510(k) Report

510(k) · Cleared

Cleared

MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner G Test Strip, Norman Glucose Con

K972669510(k) TraditionalCleared Jan 22, 1998190-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. · CGA Glucose Oxidase, Glucose

Cleared on Jan 22, 1998 after a 190-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Jan 22, 1998
Review
190 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 2 descendants cleared2004: 1 descendant cleared2002: 1 descendant cleared2015: 2 descendants cleared2016: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared1995200020052010201520202025
  1. This deviceK972669 MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000…Polymer Technology Systems, Inc. · 1998
  2. Descendant · cites it directly · 9 of its ownK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 7 of its ownK022898 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
  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

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2001: 22002: 12004: 12015: 22016: 22017: 12018: 12022: 2
2001high 2 (2001) · low 0 (2003)2026

Most influential descendants

Showing 5 of 12 · See all
  • K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · cites it directly9descendants
  • K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · 2 generations on7descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972669MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM…Polymer Technology Systems, Inc.1998—
+1K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.20011
+2K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.20021
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200410
201520
201620
201710
201810
202220
FIG. 1 — Lineage of K972669, 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.20019
K014099Bioscanner PlusPolymer Technology Systems, Inc.20017
K041750PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc.20041

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, K013173 (Polymer Technology Systems, Inc., 2001) has gone furthest, with 9 descendants of its own.

How does its category compare?

All CGA devices

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

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

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

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

Polymer Technology Systems, Inc. intends to introduce into commercial distribution the

MTM BioScanner 1000 Test System for the quantitative determination of glucose in human whole blood when used with the MTM BioScanner G Test Strip. This Monitoring System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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 CGA

The CGA category page

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  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K972669 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972669: MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner G Test Strip, Norman Glucose Con.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972669

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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