510(k) Report

510(k) · Cleared

Cleared

TRUE METRIX Self Monitoring Blood Glucose System

K262116510(k) SpecialCleared Jul 23, 202630-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Trividia Health, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jul 23, 2026 as substantially equivalent to K140100 (Nipro Diagnostics, Inc., 2014) after a 30-day review. Its family tree reaches back 1 generation to 2014. 1 of the 2 devices in its family, counting itself, has a Class I recall.

Decided
Jul 23, 2026
Review
30 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K140100 (2014). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

K140100 · True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose System · Nipro Diagnostics, Inc. · 2014 · Class I recall2010201520202025
K140100 · True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose System · Nipro Diagnostics, Inc. · 2014 · Class I recall0
  1. Root · 1 generation backK140100 True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro…Nipro Diagnostics, Inc. · 2014 · Recalled (Class I)
  2. This deviceK262116 TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

Class I recalls in this family

  • K140100 True Metrix Self-Monitoring Blood Glucose…direct predicate · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K140100True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional…Nipro Diagnostics, Inc.2014Class I
0 (this device)K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.2026—
FIG. 1 — Lineage of K262116, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NBW device

  1. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K140100True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional…
Summary page 5
…21 CFR 862.1345 Product Code(s) NBW Legally Marketed Predicate Devices Predicate # K140100 Predicate Trade Name TRUE METRIX Self Monitoring Blood Glucose…
Nipro Diagnostics, Inc.2014Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K140100True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose SystemNipro Diagnostics, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

  • Its one ancestor has a recall, Class I.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at…

Read the full statement (157 words)

The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.

The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

Indications for use as stated in the FDA summary.

More from Trividia Health, Inc.

2 FDA decisions under this applicant name. See the company

  • K143548TRUE METRIX GO Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 20161 Class I recall

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone…ACON Laboratories, Inc. · 2025

https://510kreport.com/device/K262116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262116: TRUE METRIX Self Monitoring Blood Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262116

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026