GEM Premier 5000— 510(k) K203790

Clearance details

Applicant

Instrumentation Laboratory CO

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2020-12-28

Decision date

2021-08-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Bedford, MA, US

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• K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
• K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

• K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
• K223187 — HemosIL Liquid Anti-Xa2023-06-23
• K223090 — GEM Premier ChemSTAT2023-01-27
• K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
• K213464 — HemosIL Liquid Anti-Xa2022-10-04

Death

20

Malfunction

999

Total

1,019

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-2900-2026 — GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.AClass II·Ongoing·Instrumentation Laboratory·20260521
• Z-1524-2026 — GEM Premier 5000 PAK, Part No. 00055360004.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1525-2026 — GEM Premier 5000 PAK; Part No. 00055360008.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1526-2026 — GEM Premier 5000 PAK; Part No. 00055360010.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1527-2026 — GEM Premier 5000 PAK; Part No. 00055360011.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1528-2026 — GEM Premier 5000 PAK; Part No. 00055407504.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1529-2026 — GEM Premier 5000 PAK; Part No. 00055407508.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1530-2026 — GEM Premier 5000 PAK; Part No. 00055407510.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1531-2026 — GEM Premier 5000 PAK; Part No. 00055407511.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1532-2026 — GEM Premier 5000 PAK; Part No. 00055415004.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1533-2026 — GEM Premier 5000; Part No. 00055415005.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1534-2026 — GEM Premier 5000; Part No. 00055415008.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1536-2026 — GEM Premier 5000; Part No: 00055415011.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1537-2026 — GEM Premier 5000; Part No. 00055430004.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1538-2026 — GEM Premier 5000; Part No. 00055430008.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1539-2026 — GEM Premier 5000; Model No. 00055430010.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1540-2026 — GEM Premier 5000; Part No. 00055430011.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1541-2026 — GEM Premier 5000; Part No. 00055445004.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1542-2026 — GEM Premier 5000; Part No. 00055445008.Class II·Ongoing·Instrumentation Laboratory·20260120
• Z-1543-2026 — GEM Premier 5000; Part No. 00055445010 & 00055445011.Class II·Ongoing·Instrumentation Laboratory·20260120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203790.