510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions

K060345510(k) TraditionalCleared Apr 28, 200677-day reviewClass II21 CFR 862.1345Recalls 3

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

Nova Biomedical Corp. · CGA Glucose Oxidase, Glucose

Cleared on Apr 28, 2006 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 20 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it. It has been recalled 3 times.

Decided
Apr 28, 2006
Review
77 days
Class
Class II
Product code
CGA
Recalls
3
Predicates
0

19 later devices descend from it, 3 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2015: 2 descendants cleared2014: 2 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2018: 5 descendants cleared2017: 2 descendants cleared2016: 2 descendants cleared2024: 2 descendants cleared, 1 with a Class I recall12026: 1 descendant cleared20052010201520202025
  1. This deviceK060345 Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp. · 2006
  2. Descendant · cites it directly · 12 of its ownK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
  3. Descendant · cites it directly · 5 of its ownK150281 StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015
  4. Descendant · cites it directly · 5 of its ownK121679 Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK181043 StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
  6. Descendant · 2 generations on · 3 of its ownK150461 StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 22015: 22016: 22017: 22018: 52022: 12024: 22026: 1
2012high 5 (2018) · low 0 (2019)2026

Class I recalls in this family

  • K232075 StatStrip Glucose Hospital Meter System3 generations on · 2024

Most influential descendants

Showing 5 of 19 · See all
  • K132121Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014 · cites it directly12descendants
  • K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015 · cites it directly5descendants
  • K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012 · cites it directly5descendants
  • K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018 · 2 generations on4descendants
  • K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060345Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp.2006—
+1K132121Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation2014—
+1K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation2015—
+1K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics20123
+2K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2018—
+2K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201420
201520
201620
201720
201850
202210
202421
202610
FIG. 1 — Lineage of K060345, 2006–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K132121Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation201412
K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation20155
K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics20125

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2013Class IIZ-0650-2014Component design/selectionRevised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Feb 12, 2010Not classifiedZ-1783-2010Nonconforming Material/ComponentGlucose strips report low glucose results
Feb 21, 2008Not classifiedZ-1472-2008Component design/selectionLithium batteries may fail if the glucose or creatinine meters have been dropped.

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.

  • K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Of its descendants, K132121 (Nova Biomedical Corporation, 2014) has gone furthest, with 12 descendants of its own.

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 Nova StatStrip Glucose Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous and arterial whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose…

Read the full statement (196 words)

The Nova StatStrip Glucose Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous and arterial whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control

Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Control Solutions is intended for use with the Nova StatStrip Glucose Hospital Meter and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter.

Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of the Nova StatStrip Glucose Hospital Meter System.

Indications for use as stated in the FDA 510(k) statement.

More from Nova Biomedical Corp.

89 FDA decisions under this applicant name. See the company

  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011
  • K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp. · 2010
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 201010 Class I recalls
  • K070960Nova Statstrip Xpress Glucose Hospital Meter SystemNova Biomedical Corp. · 20071 recall
  • K070255Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp. · 2007

Recent decisions in CGA

The CGA category page

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  • K220328EasyStat 300Medica Corporation · 2024
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  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K060345 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060345: Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060345

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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