510(k) Report

510(k) · Cleared

Cleared

Accu-Chek Active Test System

K012324510(k) TraditionalCleared Dec 5, 2001135-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

Roche Diagnostics Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Dec 5, 2001 as substantially equivalent to K002134 (Selfcare, Inc., 2000) and 3 other predicates after a 135-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.

Decided
Dec 5, 2001
Review
135 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K945887 (1995). 13 ancestors in all, the oldest K922888 (1992). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 3 other ancestors1998: 3 other ancestors1993: 1 other ancestor1996: 1 other ancestor1992: 2 other ancestors2002: 2 descendants cleared2007: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant clearedK945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995K970707 · Elect II Blood Glucose Monitoring System · Selfcare, Inc. · 1997K992684 · Freestyle Blood Glucose Monitoring System · Abbott Diabetes Care, Inc. · 2000 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K992684 · Freestyle Blood Glucose Monitoring System · Abbott Diabetes Care, Inc. · 2000 · recalledK970707 · Elect II Blood Glucose Monitoring System · Selfcare, Inc. · 1997K945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 19950
  1. Root · 3 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 2 generations backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
  3. 1 generation backK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
  4. This deviceK012324 Accu-Chek Active Test SystemRoche Diagnostics Corp. · 2001
  5. Descendant · cites it directly · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
  6. Descendant · cites it directly · 2 of its ownK021448 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002
  7. Descendant · 2 generations on · 1 of its ownK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
  8. Descendant · cites it directly · 1 of its ownK021827 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · Recalled
  9. Descendant · 2 generations on · 0 of its ownK163087 PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd. · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 22007: 12008: 12013: 12016: 12017: 1
2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · See all
  • K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · cites it directly2descendants
  • K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · cites it directly2descendants
  • K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013 · 2 generations on1descendant
  • K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · cites it directly1descendant
  • K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−2K970707Elect II Blood Glucose Monitoring SystemSelfcare, Inc.1997—
−1K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20002
0 (this device)K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.2001—
+1K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.2008—
+1K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.2002—
+2K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.2013—
+1K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20021
+2K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199610
199830
200030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200710
200810
201310
201610
201710
FIG. 1 — Lineage of K012324, 1995–2017Source: 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.

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? (4)

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
*K002134One Touch Ultra Blood Glucose Monitoring System
Summary page 1
…d in this 510(k) premarket notification is substantially equivalent to claims cleared for the following medical devices. Lifescan/Inverness One Touch Ultra Test System (K002134—Special) Abbott/Medisense Sof-Tact Test System (K001993—Traditional) Therasense Freestyle Test System (K992684—Traditional) Lifes…
Selfcare, Inc.2000—
*K001993Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision Control…
Summary page 1
…equivalent to claims cleared for the following medical devices. Lifescan/Inverness One Touch Ultra Test System (K002134—Special) Abbott/Medisense Sof-Tact Test System (K001993—Traditional) Therasense Freestyle Test System (K992684—Traditional) Lifescan/Inverness FastTake Test System (K001427—Special) Th…
Abbott Laboratories2000—
*K992684Freestyle Blood Glucose Monitoring System
Summary page 1
…devices. Lifescan/Inverness One Touch Ultra Test System (K002134—Special) Abbott/Medisense Sof-Tact Test System (K001993—Traditional) Therasense Freestyle Test System (K992684—Traditional) Lifescan/Inverness FastTake Test System (K001427—Special) The Accu-Chek Active Test System includes a handheld mete…
Abbott Diabetes Care, Inc.20002
*K001427Modification to Fasttake Compact Blood Glucose Monitoring System
Summary page 1
…2134—Special) Abbott/Medisense Sof-Tact Test System (K001993—Traditional) Therasense Freestyle Test System (K992684—Traditional) Lifescan/Inverness FastTake Test System (K001427—Special) The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test stri…
Selfcare, Inc.2000—

Also cleared against K002134: 9 other devices →

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082
K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20022
K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20021
K063026OK Meter Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20070

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 6 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K081403 (Bionostics, Inc., 2008) has gone furthest, with 2 descendants of its own.
  • 9 other devices also cite its predicate K002134.

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.

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 Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K002134

9 other devices cite the same predicate.

  • K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017
  • K113636Blood Glucose Monitoring System (Glucose Oxidase)Philosys Co., Ltd. · 2013
  • K123010ON Call Vivid Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2012
  • K112653ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc. · 2012
  • K111371ON Call Chosen Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2011
  • K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

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/K012324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012324: Accu-Chek Active Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012324

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