Skip to content

Exetainer

by Labco, Ltd. United States 510(k)

510(k) K880622 Product code JKA

Overview

The Exetainer is a blood collection and storage device designed for clinical chemistry applications. It is a sealed, evacuated tube system intended for the collection of venous blood samples, ensuring accurate and stable specimen preservation for laboratory analysis.

Exetainers are supplied as single-use, sterile devices and are classified under product code JKA. They are intended for use in clinical laboratory settings and must be handled according to standard aseptic techniques. The device received FDA 510(k) clearance under the Traditional pathway as substantially equivalent to a predicate device, with clearance dated April 18, 1988. No MRI safety information or reusable specifications are provided.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880622 Date18 Apr 1988ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

Full name
Labco Limited Exetainer(R)
510(k) Number
FDA Product Code
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Exetainer blood collection tube designed for?

    The Exetainer is specifically designed for clinical chemistry applications, ensuring accurate and stable preservation of venous blood samples for laboratory analysis. Its sealed, evacuated tube system prevents contamination and maintains specimen integrity until testing.

  • How is the Exetainer supplied and what are its handling requirements?

    Exetainers are supplied as single-use, sterile devices. They must be handled using standard aseptic techniques to maintain sterility and prevent cross-contamination, as they are intended for one-time use in clinical laboratory settings.

  • Is the Exetainer reusable or intended for single-use?

    The Exetainer is explicitly intended for single-use only. Its design as a sealed, evacuated tube system ensures specimen stability and sterility for one collection, making reuse unsafe and unsuitable for clinical chemistry applications.

  • What regulatory pathway and clearance does the Exetainer have?

    The Exetainer received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to a predicate device. The clearance was granted on April 18, 1988, and it falls under product code JKA for clinical chemistry applications.

  • Are there any special storage instructions for Exetainers?

    While the provided data does not specify storage conditions, as a sterile, single-use medical device, Exetainers should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines to preserve integrity until use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K880622 24 fields · synced 22 Oct 2026