510(k) · Cleared
Recalled · 2009MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Jul 22, 1998 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it. It has been recalled once.
- Decided
- Jul 22, 1998
- Review
- 86 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 4 citing it directly.
- This deviceK981493 MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220Polymer Technology Systems, Inc. · 1998
- Descendant · cites it directly · 9 of its ownK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 7 of its ownK022898 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 7 of its ownK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
- Descendant · 3 generations on · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK071507 PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · 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
- K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981493 | MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220 | Polymer Technology Systems, Inc. | 1998 | — |
| +1 | K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2001 | 1 |
| +2 | K022898 | PTS Panels Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2002 | 1 |
| +2 | K014099 | Bioscanner Plus | Polymer Technology Systems, Inc. | 2001 | — |
| +3 | K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems, Inc. | 2015 | 4 |
| +1 | K071507 | PTS Panels Chol+HDL+Glu Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-0871-2010 | Process control | The memory chip was coded with incorrect product information. |
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 CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated 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.
https://510kreport.com/device/K981493 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981493
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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