510(k) · Cleared
ClearedSof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision Control Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFR Glucose Dehydrogenase, Glucose
Cleared on Nov 13, 2000 after a 137-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 13, 2000
- Review
- 137 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK001993 Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip…Abbott Laboratories · 2000
- Descendant · cites it directly · 7 of its ownK012324 Accu-Chek Active Test SystemRoche Diagnostics Corp. · 2001
- Descendant · 2 generations on · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK021448 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002
- Descendant · 3 generations on · 1 of its ownK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK021827 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K012324Accu-Chek Active Test SystemRoche Diagnostics Corp. · 2001 · cites it directly7descendants
- K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · 2 generations on2descendants
- K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · 2 generations on2descendants
- K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013 · 3 generations on1descendant
- K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001993 | Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision… | Abbott Laboratories | 2000 | — |
| +1 | K012324 | Accu-Chek Active Test System | Roche Diagnostics Corp. | 2001 | — |
| +2 | K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | Bionostics, Inc. | 2008 | — |
| +2 | K021448 | Modification to Accu-Chek Active System | Roche Diagnostics Corp. | 2002 | — |
| +3 | K123851 | Glucose Meter-Check Solution for Roche Accu-Chek | Bionostics, Inc. | 2013 | — |
| +2 | K021827 | Modification to Accu-Chek Active System | Roche Diagnostics Corp. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012324 | Accu-Chek Active Test System | 2001 | 7 |
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?
- Of its descendants, K012324 (Roche Diagnostics Corp., 2001) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001993: Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision Control Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001993
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026