Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)— 510(k) K161954

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code JGS

Device class

Class 2

Regulation

21 CFR 862.1665

Advisory panel

Clinical Chemistry

Date received

2016-07-18

Decision date

2017-03-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tarrytown, NY, US

• K252475 — ABL90 FLEX PLUS System2026-05-01
• K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
• K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)2023-07-25
• K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer2023-07-20
• K213486 — GLP systems Track2022-03-10

• K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more2025-04-25
• K162977 — ADVIA 2120i, ADVIA 21202017-08-11
• K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL2017-03-16
• K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator2016-11-17
• K151964 — Xprecia Stride Coagulation System, Xprecia System PT Controls2016-09-30

Malfunction

535

Total

535

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 →

• Z-0496-2025 — Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20241021
• Z-1421-2020 — Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20200112
• Z-1301-2019 — Atellica Sample Handler Prime, Material Number 11069001Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20190307
• Z-0783-2019 — Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180926
• Z-0189-2019 — Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180629
• Z-0190-2019 — Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180629
• Z-0191-2019 — Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180629
• Z-1587-2018 — Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161954.