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Polychaco Indirect Hemagglutination

by Parasitic Disease Consultants

510(k) K830870

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830870 Date12 Aug 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GMM
Device Class
Class II
Regulation
21 CFR Part 866.3780
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Polychaco Indirect Hemagglutination is an in vitro diagnostic device classified as an antigen for Toxoplasma gondii, used for serological testing. It detects antibodies in human serum or plasma through the indirect hemagglutination method, aiding in the diagnosis of toxoplasmosis infections.

This device is supplied as a diagnostic reagent kit and is intended for single-use in clinical microbiology laboratories. It requires no special storage conditions beyond refrigeration and is regulated under FDA 510(k) clearance (K830870) as a Class II device under regulation number 866.3780. The product code assigned is GMM, and it falls under the microbiology specialty category.

Other devices from Parasitic Disease Consultants

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the Polychaco Indirect Hemagglutination test serve in a lab setting?

    The Polychaco Indirect Hemagglutination test is designed to detect antibodies against *Toxoplasma gondii* in human serum or plasma. By using the indirect hemagglutination method, it helps clinicians diagnose toxoplasmosis infections, a parasitic disease that can affect various organs. This test is specifically useful in clinical microbiology labs for serological testing.

  • Is this device meant for repeated use in a lab, or is it intended as a single-use reagent kit?

    This device is supplied as a diagnostic reagent kit explicitly intended for single-use in clinical microbiology laboratories. It is not designed for reuse, ensuring accuracy and preventing cross-contamination between tests.

  • What storage conditions are required for the Polychaco Indirect Hemagglutination kit?

    The kit does not require any special storage conditions beyond standard refrigeration. This makes it convenient for labs to maintain without additional infrastructure, as long as it is kept cool and protected from extreme temperatures.

  • How is the regulatory status of this device determined, and what does that mean for its use?

    The Polychaco Indirect Hemagglutination received FDA 510(k) clearance (K830870) under the traditional review pathway, classified as a Class II device (regulation number 866.3780). This means it has been deemed substantially equivalent to a legally marketed predicate device and is regulated as an in vitro diagnostic antigen for *Toxoplasma gondii* testing, ensuring it meets established safety and performance standards for clinical use.