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510(k) K141341

CL DETECT RAPID TEST by InBios International, Inc. — Product Code PIT

K141341 is an FDA 510(k) premarket notification submitted by InBios International, Inc. for the device "CL DETECT RAPID TEST". The FDA issued a decision of Substantially Equivalent on November 14, 2014. The device falls under product code PIT (Leishmania Spp. Antigen Detection Assay), a Class I device regulated under 21 CFR 866.3870. InBios International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2014
Date Received
May 21, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Leishmania Spp. Antigen Detection Assay
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.

Other clearances by InBios International, Inc.

  • K251595 — COVID-19 Detect Rapid Self -Test (October 12, 2025)
  • K233358 — SCoV-2 Ag Detect Rapid Test (August 23, 2024)
  • DEN220044 — Active Anthrax DetectTM Plus Rapid Test (February 3, 2023)
  • DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA (May 23, 2019)
  • K181473 — DENV Detect NS1 ELISA (August 27, 2018)
  • K161947 — Chagas Detect Plus Rapid Test (December 16, 2016)

FDA data resources