510(k) · Cleared
ClearedPrecision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisense, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Aug 8, 1997 as substantially equivalent to K945887 (Medisense, Inc., 1995) and 4 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1995. 3 of the 67 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it.
- Decided
- Aug 8, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K945887 (1995). 7 ancestors in all, the oldest K896951 (1990). 59 later devices descend from it, 4 citing it directly. 3 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 2 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 1 generation backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- This deviceK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- Descendant · cites it directly · 40 of its ownK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 19 of its ownK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- Descendant · 2 generations on · 16 of its ownK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- Descendant · cites it directly · 14 of its ownK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- Descendant · 2 generations on · 13 of its ownK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 59 · See all- K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Medisense, Inc. · 1999 · cites it directly40descendants
- K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005 · 2 generations on19descendants
- K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · 2 generations on16descendants
- K982303Precision PCX Point of Care Management System , QC Manager Data Manager System…Medisense, Inc. · 1998 · cites it directly14descendants
- K022941Medisense Precision PCX Point of Care Management System for Blood Glucose TestingAbbott Laboratories · 2002 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −2 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −1 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| 0 (this device) | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| +1 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| +2 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| +2 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| +1 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| +2 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 3 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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.
3 devices in this family have a Class I recall. 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K945887 | Precision Q I D Blood Glucose Test StripsSummary page 1…d Precision G Blood Glucose Test Strip Reagent test strips for Blood Glucose “Glucose Test System” - Class II per CFR 862.1345 Precision QID® Blood Glucose Test Strip - K945887, K962295 Precision G Blood Glucose Testing System - K963676 Accu-Chek Advantage Test Strips - K951887, K954833 The Precision QID… | 1995 |
| * | K962295 | Precision Qid Blood Glucose Test StripSummary page 1…on G Blood Glucose Test Strip Reagent test strips for Blood Glucose “Glucose Test System” - Class II per CFR 862.1345 Precision QID® Blood Glucose Test Strip - K945887, K962295 Precision G Blood Glucose Testing System - K963676 Accu-Chek Advantage Test Strips - K951887, K954833 The Precision QID and Prec… | 1996 |
| * | K963676 | Precision G Blood Glucose Testing SystemSummary page 1…or Blood Glucose “Glucose Test System” - Class II per CFR 862.1345 Precision QID® Blood Glucose Test Strip - K945887, K962295 Precision G Blood Glucose Testing System - K963676 Accu-Chek Advantage Test Strips - K951887, K954833 The Precision QID and Precision G Blood Glucose Test Strips are identical in… | 1997 |
| * | K951887 | Advantage Test StripsSummary page 1…lass II per CFR 862.1345 Precision QID® Blood Glucose Test Strip - K945887, K962295 Precision G Blood Glucose Testing System - K963676 Accu-Chek Advantage Test Strips - K951887, K954833 The Precision QID and Precision G Blood Glucose Test Strips are identical in test strip design. Both test strips utiliz… | 1995 |
| * | K954833 | Accu-Chek Advantage Test StripsSummary page 1…er CFR 862.1345 Precision QID® Blood Glucose Test Strip - K945887, K962295 Precision G Blood Glucose Testing System - K963676 Accu-Chek Advantage Test Strips - K951887, K954833 The Precision QID and Precision G Blood Glucose Test Strips are identical in test strip design. Both test strips utilize amperom… | 1996 |
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips… | 1999 | 40 |
| K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager System… | 1998 | 14 |
| K043245 | Eps Easy Pain Supreme Self Monitoring Blood Glucose System | 2005 | 2 |
| K022182 | Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood… | 2002 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2010 · 6 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 7 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K983504 (Medisense, Inc., 1999) has gone furthest, with 40 descendants of its own.
- 5 other devices also cite its predicate K945887.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971812
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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