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510(k) K140664

HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS by The Binding Site Group , Ltd. — Product Code DEB

K140664 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS". The FDA issued a decision of Substantially Equivalent on April 16, 2014. The device falls under product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5620. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2014
Date Received
March 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5620
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 DEB

  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (March 28, 2006)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K914389 — ALPHA-2 MACROGLOBULIN TEST RID KIT (December 20, 1991)
  • K896483 — QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (December 1, 1989)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K851282 — RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI (May 24, 1985)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K812493 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO (September 23, 1981)
  • K791340 — HUMAN ALPHA2 MACROGLOBULIN (August 16, 1979)

FDA data resources