510(k) · Cleared
Recalled · Class II · 2019The Precision / Optium Point of Care Blood Glucose Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · LFR Glucose Dehydrogenase, Glucose
Cleared on Nov 1, 2007 as substantially equivalent to K021960 (Abbott Laboratories, 2002) after a 209-day review. Its family tree reaches back 2 generations to 1998. It has been recalled 3 times.
- Decided
- Nov 1, 2007
- Review
- 209 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980731 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
- 1 generation backK021960 Precision Point of Care Blood Glucose Test Strip with True Measure…Abbott Laboratories · 2002
- This deviceK070984 The Precision / Optium Point of Care Blood Glucose Test StripsAbbott Diabetes Care, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980731 | Accu-Chek Comfort Curve Test Strips | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K021960 | Precision Point of Care Blood Glucose Test Strip with True Measure Technology | Abbott Laboratories | 2002 | — |
| 0 (this device) | K070984 | The Precision / Optium Point of Care Blood Glucose Test Strips | Abbott Diabetes Care, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K021960 | Precision Point of Care Blood Glucose Test Strip with True Measure TechnologySummary page 1…oduct code LFR) Pred Device: Precision®/ Optium® Point of Care Blood Glucose Test Strips (K021960) Description of the Device: The Precision® /Optium® Point of Care Blood Glucose Test Strips work on the principle of amperomet… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2019 | Class II | Z-1558-2020 | Labeling False and Misleading | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead… |
| Dec 22, 2010 | Not classified | Z-0994-2011 | 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-0998-2011 | 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 9 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Precision® and Optium® Point of Care Blood Test Strips quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare professionals for use in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070984: The Precision / Optium Point of Care Blood Glucose Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070984
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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