510(k) Report

510(k) · Cleared

Cleared

Bioscanner Beyond Glucose Analyzer and Test Strips

K013203510(k) TraditionalCleared Nov 16, 200152-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

Polymer Technology Systems, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Nov 16, 2001 as substantially equivalent to K982002 (Boehringer Mannheim Corp., 1998) after a 52-day review. Its family tree reaches back 2 generations to 1998. 8 later devices descend from it.

Decided
Nov 16, 2001
Review
52 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K980731 (1998). 8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2015: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared2016: 1 descendant cleared×2: 2 generations cleared close together, K980731 (1998), K982002 (1998) 1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 5 descendants4 generations forward: 1 descendant K982002 · Accu-Chek Comfort Curve Test Strip · Boehringer Mannheim Corp. · 1998 · recalledK980731 · Accu-Chek Comfort Curve Test Strips · Boehringer Mannheim Corp. · 19980
  1. Root · 2 generations backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
  2. 1 generation backK982002 Accu-Chek Comfort Curve Test StripBoehringer Mannheim Corp. · 1998 · Recalled
  3. This deviceK013203 Bioscanner Beyond Glucose Analyzer and Test StripsPolymer Technology Systems, Inc. · 2001
  4. Descendant · cites it directly · 7 of its ownK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
  5. Descendant · 2 generations on · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro…ACON Laboratories, Inc. · 2017
  7. Descendant · 4 generations on · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
  8. Descendant · 3 generations on · 0 of its ownK193406 CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2001: 12015: 22016: 12017: 12018: 12022: 2
2001high 2 (2015) · low 0 (2002)2026

Most influential descendants

Showing 5 of 8 · See all
  • K014099Bioscanner PlusPolymer Technology Systems, Inc. · 2001 · cites it directly7descendants
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · 2 generations on6descendants
  • K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc. · 2017 · 3 generations on1descendant
  • K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022 · 4 generations on0descendants
  • K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K980731Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp.1998—
−1K982002Accu-Chek Comfort Curve Test StripBoehringer Mannheim Corp.19981
0 (this device)K013203Bioscanner Beyond Glucose Analyzer and Test StripsPolymer Technology Systems, Inc.2001—
+1K014099Bioscanner PlusPolymer Technology Systems, Inc.2001—
+2K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.20154
+3K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.2017—
+4K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation2022—
+3K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201520
201610
201710
201810
202220
FIG. 1 — Lineage of K013203, 1998–2022Source: 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.

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
*K982002Accu-Chek Comfort Curve Test Strip
Summary page 1
…Test Strips are substantially equivalent to the predicate device noted below. Name: Accu-Chek Comfort Curve Test Strips Device Company: Roche Diagnostics 510(k) Number: K 982002 El Similarities and Differences (Predicate and BioScanner Beyond Glucose) Similarities e Both systems measure Gl…
Boehringer Mannheim Corp.19981

Also cleared against K982002: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K014099Bioscanner PlusPolymer Technology Systems, Inc.20017

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?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K014099 (Polymer Technology Systems, Inc., 2001) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K982002.

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.

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 BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.

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 K982002

2 other devices cite the same predicate.

  • K013068Bioscanner 2000Polymer Technology Systems, Inc. · 20011 recall
  • K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 20002 recalls

More from Polymer Technology Systems, Inc.

27 FDA decisions under this applicant name. See the company

  • K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test…Polymer Technology Systems, Inc. · 20162 recalls
  • K151530CardioChek Plus Test SystemPolymer Technology Systems, Inc. · 2015
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 20154 recalls
  • K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test…Polymer Technology Systems, Inc. · 2014
  • K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 20071 recall

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/K013203 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013203: Bioscanner Beyond Glucose Analyzer and Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013203

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026