510(k) Report

510(k) · Cleared

Recalled · 2002

Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST

K983504510(k) TraditionalCleared Jul 9, 1999276-day reviewClass II21 CFR 862.1345Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medisense, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Jul 9, 1999 as substantially equivalent to K963676 (Medisense, Inc., 1997) and 5 other predicates after a 276-day review. Its family tree reaches back 4 generations to 1995. 1 of the 51 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it. It has been recalled once.

Decided
Jul 9, 1999
Review
276 days
Class
Class II
Product code
CGA
Recalls
1
Predicates
6

Its longest line of descent runs back 4 generations to K945887 (1995). 10 ancestors in all, the oldest K850368 (1985). 40 later devices descend from it, 6 citing it directly. 1 of the 51 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor1985: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1990: 1 other ancestor2002: 1 descendant cleared2008: 7 descendants cleared2006: 4 descendants cleared2004: 2 descendants cleared2005: 1 descendant cleared2010: 3 descendants cleared, 1 with a Class I recall12007: 4 descendants cleared2009: 2 descendants cleared2013: 5 descendants cleared2018: 3 descendants cleared2016: 3 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2011: 1 descendant clearedK945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 7 descendants, 1 with a Class I recall13 generations forward: 14 descendants4 generations forward: 8 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 19950+5
  1. Root · 4 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 3 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  3. 2 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  4. 1 generation backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
  5. This deviceK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999
  6. Descendant · cites it directly · 19 of its ownK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
  7. Descendant · cites it directly · 16 of its ownK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
  8. Descendant · 2 generations on · 10 of its ownK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
  9. Descendant · 2 generations on · 8 of its ownK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
  10. Descendant · 3 generations on · 5 of its ownK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22005: 12006: 42007: 42008: 72009: 22010: 32011: 12013: 52016: 32018: 32020: 12021: 12022: 2
2002high 7 (2008) · low 0 (2003)2026

Class I recalls in this family

  • K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…2 generations on · 2010

Most influential descendants

Showing 5 of 40 · See all
  • K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005 · cites it directly19descendants
  • K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · cites it directly16descendants
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp. · 2010 · 2 generations on10descendants
  • K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006 · 2 generations on8descendants
  • K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−3K962295Precision Qid Blood Glucose Test StripMedisense, Inc.1996—
−2K963676Precision G Blood Glucose Testing SystemMedisense, Inc.1997—
−1K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.1997—
0 (this device)K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose…Medisense, Inc.1999—
+1K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc.2005—
+1K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories20043
+2K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus…Nova Biomedical Corp.2010Class I
+2K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc.2006—
+3K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199010
199110
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200510
200640
200740
200870
200920
201031
201110
201350
201630
201830
202010
202110
202220
FIG. 1 — Lineage of K983504, 1995–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has 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. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963676Precision G Blood Glucose Testing System
Summary page 1
…lucose and Ketone System Glucose Test System Class II per 21 CFR 862.1345 Ketones Test System Class I per 21 CFR 862.1435 Precision QID® Blood Glucose Testing System--K963676 Precision QID® and Precision G® Blood Glucose Test Strip-- K945887, K962295, K971812 GDS Stat-Site Meter/GDS KETOSITE® Blood Ke…
Medisense, Inc.1997—
*K945887Precision Q I D Blood Glucose Test Strips
Summary page 1
…2.1345 Ketones Test System Class I per 21 CFR 862.1435 Precision QID® Blood Glucose Testing System--K963676 Precision QID® and Precision G® Blood Glucose Test Strip-- K945887, K962295, K971812 GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test-- K911801 Sigma Diagnostics 3-Hydroxybutyrate Procedure N…
Medisense, Inc.1995—
*K962295Precision Qid Blood Glucose Test Strip
Summary page 1
…etones Test System Class I per 21 CFR 862.1435 Precision QID® Blood Glucose Testing System--K963676 Precision QID® and Precision G® Blood Glucose Test Strip-- K945887, K962295, K971812 GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test-- K911801 Sigma Diagnostics 3-Hydroxybutyrate Procedure No. 310-UV…
Medisense, Inc.1996—
*K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip
Summary page 1
…st System Class I per 21 CFR 862.1435 Precision QID® Blood Glucose Testing System--K963676 Precision QID® and Precision G® Blood Glucose Test Strip-- K945887, K962295, K971812 GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test-- K911801 Sigma Diagnostics 3-Hydroxybutyrate Procedure No. 310-UV-- K85036…
Medisense, Inc.1997—
*K911801Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con
Summary page 1
…cose Testing System--K963676 Precision QID® and Precision G® Blood Glucose Test Strip-- K945887, K962295, K971812 GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test-- K911801 Sigma Diagnostics 3-Hydroxybutyrate Procedure No. 310-UV-- K850368 The Precision™ Xtra™ Advanced Diabetes Management System for…
Gds Technology, LLC1991—
*K850368Sigms B-Hydroxybutarate Procedure NO. 310-UV
Summary page 1
…Glucose Test Strip-- K945887, K962295, K971812 GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test-- K911801 Sigma Diagnostics 3-Hydroxybutyrate Procedure No. 310-UV-- K850368 The Precision™ Xtra™ Advanced Diabetes Management System for Blood Glucose and Ketone Testing utilizes amperometric biosensor te…
Sigma Chemical Co.1985—

Also cleared against K963676: 2 other devices →

What descends from it? (40)

See all 40

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc.200519
K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories200416
K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc.20080
K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsAbbott Diabetes Care, Inc.20060
K033845Precision Xceed Diabetes Monitoring SystemAbbott Laboratories20040
K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision…Abbott Laboratories20020

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 8, 2002Not classifiedZ-0403-03OtherUse of glucose blood strips may provide false high results

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 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls

What does this lineage say?

  • The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K052980 (Liberty Healthcare Group, Inc., 2005) has gone furthest, with 19 descendants of its own.
  • 2 other devices also cite its predicate K963676.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use.

The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963676

2 other devices cite the same predicate.

  • K982303Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood…Medisense, Inc. · 1998
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997

More from Medisense, Inc.

15 FDA decisions under this applicant name. See the company

  • K982303Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood…Medisense, Inc. · 1998
  • K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc. · 1998
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997
  • K963676Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  • K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996

Recent decisions in CGA

The CGA category page

  • K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
  • K220328EasyStat 300Medica Corporation · 2024
  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K983504 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983504

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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