510(k) · Cleared
Recalled · 2010Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 27, 2005 as substantially equivalent to K023256 (Abbott Laboratories, 2003) after a 15-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled 3 times.
- Decided
- May 27, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010553 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010553 Precision Xtra Blood Glucose Test Strip with Truemeasure TechnologyAbbott Laboratories · 2001
- 1 generation backK023256 Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy…Abbott Laboratories · 2003
- This deviceK051213 Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsAbbott Laboratories, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK081975 Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS…Abbott Diabetes Care, Inc. · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K081975Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips…Abbott Diabetes Care, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure Technology | Abbott Laboratories | 2001 | — |
| −1 | K023256 | Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood… | Abbott Laboratories | 2003 | — |
| 0 (this device) | K051213 | Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips | Abbott Laboratories, Inc. | 2005 | — |
| +1 | K081975 | Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01… | Abbott Diabetes Care, Inc. | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K023256 | Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test…Summary page 2…Abbott Laboratories Same Division Abbott Diabetes Care Same 510(k) Reference K023256 Current Submission MediSense Optium Plus and Precision Same Proprietary N… | 2003 |
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 |
|---|---|---|---|
| K081975 | Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips… | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2010 | Not classified | Z-0996-2011 | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. |
| Dec 22, 2010 | Not classified | Z-0999-2011 | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. |
| Dec 22, 2010 | Not classified | Z-0997-2011 | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081975 (Abbott Diabetes Care, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NBW devicesNBW 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The strip is indicated for the quantitative measurement of glucose in fresh capillary blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051213: Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051213
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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