510(k) · Cleared
Recalled · Class II · 2019Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on Apr 21, 2006 as substantially equivalent to K983504 (Medisense, Inc., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1995. It has been recalled once.
- Decided
- Apr 21, 2006
- Review
- 30 days
- Class
- Class I
- Product code
- JIN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945887 (1995). 12 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 4 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 3 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 2 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 1 generation backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- This deviceK060768 Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone…Abbott Diabetes Care, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −5 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −4 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −3 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −2 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −1 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| 0 (this device) | K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips | Abbott Diabetes Care, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 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 JIN? 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 JIN device
- #1 K192957 VivaChek Blood Glucose and B-Ketone Monitoring…score 1.6 · 8 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Summary page 1…: Ketone Test System Class I per 21 CFR 862.1435 Product Code: JIN Predicate Device: Precision Xtra Blood f-Ketone Test Strips, K983504 Optium Blood 3-Ketone Test Strips, K040814 Description: The Precision® XtraTM Diabetes M… | 1999 |
| * | K040814 | Modification to Precision Xtra Advanced Diabetes Management SystemSummary page 1…435 Product Code: JIN Predicate Device: Precision Xtra Blood f-Ketone Test Strips, K983504 Optium Blood 3-Ketone Test Strips, K040814 Description: The Precision® XtraTM Diabetes Monitoring System utilizes amperometric bios… | 2004 |
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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 5 other devices also cite its predicate K983504.
How does its category compare?
All JIN devicesJIN Nitroprusside, Ketones (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JIN
192in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIN
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIN
4in 2025
MAUDE reports naming product code JIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 192 | 0 | 5 |
| 2019 | 0 | — | 0 | 52 |
| 2020 | 2 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 43 |
| 2022 | 0 | — | 1 | 14 |
| 2023 | 0 | — | 3 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Precision Xtra / Optium Blood β-Ketone Test Strips are intended to quantitatively measure blood β-Ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood from the fingertip. The test strips are for use outside the body (in vitro diagnostic use) and are for self-testing or healthcare professional use. Healthcare professionals may also use venous whole blood samples, provided the samples are used within 30 minutes of collection. The test strip is to be used for ketone concentrations in persons with diabetes and other conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060768: Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone 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/K060768
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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