ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM— 510(k) K121790

Name: FDA 510(k) clearance K121790
Creator: U.S. Food and Drug Administration
Published: 2013-09-25

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K121790 for ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, Substantially Equivalent on 2013-09-25. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2012-06-18
Decision date: 2013-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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K243483 — Access hsTnI2025-08-01
K242870 — Access hsTnI2025-06-16
K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System2025-01-03

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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K121790

K-number listed on FDA's recall record

Z-1025-2026 — Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin SubunitClass II·Ongoing·Beckman Coulter, Inc.·20251126
Z-1026-2026 — Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin SubunitClass II·Ongoing·Beckman Coulter, Inc.·20251126
Z-0428-2026 — Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry AnalyzerClass II·Ongoing·Beckman Coulter, Inc.·20251001
Z-0429-2026 — Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry AnalyzerClass II·Ongoing·Beckman Coulter, Inc.·20251001
Z-2687-2014 — UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.Class II·Terminated·Beckman Coulter Inc.·20140821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121790.

Data sourced from openFDA. This site is unofficial and independent of the FDA.