510(k) Report

510(k) · Cleared

Cleared

Accu-Chek Compact Test Strip

K031755510(k) SpecialCleared Jul 3, 200327-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

Roche Diagnostics Corp. · LFR Glucose Dehydrogenase, Glucose

Cleared on Jul 3, 2003 after a 27-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.

Decided
Jul 3, 2003
Review
27 days
Class
Class II
Product code
LFR
Recalls
None
Predicates
0

15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2013: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2011: 1 descendant cleared2019: 1 descendant cleared2018: 3 descendants cleared2012: 2 descendants cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
  2. Descendant · cites it directly · 12 of its ownK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
  4. Descendant · 3 generations on · 6 of its ownK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
  5. Descendant · 4 generations on · 1 of its ownK190579 TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019
  6. Descendant · 3 generations on · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22008: 12010: 22011: 12012: 22013: 12018: 32019: 12024: 1
2004high 3 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all
  • K040796Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · cites it directly12descendants
  • K082169Pro Glucose Test StripTaidoc Technology Corporation · 2008 · 2 generations on10descendants
  • K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010 · 3 generations on6descendants
  • K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019 · 4 generations on1descendant
  • K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031755Accu-Chek Compact Test StripRoche Diagnostics Corp.2003—
+1K040796Accu-Chek GO SystemRoche Diagnostics Corp.20042
+2K082169Pro Glucose Test StripTaidoc Technology Corporation2008—
+3K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation2010—
+4K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation2019—
+3K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200810
201020
201110
201220
201310
201830
201910
202410
FIG. 1 — Lineage of K031755, 2003–2024Source: 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.

Planning a device in LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

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
*—current legally marketed version of the same device
Named without a submission number
—

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K040796Accu-Chek GO SystemRoche Diagnostics Corp.200412
K113614Accu-Check Compact Plus Blood Glucose Monitoring SystemRoche Diagnostics20130
K050872Accu-Chek Integra SystemRoche Diagnostics Corp.20050

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?

  • Of its descendants, K040796 (Roche Diagnostics Corp., 2004) has gone furthest, with 12 descendants of its own.

How does its category compare?

All LFR devices

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

FDA decisions per year · LFR

1in 2015

2007: 12009: 12011: 62012: 132013: 32014: 32015: 1
2007high 13 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFR

161in 2014

2011: 296 days median2012: 152 days median2013: 212 days median2014: 161 days median
2007high 296 (2011) · low 152 (2012)2026

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

Recalls per year · LFR

1in 2012

2007: 32008: 12009: 42011: 12012: 1
2007high 4 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFR

827in 2025

2007: 23,8192008: 6,5842009: 10,8232010: 4,8652011: 3,8022012: 3,3412013: 3,8212014: 3,9602015: 3,3662016: 2,1452017: 1032018: 1082019: 1082020: 1322021: 1642022: 1012023: 1032024: 1712025: 827
2007high 23,819 (2007) · low 101 (2022)2025

MAUDE reports naming product code LFR, 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
20071—323,819
20080—16,584
20091—410,823
20100—04,865
2011629613,802
20121315213,341
2013321203,821
2014316103,960
20151—03,366
20160—02,145
20170—0103
20180—0108
20190—0108
20200—0132
20210—0164
20220—0101
20230—0103
20240—0171
20250—0827
20260—0—

What is it indicated for?

The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.

Indications for use as stated in the FDA summary.

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

Recent decisions in LFR

The LFR category page

  • K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories · 2015
  • K142089Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation · 2014
  • K133537EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
  • K131727Cera-Chek 1070 Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014
  • K131366Accu-Chek Aviva Expert Blood Glucose Monitoring SystemRoche Diagnostics Operations, Inc. · 2013

https://510kreport.com/device/K031755 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031755: Accu-Chek Compact 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/K031755

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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