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Advanced Instruments GloCyte® Instrument Assembly

Model 111000 · Advanced Instruments, LLC · DI 00816068020146

GKL — Counter, Cell, Automated (Particle Counter) · Class II · 21 CFR 864.5200

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2018-02-07Z-0640-2019Class IITerminatedRBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.k number procode

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12232021-07: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 3/device0712
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0702
2022-1203
This device (reports/month)Average device in GKL (reports/device/month)

Regulatory clearances

  • K152776 SESE 2016-05-27 (k number procode)

Predicate lineage

K152776 — cites (transitively): K112605 (d1)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Advanced Instruments, LLC

  • VAI 2017-08-04 Advanced Instruments, LLC · 4 citations
  • VAI 2017-08-04 Advanced Instruments, LLC · 4 citations
  • VAI 2012-02-07 Advanced Instruments, LLC · 4 citations
  • VAI 2012-02-07 Advanced Instruments, LLC · 4 citations