510(k) · Cleared
ClearedAfinion Lipid Panel and Afinion Lipid Panel Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Poc AS · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Mar 21, 2014 as substantially equivalent to K031824 (Roche Diagnostics Corp., 2003) and 3 other predicates after a 246-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Mar 21, 2014
- Review
- 246 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K842280 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −1 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| 0 (this device) | K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | Axis-Shield Poc AS | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 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 |
|---|---|---|---|
| * | K031824 | Cobas Integra Cholesterol Gen. 2Summary page 1…AfinionTm Lipid Panel are the following legally marketed devices: * Total Cholesterol Roche Diagnostics Cowp.: COBAS INTEGRA CHOLESTEROL GEN.2; Submission K03 1824 * Triglycerides Roche Diagnostics Corp.: ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS); Submiss… | 2003 |
| * | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsSummary page 1…EROL GEN.2; Submission K03 1824 * Triglycerides Roche Diagnostics Corp.: ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS); Submission K972250 * HDL Cholesterol Siemens ADVIA 2400 Direct HDL Cholesterol; Submission K982341 (Original applicant: Randox l… | 1997 |
| * | K982341 | Direct HDL-Cholestrol LiquidSummary page 1…CHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS); Submission K972250 * HDL Cholesterol Siemens ADVIA 2400 Direct HDL Cholesterol; Submission K982341 (Original applicant: Randox laboratories, Ltd.) Page 1 of 15 === Page 2 ==… | 1998 |
| * | K061182 | Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels…Summary page 2…ate device for AfinionTM Lipid Panel Control is the following legally marketed device: 0Clinica Corp.: CLINIQA Liquid QC Lipid Controls Levels I and 2; Submission K061 182 Intended use/Indications for use The AfinionTM Lipid Panel is an in vitro diagnostic test for quantitative determination of tot… | 2006 |
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K031824.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS 100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio are used in the…
Read the full statement (153 words)
The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS 100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS 100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS 100 Analyzer System is working properly and provides reliable results.
For use in clinical laboratories and point of care laboratory settings.
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/K132031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132031: Afinion Lipid Panel and Afinion Lipid Panel Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132031
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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