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510(k) K051638

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC by Unipath , Ltd. — Product Code GTY

K051638 is an FDA 510(k) premarket notification submitted by Unipath , Ltd. for the device "INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC". The FDA issued a decision of Substantially Equivalent on December 6, 2005. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Unipath , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2005
Date Received
June 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by Unipath , Ltd.

  • K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (July 3, 2006)
  • K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 25, 2006)
  • K050930 — E.P.T. CERTAINTY PREGNANCY TEST (May 12, 2005)
  • K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT (September 10, 2004)
  • K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST (June 8, 2004)
  • K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST (March 8, 2004)
  • K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (March 8, 2004)
  • K033658 — E.P.T. PREGNANCY TEST (January 16, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (October 20, 2003)
  • K030659 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 2, 2003)

Other clearances for product code GTY

  • K260342 — AllTest Strep A Rapid Test (April 30, 2026)
  • K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test St (November 26, 2025)
  • K212623 — Healgen Strep A Rapid Test Strip (Throat Swab) (March 16, 2022)
  • K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer (December 21, 2017)
  • K141775 — SOFIA (R) STREP A+ FIA (December 16, 2014)
  • K133343 — WONDFO RAPID STREP A TEST (January 31, 2014)
  • K123793 — SOFIA STREP A FIA (June 17, 2013)
  • K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (February 6, 2013)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)

FDA data resources