510(k) Report

510(k) · Cleared

Cleared

MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470

K990247510(k) TraditionalCleared May 28, 1999122-day reviewClass I21 CFR 862.1475

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. · LBR Ldl & Vldl Precipitation, Hdl

Cleared on May 28, 1999 after a 122-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.

Decided
May 28, 1999
Review
122 days
Class
Class I
Product code
LBR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 2 descendants cleared2006: 1 descendant cleared2002: 1 descendant cleared2007: 3 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2016: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared1995200020052010201520202025
  1. This deviceK990247 MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470Polymer Technology Systems, Inc. · 1999
  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 · 2 generations on · 7 of its ownK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
  5. Descendant · 3 generations on · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
  6. Descendant · cites it directly · 5 of its ownK060617 PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2001: 22002: 12006: 12007: 32014: 12015: 22016: 22017: 12018: 12022: 2
2001high 3 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 16 · 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 · 2 generations on7descendants
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · 3 generations on6descendants
  • K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990247MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470Polymer Technology Systems, Inc.1999—
+1K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc.20011
+2K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc.20021
+2K014099Bioscanner PlusPolymer Technology Systems, Inc.2001—
+3K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc.20154
+1K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200610
200730
201410
201520
201620
201710
201810
202220
FIG. 1 — Lineage of K990247, 1999–2022Source: 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 LBR? 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? (16)

See all 16

2 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
K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc.20065

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 LBR devices

LBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBR

1in 2015

2008: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBR

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

Recalls per year · LBR

1in 2018

2009: 42016: 12018: 1
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LBR

8in 2025

2007: 12008: 12011: 12012: 12016: 12019: 22021: 12022: 22023: 22024: 12025: 8
2007high 8 (2025) · low 0 (2009)2025

MAUDE reports naming product code LBR, 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
20070—01
20081—01
20090—40
20100—00
20110—01
20120—01
20130—00
20140—00
20151—00
20160—11
20170—00
20180—10
20190—02
20200—00
20210—01
20220—02
20230—02
20240—01
20250—08
20260—0—

What is it indicated for?

The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels 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 LBR

The LBR category page

  • K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo) · 2015
  • K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics · 2008
  • K050823Direct HDL Cholesterol and Direct HDL/LDL CalibratorTeco Diagnostics · 2005
  • K023784Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerHemagen Diagnostics, Inc. · 2002
  • K012593Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 20011 recall

https://510kreport.com/device/K990247 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990247: MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990247

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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