005
Date Received
November 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Propoxyphene
Device Class
Class II
Regulation Number
862.3700
Review Panel
TX
Submission Type

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  • K260048 — Elecsys Anti-HAV IgM (April 7, 2026)
  • K260046 — Elecsys Anti-HBc II (April 7, 2026)
  • K260049 — Elecsys Anti-HBc IgM (April 7, 2026)
  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)

Other clearances for product code JXN

  • K152495 — Wondfo Propoxyphene Urine Test (November 23, 2015)
  • K122752 — FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX D (January 30, 2013)
  • K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (December 6, 2011)
  • K040445 — ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DE (May 19, 2004)
  • K030835 — 'RAPID ONE' - PROPOXYPHENE TEST (May 22, 2003)
  • K023795 — PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST (January 21, 2003)
  • K022915 — INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (November 29, 2002)
  • K020787 — VERDICT-II PROPOXYPHENE (May 2, 2002)
  • K013100 — PROPOXYPHENE (March 20, 2002)
  • K011163 — MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (May 10, 2001)

FDA data resources