510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K234143Substantially Equivalent

i-STAT TBI Cartridge with the i-STAT Alinity System

Abbott Medical, Princton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K234143 is the FDA 510(k) clearance record for i-STAT TBI Cartridge with the i-STAT Alinity System, a class II device, cleared for Abbott Point of Care on under FDA product code QAT (Brain Trauma Assessment Test). FDA's definition for product code QAT reads: "Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR)...". FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K234143.

Clearance record

Decision date
Received
(89 days to decision)
Product code
QAT Brain Trauma Assessment Test
Regulation
21 CFR 866.5830
Device class
Class II
Review panel
Immunology
Applicant
Abbott Point of Care 400 College Rd. E., Princton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAT

Trailing 12 months

FDA records hold no clearances under product code QAT in the trailing twelve months.

FDA records show no clearances under product code QAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260