PMA P230019S002

Device: MediBeacon® Transdermal GFR Measurement System (TGFR)
Applicant: Medibeacon, Inc.
PMA number: P230019
Supplement: S002
Product code: SDK
Decision date: 2026-06-10
Classification: Gastroenterology, Urology
Generic name: Transdermal test for Assessment of Glomerular Filtration Rate
Approval order statement: approval for the following labeling revision: (Prior warning statement) Lumitrace injection may interfere with clinical laboratory tests. The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally impaired patients).(Revised warning statement) Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system, which may be for up to 72 hours.

Current openFDA PMA Record#

Device: MediBeacon® Transdermal GFR Measurement System (TGFR)
Applicant: Medibeacon, Inc.
PMA number: P230019
Supplement: S002
Product code: SDK
Generic name: Transdermal test for Assessment of Glomerular Filtration Rate
Decision date: 2026-06-10
Decision code: APPR
Date received: 2025-06-06
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for the following labeling revision: (Prior warning statement) Lumitrace injection may interfere with clinical laboratory tests. The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally impaired patients).(Revised warning statement) Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system, which may be for up to 72 hours.