510(k) · Cleared
Recalled · Class II · 2016Dimension Ahdl Flex Reagent Cartridge, Model: DF48B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JHM Colorimetric Method, Lipoproteins
Cleared on Feb 21, 2008 as substantially equivalent to K032798 (Dade Behring, Inc., 2003) after a 113-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 21, 2008
- Review
- 113 days
- Class
- Class I
- Product code
- JHM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983849 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
- 1 generation backK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
- This deviceK073072 Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK081300 Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K081300Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… | Dade Behring, Inc. | 1999 | — |
| −1 | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)… | Dade Behring, Inc. | 2003 | — |
| 0 (this device) | K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48B | Dade Behring, Inc. | 2008 | — |
| +1 | K081300 | Dimension Vista HDLC Flex Reagent Cartridge | Siemens Healthcare Diagnostics | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 JHM? 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 |
|---|---|---|---|
| * | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48ASummary page 1…Dimension® AHIDL Flex® reagent cartridge/ Class 1 3. Identification of the Predicate Device * Dimension® Al-DL Flex®greagent cartridge (K032798) FDA Guidance Document(s): * "Guidance on Informed Consent for In Vitro Diagnostic Device Stu… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081300 | Dimension Vista HDLC Flex Reagent Cartridge | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2016 | Class II | Z-1663-2016 | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples… |
| Mar 17, 2016 | Class II | Z-1659-2016 | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081300 (Siemens Healthcare Diagnostics, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032798.
How does its category compare?
All JHM devicesJHM Colorimetric Method, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JHM
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JHM
Too few JHM 510(k)s in any year since 2007 to give a median.
Recalls per year · JHM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHM
No MAUDE report names JHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073072: Dimension Ahdl Flex Reagent Cartridge, Model: DF48B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073072
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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