510(k) · Cleared
ClearedEZ LDL Cholesterol Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · MRR System, Test, Low Density, Lipoprotein
Cleared on Jul 3, 2000 as substantially equivalent to K982271 (Wako Chemicals USA, Inc., 1998) after a 242-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jul 3, 2000
- Review
- 242 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982271 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK982271 Wako Direct LDL-CWako Chemicals USA, Inc. · 1998
- This deviceK993741 EZ LDL Cholesterol Test SystemSigma Diagnostics, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982271 | Wako Direct LDL-C | Wako Chemicals USA, Inc. | 1998 | — |
| 0 (this device) | K993741 | EZ LDL Cholesterol Test System | Sigma Diagnostics, Inc. | 2000 | — |
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 |
|---|---|---|---|
| * | K982271 | Wako Direct LDL-CSummary page 1…ol test system (Procedure No. 358) is substantially equivalent to, and are the same product as the Wako Chemical USA, Inc. Direct LDL-C test system cleared by the FDA as K982271. References 1. Burtis CA, Ashwood ER: Ed Teitz Textbook of Clinical Chemistry, 2" Ed, Saunders, Philadelphia, 1994 2. Rifai N,… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
The Sigma Diagnostics EZ™ LDL- cholesterol test system is a device intended to measure LDL-cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
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/K993741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993741: EZ LDL Cholesterol Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993741
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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