510(k) Report

510(k) · Cleared

Cleared

Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision Control Solutions

K012975510(k) TraditionalCleared Feb 28, 2002176-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

Abbott Laboratories · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Feb 28, 2002 as substantially equivalent to K983504 (Medisense, Inc., 1999) and 2 other predicates after a 176-day review. Its family tree reaches back 5 generations to 1995.

Decided
Feb 28, 2002
Review
176 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K945887 (1995). 20 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1998: 3 other ancestors1997: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors1991: 1 other ancestor1985: 1 other ancestor1996: 2 other ancestors1995: 2 other ancestors1990: 1 other ancestorK945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K983504 · Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST · Medisense, Inc. · 1999 · recalled1985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors3 generations back: 5 other ancestors K983504 · Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST · Medisense, Inc. · 1999 · recalledK971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995−50
  1. Root · 5 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 4 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  3. 3 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  4. 2 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
  5. 1 generation backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
  6. This deviceK012975 Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test…Abbott Laboratories · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−4K962295Precision Qid Blood Glucose Test StripMedisense, Inc.1996—
−3K963676Precision G Blood Glucose Testing SystemMedisense, Inc.1997—
−2K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.1997—
−1K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose…Medisense, Inc.19991
0 (this device)K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip…Abbott Laboratories2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199010
199110
199220
199310
199520
199620
199710
199830
200010
FIG. 1 — Lineage of K012975, 1995–2002Source: 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? (3)

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
*K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…
Summary page 1
…e™ Diabetes Management System Self-Monitoring Blood Glucose System Glucose Test System Class II per 21 CFR 862.1345 Precision Xtra™Advanced Diabetes Management System—K983504 Amira AtLast Blood Glucose Monitoring System--K982076 TheraSense FreeStyle™ Blood Glucose Monitoring System-- K992684 The Abbot…
Medisense, Inc.19991
*K982076Amira Medical Atlast Blood Glucose Monitoring System
Summary page 1
…lucose System Glucose Test System Class II per 21 CFR 862.1345 Precision Xtra™Advanced Diabetes Management System—K983504 Amira AtLast Blood Glucose Monitoring System--K982076 TheraSense FreeStyle™ Blood Glucose Monitoring System-- K992684 The Abbott Laboratories MediSense Sof-Tact™ Diabetes Management…
Amira Medical, Inc.1998—
*K992684Freestyle Blood Glucose Monitoring System
Summary page 1
…Precision Xtra™Advanced Diabetes Management System—K983504 Amira AtLast Blood Glucose Monitoring System--K982076 TheraSense FreeStyle™ Blood Glucose Monitoring System-- K992684 The Abbott Laboratories MediSense Sof-Tact™ Diabetes Management System for Blood Glucose Testing utilizes amperometric biosensor…
Abbott Diabetes Care, Inc.20002

Also cleared against K983504: 5 other devices →

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 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 4 of the 20 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K983504.

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 Sof-Tact Diabetes Management System is intended for in vitro diagnostic use

(i.e. for external use only) for the quantitative measurement of glucose in fresh

capillary whole blood. The Sof-Tact System is for home (lay user) use.

The Sof-Tact Diabetes Management System is specifically intended for the

quantitative measurement of glucose in whole blood samples obtained from the

finger, forearm, upper arm and the base of the thumb.

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 K983504

5 other devices cite the same predicate.

  • K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc. · 2008
  • K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsAbbott Diabetes Care, Inc. · 20061 recall
  • K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
  • K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 20043 recalls
  • K033845Precision Xceed Diabetes Monitoring SystemAbbott Laboratories · 20042 recalls

More from Abbott Laboratories

1,433 FDA decisions under this applicant name. See the company

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  • P120008/S032ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)Abbott Laboratories · 2026
  • K252424Anti-HCV NextAbbott Laboratories · 2026
  • P910007/S068ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026
  • P910007/S067ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026

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/K012975 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012975: Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision Control Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012975

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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