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510(k) K160070

Rheumatoid Factor (RF) Kit for use on SPAPLUS by The Binding Site Group , Ltd. — Product Code DHR

K160070 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Rheumatoid Factor (RF) Kit for use on SPAPLUS". The FDA issued a decision of Substantially Equivalent on December 7, 2016. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2016
Date Received
January 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by The Binding Site Group , Ltd.

  • K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (October 17, 2025)
  • K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (May 23, 2025)
  • K192116 — Human IgA liquid reagent kit for Use on SPAPlus (September 4, 2019)
  • K191985 — Optilite IgA Kit (August 19, 2019)
  • K191635 — Optilite IgM Kit (July 15, 2019)
  • K191465 — Human IgM Kit for use on SPAPlus (June 27, 2019)
  • K190686 — Optilite IgM CSF Kit (May 28, 2019)
  • K183151 — Optilite IgA CSF Kit (January 23, 2019)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (August 23, 2018)

Other clearances for product code DHR

  • K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (May 20, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • K182747 — EliA RF IgM Immunoassay (December 18, 2018)
  • K162263 — Optilite Rheumatoid Factor Kit (May 3, 2017)
  • K143736 — ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA (September 23, 2015)
  • K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (September 30, 2011)
  • K100499 — ORGENTEC RHEUMATOID FACTOR EIA (October 27, 2010)
  • K083080 — IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (October 29, 2009)
  • K071247 — N LATEX RF KIT (August 8, 2007)
  • K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028 (June 6, 2006)

FDA data resources