Platelia Toxo IgM Kit

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K894948 ↗

FDA Product Code

LGD

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• QM300 Control E

  Class II

  FDA 510(k) K883537 Active Cleared 4 Nov 1988

• Modified QM300 Rheumatoid Factor Test

  Class II

  FDA 510(k) K902462 Active Cleared 21 Jun 1990

• Kallestad QM300 Calibrator C Pack

  Class II

  FDA 510(k) K880729 Active Cleared 30 Mar 1988

• Nds Thyroxine Test Kit & Nds Thyroxine Calibrator

  Class II

  FDA 510(k) K897072 Active Cleared 29 Mar 1990

• QM300 Rheumatoid Factor Antigen Pack

  Class II

  FDA 510(k) K883536 Active Cleared 7 Sep 1988

• QM2/QM300 Control a Pack

  Class I

  FDA 510(k) K871342 Active Cleared 21 May 1987

See all devices from Kallestad Diag, A Div. of Erbamont, Inc. →

• What is the Platelia Toxo IgM Kit used for?

  The Platelia Toxo IgM Kit is designed for the qualitative detection of IgM antibodies to *Toxoplasma gondii* in human serum or plasma. It helps diagnose acute toxoplasmosis by identifying immune responses to the parasitic protozoan, supporting clinical and epidemiological tracking of the infection.

• How is the Platelia Toxo IgM Kit supplied, and what samples can it analyze?

  The kit is supplied as a single-use reagent system for laboratory use only. It requires human serum or plasma collected using EDTA, heparin, or citrate as the sample type for testing.

• Is the Platelia Toxo IgM Kit sterile, and how should it be stored?

  The kit is intended for in-vitro diagnostic use and follows standard storage and handling protocols for ELISA reagents. While sterility is implied for single-use diagnostic components, specific storage instructions should align with the manufacturer’s guidelines for in-vitro diagnostics, typically involving refrigeration or room-temperature storage as per the included documentation.

• Is the Platelia Toxo IgM Kit intended for single-use or reusable applications?

  The kit is explicitly designed for single-use only, as indicated by its classification as a reagent system. Single-use ensures consistency, reduces contamination risk, and aligns with laboratory best practices for in-vitro diagnostics.

• What regulatory pathway does the Platelia Toxo IgM Kit follow, and where is it cleared for use?

  The kit is cleared under the FDA’s 510(k) pathway (K894948) and classified as a Class II device under regulation 21 CFR 866.3780. It is intended for use in qualified microbiology laboratories in the United States, adhering to standard in-vitro diagnostic protocols.