T-Spot .tb Test

FDA PMA

Class III (US FDA PMA)

PMA P070006

by Oxford Immunotec Ltd

Identity

Trade Name: T SPOT-TB TEST FDA PMA
Generic Name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test FDA PMA

Identifiers

PMA Number: P070006 FDA PMA
FDA Product Code: OJN FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Microbiology FDA PMA
FDA Decision: APPR Approved FDA PMA

The T-SPOT.TB Test is an in vitro diagnostic enzyme-linked immunospot (ELISPOT) assay designed to detect effector T cells responding to Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 by capturing interferon-gamma (IFN-γ) in human whole blood. Classified as a cell-mediated immune response test, it functions as an indirect diagnostic aid for M. tuberculosis infection, including latent and active disease.

This single-use, non-sterile device requires whole blood collected in sodium citrate or sodium/lithium heparin and is intended for use in clinical laboratories. Authorized under FDA PMA (P070006) and IVDD compliance, it is supplied as a kit (Product Code: OJN) and must be stored per manufacturer instructions. No MRI safety data or reusable components are specified.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: T-SPOT.TB - Revvity, T-SPOT Technology (ELISPOT) - Revvity, T-SPOT®.TB - Quest Diagnostics, Oxford Immunotec Limited Release: American Medical Association ..., LIMITED ADDED VALUE OF T-SPOT.TB BLOOD TEST ... - PMC

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Pending data

IVDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	European Union	IVDD	—	Class III	Pending data
FDA PMA	United States	FDA_PMA	P070006	Class III	Active

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Manufacturer

Manufacturer: Oxford Immunotec Ltd
FDA Applicant: Oxford Immunotec, Ltd.

Sources (1)

FDA PMA P070006 24 fields · synced Sep 18, 2026