510(k) Report

510(k) · Cleared

Cleared

One Drop Blood Glucose Monitoring System

K161834510(k) SpecialCleared Nov 30, 2016148-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

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

Cleared on Nov 30, 2016 as substantially equivalent to K152365 (Agamatrix, Inc., 2016) after a 148-day review. Its family tree reaches back 6 generations to 1995.

Decided
Nov 30, 2016
Review
148 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K952279 (1995). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestorK952279 · Precision Link Blood Glucose Data Management System · Medisense, Inc. · 1995K994433 · Connect Data Management System · Abbott Diabetes Care, Inc. · 2000 · recalledK062434 · Zero-Click Data Management System, Model 8000-01528 · Agamatrix · 2006K101597 · Wavesense Diabetes Manager Model Version 1.3.4 · Agamatrix · 2010K103544 · Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D · Agamatrix, Inc. · 2011K152365 · AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System · Agamatrix, Inc. · 201619952000200520102015
Other ancestors, by generation 3 generations back: 1 other ancestor K152365 · AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System · Agamatrix, Inc. · 2016K103544 · Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D · Agamatrix, Inc. · 2011K101597 · Wavesense Diabetes Manager Model Version 1.3.4 · Agamatrix · 2010K062434 · Zero-Click Data Management System, Model 8000-01528 · Agamatrix · 2006K994433 · Connect Data Management System · Abbott Diabetes Care, Inc. · 2000 · recalledK952279 · Precision Link Blood Glucose Data Management System · Medisense, Inc. · 1995−50
  1. Root · 6 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
  2. 5 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
  3. 4 generations backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
  4. 3 generations backK101597 Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
  5. 2 generations backK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
  6. 1 generation backK152365 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
  7. This deviceK161834 One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K952279Precision Link Blood Glucose Data Management SystemMedisense, Inc.1995—
−5K994433Connect Data Management SystemAbbott Diabetes Care, Inc.20001
−4K062434Zero-Click Data Management System, Model 8000-01528Agamatrix2006—
−3K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix2010—
−2K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application…Agamatrix, Inc.2011—
−1K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc.2016—
0 (this device)K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K161834, 1995–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in NBW? 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
Get a 510(k) Report

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
*K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
Summary page 4
…21 CFR 862.1345 75, Clinical Chemistry glucose, over the counter 7. Predicate Device: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System, 510(k) K152365 8. Device Description: The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative meas…
Agamatrix, Inc.2016—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 7 ancestors has a recall of any class.

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. 2016, 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 One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring 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…

Read the full statement (142 words)

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar)

levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and

should not be shared. The One Drop Blood Glucose Monitoring 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 One

Drop Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use

with neonates.

The One Drop Blood Glucose Test Strips:

The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure

blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Indications for use as stated in the FDA summary.

More from Agamatrix, Inc.

7 FDA decisions under this applicant name. See the company

  • K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
  • K132821Agamatrix Health ManagerAgamatrix, Inc. · 2013
  • K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc. · 2013
  • K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc. · 2011
  • K083265Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381Agamatrix, Inc. · 2009

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
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K161834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161834: One Drop Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161834

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026