510(k) Report

510(k) · Cleared

Cleared

MTM Bioscanner HDL Test Strips, Over the Counter (Otc)

K993377510(k) TraditionalCleared Jan 13, 2000107-day reviewClass I21 CFR 862.1175

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. · NAQ Lipoprotein, High Density, Hdl, Over The Counter

Cleared on Jan 13, 2000 after a 107-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Jan 13, 2000
Review
107 days
Class
Class I
Product code
NAQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2016: 2 descendants cleared2005: 1 descendant cleared2007: 3 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK993377 MTM Bioscanner HDL Test Strips, Over the Counter (Otc)Polymer Technology Systems, Inc. · 2000
  2. Descendant · cites it directly · 5 of its ownK060617 PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006
  3. Descendant · cites it directly · 5 of its ownK023558 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK071507 PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
  6. Descendant · 2 generations on · 1 of its ownK071593 PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2002: 12005: 12006: 12007: 32009: 12013: 12014: 12016: 22017: 1
2002high 3 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 12 · See all
  • K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006 · cites it directly5descendants
  • K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · cites it directly5descendants
  • K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · 2 generations on2descendants
  • K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 2 generations on1descendant
  • K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993377MTM Bioscanner HDL Test Strips, Over the Counter (Otc)Polymer Technology Systems, Inc.2000—
+1K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc.2006—
+1K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.20022
+2K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc.20074
+2K090405Lipidpro SystemInfopia Co, Ltd.2009—
+2K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc.20071

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200610
200730
200910
201310
201410
201620
201710
FIG. 1 — Lineage of K993377, 2000–2017Source: 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 NAQ? 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
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

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

NumberDeviceApplicantDecidedDescendants
K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc.20065
K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.20025

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, K060617 (Polymer Technology Systems, Inc., 2006) has gone furthest, with 5 descendants of its own.

How does its category compare?

All NAQ devices

NAQ Lipoprotein, High Density, Hdl, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NAQ

FDA has decided no NAQ device since 2007.

Median 510(k) review, days · NAQ

Too few NAQ 510(k)s in any year since 2007 to give a median.

Recalls per year · NAQ

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · NAQ

No MAUDE report names NAQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

What is it indicated for?

The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation A of HDL Cholesterol in whole blood when used with the BioScanner. This system Is intended .« to be used to assist the healthcare professional and individuals in screening for decreased Jevels of HDL Cholesterol as a risk factor in coronary artery disease.

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 NAQ

The NAQ category page

  • K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006

https://510kreport.com/device/K993377 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993377: MTM Bioscanner HDL Test Strips, Over the Counter (Otc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993377

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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