TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81— 510(k) K080641

Clearance details

Applicant

Home Diagnostics, Inc.

Product code

Code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2008-03-06

Decision date

2008-08-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Lauderdale, FL, US

• K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more2026-08-27
• K262116 — TRUE METRIX Self Monitoring Blood Glucose System2026-07-23
• K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more2025-10-10
• K243060 — TeleRPM Gen2 Blood Glucose Monitoring System2025-01-30
• K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel2024-11-04

• K090495 — TRUEBALANCE BLOOD GLUCOSE SYSTEM2009-03-27
• K080710 — TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-812008-08-13
• K070593 — TRACKRECORD DATA MANAGEMENT SOFTWARE2007-05-07
• K060793 — ELEMENT BLOOD GLUCOSE TEST SYSTEM2006-07-25
• K051147 — SIDEKICK BLOOD GLUCOSE TEST SYSTEM2005-07-12

Death

18

Injury

4,740

Malfunction

42,679

Other

6

Total

47,443

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-2880-2016 — TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.Class II·Ongoing·Trividia Health·20160628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080641.