Home / 510(k) Clearances / K101234

510(k) K101234

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY by Ventana Medical Systems, Inc. — Product Code OWF

K101234 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY". The FDA issued a decision of Substantially Equivalent on August 25, 2011. The device falls under product code OWF (Immunohistochemical Assay, Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2011
Date Received
May 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunohistochemical Assay, Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use

Other clearances by Ventana Medical Systems, Inc.

  • K242783 — Roche Digital Pathology Dx (December 17, 2024)
  • DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (December 5, 2024)
  • K232879 — Roche Digital Pathology Dx (VENTANA DP 200) (June 14, 2024)
  • K212176 — CINtec Histology (December 10, 2021)
  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 (October 27, 2017)
  • DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests) (March 4, 2017)
  • K142965 — Virtuoso System for IHC PR (1E2) using iScan HT (July 16, 2015)
  • K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (March 20, 2014)
  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)

FDA data resources