510(k) Report

510(k) · Cleared

Recalled · 2009

Accu-Chek Performa System

K070585510(k) TraditionalCleared May 25, 200785-day reviewClass II21 CFR 862.1345Recalls 2

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

Roche Diagnostics Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on May 25, 2007 after an 85-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 2 times.

Decided
May 25, 2007
Review
85 days
Class
Class II
Product code
NBW
Recalls
2
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2017: 2 descendants cleared2022: 1 descendant cleared2024: 2 descendants cleared20052010201520202025
  1. This deviceK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007
  2. Descendant · cites it directly · 4 of its ownK140210 Rightest Blood Glucose Monitoring System ( GM720, Rightest…Bionime Corporation · 2014
  3. Descendant · cites it directly · 3 of its ownK141351 Supercheck Plus Blood Glucose Monitoring System, Super Check Plus…Biotest Medical Corp. · 2015
  4. Descendant · 2 generations on · 2 of its ownK173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation · 2018
  5. Descendant · 3 generations on · 1 of its ownK231192 RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024
  6. Descendant · 2 generations on · 1 of its ownK171785 WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation · 2017

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 22018: 12019: 12022: 12024: 2
2014high 2 (2017) · low 0 (2016)2026

Most influential descendants

Showing 5 of 9 · See all
  • K140210Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720Bionime Corporation · 2014 · cites it directly4descendants
  • K141351Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose…Biotest Medical Corp. · 2015 · cites it directly3descendants
  • K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…Bionime Corporation · 2018 · 2 generations on2descendants
  • K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation · 2024 · 3 generations on1descendant
  • K171785WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070585Accu-Chek Performa SystemRoche Diagnostics Corp.2007—
+1K140210Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS…Bionime Corporation2014—
+1K141351Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood…Biotest Medical Corp.2015—
+2K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose…Bionime Corporation2018—
+3K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024—
+2K171785WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201720
201810
201910
202210
202420
FIG. 1 — Lineage of K070585, 2007–2024Source: 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 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? (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
*—ACCU-CHEK Aviva System
Named without a submission number
—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K140210Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720Bionime Corporation20144
K141351Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose…Biotest Medical Corp.20153

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 10, 2009Not classifiedZ-2006-2009Process controlThere may be a significant negative bias when testing neonate samples.
Jun 10, 2009Not classifiedZ-2005-2009Process controlThere may be a significant negative bias when testing neonate samples.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K140210 (Bionime Corporation, 2014) has gone furthest, with 4 descendants of its own.

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. 2007, 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?

The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.

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 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/K070585 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070585: Accu-Chek Performa System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070585

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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