510(k) · Cleared
Recalled · Class II · 2019Bioscanner Plus; Lipid Panel Test Strips
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 Oct 22, 2001 as substantially equivalent to K972669 (Polymer Technology Systems, Inc., 1998) and 3 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1987. 9 later devices descend from it. It has been recalled once.
- Decided
- Oct 22, 2001
- Review
- 28 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K870012 (1987). 5 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
- 1 generation backK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
- This deviceK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001
- Descendant · cites it directly · 7 of its ownK022898 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
- Descendant · cites it directly · 7 of its ownK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
- Descendant · 2 generations on · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 1 of its ownK163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro…ACON Laboratories, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · cites it directly7descendants
- 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
- K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870012 | Triglyceride (Gpo-Trinder) Reagent | Sigma Diagnostics, Inc. | 1987 | — |
| −1 | K991894 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems, Inc. | 2000 | — |
| 0 (this device) | K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2001 | — |
| +1 | K022898 | PTS Panels Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2002 | 1 |
| +1 | K014099 | Bioscanner Plus | Polymer Technology Systems, Inc. | 2001 | — |
| +2 | K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems, Inc. | 2015 | 4 |
| +3 | K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | 2017 | — |
| +4 | K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
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 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? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972669 | MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner…Summary page 2…, BioScanner Cholesterol, HDL Cholesterol and Triglycerides Test Strips from Polymer Technology Systems Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K990247, and K991894 Similarities and Differences between BioScanner Plus and the Predicate Device s Both systems det… | 1998 |
| * | K981493 | MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220Summary page 2…ner Cholesterol, HDL Cholesterol and Triglycerides Test Strips from Polymer Technology Systems Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K990247, and K991894 Similarities and Differences between BioScanner Plus and the Predicate Device s Both systems determine To… | 1998 |
| * | K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470Summary page 2…sterol, HDL Cholesterol and Triglycerides Test Strips from Polymer Technology Systems Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K990247, and K991894 Similarities and Differences between BioScanner Plus and the Predicate Device s Both systems determine Total Chole… | 1999 |
| * | K991894 | Bioscanner Triglycerides Test StripsSummary page 2…holesterol and Triglycerides Test Strips from Polymer Technology Systems Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K990247, and K991894 Similarities and Differences between BioScanner Plus and the Predicate Device s Both systems determine Total Cholesterol, HDL C… | 2000 |
What descends from it? (9)
2 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 |
|---|---|---|---|---|
| Jan 16, 2019 | Class II | Z-1371-2019 | Device Design | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed. |
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 13.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K022898 (Polymer Technology Systems, Inc., 2002) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K972669.
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 Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), athcrosclerosis, and various…
Read the full statement (114 words)
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), athcrosclerosis, and various liver and renal diseases. Triglycerides measurements arc used in the diagnosis and treamment of patxcnts with diabetes mellitus, nephrosis, lwer obstruction, other diseases involving lipid metabolism , or various endocrinc dzsorders
The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013173: Bioscanner Plus; Lipid Panel Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013173
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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