510(k) · Cleared
ClearedPrecision Point of Care Blood Glucose Test Strip with True Measure Technology
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 Aug 16, 2002 as substantially equivalent to K980731 (Boehringer Mannheim Corp., 1998) after a 63-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Aug 16, 2002
- Review
- 63 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980731 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
- This deviceK021960 Precision Point of Care Blood Glucose Test Strip with True Measure…Abbott Laboratories · 2002
- Descendant · cites it directly · 0 of its ownK070984 The Precision / Optium Point of Care Blood Glucose Test StripsAbbott Diabetes Care, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K070984The Precision / Optium Point of Care Blood Glucose Test StripsAbbott Diabetes Care, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980731 | Accu-Chek Comfort Curve Test Strips | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K021960 | Precision Point of Care Blood Glucose Test Strip with True Measure Technology | Abbott Laboratories | 2002 | — |
| +1 | K070984 | The Precision / Optium Point of Care Blood Glucose Test Strips | Abbott Diabetes Care, Inc. | 2007 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980731 | Accu-Chek Comfort Curve Test StripsSummary page 1…lood Glucose Test Str;p Classification: Glucose Test System Class II per 2 1 CFR 862.1345 Predicate Device: Accu-Chek Comfort Curve Test Skip K980731 Description: The PrecisiordOptiumPoint of Care Blood Glucose Test Strips with True Measure Technology… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070984 | The Precision / Optium Point of Care Blood Glucose Test Strips | 2007 | 0 |
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?
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 | — |
What is it indicated for?
The PrecisionlOptium Point of Care Blood Glucose Test Strip with True Measure TechnoIogy is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-gIucose) in fresh neonatal venous, merial and fmgertip capillary whoIe blood. The test strip is indicated for use by health care professionals in health care fmilities. The test strip is to be used for monitoring diabetes mellitus.
This strip may be used with the Precision Xtra and Optium meters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021960: Precision Point of Care Blood Glucose Test Strip with True Measure Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021960
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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