510(k) Report

510(k) · Cleared

Cleared

SD Check Gold

K082683510(k) TraditionalCleared Dec 8, 2009449-day reviewClass II21 CFR 862.1345

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

Standard Diagnostics, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Dec 8, 2009 as substantially equivalent to K032552 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 449-day review. Its family tree reaches back 1 generation to 2003. 6 later devices descend from it.

Decided
Dec 8, 2009
Review
449 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K024194 (2003). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2010: 1 descendant cleared2017: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2016: 1 descendant clearedK024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled0
  1. Root · 1 generation backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
  2. This deviceK082683 SD Check GoldStandard Diagnostics, Inc. · 2009
  3. Descendant · cites it directly · 5 of its ownK100398 Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc. · 2010
  4. Descendant · 2 generations on · 1 of its ownK132929 SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and…Sd Biosensor, Inc. · 2015
  5. Descendant · 2 generations on · 1 of its ownK123517 Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood…Sd Biosensor · 2014
  6. Descendant · 2 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
  7. Descendant · 3 generations on · 0 of its ownK153201 SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD…Sd Biosensor · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12014: 12015: 22016: 12017: 1
2010high 2 (2015) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100398Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc. · 2010 · cites it directly5descendants
  • K132929SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor…Sd Biosensor, Inc. · 2015 · 2 generations on1descendant
  • K123517Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring…Sd Biosensor · 2014 · 2 generations on1descendant
  • K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 2 generations on0descendants
  • K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi…Sd Biosensor · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc.20035
0 (this device)K082683SD Check GoldStandard Diagnostics, Inc.2009—
+1K100398Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc.2010—
+2K132929SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD…Sd Biosensor, Inc.2015—
+2K123517Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose…Sd Biosensor2014—
+2K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor2017—
+3K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor…Sd Biosensor2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201410
201520
201610
201710
FIG. 1 — Lineage of K082683, 2003–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in NBW? 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 NBW device

  1. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032552Accu-Chek Advantage System
Summary page 2
…iSDSTANDARD DIAGNOSTICS, INC. PREDICATE DEVICES Predicate Device 1 Predicate Device 2 (5 10(k) Number) K032552 K024194 (Device Name) ACCU-CHEK ADVANTAGE SYSTEM ONE…
Roche Diagnostics Corp.2003—
*K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems
Summary page 2
…Predicate Device 1 Predicate Device 2 (5 10(k) Number) K032552 K024194 (Device Name) ACCU-CHEK ADVANTAGE SYSTEM ONE TOUCH® Ultra® (Submitter by) Roche Diagno…
Lifescan, Inc.20035

Also cleared against K032552: 4 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100398Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc.20105

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K100398 (Standard Diagnostics, Inc., 2010) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K032552.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

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

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

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

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, 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
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions. The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test…

Read the full statement (136 words)

SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in

fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm.

SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and

SD CHECK GOLD control solutions.

The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold

test system as quality controls to verify the accuracy of blood glucose test results.

Testing is done outside the body (in vitro diagnostic use).

This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in

clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes

control.

This system should not be used for the screening or diagnosis of diabetes or for testing

newborns.

Indications for use as stated in the FDA summary.

Also cleared against K032552

4 other devices cite the same predicate.

  • K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
  • K070053Easyplus Mini Self Monitoring Glucose Test System, Models R1 and R2Eps Bio Technology Corp. · 2007
  • K050985Glucodr Supersensor SystemAll Medicus Co., Ltd. · 2005
  • K043474Accu-Chek Aviva SystemRoche Diagnostics Corp. · 200510 recalls

More from Standard Diagnostics, Inc.

3 FDA decisions under this applicant name. See the company

  • K100398Smartlink Gold Blood Glucose Monitoring SystemStandard Diagnostics, Inc. · 2010
  • K031798Good Morning TestStandard Diagnostics, Inc. · 2003

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K082683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082683: SD Check Gold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082683

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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