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FDA 510(k)

i-STAT TBI Plasma cartridge with the i-STAT Alinity System

K-Number: K201778 · 2021-01-08

ApplicantAbbott Laboratories
Decision Date2021-01-08
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

i-STAT TBI Plasma cartridge with the i-STAT Alinity System is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2021-01-08 under approval number K201778. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-STAT TBI Plasma cartridge with the i-STAT Alinity System?

i-STAT TBI Plasma cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2021-01-08. It is manufactured by Abbott Laboratories. The 510(k) number is K201778.

When was i-STAT TBI Plasma cartridge with the i-STAT Alinity System approved by the FDA?

i-STAT TBI Plasma cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2021-01-08, under approval number K201778.

What company makes i-STAT TBI Plasma cartridge with the i-STAT Alinity System?

i-STAT TBI Plasma cartridge with the i-STAT Alinity System is manufactured by Abbott Laboratories.

What is the FDA product code for i-STAT TBI Plasma cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT TBI Plasma cartridge with the i-STAT Alinity System is QAT.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Abbott Laboratories

K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control K173122Abbott Architect Free T4 K170320Alinity c ICT Sample Diluent K170317Alinity i Total ß-hCG Reagent Kit, Alinity i System K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

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Related Devices (Code: QAT)

DEN170045Banyan BTIBanyan Biomarkers, Inc. K232669TBIAbbott Laboratories K223602Traumatic brain injury (TBI) testAbbott Laboratories K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc. K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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