510(k) · Cleared
Recalled · 2008PTS Panels LDL Cholesterol Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · MRR System, Test, Low Density, Lipoprotein
Cleared on Jul 6, 2004 as substantially equivalent to K974733 (Boehringer Mannheim Corp., 1998) after a 111-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Jul 6, 2004
- Review
- 111 days
- Class
- Class I
- Product code
- MRR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974733 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974733 Boehringer Mannheim Direct LDL - CholesterolBoehringer Mannheim Corp. · 1998 · Recalled
- This deviceK040693 PTS Panels LDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974733 | Boehringer Mannheim Direct LDL - Cholesterol | Boehringer Mannheim Corp. | 1998 | 1 |
| 0 (this device) | K040693 | PTS Panels LDL Cholesterol Test Strips | Polymer Technology Systems, Inc. | 2004 | — |
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 MRR? 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 MRR device
- #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K974733 | Boehringer Mannheim Direct LDL - CholesterolSummary page 1…stantially equivalent to the predicate device noted below. Name: LDL-C Plus Device Company: Roche Diagnostics 510(k) Number: K974733 El Similarities… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2008 | Not classified | Z-1132-2010 | Process change control | The expiration date was extended by 20 weeks without justification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K974733.
How does its category compare?
All MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PTS PANELS LDL Cholesterol Test Strips are intended to measure low density lipoprotein.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
This system is intended for professional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040693 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040693: PTS Panels LDL Cholesterol Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040693
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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