510(k) · Cleared
ClearedEZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Jul 22, 1997 after a 50-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jul 22, 1997
- Review
- 50 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK972041 EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5)Sigma Diagnostics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK012221 Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK063852 Accessa Cholesterol PanelHome Access Health Corp. · 2007
- Descendant · cites it directly · 0 of its ownK011970 Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See all- K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002 · cites it directly1descendant
- K063852Accessa Cholesterol PanelHome Access Health Corp. · 2007 · 2 generations on0descendants
- K011970Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972041 | EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5) | Sigma Diagnostics, Inc. | 1997 | — |
| +1 | K012221 | Safe at Home Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | 2002 | — |
| +2 | K063852 | Accessa Cholesterol Panel | Home Access Health Corp. | 2007 | — |
| +1 | K011970 | Biosafe Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 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 LBS? 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
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 |
|---|---|---|---|
| * | — | Cholesterol Reference Method Laboratory Network standardized 50K molecular weight… Named without a submission number |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012221 (Biosafe Laboratories, Inc., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, 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 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Sigma Diagnostics EZ HDL™ Reagent (Procedure 354) is a device intended to measure HDL 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.
Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intended for medical purposes for use in a HDL cholesterol test system to establish points of reference that are used in the determination of values in the measurement of HDL cholesterol in human specimens.
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/K972041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972041: EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972041
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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