510(k) Report

510(k) · Cleared

Cleared

Bioscanner Plus

K014099510(k) SpecialCleared Dec 21, 20018-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 Dec 21, 2001 as substantially equivalent to K013173 (Polymer Technology Systems, Inc., 2001) and 2 other predicates after an 8-day review. Its family tree reaches back 3 generations to 1987. 7 later devices descend from it.

Decided
Dec 21, 2001
Review
8 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K870012 (1987). 9 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 4 other ancestors1999: 1 other ancestor2015: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared2016: 1 descendant clearedK870012 · Triglyceride (Gpo-Trinder) Reagent · Sigma Diagnostics, Inc. · 1987K991894 · Bioscanner Triglycerides Test Strips · Polymer Technology Systems, Inc. · 2000K013173 · Bioscanner Plus; Lipid Panel Test Strips · Polymer Technology Systems, Inc. · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 1 descendant K013173 · Bioscanner Plus; Lipid Panel Test Strips · Polymer Technology Systems, Inc. · 2001 · recalledK991894 · Bioscanner Triglycerides Test Strips · Polymer Technology Systems, Inc. · 2000K870012 · Triglyceride (Gpo-Trinder) Reagent · Sigma Diagnostics, Inc. · 19870
  1. Root · 3 generations backK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
  2. 2 generations backK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
  3. 1 generation backK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
  4. This deviceK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
  5. Descendant · cites it directly · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro…ACON Laboratories, Inc. · 2017
  7. Descendant · 3 generations on · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
  8. Descendant · 2 generations on · 0 of its ownK193406 CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022
  9. Descendant · 2 generations on · 0 of its ownK182781 PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12017: 12018: 12022: 2
2015high 2 (2015) · low 0 (2019)2026

Most influential descendants

Showing 5 of 7 · See all
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · cites it directly6descendants
  • K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc. · 2017 · 2 generations on1descendant
  • K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022 · 3 generations on0descendants
  • K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022 · 2 generations on0descendants
  • K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K870012Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc.1987—
−2K991894Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc.2000—
−1K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.20011
0 (this device)K014099Bioscanner PlusPolymer Technology Systems, Inc.2001—
+1K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.20154
+2K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.2017—
+3K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation2022—
+2K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics2022—
+2K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199840
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201710
201810
202220
FIG. 1 — Lineage of K014099, 1987–2022Source: 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? (3)

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
*K013173Bioscanner Plus; Lipid Panel Test Strips
Summary page 2
…able lists the predicate devices for this submission for determination of substantial equivalence: New Device Predicates K Numbers Modified BioScanner BioScanner Plus* K013173 Plus* BioScanner 2000* K972669 BioScanner Beyond Glucose | K013203 Analyzer* *Device Company: Polymer Technology Systems Similari…
Polymer Technology Systems, Inc.20011
*K972669MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner…
Summary page 2
…s for this submission for determination of substantial equivalence: New Device Predicates K Numbers Modified BioScanner BioScanner Plus* K013173 Plus* BioScanner 2000* K972669 BioScanner Beyond Glucose | K013203 Analyzer* *Device Company: Polymer Technology Systems Similarities and Differences Items Comp…
Polymer Technology Systems, Inc.1998—
*K013203Bioscanner Beyond Glucose Analyzer and Test Strips
Summary page 2
…tion of substantial equivalence: New Device Predicates K Numbers Modified BioScanner BioScanner Plus* K013173 Plus* BioScanner 2000* K972669 BioScanner Beyond Glucose | K013203 Analyzer* *Device Company: Polymer Technology Systems Similarities and Differences Items Compared Similarities Differences 1. Mod…
Polymer Technology Systems, Inc.2001—

Also cleared against K013173: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.20156

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 14 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 3 of the 9 ancestors have a recall of any class.
  • Of its descendants, K140068 (Polymer Technology Systems, Inc., 2015) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K013173.

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 Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians’ offices and in acute and convalescent care facility bedside testing and individuals at home. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

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 K013173

1 other device cites the same predicate.

  • K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 20021 recall

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/K014099 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014099: Bioscanner Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014099

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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